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References
Adjei, A., and Gupta, P., 1994, Pulmonary delivery of therapeutic peptides and proteins, J. ControlledRelease 29:361–373.
Albin, G., Horbett, T. A., and Ratner, B. D., 1985, Glucose sensitive membranes for controlled delivery of insulin: Insulin transport studies, J. Controlled Release 2:153–164.
Albin, G. W., Horbett, T. A., Miller, S. R., and Ricker, N. L., 1987, Theoretical and experimental studies of glucose sensitive membranes, J. Controlled Release 6:267–291.
Albisser, A. M., Lougheed, W. D., Perlman, K., and Bahoric, A., 1980, Nonaggregating insulin solutions for long-term glucose control in experimental and human diabetes, Diabetes 29:241–243.
Albisser, A. M., Williamson, J. R., and Lougheed, W. D., 1982, Desired characteristics of insulins to be used in infusion pumps. in: Hormone Drugs (J. L. Gueriguian, E. D. Bransome, and A. S. Outschoorn, eds.), U.S. Pharmacopeia1 Convention, Rockville, Maryland, pp. 84–95.
Amiel, S. A., 1993, Intensified insulin therapy, Diabetes/Metab. Rev. 9:3–24.
Amsden, B. G., and Goosen, M. F. A., 1995, Transdermal delivery of peptide and protein drugs: An overview, AIChEJ. 41:1972–1997.
Amthor, K.-F., Dahl-Jørgensen, K., Berg, T. J., Heier, M. S., Sandvik, L., Aagenæs, 0, and Hanssen, K. F., 1994, The effect of 8 years of strict glycaemic control on peripheral nerve function in IDDM patients: The Olso study, Diabetologia 37:579–584.
Arrieta-Molero, J. F., Aleck, K., Sinha, M. K., Brownscheidle, C. M., Shapiro, L. J., and Sperling, M. A., 1982, Orally administered liposome-entrapped insulin in diabetic animals, HormoneRes. 16:249–256.
Asada, H., Douen, T., Mizokoshi, Y., Fujita, T., Murakami, M., Yamamoto, A., and Muranishi, S., 1994, Stability of acyl derivatives of insulin in the small intestine: Relative importance of insulin association characteristics in aqueous solution, Pharm. Res. 11:1115–1120.
Asada, H., Douen, T., Waki, M., Adachi, S., Fujita, T., Yamamoto, A., and Muranishi, S., 1995, Absorption characteristics of chemically modified-insulin derivatives with various fatty acids in the small and large intestine, J. Pharm. Sci. 84:682–687.
Atchison, J. A., Grizzle, W. E., and Pillion, D. J., 1989, Colonic absorption of insulin: An in vitro and in vivo evaluation, J. Pharmacol. Exp. Ther. 248:567–512.
Aungst, B. J., 1994, Site-dependence and structure-effectrelationships for alkylglycosides as transmucosal absorption promoters for insulin, Int. J. Pharm. 105:219–225
Aungst, B. J., and Rogers, N. J., 1988, Site dependence of absorption-promoting actions of laureth-9, Na salicylate, Na2EDTA, and aprotinin on rectal, nasal, and buccal insulin delivery, Pharm. Res. 5:305–308.
Aungst, B. J., and Rogers, N. J., 1989, Comparison of the effects of various transmucosal absorption promoters on buccal insulin delivery, Int. J. Pharm. 53:227–235.
Aungst, B. J., Rogers, N. J., and Shefter, E., 1988, Comparison of nasal, rectal, buccal, sublingual and intramuscular insulin efficacy and the effects of a bile salt absorption promoter, J. Pharmacol. Exp. Ther. 244:23–27.
Bae, Y. H., Okano, T. O., and Kim, S. W., 1989, Insulin permeation through thermo-sensitive hydrogels, J. Controlled Release 9:271–279.
Bai, J. P. F., and Chang, L. L., 1995, Transepithelial transport of insulin: I. Insulin degradation by insulin-degrading enzyme in small intestinal epithelium, Pharm. Res. 12:1171–1175.
Bak, J. F., Nielson, 0. H., Pederson, O., and Beck-Nielson, H., 1987, Multiple insulininjections using a pen injector versus pump treatment in young diabetic patients, Diabetes Res. 6:155–158.
Baker, E. N., Blundel, T. L., Cutfield, J. F., Cutfield, S. M., Dodson, E. J., Dodson, G. G., Hodgkin, D. M. C., Hubbard, R. E., Isaacs, N. W., Reynolds, C. D., Sakabe, K., Sakabe, N., and Vijayan, N. M., 1988, The structure of 2Zn pig insulin crystals at 1.5 Å, resolution, Phil. Trans. R Soc. 319:369–456.
Bakth, S., Ertel, H. H., May, P. B., Jr., and Akgun, S., 1980, Rectal insulin: A potent hypoglycemic preparation, Horm. Metab. Res. Suppl. Ser. 12:86–87.
Balschmidt, P., and Brange, J., 1992, Fast acting human insulin analogues with a single amino acid deletion in the B-chain, Diabetologia 35(Suppl. 1):A4(Abstract).
Balschmidt, P., Hansen, F. B., Dodson, E. J., Dodson, G. G., and Korber, F., 1991, Structure of porcine insulin cocrystallized with clupeine Z Acta Crystallogr. B47:975–986.
Banga, A. K., and Chien, Y. W., 1988a, Systemic delivery of therapeutic peptides and proteins, Int. J. Pharm. 48:15–50.
Banga, A. K., and Chien, Y. W., 1988b, Iontophoretic delivery of drugs: Fundamentals, developments and biomedical applications, J. Controlled Release 7:1–24.
Banga, A. K., and Chien, Y. W., 1993, Characterisation of in vitro transdermal iontophoretic delivery of insulin, Drug. Dev. Ind. Pharm. 19:2069–2087.
Banting, F. G., and Best, C. H., 1922, Pancreatic extracts, J. Lab. Clin. Med. 7:464–472.
Bar-on, H., Berry, E. M., Eldor, A., Kidron, M., Lichtenberg, D., and Ziv, E., 1981, Enteral administration of insulin in the rat, Br. J. Pharmacol. 73:21–24.
Bartlett, J. D., Slusser, T. G., Turner-Henson, A., Singh, K. P., Atchison, J. A., and Pillion, D. J., 1994a, Toxicity of insulin administered chronically to human eye in vivo, J. Ocul. Pharmacol. 10:101–107.
Bartlett, J. D., Turner-Henson, A., Atchison, J. A., Wooley, T. W., and Pillion, D. J., 1994b, Insulin administration to the eyes of normoglycemic human volunteers, J. Ocul. Pharmacol. 10:683–690.
Bechgaard, E., Gizurarson, S., Jørgensen, L., and Larsen R., 1992, The viability of isolated rabbit nasal mucosa in the Ussing chamber, and the permeability of insulin across the membrane, Int. J. Pharm. 87:125–132.
Bendayan, M., Ziv, E., Ben-Sasson, R., Bar-on, H., and Kidron, M., 1990, Morpho-cytochemical evidence for insulin absorption by the rat ileal epithelium, Diabetologia 33:197–204.
Bendayan, M., Ziv, E., Gingras, D., Ben-Sasson, R., Bar-on, H., and Kidron, M., 1994, Biochemical and morpho-cytochemical evidence for the intestinal absorption of insulin in control and diabetic rats. Comparison between the effectiveness of duodenal and colon mucosa, Diabetologia 37: 19–126.
Benson, E. A., Benson, J. W., Jr., Fredlund, P. N., Mecklenburg, R. S., and Metz, R., 1988, Flocculation and loss of potency of human NPH insulin, Diabetes Care 11:563–566.
Bentley, G. A., Brange, J., Derewenda, Z., Dodson, E. J., Dodson, G. G., Markussen, J., Wilkinson, A. J., Wollmer, A., and Xiao, B., 1992, Role of B13 Glu in insulin assembly. The hexamer structure of recombinant mutant (B13 Glu-Gin) insulin, J. Mol. Biol. 228:1163–1176.
Berger, M., 1993, Oral insulin 1922–1992 The history of continuous ambition and failure, in; Frontiers in Insulin Pharmacology (M. Berger and F. A. Gries, eds.), Thieme Verlag, Stuttgart, pp. 144–148.
Berger, M., Cüppers, H. J., Halban, P. A., and Offord, R. E., 1980, The effect of aprotinin on the absorption of subcutaneously injected regular insulin in normal subjects, Diabetes 29: 81–83.
Berger, M., Cüppers, H. J., Hegner, J., Jörgens, V., and Berchtold, P., 1982, Absorption kinetics and biological effect of subcutaneously injected insulin preparations, Diabetes Care 5:77–91.
Binder, C., 1969, Absorption of injected insulin, Acta Pharmacol. Toxicol. Suppl. 2:1–87.
Binder, C., Nielsen, A., and Jørgensen, K., 1967, The absorption of an acid and a neutral insulin solution after subcutaneous injection into different regions in diabetic patients, Scand. J. Clin. Lab. Invest. 19:156–163.
Birdi, K. S., 1973, The binding of cationic detergent to insulin, zinc-insulin and iso-insulin, Biochem. J. 135:253–255.
Björk, E., and Edman, P., 1988, Degradable starch microspheres as a nasal delivery system for insulin, Int. J. Pharm. 47:233–238.
Blackshear, P. J., Rohde, T. D., Palmer, J. L., Wigness, B. D., Rupp, W. M., and Buchwald, H., 1983, Glycerol prevents insulin precipitation and interruption of flow in an implantable insulin infusion pump, Diabetes Care 6:387–392.
Brange, J., 1977, Improvements in or relating to biphasic insulin preparations comprising crystalline insulin and monodesamido insulin, United Kingdom Patent 1560232.
Brange, J., 1994, Stability of Insulin. Studies on the Physical and Chemical Stability of Insulin in Pharmaceutical Formulation, Thesis, Royal Danish School of Pharmacy; Kluwer Academic Publishers, Boston.
Brange, J., and Havelund, S., 1983a, Insulin pumps and insulin quality-requirementsand problems, Acta Med. Scand. 671(Suppl.):135–138.
Brange, J., and Havelund, S., 1983b, Properties of insulin in solution, in: Artificial Systems for Insulin Delivery (P. Brunetti, K. G. M. M. Alberti, A. M. Albisser, K. D. Hepp, and M. M. Benedetti, eds.), Raven Press, New York, pp. 83–88.
Brange, J., and Havelund, S., 1991, Novel insulin analogues stabilized against chemical modifications, European Patent 0419504.
Brange, J., and Langkjær, L., 1993, Insulin structure and stability, in: Stability and Characterization of Protein and Peptide Drugs: Case Histories (Y. J. Wang and R. Pearlman, eds.), Plenum Press, New York, pp. 315–350.
Brange, J. Havelund, S., Hansen, P., Langkjær, L., Sørensen, E., and Hildebrandt, P., 1982, Formulation of physically stable neutral solutions for continuous infusion by delivery systems, in: Hormone Drugs (J. L. Gueriguian, E. D. Bransome, and A. S. Outschoom, eds.), U.S. Pharmacopeia1 Convention, Rockville, Maryland, pp. 96–105.
Brange, J., Havelund, S., Hommel, E., Sørensen, E., and Kühl, C., 1986, Neutral insulin solutions physically stabilized by addition of Zn2+, Diabetic Med. 3:532–536.
Brange, J., Skelbaek-Pedersen, B., Langkjaer, L., Damgaard, U., Ege, H., Havelund, S., Heding, L. G., Jørgensen, K. H., Lykkeberg, J., Markussen, J., Pingel, M., and Rasmussen, E., 1987, Galenics of Insulin: The Physico-chemical and Pharmaceutical Aspects of Insulin and Insulin Preparations, Springer-Verlag, Berlin.
Brange, J., Ribel, U., Hansen, J. F., Dodson, G., Hansen, M. T., Havelund, S., Melberg, S. G., Norris, F., Norris, K., Snel, L., Sørensen, A. R., and Voigt, H. O., 1988, Monomeric insulins obtained by protein engineering and their medical implications, Nature 333:679–682.
Brange, J., Drejer, K., Hansen, J. F., Havelund, S., Kaarsholm, N. C., Melberg, S. G., and Sørensen, A. R., 1989, Design of novel insulins with changed self-association and ligand binding properties, in: Advances in Protein Design, International Workshop 1988 (H. Blocker, J. Collins, R. D. Schmid, and D. Schomburg, eds.), VCH Publishers, Weinheim, pp. 139–144.
Brange, J., Owens, D. R., Kang, S., and Vølund, A., 1990, Monomeric insulins, and their experimental and clinical implications, Diabetes Care 13:923–954.
Brange, J., Hallund, O., and Sørensen, E., 1992, Chemical stability of insulin: 5. Isolation, characterization and identification of insulin transformation products, Acta Pharm. Nord. 4:223–232.
Brems, D. N., Alter, L. A., Beckage, M. J., Chance, R. E., DiMarchi, R. D., Green, L. K., Long, H. B., Pekar, A. H., Shields, J. E., and Frank, B. H., 1992, Altering the association properties of insulin by amino acid replacement, Protein Eng. 5:527–533.
Brennan, J. R., Gebhart, S. P., and Blackard, W. G., 1985, Pump-induced insulin aggregation. A problem with the Biostator, Diabetes 34:353–359.
Bringer, J., Heldt, A., and Grodsky, G. M., 1981, Prevention of insulin aggregation by dicarboxylic amino acids during prolonged infusion, Diabetes 30:83–85.
Brown, L., Munoz, C., Siemer, L., Edelman, E., and Langer, R., 1986a, Controlled release of insulin from polymer matrices. Control of diabetes in rats, Diabetes 35:692–697.
Brown, L., Siemer, L., and Munoz, C., 1986b, Controlled release of insulin from polymer matrices. In vitro kinetics, Diabetes 35:684–691.
Brown, R. A., Jr., and Schanker, L. S., 1983, Absorption of aerosolized drugs from the rat lung, Drug Metab. Dispos. 11:355–360.
Brownlee, M., and Cerami, A., 1970, A glucose-controlled insulin-delivery system: Semisynthetic insulin bound to lectin, Science 206:1190–1191.
Brownlee, M., and Cerami, A., 1983, Glycosylated insulin complexed to concanavalin A. Biochemical basis for a closed-loop insulin delivery system. Diabetes 32:499–504.
Bruce, D. G., Chisholm, D. J., Storlien, L. H., Borkman, M., and Kraegen, E. W., 1991, Meal-time intranasal insulin delivery in type 2 diabetes, Diabetic Med. 8:366–370.
Buchwald, H., Rohde, T. D., Dorman, F. D., Skakoon, J. G., Wigness, B. D., Prosl, F. R., Tucker, E. M., Rublein, T. G., Blackshear, P. J., and Varco, R. L., 1980, A totally implantable drug infusion device: Laboratory and clinical experiences using a model with single flow rate and new design for modulated insulin infusion, Diabetes Care 3:351–358.
Byron, P. R., 1990, Determinants of drug and polypeptide bioavailability from aerosols delivered to the lung, Adv. Drug Delivery Rev. 5:107–132.
Byron, P. R., and Patton, J. S., 1994, Drug delivery via the respiratory tract, J. Aerosol Med Deposition Clear. Eff Lung 7:49–75.
Caldwell, L., Nishihata, T., Rytting, J. H., and Higuchi, T., 1982, Lymphatic uptake of water-soluble drugs after rectal administration, J. Pharm. Pharmacol. 34:520–522.
Carstens, S., Danielsen, G., Guldhammer, B., and Frederiksen, O., 1993, Transport of insulin across rabbit nasal mucosa in vitro induced by didecanoyl-L-a-phosphatidylcholine, Diabetes42:1032–1040.
Champion, M. C., Shepherd, G. A. A., Rodger, N. W., and Dupre, J., 1980, Continuous subcutaneous infusion of insulin in the management of diabetes mellitus, Diabetes 29:206–212
Chandler, S. G., Thomas, N. W., and Illum, L., 1994, Nasal absorption in the rat. III. Effect of lysophospholipids on insulin absorption and nasal histology, Pharm. Res. 11:1623–1630.
Chang, T. M. S., 1976, Biodegradable semipermeable microcapsules containing enzymes, hormones, vaccines, and other biologicals, J. Bioeng. 1:25–32.
Chawla, A. S., Hinberg, I., Blais, P., and Johnson, D., 1985, Aggregation of insulin, containing surfactants, in contacts with different materials, Diabetes 34:420–424.
Chien, Y. W., 1991, Transdermal route of peptide and protein drug delivery, in: Peptide and Protein Drug Delivery (V. H. L. Lee, ed.), Marcel Dekker, New York, pp. 667–689.
Chien, Y. W., Siddiqui, O., Sun, Y., Shi, W. M., and Liu, J. C., 1987, Transdermal iontophoretic delivery of therapeutic peptides/proteins. I: Insulin, Ann. N. Y. Acad. Sci. 507:32–50.
Chiou, G. C. Y., and Chuang, C. Y., 1989, Improvement of systemic absorption of insulin through eyes with absorption enhancers, J. Pharm. Sci. 78:815–818.
Chiou, G. C. Y., and Li, B. H. P., 1993, Chronic systemic delivery of insulin through the ocular route, J. Ocul. Pharmacol. 9:85–90.
Chiou, G. C. Y., Chuang, C. Y., and Chang, M. S., 1988, Reduction of blood glucose concentration with insulin eye drops, Diabetes Care 11:750–751.
Chiou, G. C. Y., Chuang, C. Y., and Chang, M. S., 1989, Systemic delivery of insulin through eyes to lower the glucose concentration, J. Ocul. Pharmacol. 5:81–91.
Chisholm, D. J., Kraegen, E. W., Hewett, M. J., and Furler, S., 1984, Low subcutaneous degradation and slow absorption of insulin in insulin-dependent diabetic patients during continuous subcutaneous insulin infusion at basal rate, Diabetologia 27:238–241.
Cho, Y. W., and Flynn, M., 1993, Oral delivery of insulin, Lancet ii:1518–1519.
Christiansen, J. S., and Lauritzen, T., 1991, Pharmacokinetic aspects of insulin therapy—with special reference to pumps and pens versus conventional insulin treatment, in: Pharmacology of Diabetes. Present Practice and Future Perspectives (C. E. Mogensen and E. Standl, eds.), de Gruyter, Berlin, pp. 23–38.
Chung, D.-J., Ito, Y., and Imanishi, Y., 1992, An insulin-releasing membrane system on the basis of oxidation reaction of glucose, J. Controlled Release 18:45–54.
Coates, P. A., Ismail, I. S., Luzio, S. D., Griffiths, I., Ollerton, R. L., Vølund, A., and Owens, D. R., 1995, Intranasal insulin: The effect of three dose regimens on postprandial glycaemic profiles in type II diabetic subjects, Diabetic Med. 12:235–239.
Colthorpe, P., Farr, S. J., Taylor, G., Smith, I. J., and Wyatt, D., 1992, The pharmacokinetics of pulmonary-delivered insulin: A comparison of intratracheal and aerosol administration to the rabbit, Pharm. Res. 9:764–768.
Couvreur, P., and Puisieux, F., 1993, Nano-and microparticles for the delivery of polypeptides and proteins, Adv. Drug Delivery Rev. 10:141–162.
Couvreur, P., Lenaerts, V., Kante, B., Roland, M., and Speiser, P. P., 1980, Oral and parenteral administration of insulin associated to hydrolysable nanoparticles, Acta Pharm. Technol. 26:220–222.
Crane, C. W., Path, M. C., and Luntz, G. R. W. N., 1968, Absorption of insulin from the human small intestine, Diabetes 17:625–627.
Creque, H. M., Langer, R., and Folkman, J., 1980, One month of sustained release of insulin from a polymer implant, Diabetes 29:37–40.
Cullander, C., 1992, What are the pathways of iontophoretic current flow through mammalian skin?, Adv. Drug Delivery Rev. 9:119–135.
Cullander, C., and Guy, R. H., 1992, Transdermal delivery of peptides and proteins, Adv. Drug Delivery Rev. 8:291–329.
Cunningham, L. W., Fischer, R. L., and Vestling, C. S., 1955, A study of the binding of zinc and cobalt by insulin, J. Am. Chem. Soc. 77:5703–5707.
Damgé, C., 1991, Oral insulin, in: Biotechnology of Insulin Therapy (J. C. Pickup, ed.), Blackwell Scientific Oxford, pp. 97–112.
Damgé, C., Michel, C., Aprahamian, M., and Couvreur, P., 1988, New approach for oral administration of insulin with polyalkylcyanoacrylate nanocapsules as drug carrier, Diabetes 37:246–251.
Damgé, C., Michel, C., Aprahamian, M., Couvreur, P., and Devissaguet, J. P., 1990, Nanocapsules as carriers for oral peptide delivery, J. Controlled Release 13:233–239.
Dandona, P., Hooke, D., and Bell, J., 1978, Exercise and insulin absorption from subcutaneous tissue, Br. Med J. 1:479–480.
Dapergolas, G., and Gregoriadis, G., 1976, Hypoglycaemic effect of liposome-entrapped insulin administered intragastrically into rats, Lancet ii:824–827.
Das, N., Basu, M. K., and Das, M. K, 1988, Oral application of insulin encapsulated liposomes, Biochem. Int. 16:983–989.
Davis, B. K., 1972, Control of diabetes with polyacrylamide implants containing insulin, Experientia 28:348.
de Boer, A. G., Hoogdalem, E. J., and Breimer, D. D., 1992, Rate-controlled rectal peptide drug absorption enhancement, Adv. Drug. Delivery Rev. 8:237–251.
Denne, J. R., Andrews, K. L., Lees, D. V., and Mook, W., 1992, A survey of patient preference for insulin jet injectors versus needle and syringe, Diabetes Educ. 18:223–227.
Deurloo, M. J. M., Hermens, W. A. J. J., Romeyn, S. G., Verhoef, J. C., and Merkus, F. W. H. M., 1989, Absorption enhancement of itranasally administered insulin by sodium taurodihydrofusidate (STDHF) in rabbits and rats, Pharm. Res. 6:853–856.
Dillon, R. S., 1983, Improved serum insulin profiles in diabetic individuals who massaged their insulin injection sites, Diabetes Care 6:399–401.
Dobre, V., Georgescu, D., Simionescu, L., Aman, E., Stroescu, V., and Motas, C., 1983, The entrapment of biologically active substances into liposomes. I. Effects of the oral administration of liposomally entrapped insulin in normal rats. Rev. Roum. Biochim. 20:15–20.
Dobre, V., Simionescu, L., Stroescu, V., Georgescu, D., Aman, E., Trandaburu, T., and Motas, C., 1984, The entrapment of biological active substances into liposomes. II. Effects of oral administration of liposomally entrapped insulin in normal and alloxanized rats, Rev. Roum. Med. Endocrinol. 22:253–260.
Dondeti, P., Zia, H., and Needham, T. E., 1995, In vivo evaluation of spray formulations of human insulin for nasal delivery, Int. J. Pharm. 122:91–105.
Douglas, S. J., Davis, S. S., and Illum, L., 1987, Poly(alkyl 2-cyanoacrylate) microspheres as drug carrier systems, in: Polymers in Controlled Drug Delivery (L. Illum and S. S. Davis, eds.), IOP Publishing, Bristol, U.K., pp. 66–72.
Drejer, K., Vaag, A., Bech, K., Hansen, P., Sørrensen, A. R., and Mygind, N., 1991, Intranasal insulin administration, in: Diabetes 1991 (H. Rifkin, J. A. Colwell, and S. Taylor, eds.), Elsevier, Amsterdam, pp. 1261–1264.
Drejer, K., Vaag, A., Bech, K., Hansen, P., Sørensen, A. R., and Mygind, N., 1992, Intranasal administration of insulin with phospholipid as absorption enhancer: Pharmacokinetics in normal subjects, Diabetic Med. 9:335–340.
Earle, M. P., 1972, Experimental use of oral insulin, Isr. J. Med. Sci. 8:899–900.
Edman, P., and Bj�F6;rk, E., 1992, Nasal delivery of peptide drugs, Adv. Drug Delivery Rev. 8:165–177.
Edman, P., Björk, E., and Rydén, L., 1992, Microspheres as a nasal delivery system for peptide drugs, J. Controlled Release 21:165–172.
Edsberg, B., Herly, D., Hildebrandt, P., and Kühl, C., 1987, Insulin bolus given by sprinkler needle: Effect on absorption and glycaemic response to a meal, Br. Med. J. 294:1373–1376.
El-Etr, M., Slama, G., and Desplanque, N., 1987, Preprandial intranasal insulin as adjuvant therapy in type II diabetes, Lancet ii:1085–1086.
Elliott, R. B., Edgar, B. W., Pilcher, C. C., Quested, C., and McMaster, J., 1987, Parenteral absorption of insulin from the lung in diabetic children, Aust. Paediatr. J. 23:293–297.
El-Shattawy, H. H., El-Ahmady, O., Hosny, E. A., Nabib, A. E., El-Damasy, H., El-Deen, S. G., and El-Kabbany, N., 1994, Effectiveness of rectal insulin suppositories containing sodium cholate in normal and insulin dependent diabetic subjects, Drug Dev. Ind. Pharm. 20:357–366.
Eppstein, D. A., and Longenecker, J. P., 1988, Alternative delivery systems for peptides and proteins as drugs, Crit. Rev. Ther. Drug Carrier Syst. 5:99–139.
Fahlén, M., Odén, A., Björntorp, P., and Tibblin, G., 1971, Seasonal influence on insulin secretion in man, Clin. Sci. 41:453–458.
Farraj, N. F., Johansen, B. R., Davis, S. S., and Illum, L., 1990, Nasal administration of insulin using bioadhesive microspheres as a delivery system, J. Controlled Release 13:253–261.
Feingold, V., Jenkins, A. B., and Kraegen, E. W., 1984, Effect of contact material on vibration-induced insulin aggregation, Diabetologia 27:373–378.
Fernqvist, E., Linde, B., Ö’stman, J., and Gunnarsson, R., 1986, Effects of physical exercise on insulin absorption in insulin-dependent diabetics: A comparison between human and porcine insulin, Clin. Physiol. 6:489–498.
Fineberg, S. E., Galloway, J. A,, Fineberg, N. S., Rathbun, M. J., and Hufferd, S., 1983, Immunogenicity of recombinant DNA human insulin, Diabetologia 25:465–469.
Fischel-Ghodsian, F., Brown, L., Mathiowitz, E., Brandenburg, D., and Langer, R., 1988, Enzymatically controlled drug delivery, Proc. Natl. Acad. Sci. USA 85:2403–2406.
Fischer, U., Rebrin, K., Salzsieder, E., and Volund, A., 1993, Pharmacodynamics of fastabsorbed human insulin (HM) analogues, Diabetologia 36(Suppl. 1):A30 (Abstract).
Forlani, G., Santacroce, G., Ciavarella, A., Capelli, M., Mattioli, L., and Vannini, P., 1986, Effects of mixing short-and intermediate-acting insulins on absorption course and biologic effect of short-acting preparation, Diabetes Care 9:587–590.
Frauman, A. G., Cooper, M. E., Parsons, B. J., Jerums, G., and Louis, W. J., 1987a, Long-term use of intranasal insulin in insulin-dependent diabetic patients, Diabetes Care 10:3573–578.
Frauman, A. G., Jerums, G., and Louis, W. J., 1987b, Effects of intranasal insulin in non-obese type II diabetics, Diabetes Res. Clin. Pract. 3:197–202.
Frid, A., and Linde, B., 1993, Clinically important differences in insulin absorption from abdomen in IDDM, Diabetes Res. Clin. Pract. 21:137–141.
Frid, A., Gunnarsson, R., Güntner, P., and Linde, B., 1988, Effects of accidental intramuscular injection on insulin absorption in IDDM, Diabetes Care 11:41–45.
Fujii, S., Yokoyama, T., Ikegaya, K., Sato, F., and Yokoo, N., 1985, Promoting effect of the new chymotrypsin inhibitor FK-448 on the intestinal absorption of insulin in rats and dogs, J. Pharm. Pharmacol. 37:545–549.
Fujita, S., Kamado, K., Takimoto, T., Yoshioka, H., Yamasaki, Y., Shichiri, M., and Hoshi, M., 1983, Insulin suppositories to stabilize brittle diabetes, in: Current and Future Therapies with Insulin (N. Sakamoto and K. G. M. M. Alberti, eds.), Excerpta Medica, Amsterdam, pp. 268–271.
Fukushima, K., 1987, Experimental approaches to oral administration of insulin by cinnamoyl phenylalanine derivatives as adjuvants in streptozotocin-diabetic animals, in: Best Approach to the Ideal Therapy of Diabetes Mellitus (Y. Shigeta, H. E. Lebovitz, J. E. Gerich, and W. J. Malaisse, eds.), Elsevier, Amsterdam, pp. 367–370.
Fukushima, K., and Toyoshima, S., 1983, Oral administration of insulin in combination with amino acid derivatives in animal experiments, in: Current and Future Therapies with Insulin, (N. Sakamoto and K. G. M. M. Alberti, eds.), Excerpa Medica, Amsterdam, pp. 257–262.
Gall, M.-A., Mathiesen, E. R., Skøtt, P., Musaeus, L., Damm, S., Beck-Nielsen, H., and Parving, H.-H., 1989, Effect of multiple insulin injections with a pen injector on metabolic control and general well-being in insulin-dependent diabetes mellitus, Diabetes Res. 11:97–101.
Galloway, J. A., and Root, M. A., 1972, New forms of insulin, Diabetes 21(Suppl. 2):637–648.
Galloway, J. A., Root, M. A., Rathmacher, R. P., and Carmichael, R. H., 1973, A comparison of acid regular and neutral regular insulin: Responses of normal fasted subjects to varying doses of regular insulin, Diabetes 22:471–479.
Galloway, J. A., Spradlin, C. T., Nelson, R. L., Wentworth, S. M., Davidson, J. A., and Swarner, J. L., 1981, Factors influencing the absorption, and blood glucose responses after injections of regular insulin and various insulin mixtures, Diabetes Care 4:366–376.
Gänsslen, M., 1925, Uber Inhalation von Insulin, Klin. Wochenschr. 471.
Geary, R. S., and Schlameus, H. W., 1993, Vancomycin and insulin used as models for oral delivery of peptides, J. Controlled Release 23:65–74.
Gill, I. J., Fisher, A. N., Hinchcliffe, M., Whetstone, J., Farraj, N., Ponti, R. D., and Illum, L., 1994, Cyclodextrins as protection agents against enhancer damage in nasal delivery systems II. Effect on in vivo absorption of insulin and histopathology of nasal membrane, Eur. J. Pharm. Sci. 1:237–248.
Gizurarson, S., and Bechgaard, E., 1991a, Study of nasal enzyme activity towards insulin. In vitro, Chem. Pharm. Bull. 39:2155–2157.
Gizurarson, S., and Bechgaard, E., 1991b, Intranasal administration of insulin to humans, Diabetes Res. Clin. Pract. 12:71–84.
Golomb, G., Avramoff, A., and Hoffman, A., 1993, A new route of drug administration: Intrauterine delivery of insulin and calcitonin, Pharm. Res. 10:828–833.
Goosen, M. F. A., Leung, Y. F., Chou, S., and Sun, A. M., 1982, Insulin-albumin microbeads: An implantable, biodegradable system, Biomater. Med Devices Artif. Organs 10:205–218.
Goosen, M. F. A., Leung, Y. F., O’shea, G. M., Chou, S., and Sun, A. M., 1983, Long-acting insulin. Slow release of insulin from a biodegradable matrix implanted in diabetic rats, Diabetes 32:478–481.
Gordon, G. S., Moses, A. C., Silver, R. D., Flier, J. S., and Carey, M. C., 1985, Nasal absorption of insulin: Enhancement by hydrophobic bile salts, Proc. Natl. Acad. Sci. USA 82:7419–7423.
Grau, U., 1985, Chemical stability of insulin in a delivery system environment, Diabetologia 28:458–463.
Grau, U., Seipke, G., Obermeier, R., and Thurow, H., 1982, Stabile Insulinlösungen fur automatische Dosiergeräte, in: Neue Insuline. 1. Internationales Symposium (K.-G. Petersen, K. J. Schlüter, and L. Kerp, eds.), Freiburg Graphischer Betriebe, Freiburg, pp. 411–419.
Grau, U., Geisen, K., and Jährling, P., 1989, Preclinical evaluation of a remote-controlled implantable pump with a compatible insulin preparation: Studies on long-term stability of the insulin, Diabetes Nutr. Metab. 2:43–52.
Gwinup, G., Elias, A. N., and Domurat, E. S., 1991, Insulin and c-peptide levels following oral administration of insulin in intestinal-enzyme protected capsules, Gen. Pharmacol. 22:243–246.
Hagedorn, H. C., Jensen, B. N., Krarup, N. B., and Wodstrup, I., 1936, Protamine insulinate, J. Am. Med. Assoc. 106:177–180.
Hallas-Møller, K., 1956, The ‘Lente’ insulins, Diabetes 5:7–14.
Hallas-Møller, K., Petersen, K., and Schlichtkrull, J., 1952, Crystalline and amorphous insulin-zinccompounds with prolonged action, Science 116:394–399.
Hansen, P. E., Brange, J., and Havelund, S., 1986, Stabilized insulin preparations and a process for preparation thereof, U.S. Patent 4,614,730.
Harris, D., and Robinson, J. R., 1990, Bioadhesive polymers in peptide drug delivery, Biomaterials 11:652–658.
Harris, D., Liaw, J.-H., and Robinson, J. R., 1992, Ocular delivery of peptide and protein drugs, Adv. Drug Delivery Rev. 8:331–339.
Hastings, R. H., Grady, M., Sakuma, T., and Matthay, M. A., 1992, Clearance of different-sized proteins from the alveolar space in humans and rabbits, J. Appl. Physiol. 73:1310–1316.
Hauss, D. J., Ando, H. Y., Grasela, D. M., and Sugita, E. T., 1991, The relationship of salicylate lipophilicity to rectal insulin absorption enhancement and relative lymphatic uptake, J. Pharmacobio-Dyn. 14:139–151.
Hayakawa, E., Chien, D.-S., Inagaki, K., Yamamoto, A., Wang, W., and Lee, V. H. L., 1992, Conjunctival penetration of insulin and peptide drugs in the albino rabbit, Pharm. Res. 9:769–775.
Heine, R. J., 1993, Insulin therapy, in: Diabetes Annual/7 (S. Marshall, P. D. Home, K. G. M. M. Alberti, and L. P. Krall, eds.), Elsevier, Amsterdam, pp. 284–302.
Heine, R. J., Bilo, H. J. G., Fonk, E. A., Veen, E. R., and Meer, J., 1984, Absorption kinetics and actionprofiles ofmixtures ofshort-andintermediate-actinginsulins, Diabetologia 27:558–562.
Heinemann, L., Starke, A. A. R., Heding, L., Jensen, I., and Berger, M., 1990, Action profile of fast onset insulin analogues, Diabetologia 33:384–386.
Heinemann, L., Chantelau, E. A., and Starke, A. A. R., 1992, Pharmacokinetics and pharmacodynamics of subcutaneously administered U40 and U100 formulations of regular human insulin, Diabetes Metab. 18:21–24.
Heinemann, L., Heise, T., Ampudia, J., and Starke, A. A. R., 1993a, Action profiles of rapid-acting human insulin analogues, in: Frontiers in Insulin Pharmacology (M. Berger and F. A. Gries, eds.), Thieme Verlag, Stuttgart, pp. 87–96.
Heinemann, L., Heise, T., Jorgensen, L. N, and Starke, A. A. R., 1993b, Action profile of the rapid acting insulin analogue: Human insulin B28Asp, Diabetic Med. 10:535–539.
Heller, J., 1993a, Modulated release from drug delivery devices, Crit. Rev. Ther. Drug Carrier Syst. 10:253–305.
Heller, J., 1993b, Polymers for controlled parenteral delivery of peptides and proteins, Adv. Drug. Delivery Rev. 10:163–204.
Heller, J., Chang, A. C., Rodd, G., and Grodsky, G. M., 1990, Release of insulin from pH-sensitive poly(orthoesters), J. Controlled Release 13:295–302.
Henriksen, J. E., Djurhuus, M. S., Vaag, A., Thye-Rønn, P., Knudsen, D., Hother-Nielsen, O., and Beck-Nielsen, H., 1993, Impact of injection sites of soluble insulin on glycaemic control in Type 1 (insulin dependent) diabetic patients treated with a multiple insulin injection regimen, Diabetologia 36:752–758.
Hildebrandt, P., Sestoft, L., and Nielson, S. L., 1983, The absorption of subcutaneously injected short-acting soluble insulin: Influence of injection technique and concentration, Diabetes Care 6:459–462.
Hildebrandt, P., Birch, K., Sestoft, L., and Vølund, A., 1984a, Dose-dependent subcutaneous absorption of porcine, bovine and human NPH insulins, Acta Med. Scand 215:69–73.
Hildebrandt, P., Ilius, A., Lotz, U., and Schiliack, V., 1984b Effect of insulin suppositories in type I diabetic patients, Exp. Clin. Endocrinol. 83:168–172.
Hildebrandt, P., Berger, A., Vølund, A., and Kühl, C., 1985a, The subcutaneous absorption of human and bovine ultralente insulin formulations, Diabetic Med 2:355–359.
Hildebrandt, P., Birch, K., Sestoft, L., and Nielsen, S. L., 1985b, Orthostatic changes in subcutaneous blood flow and insulin absorption, Diabetes Res. 2:187–190.
Hilsted, J., Madsbad, S., Hvidberg, A., Rasmussen, M. H., Krarup, T., Ipsen, H., Hansen, B., Pedersen, M., Djurup, R., and Oxenbøll, B., 1995, Intranasal insulin therapy: The clinical realities, Diabetologia 38:680–684.
Hirai, S., Ikenaga, T., and Matzuzawa, T., 1978, Nasal absorption of insulin in dogs, Diabetes 27:296–299.
Hirai, S., Yashiki, T., and Mima, H., 1981a Effect of surfactants on the nasal absorption of insulin in rats, Int. J. Pharm. 9:165–172.
Hirai, S., Yashiki, T., and Mima, H., 1981b, Mechanism for the enhancement of the nasal absorption of insulin by surfactants, Int. J. Pharm. 9:173–184.
Hirata, Y., Kohama, T., and Ooi, K., 1983, Nasal administration of insulin in healthy subjects and diabetic patients, in: Current and Future Therapies with Insulin (N. Sakamoto and K. G. M. M. Alberti, eds.), Excerpa Medica, Amsterdam, pp. 263–267.
Hirsch, I. B., Farkas-Hirsch, R., and Skyler, J. S., 1990, Intensive insulin therapy for treatment of type I diabetes, Diabetes Care 13:1265–1283.
Hirsch, J. I., Wood, J. H., and Thomas, R. B., 1981, Insulin adsorption to polyolefin infusion bottles and polyvinyl chloride administration sets, Am. J. Hosp. Pharm. 38:995–997.
Ho, N. F. H., Barsuhn, C. L., Burton, P. S., and Merkle, H. P., 1992, Mechanistic insight to buccal delivery of proteinaceous substances, Adv. Drug Delivery Rev. 8:197–235.
Hoffmann, J. A., Chance, R. E., and Johnson, M. G., 1990, Purification and analysis of the major components of chum salmon protamine contained in insulin formulations using high-performance liquid chromatography, Protein Expr. Purif 1:127–133.
Holman, R. R., 1993, Intranasal insulin in type I diabetes, in: Frontiers in Insulin Pharmacology (M. Berger and F. A. Gries, eds.), Thieme Verlag, Stuttgart, pp. 138–143.
Home, P. D., and Alberti, K. G. M. M., 1992, Insulin therapy, in: International Textbook of Diabetes Mellitus (K. G. M. M. Alberti, R. A. DeFronzo, H. Keen, and P. Zimmet, eds.), John Wiley & Sons, Chichester, U.K., pp. 831–863.
Home, P. D., Gill, G. V., Husband, D., Kruszynska, Y. T., Marshall, S., and Alberti, K. G. M. M., 1985, Alternative routes and methods of insulin delivery, Neth. J. Med. 28(Suppl. 1):32–36.
Home, P. D., Thow, J. C., and Tunbridge, F. K. E., 1989, Insulin treatment: A Decade of change, Br. Med Bull. 45:92–110.
Hoogdalem, E. J., Heijligers-Feijen, C. D., Verhoef, J. C., de Boer, A. G., and Breimer, D. D., 1990, Absorption enhancement of rectally infused insulin by sodium tauro-24,25-dihydrofusidate (STDHF) in rats, Pharm. Res. 7:180–183.
Horbett, T. A., Ratner, B. D., Kost, J., and Singh, M., 1984, A bioresponsive membrane for insulin delivery, in: Recent Advances in Drug Delivery Systems (J. M. Andersen and S. W. Kim, eds.), Plenum Press, New York, pp. 209–220.
Hori, R., Komadea, F., and Okumura, K., 1983, Pharmaceutical approach to subcutaneous dosage forms of insulin, J. Pharm. Sci. 72:435–439.
Hori, R., Komada, F., Iwakawa, S., Seino, Y., and Okumura, K., 1989, Enhanced bioavailability of subcutaneously injected insulin coadministered with collagen in rats and humans, Pharm. Res. 68:13–816.
Hosny, E. A., Bayomi, M., El-Shattawy, H. H., El-Kabany, N., El-Deen, S. G., El-Damasy, H., and Nabih, A. E., 1994a, Absorption promoters for delivery of insulin from suppositories in humans, Pharm. Ind. 56:576–578.
Hosny, E., El-Ahmady, O., El-Shattawy, H., Nabih, A. El-M., El-Damacy, H., Gamal-El-Deen, S., and El-Kabbany, N., 1994b, Effect of sodium salicylate on insulin rectal absorption in humans, Arzneim.-Forsch./Drug Res. 44(I):611–613.
Houtzagers, C. M. G. J., 1989, Subcutaneous insulin delivery: Present status, Diabetic Med. 6:754–761.
Houtzagers, C. M. G. J., Berntzen, P. A., Stap, H., Heine, R. J., and Veen, E. A., 1988, Absorption kinetics of short-and intermediate-acting insulins after jet injection with Medijector II, Diabetes Care 11:739–742.
Howell, S. L., Tyhurst, M., Duvefelt, H., Anderson, A., and Hellerström, C., 1978, Role of zinc and calcium in the formation and storage of insulin in the pancreatic B-cell, Cell Tissue Res. 188:107–118.
Howey, D. C., Bowsher, R. R., Brunelle, R. L., and Woodworth, J. R., 1994, [Lys(B28), Pro(B29)]-humaninsulin. Arapidly absorbed analogue of human insulin, Diabetes 43:396–402.
Ichikawa, K., Ohata, I., Mitomi, M., Kawamura, S., Maeno, H., and Kawata, H., 1980, Rectal absorption of insulin suppositories in rabbits, J. Pharm. Pharmacol. 32:314–318.
Illum, L., Farraj, N. F., Critchley, H, Johansen, B. R., and Davis, S. S., 1989, Enhanced nasal absorption of insulin in rats using lysophosphatidylcholine, Int. J. Pharm. 57:49–54.
Illum, L., Farraj, N. F., and Davies, S. S., 1994a, Chitosan as a novel nasal delivery system for peptide drugs, Pharm. Res. 11:1186–1189.
Illum, L., Farraj, N. F., Fisher, A. M., Gill, I, Miglietta, M., and Benedetti, L. M., 1994b, Hyaluronic acid ester microspheres as a nasal delivery system for insulin, J. Controlled Release 29:133–141.
Irie, T., Wakamatsu, K., Arima, H., Aritomi, H., and Uekama, K., 1992, Enhancing effects of cyclodextrins on nasal absorption of insulin in rats, Int. J. Pharm. 84:129–139.
Irsigler, K, and Kritz, H., 1979, Long-term continuous intravenous insulin therapy with a portable insulin dosage-regulating apparatus, Diabetes 28:196–203.
Irsigler, K., Kritz, H., Hagmüller, G., Franetzki, M, Prestele, K., Thurow, H., and Geisen, K., 1981, Long-term continuous intraperitoneal insulin infusion with an implanted remotecontrolled insulin infusion device, Diabetes 30:1072–1075.
Ishida, M., Machida, Y., Nambu, N., and Nagai, T., 1981, New mucosal dosage form of insulin, Chem. Pharm. Bull. 29:810–816.
Ishihara, K., and Matsui, K., 1986, Glucose-responsive insulin release from polymer capsule, J. Polym. Sci. 24:413–417.
Ishihara, K., Kobayashi, M., Ishimaru, N., and Shinohara, I., 1984, Glucose induced permeation control of insulin through a complex membrane consisting of immobilized glucose oxidase and a poly(amine), Polym. J. 16:625–631.
Ito, Y., Casolaro, M., Kono, K., and Imanishi, Y., 1989, An insulin system that is responsive to glucose, J. Controlled Release 10:195–203.
Jacobs, M. A. J. M., Schreuder, R. H., Jap-a-joe, K., Nauta, J. J., Andersen, P. M., and Heine, R. J., 1993, The pharmacodynamics and activity of intranasally administered insulin in healthy male volunteers, Diabetes 42:1649–1655.
Jefferson, I. G., Marteau, T. M., Smith, M. A., and Baum, J. D., 1985, A multiple injection regimen using an insulin injection pen and pre-filled cartridged soluble human insulin in adolescents with diabetes, Diabetic Med. 2:493–497.
Jensen, H. F., 1938, Insulin. Its Chemistry and Physiology, Commonwealth Foundation, New York, pp. 93–112.
Jones, A. L., Taylor, G., and Kellaway, I. W., 1987, An investigation of the pulmonary absorption of insulin in the rat, in: Proceedings of the Third European Congress of Biopharmaceutics and Pharmacokinetics in Freiburg — Volume II. Experimental Pharmacokinetics (J. M. Aiache and J. Hirtz, eds.), pp. 143–149.
Jorpes, J. E., 1949, Recrystallized insulin for diabetic patients with insulin allergy, Arch. Intern. Med. 833:363–371.
Jovanovic-Peterson, L., Sparks, S., Palmer, J. P., and Peterson, C. M., 1993, Jet-injected insulin is associated with decreased antibody production and postprandial glucose variability when compared with needle-injected insulin in gestational diabetic women, Diabetes Care 16: 1479–1484.
Kahn, M., Barney, N. P., Briggs, R. M., Bloch, K. J., and Allansmith, M. R., 1990, Penetrating the conjunctival barrier. The role of molecular weight, Invest. Ophthalmol. Visual Sci. 31:258–261.
Kang, S., Owens, D. R., Vora, J. P., and Brange, J., 1990, Recombinant DNA derived insulin analogue B9AspB27Glu: Comparisons with soluble human insulin in insulin treated diabetics, Lancet 335:303–306.
Kang, S., Creag, F. M., Peters, J. R., Brange, J., Vølund, A., and Owens, D. R., 1991a, Comparison of subcutaneous soluble human insulin and insulin analogues (AspB9, GluB27; AspB10; AspB28) on meal-related plasma glucose excursions in type I diabetic subjects, Diabetes Care 14:571–577.
Kang, S., Brange, J., Burch, A., Vølund, A., and Owens. D. R., 1991b, Subcutaneous insulin absorption explained by insulin’s physicochemical properties. Evidence from absorption studies of soluble human insulin and insulin analogues in humans, Diabetes Care 14:942–948.
Kang, S., Brange, J., Burch, A., Vølund, A., and Owens, D. R., 1991c, Absorption kinetics and action profiles of subcutaneously administered insulin analogue (AspB9GluB27, AspB10, AspB28) in healthy subjects, Diabetes Care 14:1057–1965.
Kari, B., 1986, Control of blood glucose levels in alloxan diabetic rabbits by iontophoresis of insulin, Diabetes 35:217–221.
Kemmer, F. W., Sonnenberg, G., Cüppers, H. J., and Berger, M., 1982, Absorption kinetics of semisynthetic human insulin and biosynthetic (recombinant DNA) human insulin, Diabetes Care 5:23–28.
Kidron, M., Bar-on, H., Berry, E. M., and Ziv, E., 1982, The absorption of insulin from various regions of the rat intestine, Life Sci. 31:2837–2841.
Kidron, M., Krausz, M. M., Raz, I., Bar-on, H., and Ziv, E., 1989, The absorption of insulin. The absorption of insulin from the intestine in dogs, Tenside Surf Deterg. 26:352–354.
Kim, S., Nishihata, T., Kawabe, S., Okamura, Y., Kamada, A., Yagi, T., Kawamori, R., and Shichiri, M., 1984, Effect of gelatin in the formulation on rectal insulin absorption in the presence of enamine in normal rats and depancreatized dogs, Int. J. Pharm. 21:179–186.
Kim, S. W., Pai, C. M., Makino, K., Seminoff, L. A. Holmberg, D. L., Gleeson, J. M., Wilson, D. E., and Mack, E. J., 1990, Self-regulated glycosylated insulin delivery, J. Controlled Release 11:193–201.
Kimmerle, R., Griffing, G., McCall, A., Ruderman, N. B., Stoltz, E., and Melby, J. C., 1991, Could intranasal insulin be useful in the treatment of non-insulin-dependent diabetes mellitus? Diabetes Res. Clin. Pract. 13:69–76.
Kitano, S., Koyama, Y., Kataoka, K., Okano, T., and Sakurai, Y., 1992, A novel drug delivery system utilizing a glucose responsive polymer complex between poly(vinyl alcohol) and poly(N-vinyl-2-pyrrolidone) with a phenylboronic acid moiety, J. Controlled Release 19: 161–170.
Klemp, P., Staberg, B., Madsbad, S., and Kølendorf, K., 1982, Smoking reduces insulin absorption from subcutaneous tissue, Br. Med. J. 284:237.
Köhler, D., Schlüter, K. J., Kerp, L., and Matthys, H., 1987, Nicht radioaktives Verfahren zur Messung der Lungenpermeabilität: Inhalation von Insulin, Atemwegs-Lungenkrankh. 13:230–232.
Koivisto, V. A., 1993, Insulin therapy in type II diabetes, Diabetes Care 16(Suppl. 3):29–39.
Koivisto, V. A., and Felig, P., 1978, Effect of leg exercise on insulin absorption in diabetic patients, N. Engl. J. Med. 298:79–83.
Koivisto, V. A., and Felig, P., 1980, Alterations in insulin absorption and in blood glucose control associated with varying insulin injection sites in diabetic patients, Ann. Intern. Med. 92:59–61.
Koivisto, V. A., Fortney, S., Hendler, R., and Felig, P., 1981, A rise in ambient temperature augments insulin absorption in diabetic patients, Metabolism 30:402–405.
Kost, J., 1993, Ultrasound induced delivery of peptides, J. Controlled Release 24:247–255.
Kost, J., and Langer, R., 1991, Responsive polymeric delivery systems, Adv. Drug Delivery Rev. 6:19–50.
Kost, J., Wolfrum, J., and Langer, R., 1987, Magnetically enhanced insulin release in diabetic Hosp. Nord Insulinlab. 1:60–73.
KrayenbüChl, C., and Rosenberg, T., 1946, Crystalline protamine insulin, Rep. Steno Mem Hosp. Nord Insulinlab. 1:60–73.
Kurtzhals, P., and Ribel, U., 1995, Action profile of cobalt(III)-insulin. A novel principle of protraction of potential use for basal insulin delivery, Diabetes 44:1381–1385.
Kurtzhals, P., Kiehr, B., and Sørensen, A. R., 1995a, The cobalt(III)-insulin hexamer is a prolonged-acting insulin prodrug, J. Pharm. Sci. 84:1164–1168.
Kurtzhals, P., Havelund, S., Jonassen, I., Kiehr, B., Larsen, U. D., Ribel, U., and Markussen, J., 1995b, Albumin binding of insulins acylated with fatty acids: Characterization of the ligand-protein interaction and correlation between affinity and timing of the insulin effect in vivo, Biochem. J. 312:725–731.
Kwon, I. C., Bae, Y. H., and Kim, S. W., 1991, Electrically erodible polymer gel for controlled release of drugs, Nature 354:291–293.
Kwong, A. K., Chou, S., Sun, A. M., Sefton, M. V., and Goosen, M. F. A., 1986, In vitro and in vivo release of insulin from poly(lactic acid) microbeads and pellets, J. Controlled Release4:47–62.
Langkær, L., Kornfeldt, T., Markussen, J, Norris, K., Plum, A., Sørensen, A. R., and Sørensen, E., 1988, Stable insulin solutions with prolonged action, Diabetologia 31:512A.
Langkær, L., Brange, J., Grodsky, G. M., and Guy, R. H., 1994, Transdermal delivery of monomeric insulin analogues by iontophoresis, Proc. Int. Symp. Control. Rel. Bioact. Mater. 21:172–173.
Lassmann-Vague, V., 1991, The intranasal route for insulin administration, in: Biotechnology ofInsulin Therapy (J. C. Pickup, ed.), Blackwell Scientific, Oxford, pp. 113–125.
Lassmann-Vague, V., Thiers, D., Vialettes, B., and Vague, P., 1988, Preprandial intranasal insulin, Lancet i:367–368.
Lassmann-Vague, V., Belicar, P., Raccah, D., Vialettes, B., Dodoyez, J. C., and Vague, P., 1995, Immunogenicity oflong-term intraperitoneal insulin administration with implantable programmable pumps, Diabetes Care 18:498–503.
Laube, B. L., Georgopoulos, A., and Adams, G. K., 1993, Preliminary study of the efficacy of insulin aerosol delivered by oral inhalation in diabetic patients, J. Am. Med. Assoc. 269:2106–2109.
Lauritzen, T., Pramming, S., Deckert, T., and Binder, C., 1983, Pharmacokinetics of continuous subcutaneous insulin infusion, Diabetologia 24:326–329.
Lee, S., and Sciarra, J. J., 1976, Development of an aerosol dosage form containing insulin, J. Pharm. Sci. 65:561–572.
Lee, V. H. L., 1986, Enzymatic barriers topeptide and protein absorption and the use of penetration enhancers to modify absorption, in: Delivery Systems for Peptide Drugs (S. S. Davis, L. Illum, and E. Tomlinson, eds.), Plenum Press, New York, pp. 87–104.
Lee, V. H. L., Kashi, S. D., Patel, R. M., Kayakawa, E., and Inagaki, K., 1987, Mucosal peptide and protein delivery: Proteolytic activities in mucosal homogenates, Proc. Int. Symp. Control. Rel. Bioact. Mater. 14:23–24.
Lee, V. H. L., Traver, R. D., and Taub, M. E., 1991a, Enzymatic barriers to peptide and protein drug delivery, in: Peptide and Protein Drug Delivery (V. H. L. Lee, ed.), Marcel Dekker, New York, pp. 303–358.
Lee, V. H. L., Dodda-Kashi, S., Grass, G. M., and Rubas, W., 1991b, Oral route of peptide and protein delivery, in: Peptide and Protein Drug Delivery (V. H. L. Lee, ed.), Marcel Dekker, New York, pp. 691–738.
Lee, W. A., Lu, H. F.-L., Maffuid, P. W., Botet, M. T., Baldwin, P. A,, Benkert, T. A., and Klingbeil, C. K., 1992, The synthesis, characterization and biological testing of a novel class of mucosal permeation enhancers, J. Controlled Release 22:223–237.
Levandoski, L. A., White, N. H., and Santiago, J. V., 1982, Localized skin reactions to insulin: Insulin lipodystrophies and skin reactions to pumped subcutaneous insulin therapy, Diabetes Care 5(Suppl. 1):6–10.
Li, Y., and Mitra, A. K., 1994, Effects of formulation variables on the pulmonary delivery on insulin, Drug Dev. Ind. Pharm. 20:2017–2024.
Li, Y., Shao, Z., and Mitra, A. K., 1992, Dissociation of insulin oligomers by bile salt micelles and its effects on a-chymotrypsin-mediated proteolytic degradation, Pharm. Res. 9:864–869.
Li, Y., Shao, Z., DeNicola, D. B., and Mitra, A. K., 1993, Effects of a conjugated bile salt on the pulmonary absorption of insulin in rats, Eur. J. Pharm. Biopharm. 39:216–221.
Liedtke, R. K., Suwelack, K., and Karzel, K., 1990, Wirkung peroraler und transdermaler Insulin-Praparationen auf die Blutglukose-Konzentration bei Mäusen, Arzneim.-Forsch./ DrugRes. 40:880–883.
Linde, B., 1986, Dissociation of insulin absorption and blood flow during massage of a subcutaneous injection site, Diabetes Care 9:570–574.
Linde, B., and Gunnarsson, R., 1985, Influence of aprotinin on insulin absorption and subcutaneous blood flow in type 1 (insulin-dependent) diabetes, Diabetologia 28:645–648.
Linde, B., and Philip, A., 1989, Massage-enhanced insulin absorption–increased distribution or dissociation of insulin? Diabetes Res. 11:191–194.
Liu, F., Kildsig, D. O., and Mitra, A. K., 1992, Pulmonary biotransformation of insulin in rat and rabbit, Life Sci. 51:1683–1689.
Liu, F., Shao, Z., Kildsig, D. O., and Mitra, A. K., 1993, Pulmonary delivery of free and liposomal insulin, Pharm. Res. 10:228–232.
Liu, J.-C., Sun, Y., Siddiqui, O., Chien, Y. W., Shi, W. M., and Li, J., 1988, Blood glucose control in diabetic rats by transdermal iontophoretic delivery of insulin, Int. J. Pharm. 44:197–204.
Liversidge, G. G., Nishihata, T., Engle, K. K., and Higuchi, T., 1985, Effect of rectal suppository formulation on the release of insulin and on the glucose plasma levels in dogs, int. J. Pharm.23:87–95.
Liversidge, G. G., Nishihata, T. Engle, K. K., and Higuchi, T., 1986, Effect of suppository shape on the systemic availability of rectally administered insulin and sodium salicylate, Int. J. Pharm.30:247–250.
Longenecker, J. P., Moses, A. C., Flier, J. S., Silver, R. D., Carey, M. C., and Dubovi, E. J., 1987, Effects of sodium taurodihydrofusidate on nasal absorption of insulin in sheep, J. Pharm. Sci. 76:351–355.
Losse, G., Muller, F., Raddatz, H., Naumann, W., and Kossowicz, J., 1988, Verzögerungsformen des Insulins durch Matrixeinschluss oder Komplexbildung, Pharmazie 43:355–357.
Losse, G., Muller, F., Fischer, S., Wunderlich, G., and Hacker, E., 1989, Szintigraphische Verfolgung der retardierten Insulinliberation aus Agar-Einbettungen in Suppositorien, Pharmazie44:331–332.
Lougheed, W. D., Woulfe-Flanagan, H., Clement, J. R., and Albisser, A. M., 1980, insulin aggregation in artificial delivery systems, Diabetologia 19:1–9.
Lougheed, W. D., Albisser, A. M., Martindale, H. M., Chow, J. C., and Clement, J. R., 1983, Physical stability of insulin formulations, Diabetes 32:424–432.
Luttermann, J. A., Pijpers, E., Netten, P. M., and Jørgensen, L. N., 1993, Glycaemic control in IDDM patients during one day with injection of human insulin or the insulin analogues insulin X14 and insulin X14(+Zn), in: Frontiers in Insulin Pharmacology (M. Berger and F. A. Gries, eds.), Thieme Verlag, Stuttgart, pp. 102–109.
Maberly, G. F., Wait, G. A., Kilpatric, J. A., Loten, E. G., Gain, K. R., Stewart, R. D. H., and Eastman, C. J., 1982, Evidence for insulin degradation by muscle and fat issue in an insulin resistant diabetic patient, Diabetologia 23:333–336.
Maitani, Y., Asano, S., Takahashi, S., Nakagaki, M., and Nagai, T., 1992, Permeability of insulin entrappedinliposomesthroughthenasalmucosaofrabbits, Chem Pharm. Bull. 40:1569–1572.
Maitani, Y., Yamamoto, T., Takayama, K., and Nagai, T., 1995, The effect of soybeam-derived sterol and its glycoside as an enhancer of nasal absorption of insulin in rabbits in vitro and in vivo, Int. J. Pharm. 117:129–137.
Malone, J. I., Lowitt, S., Grove, N. P., and Shah, S. C., 1986, Comparison of insulin levels after injection by jet stream and disposable insulin syringe, Diabetes Care 9:637–640.
Manosroi, A., and Bauer, K. H., 1990, Effects of gastrointestinal administration of human insulin and human insulin-DEAE-dextran complex entrapped in different compound liposomes on blood glucose in rats, Drug Dev. Ind. Pharm. 16:1521–1538.
Markussen, J., Diers, I., Hougaard, P., Langkjær, L., Norris, K, Snel, L., Sørensen, A. R., Sørensen, E., and Voigt, H. O., 1988, Soluble, prolonged-acting insulin derivatives. III. Degree of protraction, crystallizability and chemical stability of insulins substituted in position A21, B13, B23, B27 and B30, Protein Eng., 2:157–166.
Markussen, J., Havelund, S., Kurtzhals, P., Andersen, A. S., Halstrøm, J., Hasselager, E., Larsen, U. D., Ribel, U., Schäffer, L., Vad, K., and Jonassen, I., 1996, Soluble, fatty acid acylated insulins bind to albumin and show protracted action in pigs, Diabetologia 39:281–288.
Marshall, M. O., Heding, L. G., Villumsen, J., Åkerblom, H. K., Baevre, H., Dahlquist, G., Kjaergaard, J.-J., Knip, M., Lindgren, F., Ludvigsson, J., Persson, B., Rilva, A., Stenhammar, L., Strzömberg, L., Søvik, O., Thalme, B., Vidnes, J., and Wefring, K., 1988, Development of insulin antibodies, metabolic control and B-cell function in newly diagnosed insulin dependent diabetic children treated with monocomponent human or monocomponent porcine insulin, Diabetes Res. 9:169–175.
Marshall, S. M., Home, P. D., Taylor, R., and Alberti, K. G. M. M., 1987, Continuous subcutaneous insulin infusion versus injection therapy: A randomised cross-over trial under usual diabetic clinic conditions, Diabetic Med. 4:521–525.
Mathiowitz, E., and Langer, R., 1987, Polyanhydride microspheres as drug carriers. I. Hot-melt microencapsulation, J. Controlled Release 5:13–22.
Mathiowitz, E., Saltzman, W. M., Domb, A., Dor, P., and Langer, R. 1988, Polyanhydride microspheres as drug carriers. II. Microencapsulation by solvent removal, J. Appl. Polym. Sci.35:755–774.
Mecklenburg, R. S., and Guinn, T. S., 1985, Complications of insulin pump therapy: The effect of insulin preparation, Diabetes Care 8:367–370.
Medan, V. M., Walmsley, A. D., and Irwin, W. J., 1995, Phonophoresis—is it a reality? Int. J. Pharm.118:129–149.
Melberg, S. G., Havelund, S., Villumsen, J., and Brange, J., 1988, Insulin compatibility with polymer materials used in external pump infusion systems, Diabetic Med. 5:243–247.
Merkle, H. P., and Wolany, G., 1992, Buccal delivery for peptide drugs, J. Controlled Release 21:155–164.
Merkus, F. W. H. M., Verhoef, J. C., Romeijn, S. G., and Schipper, N. G. M., 1991a, Absorption enhancing effect of cyclodextrins on intranasally administered insulin in rats, Pharm. Res. 8:588–592.
Merkus, F. W. H. M., Verhoef, J. C., Romeijn, S. G., and Schipper, N. G. M., 1991b, Interspecies differences in the nasal absorption of insulin, Pharm. Res. 8:1343.
Merkus, F. W. H. M., Schipper, N. G. M., Hermens, W. A. J. J., Romeijn, S. G., and Verhoef, J. C., 1993, Absorption enhancers in nasal drug delivery: Efficacy and safety, J. Controlled Release24:201–208.
Mesiha, M. S., 1981, Bioavailability of insulin from oral solid dispersion systems, Arch. Pharm. Chemi., Sci. Ed. 9:137–142.
Mesiha, M. S., and El-Bitar, H. I., 1981, Hypoglycaemic effect of oral insulin preparations containing Brij 35, 52, 58, or 92 and stearic acid, J. Pharm. Pharmacol, 33:733–734.
Mesiha, M. S., Lobel, S., Salo, D. P., Khaleeva, L. D., and Zekova, N. Y., 1981, Biopharmaceutical study of insulin suppositories, Pharmazie 36:29–32.
Meyer, B. R., Katzeff, H. L., Eschbach, J. C., Trimmer, J., Zacharias, S. B., Rosen, S., and Sibalis, D., 1989, Transdermal delivery of human insulin to albino rabbits using electrical current, Am. J. Med. Sci. 297: 321–325.
Michel, C., Aprahamian, M., Defontaine, L., Couvreur, P., and Damgé, C., 1991, The effect of site of administration in the gastrointestinal tract on the absorption of insulin from nanocapsules in diabetic rats, J. Pharm. Pharmacol. 43: 1–5.
Mirsky, I. A., and Kawamura, K., 1966, Heterogeneity of crystalline insulin, Endocrinology 78: 1115–1119
Mishima, M., Wakita, Y., and Nakano, M., 1987, Studies on the promoting effects of medium chain fatty acid salts on the nasal absorption of insulin in rats, J. Pharmacobio-Dyn. 10: 624–631.
Mishima, M., Okada, S., Wakita, Y., and Nakano, M., 1989, Promotion of nasal absorption of insulin by glycyrrhetinic acid derivatives, J. Pharmacobio-Dyn. 12: 31–36.
Mitragotri, S., Blankschtein, D., and Langer, R., 1995, Ultrasound-mediated transdermal protein delivery, Science 269: 850–853.
Mitrano, F. P., and Newton, D. W., 1982, Factors affecting insulin adherence to type I glass bottles, Am. J. Hosp. Pharm. 39: 1491–1495.
Miyazaki, S., Yokouchi, C., and Takada, M., 1988, External control of drug release: Controlled release of insulin from a hydrophilic polymer implant by ultrasound irradiation in diabetic rats, J. Pharm. Pharmacol. 40: 716–717.
Morimoto, K., Hama, I., Nakamoto, Y., Takeeda, T., Hirano, E., and Morisaka, K., 1980, Pharmaceutical studies of polyacrylic acid aqueous gel bases: Absorption of insulin from polyacrylic acid aqueous gel bases following rectal administration in alloxan diabetic rats and rabbits, J. Pharmacobio-Dyn. 3: 24–32.
Morimoto, K., Takeeda, T., Nakamoto, Y., and Morisaka, K., 1982, Effective vaginal absorption of insulin in diabetic rats and rabbits using polyacrylic acid aqueous gel bases, Int. J. Pharm. 12: 107–111.
Morimoto, K., Kamiya, E., Takeeda, T., Nakamoto, Y., and Morisaka, K., 1983, Enhancement of rectal absorption of insulin in polyacrylic acid aqueous gel bases containing long chain fatty acid in rats, Int. J. Pharm. 14: 149–157.
Morimoto, K., Morisaka, K., and Kamada, A., 1985, Enhancement of nasal absorption of insulin and calcitonin using polyacrylic acid gel, J. Pharm. Pharmacol. 37: 134–136.
Morishita, M., Morishita, I., Takayama, K., Machida, Y., and Nagai, T., 1992a, Novel oral microspheres of insulin with protease inhibitor protecting from enzymatic degradation, Int. J. Pharm. 78: 1–7.
Morishita, I., Morishita, M., Takayama, K., Machida, Y., and Nagai, T., 1992b, Hypoglycemic effect of novel oral microspheres of insulin with protease inhibitor in normal and diabetic rats, Int. J. Pharm. 78: 9–16.
Morishita, I., Morishita, M., Takayama, K., Machida, Y., and Nagai, T., 1993a, Enteral insulin delivery by microspheres in 3 different formulations using Eudragit L100 and S100, Int. J. Pharm. 91: 29–37.
Morishita, M., Morishita, I., Takayama, K., Machida, Y., and Nagai, T., 1993b, Site-dependent effect of aprotinin, sodium caprate, Na2EDTA and sodium glycocholate on intestinal absorption of insulin, Biol. Pharm. Bull. 16: 68–72.
Moses, A. C., Gordon, G. S., Carey, M. C., and Flier, J. S., 1983, Insulin administered intranasally as an insulin-bile salt aerosol. Effectiveness and reproducibility in normal and diabetic subjects, Diabetes 32: 1040–1047.
Muzina, D. J., Snow, K. R., and Bajpai, P. K., 1989, Regulation of blood glucose by sustained delivery of insulin via ALCAP ceramics in rats, in: Biomedical Sciences Instrumentation, Vol. 25 (D. Carlson, ed.), Instrument Society of America, Research Triangle Park, North Carolina, pp. 191–202.
Nagai, T., 1985, Adhesive topical drug delivery system, J. Controlled Release 2: 121–134.
Nagai, T., Nishimoto, Y., Nambu, N., Suzuki, Y., and Sekine, K., 1984, Powder dosage form of insulin for nasal administration. J. Controlled Release 1: 15–22.
Nathan, D. M., Siebert, C., and Genuth, S., 1994, DCCT Design, outcome and implications, IDFBull. 39:(Suppl.):5–10.
Newman, S. P., Steed, K. P., Hardy, J. G., Wilding, I. R., Hooper, G., and Sparrow, R. A,, 1994, The distribution of an intranasal insulin formulation in healthy volunteers: Effect of different administration techniques, J. Pharm. Pharmacol. 46: 657–660.
Nishihata, T., Rytting, J. H., Kamada, A., and Higuchi, T., 1981a, Enhanced intestinal absorption of insulin in rats in the presence of sodium 5-methoxysalicylate, Diabetes 30: 1065–1067.
Nishihata, T., Rytting, J. H., Higuchi, T., and Caldwell, L., 1981b, Enhanced rectal absorption of insulin and heparin in rats in the presence of non-surfactant adjuvants, J. Pharm. Pharmacol. 33: 334–335.
Nishihata, T., Liversidge, G., and Higuchi, T., 1983a, Effect of aprotinin on the rectal delivery of insulin, J. Pharm. Pharmacol. 35: 616–617.
Nishihata, T., Kim, S., Morishita, S., Kamada, A., Yata, N., and Higuchi, T., 1983b Adjuvant effects of glyceryl esters of acetoacetic acid on rectal absorption of insulin and insulin in rabbits, J. Pharm. Sci. 72: 280–285.
Nishihata, T., Rytting, J. H., Kamada, A., Higuchi, T., Routh, M., and Caldwell, L., 1983c, Enhancement of rectal absorption of insulin using salicylates in dogs, J. Pharm. Pharmacol. 35: 148–151
Nishihata, T., Okamura, Y., Kamada, A., Higuchi, T., Yagi, T., Kawamori, R., and Shichiri, M., 1985, Enhanced bioavailability of insulin after rectal administration with enamine as adjuvant in depancreatized dogs, J. Pharm. Pharmacol. 37: 22–26.
Nishihata, T., Okamura, Y., Inagaki, H., Sudho, M., Kamada, A., Yagi, T., Kawamori, R., and Shichiri, M., 1986, Trials of rectal insulin suppositories in healthy humans, Int. J. Pharm. 34: 157–161.
Nishihata, T., Sudoh, M., Inagaki, H., Karnada, A., Yagi, T., Kawamori, R., and Shichiri, M., 1987, An effective formulation for an insulin suppository; examination in normal dogs, Int. J. Pharm. 38: 83–90.
Nishihata, T., Kamada, A., Sakai, K., Yagi, T., Kawamori, R., and Shichiri, M., 1989, Effectiveness of insulin suppositories in diabetic patients, J. Pharm. Pharmacol. 4: 799–801.
Nolte, M. S., Poon, V., Grodsky, G. M., Forsham, P. H., and Karam, J. H., 1983, Reduced solubility of short-acting soluble insulins when mixed with longer-acting insulins, Diabetes 32: 1177–1181.
Nolte, M. S., Taboga, C., Salamon, E., Moses, A., Longenecker, J., Flier, J., and Karam, J. H., 1990, Biological activity of nasally administered insulin in normal subjects, Horm. Metab. Res. Suppl. Ser. 22: 170–174.
Nomura, M., Kuboto, M. A., Sekiya, M., Hoshiyama, S., Imano, E., Matushima, Y., Ishimoto, I., Kawamori, R., and Kamada, T., 1990, Insulin absorption from conjunctiva studied in normal and diabetic dogs, J. Pharm. Pharmacol. 42: 292–294.
Nomura, M., Kubota, M. A., Kawamori, R., Yamasaki, Y., Kamada, T., and Abe, H., 1994, Effect of addition of hyaluronic acid to highly concentrated insulin on absorption from the conjunctiva in conscious diabetic dogs, J. Pharm. Pharmacol. 46: 768–770.
Oh, C. K., and Ritschel, W. A., 1990a, Biopharmaceutic aspects of buccal absorption of insulin, Methods Find Exp. Clin Pharmacol. 12: 205–212.
Oh, C. K., and Ritschel, W. A., 1990b, Absorption characteristics of insulin through the buccal mucosa, Methods Find Exp. Clin. Pharmacol. 12: 275–219.
Okada, H., Yamazaki, I., Yashiki, T., and Mima, H., 1983% Vaginal absorption of a potent luteinizing hormone-releasing hormone analogue (leuprolide) in rats II: Mechanism of absorption enhancement with organic acids, J. Pharm. Sci. 72: 75–78.
Okada, H., Yashiki, T., and Mima, H., 1983b, Vaginal absorption of a potent luteinizing hormone-releasing analogue (leuprolide) in rats. III. Effect of estrous cycle on vaginal absorption of hydrophilic model compounds, J. Pharm. Sci. 72: 173–176.
Okumura, K., Iwakawa, S., Yoshida, T., Seki, T., and Komada, F., 1992, Intratracheal delivery of insulin. Absorption from solution and aerosol by rat lung, Int. J. Pharm. 88: 63–73.
Oppenheim, R. C., Stewart, N. F., Gordon, L., and Patel, H. M., 1982, The production and evaluation of orally administered insulin nanoparticles, Drug Dev. Ind. Pharm. 8: 53 1–546.
Owens, D. R., Jones, M. K., Birtwell, A. J., Burge, C. T. R., Jones, I. R., Heyburn, P. J., Hayes, T. M., and Heding, L. G., 1984, Pharmacokinetics of subcutaneously administered human, porcine and bovine neutral soluble insulin to normal man, Horm. Metab. Res. 16: 195–199.
Owens, D. R., Vora, J. P., Luzio, S., and Hayes, T. M., 1988. The influence of aprotinin on regional absorption of soluble human insulin, Br. J. Clin. Pharmacol. 25: 453–456.
Pai, C. M., Bae, Y. H., Mack, E. J., Wilson, D. E., and Kim, S. W., 1992, Concanavalin A microspheres for a self-regulating insulin delivery system, J. Pharm. Sci. 81: 532–536.
Paquot, N., Scheen, A. J., Franchimont, P., and Lefebvre, P. J., 1988, The intranasal administration of insulin induces significant hypogl ycaemia and classical counterregulatory hormonal responses in normal man, Diabetes Metab. 14: 31–36.
Patel, H. M., and Ryman, B. E., 1976, Oral administration of insulin by encapsulation within liposomes, FEBS Lett. 62: 60–63.
Patel, H. M., and Ryman, B. E., 1977. Orally administered liposomally entrapped insulin, Biochem. Soc. Trans. 5: 1739–1741.
Patel, H. M., Harding, N. G. L., Logue, F., Kesson, C., MacCuish, A. C., MacKenzie, J. C., Ryman, B. E., and Scobie, I., 1978, Intrajejunal absorption of liposomally entrapped insulin in normal man Biochem. Soc. Trans. 6: 784–785.
Patel, H. M., Stevenson, R. W., Parsons, J. A., and Ryman, B. E., 1982, Use of liposomes to aid intestinal absorption of entrapped insulin in normal and diabetic dogs, Biochim. Biophys. Acta 716: 188–193.
Paton, J. S., Wilson, M., Ireland, J. T., and Reith, S. B. M., 1981, Convenient pocket insulin syringe, Lancet i: 189–190.
Patrick, A. W., Collier, A., Matthews, D. M., Macintyre, C. C. A., and Clarke, B. F., 1988, The importance of the time interval between insulin injection and breakfast in determining postprandial glycaemic control: A comparison between human and porcine insulin, Diabetic Med. 5: 32–35.
Patton, J. S., and Platz, R. M., 1992, Pulmonary delivery of peptides and proteins, Adv. Drug. Delivery Rev. 8: 179–196.
Paulsen, E. P., Courtney, J. W., III, and Duckworth, W. C., 1979, Insulin resistance caused by massive degradation of subcutaneous insulin, Diabetes 28: 640–645.
Pickup, J. C., Keen, H., Parsons, A. J., and Alberti, K. G. M. M., 1978, Continuous subcutaneous insulin infusion: An approach to achieving normoglycaemia, Br. Med J. 1: 204–207.
Pietri, A., and Raskin, P., 1981, Cutaneous complications of chronic continuous subcutaneous infusion therapy, Diabetes Care 4: 624–626.
Pillion, D. J., Bartlett, J. D., Meezan, E. Yang, M. Crain, R. J., and Grizzle, W. E., 1991, Systemic absorption of insulin delivered topically to the rat eye, Invest. Ophthalmol. Visual Sci. 32: 3021–3027.
Pillion, D. J., Atchison, J. A., Wang, R.-X., and Meezan, E., 1994a, Alkylglycosides enhance systemic absorption of insulin applied topically to the rat eye, J. Pharmacol. Exp. Ther. 271: 1274–1280.
Pillion, D. J., Atchison, J. A., Gargiulo, C., Wang, R.-X., Wang, P., and Meezan, E., 1994b, Insulin delivery in nosedrops: New formulations containing alkylglycosides, Endocrinology 135:2386–2391.
Pitt, C. G., 1990, The controlled parenteral delivery of polypeptides and proteins, Int. J. Pharm. 59:173–196.
Plevin, S., and Sadur, C., 1993, Use of a prefilled insulin syringe (Novolin Prefilled™) by patients with diabetes, Clin. Ther. 15:423–431.
Pongor, S., Brownlee, M., and Cerami, A., 1983, Preparation of high-potency, non-aggregating insulins using a novel sulfation procedure, Diabetes 32:1087–1901.
Pontiroli, A. E., and Pozza, G., 1990, Intranasal administration of peptide hormones: Factors affecting transmucosal absorption, Diabetic Med. 7:770–774.
Pontiroli, A. E., Alberetto, M., Secchi, A., Dossi, G., Bosi, I., and Pozza, G., 1982, Insulin given intranasally induces hypoglycaemia in normal and diabetic subjects, Br. Med. J. 284:303–306.
Pontiroli, A. E., Alberetto, M., Calderara, A., Pajetta, E., and Pozza, G., 1986, Metabolic effects of intranasally administered insulin and glucagon in man, in: Delivery Systems for Peptide drugs (S. S. Davis, L. Illum, and E. Tomlinson, eds.), Plenum Press, New York, pp. 243–248.
Pontiroli, A. E., Alberetto, M., Pajetta, E., Calderara, A., and Pozza, G., 1987, Human insulin plus sodium glycocholate in a nasal spray formulation: Improved bioavailability and effectiveness in normal subjects, Diabetes Metab. 13:441–443.
Pramming, S., Lauritzen, T., Thorsteinsson, B., Johansen, K., and Binder, C., 1984, Absorption of soluble and isophane semi-synthetic human and porcine insulin in insulin-dependent diabetic subjects, Acta Endocrinol. 105:215–220.
Prieto, G., Rio, J. M., Andrade, M. I. P., Sarmiento, F., and James, M. N., 1993, Interaction between sodium n-undecyl sulfate and insulin, Int. J. Biol. Macromol. 15:343–345.
Quinn, R., and Andrade, J. D., 1983, Minimizing the aggregation of neutral insulin solutions, J. Pharm. Sci. 73:1472–1473.
Ratner, R. E., and Steiner, M.L., 1987, Insulin-pump therapy: Effect of phosphate-buffered human insulin, Diabetes Care 10:787–788.
Raz, I., Bar-on, H., Kidron, M., and Ziv, E., 1984, Rectal administration of insulin, Isr. J. Med. Sci. 20:173–175.
Reeves, M. L., Seigler, D. E., Ryan, E. A., and Skyler, J. S., 1982, Glycemic control in insulin-dependent diabetes mellitus: Comparison of outpatient intensified conventional therapy with continuous subcutaneous insulin infusion, Am. J. Med. 72:637–680.
Richardson, J. L., and Illum, L., 1992, The vaginal route of peptide and protein drug delivery, Adv. Drug Delivery Rev. 8:341–366.
Richardson, J. L., Illum, L., and Thomas, N. W., 1992a, Vaginal absorption of insulin in the rat: Effect of penetration enhancers on insulin uptake and mucosal histology, Pharm. Res. 9:878+883.
Richardson, J. L., Farraj, N. F., and Illum, L., 1992b, Enhanced vaginal absorption of insulin in sheep using lysophosphatidylcholine and a bioadhesive microsphere delivery system, Int. J. Pharm. 88:319–325.
Ritschel, W. A., and Ritschel, G. B., 1984, Rectal administration of insulin, Methods Find. Exp. Clin. Pharmacol. 6:513–529.
Ritschel, W. A., Ritschel, G. B., Forusz, H., and Kraeling, M., 1989, Buccal absorption of insulin in the dog, Res. Commun. Chem. Pathol. Pharmacol. 63:53–67.
Ron, E., Turek, T., Mathiowitz, E., Chasin, M., Hageman, M., and Langer, R., 1993, Controlled release of polypeptides from polyanhydrides, Proc. Natl. Acad. Sci. USA 90:4176–4180.
Rosak, C., Burkard, G., Hoffman, J. A., Humburg, E., Look, D., and Landgraf, R., 1993, Metabolic effect and acceptance of an insulin pen treatment in 20, 262 diabetic patients, Diabetes Nutr. Metab. 6:139–145.
Rowland, R. N., and Woodley, J. F., 1981, Uptake of free and liposome-entrapped insulin by rat intestinal sacs in vitro, Biosci. Rep. 1:345–352.
Rydén, L., and Edman, P., 1992, Effect of polymers and microspheres on the nasal absorption of insulin in rats, Int. J. Pharm. 83:1–10.
Saffran, M., Kumar, G. S., Savariar, C., Burnham, J. C., Williams, F., and Neckers, D. C., 1986, A new approach to the oral administration of insulin and other peptide drugs, Science 233:1081–084.
Sage, B. H., Jr., and Riviere, J. E., 1992, Model systems in iontophoresis-transport efficacy, Adv. Drug Delivery Rev. 9:265–287.
Sakr, F. M., 1992, A new approach for insulin delivery via the pulmonary route: Design and pharmacokinetics in non-diabetic rabbits, Int. J. Pharm. 86:1–7.
Salzman, R., Manson, J. E., Griffing, G. T., Kimmerle, R., Ruderman, N., McCall, A., Stolz, E. I., Mullin, C., Small, D., Armstrong, J., and Melby, J. C., 1985, Intranasal aerosolized insulin. Mixed-meal studies and long-term use in type I diabetes, N. Engl. J. Med. 312:1078–1084.
Sandler, M., 1990, Is the lung a ‘target organ’ in diabetes mellitus? Arch. Intern. Med. 150:1385–1388.
Sandler, M., Bunn, A. E., and Stewart, R. I., 1986, Pulmonary function in young insulin-dependent diabetic subjects, Chest 90:671–675.
Sarmiento, F., Prieto, G., and Jones, M. N., 1992, Thermodynamic studies on the interaction of n-alkyl sulfates with insulin in aqueous solution, J. Chem. Soc., Faraday Trans. 88:1003–1007.
Sasaki, H., Tei, C., Yamamura, K., Nishida, K., and Nakamura, J., 1994, Effect of preservatives on systemic delivery of insulin by ocular instillation in rabbits, J. Pharm. Pharmacol. 46:871–875.
Saslawski, O., Weingarten, C., Benoit, J. P., and Couvreur, P., 1988, Magnetically responsive microspheres for the pulsed delivery of insulin, Life Sci. 42:1521–1528.
Sato, S., Jeong, S. Y., McRea, J. C., and Kim, S. W., 1984a, Glucose stimulated insulin delivery systems, PureAppl. Chem. 56:1323–1328.
Sato, S., Jeong, S. Y., McRea, J. C., and Kim, S. W., 1984b, Self-regulating insulin delivery systems. II. In vitro studies, J. Controlled Release 1:67–77.
Sato, T., Ebert, C. D., and Kim, S. W., 1983, Prevention of insulin self-association and surface adsorption, J. Pharm. Sci. 72:228–232.
Saudek, C. D., 1990, Implantable insulin pumps: A current look, Diabetes Res. Clin. Pract. 10:109–114.
Saudek, C. D., 1993, Future developments in insulin delivery systems, Diabetes Care 16:(Suppl.3):122–132.
Saudek, C. D., Fishell, R. E., and Swindle, M. M., 1990, The programmable implantable medication systems (PIMS): Design features and pre-clinical trials, Horm. Metab. Res. 22:201–206.
Schade, D. S., Eaton, R. P., Edwards, S., Doberneck, R. C., Spencer, W. J., Carlson, G. A. B., Bair, R. E., Love, J. T., Urenda, R. S., and Gaona, J. I., Jr., 1982, A remotely programmable insulin delivery system. Successful short-term implantation in man, J. Am. Med. Assoc. 247:1848–1853.
Schanker, L. S., Mitchell, E. W., and Brown, R. A., Jr., 1986, Species comparison of drug absorption from the lung after aerosol inhalation or intratracheal injection, Drug Metab. Dispos. 14:79–88.
Schildt, B., Ahlgren, T., Berghem, L., and Wendet, Y., 1978, Adsorption of insulin by infusion materials, Acta Anaesthesiol. Scand. 22:556–562.
Schilling, R. J., and Mitra, A. K., 1990, Intestinal mucosal transport of insulin, Int. J. Pharm. 62:53–64.
Schilling, R. J., and Mitra, A. K., 1992, Pharmacodynamics of insulin following intravenous and enteral administrations of porcine-zinc insulin to rats, Pharm. Res. 9:1003–1009.
Schipper, N. G. M., Verhoef, J., Romeijn, S. G., and Merkus, F. W. H. M., 1992, Absorption enhancers in nasal insulin delivery and their influence on nasal ciliary functioning, J. Controlled Release 21:173–186.
Schipper, N. G. M., Romeijn, S. G., Verhoef, J. C., and Merkus, F. W. H. M., 1993, Nasal insulin delivery with dimethyl-b-cyclodextrin as an absorption enhancer in rabbits: Powder more effective than liquid formulations, Pharm. Res. 10:682–686.
Schlichtkrull, J., 1957, The anisotropic growth of insulin crystals, Acta Chem. Scand. 11:484–486.
Schlichtkrull, J., 1959, New insulin crystal suspensions with various timings of action and containing no added zinc, in: Diabetes Mellitus III. Kongress der International Diabetes Federation 1958 (K. Oberdisse and K. Jahnke, eds.), Georg Thieme, Stuttgart, pp. 773–777.
Schlichtkrull, J., Munck, O., and Jersild, M., 1965, Insulin Rapitard and insulin Actrapid, Acta. Med. Scand. 177:103–113.
Schrezenmeir, J., Tato, F., Tato, S., Achterberg, H., Schulz, G., Strack, T., Aerssen, M., Kasper, H., and Beyer, J., 1985, Food-dependent insulin consumption, in: Computer Systems for Insulin Adjustment in Diabetes Mellitus (J. Beyer, M. Albisser, J. Schrezenmeir, and L. Lehmann, eds.), Panscienta-Verlag, Hedingen, Switzerland, pp. 43–53.
Scott, D. A., 1934, Crystalline insulin, Biochem. J. 28:1592–1602.
Scott, D. A., and Fisher, A. M., 1936, Studies on insulin with protamine, J. Pharmacol. Exp. Ther. 58:78–92.
Scott, E. R., Laplaza, A. L., White, H. S., and Phipps, J. B., 1993, Transport of ionic species in skin: Contribution of pores to the overall skin conductance, Pharm. Res. 10:1699–1709.
Scott-Moncrieff, J. C., Shao, Z., and Mitra, A. K., 1994, Enhancement of intestinal insulin absorption by bile salt-fattyacid mixed micelles in dogs, J. Pharm. Sci. 83:1465–1469.
Sefton, M. V., and Antonacci, G. M., 1984, Adsorption isotherms of insulin onto various materials, Diabetes 33:674–680.
Seigler, D. E., Olsson, G. M., Agramonte, R. F., Lohman, V. L., Ashby, M. H., Reeves, M. L., and Skyler, J. S., 1991, Pharmacokinetics of long-acting (ultralente) insulin preparations, Diabetes Nutr. Metab. 4:267–273.
Selam, J.-L., and Charles, M. A., 1990, Devices for insulin administration, Diabetes Care 13:955–979.
Selam, J.-L., Zirinis, P., Mellet, M., and Mirouze, J., 1987, Stable insulin for implantable delivery systems: In vitro studies with different containers and solvents, Diabetes Care 10:343–347.
Seminoff, L. A., Olsen, G. B., and Kim, S. W., 1989a, A self-regulating insulin delivery system. I. Characterization of a synthetic glycosylated insulin derivative, Int. J. Pharm. 54:241–249.
Seminoff, L. A., Gleeson, J. M., Zheng, J. Olsen, G. B., Holmberg, D., Mohammad, S. F., Wilson, D., and Kim, S. W., 1989b, A self-regulating insulin delivery system. II. In vivo characteristics of a synthetic glycosylated insulin, Int. J. Pharm. 54:251–257.
Shao, Z., and Mitra, A. K., 1992, Nasal membrane and intracellular protein and enzyme release by bile salts and bile salt-fatty acid mixed micelles: Correlation with facilitated drug transport, Pharm. Res. 9:1184–1189.
Shao, Z., Krishnamoorthy, R., and Mitra, A. K., 1992, Cyclodextrins as nasal absorption promotors of insulin: Mechanistic evaluations, Pharm. Res. 9:1157–1163.
Shao, Z., Li, Y., Chermak, T., and Mitra, A. K., 1994a, Cyclodextrins as mucosal absorption promotors of insulin. II. Effects of b-cyclodextrin derivatives on a-chymotryptic degradation and enteral absorption of insulin in rats, Pharm. Res. 11:1174–1179.
Shao, Z., Li, Y., and Mitra, A. K., 1994b, Cyclodextrins as mucosal absorption promotors of insulin. III. Pulmonary route of delivery, Eur. J. Pharm. Biopharm. 40:283–288.
Shenfield, G. M., and Hill, J. C., 1982, Infrequent response by diabetic rats to insulin-liposomes, Clin. Exp. Pharmacol. Physiol. 9:355–361.
Shichiri, M., Yamasaki, Y., Kawamori, R., Kikuchi, M., Hakui, N., and Abe, H., 1978, Increased absorption of insulin: An insulin suppository, J. Pharm. Pharmacol. 30:806–808.
Shiino, D., Murata, Y., Kataoka, K., Koyama, Y., Yokoyama, M., Okana, T., and Sakurai, Y., 1994, Preparation and characterization of a glucose-responsive insulin-releasing polymer device, Biomaterials 15:121–128.
Siddiqui, O., Sun, Y., Liu, J.-C., and Chien, Y. W., 1987, Facilitated transdermal transport of insulin, J. Pharm. Sci 76:341–345.
Siegel, R. A., and Firestone, B. A., 1990, Mechanochemical approaches to self-regulating insulin pump design, J. Controlled Release 11:181–192.
Siegel, R. A., and Langer, R., 1984, Controlled release of polypeptides and other macromolecules, Pharm. Res. 1:2–10.
Siegel, R. A., Falamarzian, M., Firestone, B. A., and Moxley, B. C., 1988, pH-controlled release from hydrophobic/polyelectrolyte copolymer hydrogels, J. Controlled Release 8:179–182.
Sinay, I. R., Schlimovich, S., Damilano, S., Cagide, A. L., Faingold, M. C., Facco, E. B., Gurfinkiel, M. S., and Arias, P., 1990, Intranasal insulin administration in insulin dependent diabetes: Reproducibility of its absorption and effects, Horm. Metab. Res. Suppl. Ser. 22:307–308.
Sindelka, G., Heinemann, L., Berger, M., Frenck, W., and Chantelau, E., 1994, Effect of insulin concentration, subcutaneous fat thickness and skin temperature on subcutaneous insulin absorption in healthy subjects, Diabetologia 37:377–380.
Singh, J., and Maibach, H. I., 1993, Topical iontophoretic drug delivery in vivo: Historical development, devices and future perspectives, Dermatology 187:235–238.
Singh, M., Vasudevan, P., Sinha, T. J. M., Ray, A. R., Misro, M. M., and Guha, K., 1981, An insulin delivery system from oxidized cellulose, J. Biomed. Mater. Res. 15:655–661.
Sluzky, V., Tamada, J. A., Klibanov, A. M., and Langer, R., 1991, Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces, Proc. Natl. Acad. Sci. USA 88:9377–9381.
Sluzky, V., Klibanov, A. M., and Langer, R., 1992, Mechanism of insulin aggregation and stabiization in agitated aqueous solutions, Biotechnol. Bioeng. 40:895–903.
Smith, P. L., Wall, D. A., Gochoco, C. H., and Wilson, G., 1992. Oral absorption of peptides and proteins, Adv. Drug Delivery Rev. 8:253–290.
Spangler, R. S., 1990, Insulin administration via liposomes, Diabetes Care 13:911–922.
Spraul, M., Chanteleau, E., Koumoulidou, J., and Berger, M., 1988, Subcutaneous or nonsub-cutaneous injection of insulin, Diabetes Care 11:733–736.
Steiner, D. F., 1967, Evidence for a precursor in the biosynthesis of insulin, Trans. N.Y; Acad. Sci. 30(Ser. II):60–68.
Steiner, D. F., Hallund, O., Rubenstein, A., Cho, S., and Bayliss, C., 1968, Isolation and properties of proinsulin, intermediate forms, and other minor components from crystalline bovine insulin, Diabetes 17:725–736.
Stephen, R. L., Petelenz, T. J., and Jacobsen, S. C., 1984, Potential novel methods for insulin administration: I. Iontophoresis, Biomed. Biochim. Acta 43:553–558.
Stevenson, R. W., Patel, H. M., Parsons, J. A., and Ryman, B. E., 1982, Prolonged hypoglycemic effect in diabetic dogs due to subcutaneous administration of insulin in liposomes, Diabetes 31:506–511.
Storm, M. C., and Dunn, M. F., 1985, The Glu(B13) carboxylates of the insulin hexamer form a cage for Cd2+ and Ca2+ ions, Biochemistry 24:1749–1756.
Su, K. S. E., 1991, Nasal route of peptide and protein drug delivery, in: Peptide and Protein Drug Delivery (V. H. L. Lee, ed.), Marcel Dekker, New York, pp. 595–631.
Sudmeier, J. L., Bell, S. J., Storm, M. C., and Dum, M. F., 1981, Cadmium-113 nuclear magnetic resonance studies of bovine insulin: Two-zinc hexamer specifically binds calcium, Science 212:560–562.
Susstrunk, H., Morell, B., Ziegler, W. H., and Froesch, E. R., 1982, Insulin absorption from the abdomen and the thigh in healthy subjects during rest and exercise: Blood glucose, plasma insulin, growth hormone, adrenaline and noradrenaline levels, Diabetologia 22:171–174.
Tabata, Y., Takebayashi, Y., Ueda, T., and Ikada, Y., 1993, A formulation method using D,L-lactic acid oligomer for protein release with reduced initial burst, J. Controlled Release 23:55–64.
Tachibana, K., 1992, Transdermal delivery of insulin to alloxan-diabetic rabbits by ultrasound exposure, Pharm. Res. 9:952–954.
Tachibana, K., and Tachibana, S., 1991, Transdermal delivery of insulin by ultrasonic vibration, J. Pharm. Pharmacol. 43:270–271.
Takeyama, M., Ishida, T., Kokubu, N., Komada, F., Iwakawa, S., Okumura, K., and Hori, R., 1991, Enhanced bioavailability of subcutaneously injected insulin by pretreatment with ointment containing protease inhibitors, Pharm. Res. 8:60–64.
Tamborlane, W. V., Sherwin, R. S., Genel, M., and Felig, P., 1979, Reduction to normal of plasma glucose in juvenile diabetes by subcutaneous administration of insulin with a portable infusion pump, N. Engl. J. Med. 300:573–578.
Taylor, R., Home, P. D., and Alberti, K. G. M. M., 1981, Plasma free insulin profiles after administration of insulin by jet and conventional syringe injection, Diabetes Care 4:377–379.
Thow, J. C., Johnson, A. B., Antsiferov, M., and Home, P. D., 1989, Effect of raising injection-site skin temperature on isophane (NPH) insulin crystal dissociation, Diabetes Care 12: 432–434.
Thow, J. C., Johnson, A. B., Fulcher, G., and Home, P. D., 1990, Different absorption of isophane (NPH) insulin from subcutaneous and intramuscular sites suggests a need to reassess recommended insulin injection technique, Diabetic Med. 7:600–602.
Thurow, H., 1980, Studies on the denaturation of dissolved insulin, in: Insulin. Chemistry Structure and Function of Insulin and Related Hormones (D. Brandenburg and A. Wollmer, eds.), de Gruyter, Berlin, pp. 215–221.
Thurow, H., and Geisen, K, 1984, Stabilisation of dissolved proteins against denaturation at hydrophobic interfaces, Diabetologia 27:212–218.
Touitou, E., and Donbrow, M., 1983, Promoted rectal absorption of insulin: Formulative parameters involved in the absorption from hydrophilic bases, Int. J. Pharm. 15: 13–24.
Touitou, E., and Rubinstein, A., 1986, Targeted enteral delivery of insulin to rats, Int. J. Pharm. 30:95–99.
Touitou, E., Donbrow, M., and Azaz, E., 1978, New hydrophilic vehicle enabling rectal and vaginal absorption of insulin, heparin, phenol red and gentamicin, J. Pharm. Pharmacol. 30:662–663.
Touitou, E., Donbrow, M., and Rubinstein, A., 1980, Effective intestinal absorption of insulin in diabetic rats using a new formulation approach, J. Pharm. Pharmacol. 32: 108–110.
Touitou, E., Alhaique, F., Fisher, P., Memoli, A., Riccieri, F. M., and Santucci, E., 1987, Prevention of molecular self-association by sodium salicylate: Effect on insulin and 6-carboxfluorescein, J. Pharm. Sci. 76:791–793.
Tunbridge, F. K. E., Newens, A., Home, P. D., Davis, S. N., Murphy, M., Burrin, J. M., Alberti, K. G. M. M., and Jensen, I., 1989, Double-blind crossover trial of isophane (NPH)-and lente-based insulin regimens, Diabetes Care 12:115–119.
Ushiwata, A., Nakaya, K., and Nakamura, Y., 1975, Interaction between proteins and detergents which contains a hydrocarbon chain longer than 16 carbon atoms. II. Difference spectra of various proteins in cetyldimethyl-benzylammonium chloride, Biochim. Biophys. Acta 393:215–224.
Verhoef, J. C., Schipper, N. G. M., Romeijn, S. G., and Merkus, F. W. H. M., 1994, The potential of cyclodextrins as absorption enhancers in nasal delivery of peptide drugs, J. Controlled Release 29:351–360.
Vora, J. P., and Owens, D. R., 1991, Future trends in insulin therapy: Clinical implications of novel insulin analogues and nasal administration of insulin, in: Pharmacology of Diabetes. Present Practice and Future Perspectives (C. E. Mogensen and E. Standl, eds.), de Gruyter, Berlin, pp. 39–56.
Vora, J. P., Owens, D. R., Dolben, J., Atiea, J. A., Dean, J. D., Kang, S., Burch, A., and Brange, J., 1988, Recombinant DNA derived monomeric insulin analogue: Comparison with soluble human insulin in normal subjects, Br. Med. J. 297:1236–1239.
Wall, D. A., 1995, Pulmonary absorption of peptides and proteins, Drug Delivery 2:1–20.
Walters, D. P., Smith, P. A., Marteau, T. M., Brimble, A., and Borthwick, L. J., 1985, Experience with NovoPen, an injection device using cartridged insulin, for diabetic patients, Diabetic Med. 2:496–497.
Wang, P. Y., 1987, Prolonged release ofinsulin by cholesterol-matrix implant, Diabetes 36:1068–1072.
Wang, P. Y., 1989a, Lipids as excipient in sustained release insulin implants, Int. J. Pharm. 54:223–230.
Wang, P. Y., 1989b, Implantable reservoir for supplemental insulin delivery on demand by external compression, Biomaterials 10:197–201.
Wang, P. Y., 1991a, Sustained-release implants for insulin delivery, in: Biotechnology of Insulin Therapy (J. C. Pickup, ed.), Blackwell Scientific, Oxford, pp. 42–74.
Wang, P. Y., 1991b, Palmitic acid as an excipient in implants for sustained release of insulin, Biomaterials 12:57–62.
Wang, P. Y., 1993, Control of hyperglycaemia in diabetic rabbits by a combination of implants, J. Biomed. Eng. 15:106–112.
Wehner, H., Huber, H., and Kronenberg, K. H., 1973, The glomerular basement membrane of the rabbit kidney on long-term treatment with heterologous insulin preparations of different purity, Diabetologia 9:255–263.
Weiner, A. L., Carpenter-Green, S. S., Soehngen, E. C., Lenk, R. P., and Popescu, M. C., 1985, Liposome-collagen gel matrix: A novel sustained drug delivery system, J. Pharm. Sci. 74:922–925.
Weingarten, C., Moufti, A., Desjeux, J. F., Luong, T. T., Durand, G., Devissaguet, J. P., and Puisieux, F., 1981, Oral ingestion of insulin liposomes: Effect of the administration route, Life Sci. 28:2747–2752.
Wiefels, K., Kuglin, B., Hübinger, A., Jorgensen, L. N., and Gries, F. A., 1993, Insulin kinetics and dynamics in insulin-dependent diabetic patients after injections of human insulin or the insulin analogues X14 and X14 + Zn, in: Frontiers in Insulin Pharmacology (M. Berger and F. A. Gries, eds.), Thieme Verlag, Stuttgart, pp. 97–101.
Wigley, F. M., Londono, J. H., Wood, S. H., Shipp, J. C., and Waldman, R. H., 1971, Insulin across respiratory mucosae by aerosol delivery, Diabetes 20:552–556.
Williams, G., Pickup, J. C., Bowcock, S., Cooke, E., and Keen, H., 1983, Subcutaneous aprotinin causes local hyperaemia. A possible mechanism by which aprotinin improves control in some diabetic patients, Diabetologia 24:91–94.
Woodley, J. F., 1986, Liposomes for oral administration of drugs, Crit. Rev. Ther. Drug Carrier Syst. 21–18.
Woodley, J. F., and Prescott, A. R., 1988, Body distribution of liposome-entrapped 125I-labelled insulin after oral administration to rats, Biochem. Soc. Trans. 16:343–344.
Yagi, T., Hakui, N., Yamasaki, Y., Kawamori, R., Shichiri, M., Abe, H., Kim, S., Miyake, M., Kamikawa, K., Nishihata, T., and Kamada, A., 1983, Insulin suppository: Enhanced rectal absorption of insulin using an enamine derivative as a new promotor, J. Pharm. Pharmacol. 35: 177–178.
Yamakawa, I., Kawahara, M., Watanabe, S., and Miyake, Y., 1990, Sustained release of insulin by double-layered implant using poly(d,l-lactic acid), J. Pharm Sci. 79:505–509.
Yamamoto, A., Luo, A. M., Dodda-Kashi, S., and Lee, V. H. L., 1989, The ocular route for systemic insulin delivery in the albino rabbit, J. Pharmacol. Exp. Ther. 249:249–255.
Yamamoto, A., Hayakawa, E., and Lee, V. H. L., 1990, Insulin and proinsulin proteolysis in mucosal homogenates of the albino rabbit: Implications in peptide delivery from nonoral routes, Life Sci. 47:2465–2474.
Yamamoto, A., Hayakawa, E., Kato, Y., Nishiura, A., and Lee, V. H. L., 1992, A mechanistic study on enhancement of rectal permeability to insulin in the albino rabbit, J. Pharmacol. Exp. Ther. 263:25–31.
Yamamoto, A., Umemori, S., and Muranishi, S., 1994, Absorption enhancement of intrapulmonary administered insulin by various absorption enhancers and protease inhibitors in rats, J. Pharm. Pharmacol. 46:14–18.
Yamasaki, Y., Shichiri, M., Kawamori, R., Shigeta, Y., and Abe, H., 1978, Efficacy of rectal administration of insulin in diabetic dogs, J. Jpn. Diabetes Soc. 21:249–252.
Yamasaki, Y., Shichiri, M., Kawamori, R., Kikuchi, M. Yagi, T., Arai, S., Tohdo, R., Hakui, N., Oji, N., and Abe, H., 1981a The effectiveness of rectal administration of insulin suppository on normal and diabetic subjects, Diabetes Care 4:454–458.
Yamasaki, Y., Shichiri, M., Kawamori, R., Morishima, T., Hakui, N., Yagi, T., and Abe, H., 1981b, The effect of rectal administration of insulin on the short-term treatment of alloxan-diabetic dogs, Can. J. Physiol. Pharmacol. 59: 1–6.
YoKosuka, T., Omori, Y., Hirata, Y., and Hirai, S., 1977, Nasal and sublingual administration of insulin in man, J. Jpn. Diabetes Soc. 20:146–152.
Yoshida, H., Okumura, K., Hori, R., Anmo, T., and Yamaguchi, H., 1979, Absorption of insulin delivered to rabbit trachea using aerosol dosage form, J. Pharm. Sci. 68:670–671.
Zhou, X. H., 1994, Overcoming enzymatic and absorption barriers to non-parenterally administered protein and peptide drugs, J. Controlled Release 29:239–252.
Zhou, X. H. and Po, A. L. W., 1991, Effects of cholic acid and other enhancers on the bioavailability of insulin from a subcutaneous site, Int. J. Pharm. 69:29–41.
Zinman, B., 1989, The physiologic replacement of insulin: An elusive goal, N. Engl. J. Med. 321:363–370.
Ziv, E., Kidron, M., Berry, E. M., and Bar-on, H., 1981, Bile salts promote the absorption of insulin from the rat colon, Life Sci. 29:803–809.
Ziv, E., Kleinman, Y., Bar-on, H., and Kidron, M., 1984, Treatment of diabetic rats with enteral insulin, in: Lessons from Animal Diabetes (E. Shafrir and A. E. Renold, eds.), Libbey, London, pp. 642–647.
Ziv, E., Lior, O., and Kidron, M., 1987, Absorption of protein via the intestinal wall. A quantitative model, Biochem. Pharmacol 36:1035–1039.
Ziv, E., Kidron, M., Raz, I., Krausz, M., Blatt, Y., Rotman, A., and Bar-on, H., 1994, Oral administration of insulin in solid form to nondiabetic and diabetic dogs, J. Pharm. Sci. 83:792–794.
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Brange, J., Langkjær, L. (2002). Insulin Formulation and Delivery. In: Sanders, L.M., Hendren, R.W. (eds) Protein Delivery. Pharmaceutical Biotechnology, vol 10. Springer, Boston, MA. https://doi.org/10.1007/0-306-46803-4_13
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