Biomaterials in Their Role in Creating New Approaches for the Delivery of Drugs, Proteins, Nucleic Acids, and Mammalian Cells

Abstract

The use of biomaterials to enable and enhance life-saving therapies in medicine has its documented roots in the 1600s. Historically, drugs were administered systemically for acute emergency situations. As injectable drug technologies developed, it was soon observed that drug administration would often be more effective if given in sustained-release or tailored-release profiles. However, the potential safety risks of drugs administered by these novel devices and biomaterials were also quickly realized. This chapter will examine the documented evolution of the delivery of such compounds, the challenges encountered, and the solutions developed to address the need for safe delivery of drugs, proteins, and cells for human use. Each biomaterial-based drug delivery system is unique to the drug, peptide, or protein employed in the system. Therefore, this chapter will focus on the safety considerations along with the therapeutic efficacy offered by this evolving developing area of therapeutics.

Keywords

Human Insulin Insulin Glargine Therapeutic Protein Insulin Analogue Insulin Detemir 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References and Further Reading

  1. Adagen® Package Insert, Enzon Pharmaceuticals (2008)Google Scholar
  2. Alconcel SN, Baas AS, Maynard HD (2011) FDA-approved poly(ethylene glycol)-protein conjugate drugs. Poly Chem 2:1442–1448CrossRefGoogle Scholar
  3. Anthony L, Freda PU (2009) From somatostatin to octreotide LAR: evolution of a somatostatin analogue. Curr Med Res Opin 25(12):2989–2999PubMedCrossRefGoogle Scholar
  4. Atala A, Bauer SB, Soker S, Yoo JJ, Retik AB (2006) Tissue-engineered autologous bladders for patients needing cystoplasty. Lancet 367(9518):1241–1246PubMedCrossRefGoogle Scholar
  5. Avramis VI, Panosyan EH (2005) Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet 44(4):367–393PubMedCrossRefGoogle Scholar
  6. Banting FG, Best CH (1922) The internal secretion of the pancreas. J Lab Clin Med 8(5):1–16Google Scholar
  7. Berg P, Baltimore D, Bowyer HW, Cohen SN, Hogness DS, Nathans D et al (1974) Potential biohazards of recombinant DNA molecules. Proc Natl Acad Sci USA 71(7):2593–2594CrossRefGoogle Scholar
  8. Biological Evaluation of Medical Devices (2007) Retrieved from International Organization of Standardization. http://www.iso.org/iso/home.htm
  9. Blundell J (1829) Successful case of transfusion. Lancet 1:431–432Google Scholar
  10. Bourges JL, Bloquel C, Thomas A, Froussart F, Bochot A, Azan F et al (2006) Intraocular implants for extended drug delivery: therapeutic applications. Adv Drug Deliv Rev 58:1182–1202PubMedCrossRefGoogle Scholar
  11. Brown LR (2005) Commercial challenges of protein drug delivery. Expert Opin Drug Deliv 2(1):29–42PubMedCrossRefGoogle Scholar
  12. Brown L, Munoz C, Siemer L, Edelman E, Langer R (1986) Controlled release of insulin from polymer matrices: control of diabetes in rats. Diabetes 35(6):692–696PubMedCrossRefGoogle Scholar
  13. Bunck MC, Diamant M, Cornér A, Eliasson B, Malloy JL, Shaginian RM et al (2009) One-year treatment with exenatide improves β-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients. Diabetes Care 32(5):762–768PubMedCrossRefGoogle Scholar
  14. Burger C, Kabir K, Rangger C, Mueller M, Minor T, Tolba RH (2006) Polylactide (LTS) causes less infammation response than polydioxanone (PDS): a meniscus repair model in sheep. Arch Orthop Trauma Surg 126(10):695–705PubMedCrossRefGoogle Scholar
  15. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Duport P et al (2002) Pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Eng J Med 346(7):469–475CrossRefGoogle Scholar
  16. Center for Devices and Radiological Health (2010) U.S. Food and Drug Administration. Retrieved August 31, 2011, from guidance for industry and FDA staff—non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071863.htm
  17. Choonara YE, Pillay V, Danckwerts MP, Carmichael TR, Du Toit LC (2010) A review of implantable intravitreal drug delivery technologies for the treatment of posterior segment eye diseases. J Pharm Sci 99(5):2219–2239PubMedCrossRefGoogle Scholar
  18. Code of Federal Regulations, Title 21 (2005) Product Jurisdication. Retrieved July 25, 2011, from electronic code of federal regulations. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=72ed5148597167f34fa56953ede7b0cf&rgn=div8&view=text&node=21:1.0.1.1.3.1.31.2&idno=21
  19. Dailey G, Rosenstock J, Moses RG, Ways K (2004) Insulin Glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care 27:2363–2368PubMedCrossRefGoogle Scholar
  20. DeFelippis MR, Bakaysa DL, Bell MA, Heady MA, Li S, Pye S et al (1988) Preparation and characterization of a cocrystalline suspension of [LysB28, ProB29]-human insulin analogue. J Pharm Sci 87(2):170–176CrossRefGoogle Scholar
  21. Dippenaar JM (2007) Local anaesthetic toxicity. South Afr J Anesth Analg 13(3):23–28Google Scholar
  22. Duckworth WC, Bennett RG, Hamel FG (1998) Insulin degradation: progress and potential. Endocr Rev 19(5):608–624PubMedCrossRefGoogle Scholar
  23. Ellis-Behnke RG, Liang YX, You SW, Tay DK, Zhang S, So KF et al (2006) Nano neuro knitting: peptide nanofiber scaffold for brain repair and axon regeneration with functional return of vision. Proc Natl Acad Sci USA 103(13):2006CrossRefGoogle Scholar
  24. Erichen JE (1874) Hospitalism and the causes of death after operations. Br. Med J. 1:65–67CrossRefGoogle Scholar
  25. European Medicines Agency (2006) Concept paper on guideline on immunogenicity of therapeutic proteins. European Medicines Agency, London, Doc. Ref. EMEA/CHMP/BMWP/246511/2005Google Scholar
  26. Fire A, Xu S, Montgomery MK, Kostas SA, Driver SE, Mello CC (1998) Potent and specific genetic interference by double-stranded RNA in Caenorhabditis elegans. Nature 391:806–811PubMedCrossRefGoogle Scholar
  27. Fischer J, Edelman S, Schwartz S (2008) United States patient preference and usability for new disposable insulin device Solostar® versus other disposible pens. J Diabetes Sci Technol 2(6):1157–1160PubMedGoogle Scholar
  28. Fry DW, Richardson KE (1979) Isolation and characterization of glycolic acid dehydrogenase from human liver. Biochim Biophys Acta (BBA) Enzymol 567(2):482–491CrossRefGoogle Scholar
  29. Fung AE, Lalwani GA, Rosenfeld PJ, Dobovy SR, Michels S, Feuer WJ et al (2007) An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular Age-related macular degeneration. Am J Ophthalmol 143(2):566–583PubMedCrossRefGoogle Scholar
  30. Gillies PS, Figgitt DP, Lamb HM (2000) Insulin gIargine. Drugs 59:199–260Google Scholar
  31. Hagedorn HC, Jensen BN, Wodstrup K, Karup NB (1936) Protamine insulinate. J Am Med Assoc 106(3):177–180CrossRefGoogle Scholar
  32. Hallas-Moller K, Jersild M, Peterson K, Schlichtkrull J (1952) Insulin preparations for single daily injection, clinical studies of new preparations with prolonged action. J Am Med Assoc 150(17):1667–1671CrossRefGoogle Scholar
  33. Heathcote EJ, Shiffman ML, Cooksley WG, Dusheiko GM, Lee SS, Balart L et al (2000) Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 343(23):1673–1680PubMedCrossRefGoogle Scholar
  34. Home PD, Barriocanal L, Lindholm A (1999) Comparative pharmacokinetics and pharmacodynamics of the novel rapid acting insulin analogue, insulin aspart, in healthy volunteers. Eur J Clin Pharmacol 55:199–203PubMedCrossRefGoogle Scholar
  35. Hwang CW, Wu D, Edelman ER (2001) Physiological transport forces govern drug distribution for stent-based delivery. Circulation 104:600–605PubMedCrossRefGoogle Scholar
  36. Indepdence Blue Cross (2010) Self-injectable drug list. Retrieved August 31, 2011, from Indepdence Blue Cross. http://www.ibx.com/pdfs/providers/communications/update/supplementary/self_injectable_druglist_ibc.pdf
  37. International Organization for Standardization (2010) Biological evaluation of medical devices, parts 1–20. International Organization for Standardization, GenevaGoogle Scholar
  38. Kessler M, Goldsmith D, Schellekens H (2006) Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant 21(Suppl 5):v9–v12PubMedCrossRefGoogle Scholar
  39. Knobil E (1990) The GnRH pulse generator. Am J Obstet Gynecol 163:1721–1727PubMedGoogle Scholar
  40. Kozlowski A, Harris JM (2001) Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Control Release 72:217–224PubMedCrossRefGoogle Scholar
  41. Lancranjan I, Bruns C, Grass P, Jaquet P, Jervell J, Kendall-Taylor P et al (1996) Sandostatin LAR®: pharmacokinetics, pharmacodynamics, efficacy, and tolerability in acromegalic patients. Metabolism 44(S1):18–26Google Scholar
  42. Landsteiner K (1900) Zur kenntnis der antifermentativen, lytischen und agglutinierenden wirkungen des blutserums und der lymphe. Centralbl Bakteriol 27:357–362Google Scholar
  43. Leacock JH (1817) On transfusion of blood in extreme cases of haemorrhage. Med Chir J Rev 3:276–284Google Scholar
  44. Learoyd P (2006) A short history of blood transfusion. Scientific and Technical Training, STT-042Google Scholar
  45. Levemir® Insulin Detemir (rDNA) Injection, Package Insert Novo NordiskGoogle Scholar
  46. Lister J (1867) On the antiseptic principle in the practise of surgery. Br Med J 2(351):246–248PubMedCrossRefGoogle Scholar
  47. Lower R (1932). Tractatus de corde item de motu et colore sanguinis et chyli in cum transitu (1669). In: Gunther RT (ed) Early science in Oxford: biological sciences and biological collections, Facsimile edn. Dawsons Pall Mall, London, p 9Google Scholar
  48. Luzio SD, Beck P, Owens DR (2003) Comparison of the subcutaneous absorption of insulin glargine (Lantus) and NPH insulin in patients with type 2 diabetes. Diabetes Care 35(7):434–438Google Scholar
  49. Lv H, Zhang S, Wang B, Cui S, Yan J (2006) Toxicity of cationic lipids and cationic polymers in gene delivery. J Control Release 114(1):100–109PubMedCrossRefGoogle Scholar
  50. Macdougall IC, Padhi D, Jang G (2007) Pharmacology of darbepoetin alfa. Nephrol Dial Transplant 22(4):iv2–iv9PubMedCrossRefGoogle Scholar
  51. Meade KR, Silver FH (1990) Immunogenicity of collagenous implants. Biomaterials 11(3):176–180PubMedCrossRefGoogle Scholar
  52. Mehvar R (2000) Modulation of the pharmacokinetics and pharmacodynamics of proteins by polyethylene glycol conjugation. J Pharm Sci 3(1):125–136Google Scholar
  53. Morice M-C, Serruys PW, Barragan P, Bode C, Van Es G-A, Stoll HP et al (2007) Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol 50(14):1299–1304PubMedCrossRefGoogle Scholar
  54. Morrow JF, Cohen SN, Chang AC, Boyer HW, Goodman HM, Helling RB (1974) Replication and transcription of eukaryotic DNA in Escherichia coli. Proc Natl Acad Sci USA 71(5):1743–1747PubMedCrossRefGoogle Scholar
  55. Naik G (2011) Lab-made trachea saves man. The Wall Street Journal, July 8Google Scholar
  56. Neulasta® Package Insert, Amgen, Inc. (2002)Google Scholar
  57. Nutropin Depot Package Insert (1999)Google Scholar
  58. Nutropin Depot®, Genentech, Inc. (2002)Google Scholar
  59. Office of combination products Food and Drug Administration (2011) Classification of products as drugs and devices & additional product classification issues. Retrieved from FDA. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM258957.pdf
  60. Okada H (1997) One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv Drug Deliv Rev 28(1):43–70PubMedCrossRefGoogle Scholar
  61. Overbay DK, Manley HJ (2002) Darbepoetin-alpha: a review of the literature. Pharmacotherapy 22(7):889–897PubMedCrossRefGoogle Scholar
  62. R&D Directorate Report No. 54 (1996) Coserelin or other gonadotrophin releasing hormone (GnRH) analogues in the treatment of advanced prostate cancer. NHS executive south and west, report to the development and evaluation committeeGoogle Scholar
  63. Retisert Package Insert, Bausch & Lomb (2009)Google Scholar
  64. Russel-Jones D (2009) Molecular, pharmacological and clinical aspects of liraglutide, a once-daily human GLP-1 analogue. Mol Cell Endocrinol 297:137–140CrossRefGoogle Scholar
  65. Rynd F (1845) Neuralgia - introduction of fluid to the nerve. Dublin Medical Press 13:167–168.Google Scholar
  66. Scarpignato C, Pelonsini IS (2001) Somatostatin analogs for cancer treatment and diagnosis: an overview. Chemotherapy 47(2):1–29PubMedCrossRefGoogle Scholar
  67. Schmidt PJ, Leacock AG (2002) Forgotten transfusion history: John Leacock of Barbados. Br Med J 325:1485–1487CrossRefGoogle Scholar
  68. Schorr MR (1966) Needles, some points to think about. Curr Res Anesth Analg 45(4):509–513Google Scholar
  69. Schreiber I, Buchfelder M, Droste M, Forssmann K, Mann K, Saller B et al (2007) Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: safety and efficacy evaluation from the German pegvisomant observational study. Eur J Endocrinol 156:75–82PubMedCrossRefGoogle Scholar
  70. Siegel JD, Rhinehart E, Jackson M, Chiarello L (2007) 2007 Guidelines for isolation precaustions: preventing transmission of Infectious agents in healthcare settings. Retrieved from Center for Disease Control. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf
  71. Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L (1987) Intravascular stents to prevent occlusion and re-stenosis after transluminal angioplasty. N Engl J Med 316:701–706PubMedCrossRefGoogle Scholar
  72. Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T et al (2003) Biodegradable stents as a platform to drug loading. Int J Cardiovasc Intervent 5(1):13–16PubMedGoogle Scholar
  73. Veronese FM (2001) Peptide and protein PEGylation: a review of problems and solutions. Biomaterials 22(5):405–417PubMedCrossRefGoogle Scholar
  74. Vitrasert Package Insert, Bausch & Lomb (2003)Google Scholar
  75. Warner B, Worgul TJ, Drago J, Demers L, Dafau M, Max D et al (1983) Effect of very high dose d-leucine6-gonadotropin-releasing hormone proethylamide on the hypothalmic-pituitary testicular axis in patients with prostatic cancer. J Clin Invest 71(6):1842–1853PubMedCrossRefGoogle Scholar
  76. Watson E, Jonker DM, Jaconsen LV, Ingwersen SH (2010) Opulation pharmacokinetics of liraglutide, a once-daily human glucagon-like peptide-1 analog, in healthy volunteers and subjects with type 2 diabetes, and comparison to twice-daily exenatide. J Clin Pharmacol 50(8):886–894PubMedCrossRefGoogle Scholar
  77. Wood A (1855) New methods of treating neuralgia by the direct of opiates to the painful points. Edinburgh Med Surg J 16:265–281Google Scholar
  78. Yew NS, Scheule RK (2005) Toxicity of cationic lipid-DNA complexes. Adv Genet 53:189–214PubMedCrossRefGoogle Scholar
  79. Yilin C, Vacanti JP, Paige KT, Upton J, Vacanti C (1997) Transplantation of chondrocytes utilizing a polymer-cell construct to produce tissue-engineered cartilage in the shape of a human ear. Plast Reconstr Surg 100(2):297–302CrossRefGoogle Scholar
  80. Zabner J, Fasbender AJ, Moninger T, Poellinger KA, Welsh MJ (1995) Cellular and molecular barriers to gene transfer by a cationic lipid. J Biol Chem 270:18997–19007PubMedCrossRefGoogle Scholar
  81. Zhang S (2003) Fabrication of novel biomaterials through molecular self-assembly. Nat Biotechnol 21(10):1171–1178PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.MITCambridgeUSA

Personalised recommendations