No Heading
The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) presents this paper in order to contribute to public discussion regarding best approaches to foreign particles testing in orally inhaled and nasal drug products (OINDPs) and to help facilitate development of consensus views on this subject. We performed a comprehensive review of industry experience and best practices regarding foreign particles testing in OINDPs, reviewed current guidances and techniques, and considered health and safety perspectives. We also conducted and assessed results of an industry survey on U.S. Food and Drug Administration requirements for foreign particles testing. We provide here a result of our review and survey: a summary of industry best practices for testing and controlling foreign particles in OINDPs and proposals for developmental characterization and quality control strategies for foreign particles. We believe that clear consensus-based recommendations and standards for foreign particles testing and control in OINDPs are needed. The proposals contained in this paper could provide a starting point for developing such consensus recommendations and standards.
Similar content being viewed by others
References
1. G. Oberdorster, J. Ferin, and B. E. Lehnert. Correlation between particle size, in vivo particle persistence, and lung injury. Environ. Health Perspect. 102:173–179 (1994).
2. J. Heyder, J. Gebhart, G. Rudolf, C. F. Schiller, and W. Stahlhofen. Deposition of particles in human respiratory tract on the size range 0.005-15 μm. J. Aerosol Sci. 17:811–825 (1986).
3. Task Group of the International Commission on Radiological Protection. Human Respiratory Tract Model for Radiological Protection. Annals ICRP 66, 1994.
4. O. G. Raabe, M. A. Al-Bayati, S. V. Teague, and A. Rasolt. Regional deposition of inhaled monodisperse course and fine aerosols in small laboratory animals. Ann. Occup. Hyg. 32:53–63 (1988).
5. M. J. Tobin, T. S. Chadha, G. Jenouri, et al. Breathing Patterns. 2. Diseased Subjects. Chest 84:286–294 (1983).
6. J. Hamoir, A. Nemmar, D. Halloy, D. Wirth, G. Vincke, A. Vanderplasschen, B. Nemery, and P. Gustin. Effect of polystyrene particles on lung microvascular permeability in isolated perfused rabbit lungs: role of size and surface properties. Toxicol. Appl. Pharmacol. 190:278–285 (2003).
7. D. M. Brown, M. R. Wilson, W. MacNee, V. Stone, and K. Donaldson. Size-dependent proinflammatory effects of ultrafine polystyrene particles: a role for surface area and oxidative stress in the enhanced activity of ultrafines. Toxicol. Appl. Pharmacol. 175:191–199 (2001).
8. G. Oberdorster. Pulmonary effects of inhaled ultrafine particles. Int. Arch. Occup. Environ. Health 74:1–8 (2001).
9. J. Ferin, G. Oberdorster, and D. P. Penney. Pulmonary retention of ultrafine and fine particles in rats. Am. J. Respir. Cell Mol. Biol. 6:535–542 (1992).
10. K. Philipson, R. Falk, M. Svartengren, N. Jarvis, M. Bailey, R. Bergmann, W. Hofmann, and P. Camner. Does lung retention of inhaled particles depend on their geometric diameter? Exp. Lung Res. 26:437–455 (2000).
11. D. Lison, C. Lardot, F. Huaux, G. Zanetti, and B. Fubini. Influence of particle surface area on the toxicity of insoluble manganese dioxide dusts. Arch. Toxicol. 71:725–729 (1997).
12. R. Hauser, J. J. Godleski, V. Hatch, and D. C. Christiani. Ultrafine particles in human lung macrophages. Arch. Environ. Health 56:150–156 (2001).
13. S. A. Murphy, K. A. BeruBe, F. D. Pooley, and R. J. Richards. The response of lung epithelium to well characterised fine particles. Life Sci. 62:1789–1799 (1998).
14. K. T. Whitby, R. E. Charlson, W. E. Wilson, and R. K. Stevens. The size of suspended particulate matter in air. Science 183:1098–1099 (1974).
15. D. W. Dockery, C. A. Pope III, and X. Xu. An association between air pollution and mortality in six U.S. cities. N. Engl. J. Med. 329:1753–1759 (1993).
16. C. A. Pope III, M. J. Thun, M. M. Namboodiri, et al. Particulate air pollution as a predictor of mortality in a prospective study of US adults. Am. J. Respir. Crit. Care Med. 151:669–674 (1995).
17. H. J. Humecki. Practical Guide to Infrared Microspectroscopy, Marcel Dekker, New York, 1995.
18. R. G. Messerschmidt and M. A. Harthcock. Infrared Microspectroscopy: Theory and Applications, Marcel Dekker, New York, 1988.
19. J. I. Goldstein, et al. Scanning Electron Microscopy and X-Ray Microanalysis, Kluwer Academic/Plenum Publishers, New York, 2003.
20. W. C. McCrone, L. B. McCrone, and J. G. Delly. Polarized Light Microscopy, McCrone Research Institute, Chicago, 1999.
21. W. C. McCrone, et al. The Particle Atlas Electronic Edition, MicroDataware, Hayward, CA, 1993.
22. J. Hunt. Particularly clean. Precision Cleaning Magazine 8 (2000).
23. Particle Counting in Parenteral Solutions. Applications Note 40-09/01, Particle Measuring Systems, Inc., Boulder, CO, 2001.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Blanchard, J., Coleman, J., Hayling, C. et al. Foreign Particles Testing in Orally Inhaled and Nasal Drug Products. Pharm Res 21, 2137–2147 (2004). https://doi.org/10.1007/s11095-004-7665-7
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11095-004-7665-7