Microbiological considerations when selecting excipients during product development

American Pharmaceutical Review

Volumn 7, Issue 4, 2004, Pages 34-39

  Montgomery, Eda Ross ^a   Manu Tawiah, Wireko ^b  

^a Vertex Pharmaceuticals Company

^b Global Quality Analytical Development New Products

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; EXCIPIENT; GINSENG EXTRACT;

ANTIMICROBIAL ACTIVITY; DRUG CONTAMINATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SYNTHESIS; EXPIRATION DATE; MICROBIAL CONTAMINATION; QUALITY CONTROL; REVIEW;

EID: 4544372278     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (24)

1. Payne, D.N. (1990). Microbiological Ecology of the Production Process. In Guide to Microbiological Control in Pharmaceutical, Denyer, S. and Baird, R. (eds), p. 53-56.
2. Grigo, J. (1976). Microorganisms in Drugs and Cosmetics: Occurrence, Harms and Consequences in Hygienic Manufacturing. Zentbl. Bakt. Hyg. Abt. I Orig, B., 162: 233-287
3. Baggerman, C. and Kannegieter L.M. (1984). Microbiological Contamination of Raw Materials for Large Volume Parenterals. Appl. Environ. Microbiol. 48: 662-664.
4. USP <1111>, Microbiological Attributes of Nonsterile Pharmaceutical Articles. Pharmacopeial Forum, Vol 5(2), p. 7786-7787, 1999.
5. Orth, D.S. and Milstein, S.R. (1989). Rational Development of Preservative Systems for Cosmetic Products, Cosmet. Toilet. 104(11) 91, 92, 94-100, 102, 103.
6. Van Doorne, H. (1990). Interactions Between Preservatives and Pharmaceutical Components. In Guide to Microbiological Control in Pharmaceuticals, Denyer S. and Baird R. (eds),p. 274-291.
7. Richard, R.M.E. and Mcbride, R.J. (1973). Enhancement of Benzalkonium Chloride and Chlorhexidine Acetate Activity Against Pseudomonas Aeroginosa by Aromatic Alcohols J. Pharma Sci.; 62: 2035-2037.
8. Van Doorne, H. and Dubois, F.L. (1980). The Preservation of Lanette Wax Cream. Pharm. Weekbl. Sci. Ed.; 2: 19-24.
9. Handbook of Pharmaceutical Excipients, Kibbe A.H. (Ed). 2000; p. 54.
10. McCarthy, T.J. (1969). The Influence of Insoluble Powders on Preservatives in Solution. J. Mond. Pharm. 4: 321-329.
11. Yousef R.T., El-Nakeeb, M.A., and Salama, S. (1973). Effect of Some Pharmaceutical Materials on the Bacteriostastic and Bactericidal Activity of Benzalkonium Chloride. Pharmaz. Ind. 35: 154-156.
12. Toama, M.A., Mahrom, H., El-Fatatry, H.M. and Swealem, A.A. (1981). Microbiological Studies of Saccharin-sodium Methyl, Propyl and Butyl Parabens Interactions. Pharmaz. Ind.; 43: 874-877.
13. Royce, A. and Sykes, G. (1957). Loss of Bacteriostats from Injections in Rubber Closed Containers. J. Pharm. Pharmacpl.; 9: 814-823.
14. Harris, WA. (1961). The Inactivation of Cationic Antiseptics by Bentonite Suspension, Aust. J. Pharm. Pharmacol.; 42: 583-588.
15. Hussian, M.A., Angust, B.J., Maurin, M.B., and Wu, L.S. (1991). Injectable Suspensions for Prolonged Release Nalbuphine, Drug Dev. Ind. Pharm.; 17: 67-76.
16. Khan, K.A. and Rhoda, C.T. (1975). Evaluation of Different Viscosity Grades of Sodium Carboxymethylcellulose as Tablet Disintegrant, Pharm Acta Helv; 50: 99-102.
17. Khan, K.A. and Rhodes, C.T. (1975). Water-sorption Properties of Tablet Disintegrants. J. Pharm. Sci.; 64: 447-451.
18. Friedel, R.R. and Cundell, A.M. (1998). The Application of Water Activity Measurement to Microbiological Attributes Testing of Non-sterile Over-the-counter Drug Product. Pharmacopieal Forum, 24(2): 6087-6090.
19. Davison, A.L. (1990). Microbial Standards for Pharmaceuticals. In Denyer and Baird (eds). Guide to Microbiological Control in Pharmaceuticals. Ellis Horwood, New York, (1990) p.356-365.
20. Microbiological Examination of Non-sterile Products (Total Viable Aerobic Count and Test for Specific Microorganisms). (Section 2.6.12 to 2.6.13) European Pharmacopoeia 3rd Edition 2000 supplement, 52-60.
21. Microbial Limit Tests <61>, U.S. Pharmacopoeia 24 & National Formulary 19: 1814-1818.
22. Manu-Tawiah, W, Brescia, B., and Montgomery, E.R. (2001). Setting Threshold Limits for the Significance of Objectionable Microorganisms in Oral Pharmaceutical Product. PDA Journal of Pharmaceutical Science and technology, Vol 55 (3), p. 171-175.
23. Orth, D.S. (1990). Principle of Preservation. In Guide to Microbiological Control in Pharmaceuticals, Denyer S. and Baird, R. (eds.), p. 243.
24. The 1998 USP Microbiology Updates. Elite MicroSource, Fairfield, NJ.