The safety of pharmaceutical excipients

Farmaco

Volumn 58, Issue 8, 2003, Pages 541-550

  Pifferi, Giorgio ^a   Restani, Patrizia ^b  

^a Inst Pharmaceutical/T   (Italy)

^b Dept of Pharmacological Sciences ^*  (Italy)

Author keywords

Pharmaceutical excipients; Safety; Toxicity

Indexed keywords

4 HYDROXYBENZOIC ACID ESTER; ANESTHETIC AGENT; ANTIINFECTIVE AGENT; ANTIOXIDANT; BACTERICIDE; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; BUTYLATED HYDROXYANISOLE; BUTYLCRESOL; CHLORBUTOL; COLORING AGENT; CORTICOSTEROID; DIAZEPAM; ERYTHROMYCIN; EXCIPIENT; FREON; FUNGICIDE; GLIADIN; GLYCEROL; HALOGENATED HYDROCARBON; HALOTHANE; LACTOSE; MACROGOL; ORGANOMERCURY COMPOUND; PETROLATUM; PRESERVATIVE; SOLVENT; SULFANILAMIDE; SULFITE; THIOMERSAL; UNINDEXED DRUG;

ALLERGY; ANGIONEUROTIC EDEMA; ASTHMA EXACERBATION; BRADYCARDIA; BRAIN TOXICITY; BRONCHOSPASM; CARCINOMA; CARDIOTOXICITY; CONTACT DERMATITIS; DELAYED HYPERSENSITIVITY; DERMATITIS; DISEASE CARRIER; DRUG BIOAVAILABILITY; DRUG CONTAMINATION; DRUG FATALITY; DRUG FORMULATION; DRUG HYPERSENSITIVITY; DRUG IMPURITY; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG QUALITY; DRUG RELEASE; DRUG SAFETY; DRUG SOLUBILITY; DRUG USE; ECZEMA; FOOD INDUSTRY; GENETIC PREDISPOSITION; HEADACHE; HEART ARRHYTHMIA; HIGH RISK POPULATION; HUMAN; HYPERPLASIA; HYPOTENSION; LIVER INJURY; METHEMOGLOBINEMIA; MOLECULAR WEIGHT; NAUSEA; NEUROTOXICITY; NONHUMAN; PHYSICAL CHEMISTRY; PRURITUS; REVIEW; SIDE EFFECT; SKIN IRRITATION; SOMNOLENCE; TERATOGENICITY; THORAX PAIN; THROMBOPHLEBITIS; TOXICITY; URTICARIA; VOMITING;

EID: 0038160840     PISSN: 0014827X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0014-827X(03)00079-X     Document Type: Article

References (48)

1. Morton's, The Nurse Dictionary, 24th ed. Faber & Faber, London, 1957
2. Dorland's Medical Dictionary, 25th ed., W.B. Saunders, Philadelphia, PA, 1974.
3. Winek C.L. History of excipient safety and toxicity. Drugs Pharm.Sci. 103:2000;59.
4. Blecher L. Pharm. Technol. 15:1991;54.
5. G. Pifferi, Eccipienti ieri e oggi, Rapporti GSIRS no. 96-97, Milan, 27 November, 1996.
6. M.G. Vellvè, The global excipient market: future trends and challenges, Pharmaceutical Techn. Europe, June 2000, pp. 20-24.
7. P. Crowley, C. Martini, Drug-excipient interactions, Pharmaceutical Techn. Europe, March 2001, pp. 26-34.
8. Baldrick P. Pharmaceutical excipient development: the need for clinical guidance. Regul. Toxicol. Pharmacol. 32:2000;210.
9. M.S. Lesney, More than just the sugar in the pill, Today's Chemist at Work, January 2001, pp. 38-43.
10. Pifferi G., Santoro P., Pedrani M. Quality and functionality of excipients. Farmaco. 54:1999;1.
11. Weiner M.L., Katkoskie L.A. Excipient toxicity and safety. Drugs and Pharmaceutical Sciences. 1999;Marcel Dekker, New York.
12. G. Pifferi, La sicurezza degli eccipienti, Rapporti GSISR no. 9-10, Milan, 22 May, 2001.
13. E.M.K. Geiling, P.R. Cannon, J. Am. Med. Assoc. (1938) 916.
14. Starting Materials for Pharmaceuticals: Control and Safe Trade, WHO PHARM/98.605.
15. R.C. Moreton, Aspects relating to excipient quality and specifications, Pharmaceutical Techn. Europe, December 1999, pp. 26-31.
16. Int. Pharm. Excipients Council, Practice Guide for Bulk Pharmaceutical Excipients, 1997.
17. GMP: Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients, WHO Technical Report Series no. 885.
18. Impurities: Guideline for Residual Solvents, ICH Harmonized Tripartite Guideline, July 1997.
19. Pifferi G., Mannucci A. Drug impurities: problems and regulations. Boll. Chim. Farm. 138:1999;500.
20. Ipec Europe, Good Distribution Practice - A New Challenge to Improve Excipient Safety, Pharmaceutical Techn. Europe, October 2000, pp. 21-24.
21. Pifferi G. Compatibilità chimico-fisica tra tiocolchicoside e farmaci antinfiammatori non steroidei. Boll. Chim. Farm. 132:1993;203.
22. Indrayanto G., Mugihardjo M., Handanyi R. Drugs Dev. Int. Pharm. 20:1994;911.
23. Botha S., Lotter A. Drugs Dev. Int. Pharm. 16:1990;1945.
24. Czaja J., Mielck J.B. Pharm. Acta Helv. 57:1982;153.
25. The Safety Committee of the Int. Pharmaceutical Excipients Council, Regul. Toxicol. Pharmacol. 24 (1996) 149.
26. IPEC-Europe, European Pharmaceutical Review, November 1997, pp. 13-20.
27. JEFCA, Joint FAO/WHO Expert Committee on Food Additives, 22nd Technical Report Series (1989) 776. JEFCA, Joint FAO/WHO Expert Committee on Food Additives, 33rd Technical Report Series, 1995, p. 859. JEFCA, Joint FAO/WHO Expert Committee on Food Additives, 51st Technical Report Series, 2000, p. 891.
28. Jameson W.A., Guill M.F., Wray B.B. Metabisulfite sensitivity: case report and literature review. Annals of Allergy. 54:1985;115.
29. American Academy of Pediatrics, 'Inactive' ingredients in pharmaceutical products, Pediatrics 99 (1997) 268.
30. Golightly L.K., Smolinske S.S., Bennett M.L., Sutherland E.W. III, Rumack B.H. Pharmaceutical excipients: adverse effects associated with inactive ingredients in drug products. Med. Toxicol (Pt. I). 3:1988;126.
31. Golightly L.K., Smolinske S.S., Bennett M.L., Sutherland E.W. III, Rumack B.H. Pharmaceutical excipients: adverse effects associated with inactive ingredients in drug products. Med. Toxicol (Pt. II). 3:1988;209.
32. Miller J.R. Sensitivity to contact lens solutions. West. J. Med. 140:1984;791.
33. Fagan D.G., Pritchard J.S., Clarkson T.W. Organ mercury levels in infants with omphaloceles treated with organic mercurial antiseptic. Arch. Dis. Childhood. 52:1977;962.
34. Garriot J., Petty C.S. Clin. Toxicol. 16:1980;305.
35. Aviado D.M. Toxicology. 3:1975;321.
36. Lockey S.D. Am. Allergy. 29:1971;461.
37. Pollock I., Young E., Stoneham M., Slater N., Wilkinson J.D., Warner J.O. Survey of colouring and preservatives in drugs. Br. Med. J. 299:1989;649.
38. Napke E., Stevens D.G.H. Excipients and additives: hidden hazards in drug products and in product substitution. Can. Med. Assoc. J. 131:1984;1449-1451.
39. Larsen W.G. Perfum dermatitis. J. Am. Acad. Dermatol. 12:1985;1.
40. Levenson S.D., et al. Gastroenterology. 89:1985;1.
41. S. Ettinger, Krause's Food, Nutrition, and Diet Therapy. Chapter 3, Saunders Company Philadelphia, 2000, p. 37.
42. European Commission, 97/534/EC, Brussels (1997).
43. de Jong H.J. The safety of pharmaceutical excipients. Therapie. 54:1999;11.
44. Scott A.W. Non-medicinal ingredients. Drug Saf. 5:(Suppl. 1):1990;95.
45. Wade A., Weller P. Handbook of Pharmaceutical Excipients. 2nd ed. 1994;American Pharmaceutical Association, Washington, DC.
46. Artiges A. Excipients: regulatory aspects. Therapie. 54:1999;15.
47. Steinberg M., Barzelleca J.F., Enters E.K., Kinashita F.K., Lopez A., Mitchell D.B., Tamulinas C.B., Weiner M.L. A new approach to the safety assessment of pharmaceutical excipients. Regul. Toxicol. Pharmacol. 24:1996;149.
48. Barzelleca J.F. Development of safety evaluation guidelines. Drugs Pharm. Sci. 103:2000;101.