Understanding and predicting pharmaceutical product shelf-life

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Volumn 9780387856278, Issue , 2009, Pages 115-135

  Waterman, Kenneth C ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78649935523     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-0-387-85627-8_6     Document Type: Chapter

References (13)

1. ICH Harmonised Tripartite Guideline: Stability Testing of New Drug Substances and Products, http://www.ich.org/LOB/media/MEDIA419.pdf.
2. Singhal, D.; Curatolo, W. Drug polymorphism and dosage form design: a practical perspective. Adv. Drug Delivery Rev. 56 (3) (2004) 335-347.
3. Airaksinen S, Karjalainen M, Shevchenko A, Westermarck S, Leppanen E, Rantanen J, Yliruusi J (2005) Role of water in the physical stability of solid dosage formulations. J Pharm Sci 94(10):2147-2165.
4. Bauer M (2005) Stability of drug substances and drug products: considerations on the stability of drug substances and formulation in the pharmaceutical industry domain. STP Pharma Pratiques, 15(3):232-246.
5. Carstensen JT (2000) Solution kinetics. Drugs Pharm Sci 107 (Drug Stability) pp. 19-55.
6. Guerrieri P, Salameh AK, Taylor LS (2007) Effect of small levels of impurities on the water vapor sorption behavior of ranitidine HCl. Pharm Res 24(1):147-156.
7. Guillory JK, Poust RI (2002) Chemical kinetics and drug stability. Drugs Pharm Sci 121 (Modern Pharmaceutics, 4th Edition) pp. 139-166.
8. Li S, Wei B, Fleres S, Comfort A, Royce A (2004) Correlation and prediction of moisturemediated dissolution stability for benazepril hydrochloride tablets. Pharm Res 21(4):617-624.
9. Pogocki D, Schoneich C (2000) Chemical stability of nucleic acid-derived drugs. J Pharm Sci 89(4):443-456.
10. Waterman KC, Adami RC (2005) Accelerated aging: prediction of chemical stability of pharmaceuticals. Inter J Pharm 293:101-125.
11. Waterman KC, Adami RC, Alsante KM, Antipas AS, Arenson DR, Carrier R, Hong J, Landis MS, Lombardo F, Shah JC, Shalaev EY, Smith SW, Wang H (2002) Hydrolysis in pharmaceutical formulations. Pharm Dev Tech 7:113-146.
12. Waterman KC, Adami RC, Alsante KM, Hong J, Landis MS, Lombardo F, Roberts CJ (2002) Stabilization of pharmaceuticals to oxidative degradation. Pharm Dev Tech 7:1-32.
13. Waterman KC, Carella AJ, Gumkowski MJ, Lukulay P, MacDonald BC, Roy MC, Shamblin SL (2007) Improved protocol and data analysis for accelerated shelf-life estimation of solid dosage forms. Pharm Res 24(4):780-790.