Basis for using moisture vapor transmission rate per unit product in the evaluation of moisture-barrier equivalence of primary packages for solid oral dosage forms

Pharmacopeial Forum

Volumn 31, Issue 1, 2005, Pages 262-269

  Barry, J ^a   Bergum, J ^a   Chen, Y ^b   Chern, R ^a   Hollander, R ^c   Klein, D ^d   Lockhart, H ^e   Malinowski, D ^c   McManus, R ^a   Moreton, C ^a   Mueller, A ^d   Nottingham, L ^b   Okeke, Claudia ^f,h   O'Reilly, D ^g   Rinesmith, K ^a   Shorts, S ^a  

^a Wyeth ^*  (United States)

^b ABBOTT LABORATORIES   (United States)

^c PFIZER

^d CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^e MICHIGAN STATE UNIVERSITY   (United States)

^f UNIVERSITY OF SÃO PAULO   (Brazil)

^g Medtronic

^h UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33746598592     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Review

References (3)

1. FDA Guidance for Industry, Container-Closure Systems for Packaging Human Drugs and Biologies, Section III G, "Solid Oral Dosage Forms and Powders for Reconstitution," May 1999, 33.
2. S.I.F. Badawy, A.J. Gawronski, and F.J. Alvarez. Application of sorption-desorption moisture transfer modeling to the study of chemical stability of a moisture-sensitive drug product in different packaging configurations. Int J Pharm. 2001;223:1-13.
3. C. Ahlneck and G. Zografi. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid state. Int J Pharm. 1990;62:87-95.