کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10161977 | 1114310 | 2015 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are reviewed to evaluate whether a waiver of in vivo bioequivalence (BE) testing of immediate-release (IR) dosage forms formulated as tablets and soft gelatin capsules is warranted. Nifedipine's solubility and permeability, its therapeutic use and index, pharmacokinetics, food drug interactions, and any reported BE/bioavailability problems were all taken into consideration. Solubility and BA data indicate conclusively that nifedipine is a class II substance of biopharmaceutics classification system (BCS) and that the formulation of drug product plays a key role on the dissolution characteristics of the API. Therefore, a BCS biowaiver-based approval of nifedipine containing IR oral dosage forms cannot be recommended for reformulated/new multisource drug products or for major scale-up and postapproval changes to the existing drug products. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3259-3288, 2015
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 104, Issue 10, October 2015, Pages 3289-3298
Journal: Journal of Pharmaceutical Sciences - Volume 104, Issue 10, October 2015, Pages 3289-3298
نویسندگان
Jayachandar Gajendran, Johannes Krämer, Vinod P. Shah, Peter Langguth, James Polli, Mehul Mehta, D.W. Groot, Rodrigo Cristofoletti, Bertil Abrahamsson, Jennifer B. Dressman,