کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2480514 1556189 2014 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms
چکیده انگلیسی

Excipients encompass a wide range of properties that are of importance for the resulting drug product. Regulatory guidelines on biowaivers for immediate release formulations require an in depth understanding of the biopharmaceutic effects of excipients in order to establish bioequivalence between two different products carrying the same API based on dissolution tests alone. This paper describes a new approach in evaluating biopharmaceutic excipient effects. Actually used quantities of a model excipient, lactose, formulated in combination with APIs from different BCS classes were evaluated. The results suggest that companies use different (relative) amounts depending on the characteristics of the API. The probability of bioinequivalence due to a difference in lactose content between test and reference products was classified as low for BCS class I APIs and medium for BCS class II and III APIs, whereas a high probability was assigned to the combination of lactose and BCS class IV APIs. If repeated for other excipients, this retrospective, top-down approach may lead to a new database and more widespread applications of the biowaiver approach.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: European Journal of Pharmaceutical Sciences - Volume 61, 30 September 2014, Pages 27–31
نویسندگان
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