Dissolution Method Development for Immediate Release Solid Oral Dosage Forms
نویسندگان
چکیده
منابع مشابه
A Strategy for Quality Control Dissolution Method Development for Immediate-Release Solid Oral Dosage Forms
Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. The method development and selection process remains subjective due to the po...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: ibuprofen.
Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: lamivudine.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing lamivudine as the only active pharmaceutical ingredient were reviewed. The solubility and permeability data of lamivudine as well as its therapeutic index, its pharmacokinetic properties, data indicating excipient interac...
متن کاملBiowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a "worst case" approach, ribavirin ...
متن کاملBiowaiver monographs for immediate release solid oral dosage forms: prednisone.
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing prednisone are reviewed. Due to insufficient data prednisone cannot be definitively classified according to the current Biopharmaceutics Classification System (BCS) criteria as both the solubility and the permeability of ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Dissolution Technologies
سال: 2005
ISSN: 1521-298X
DOI: 10.14227/dt120305p12