Perspectives on Physicochemical and In Vitro Profiling of Ophthalmic Ointments.
Perspectives on Physicochemical and In Vitro Profiling of Ophthalmic Ointments.
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DOI：
10.1007/s11095-018-2513-3
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发表时间：
2018-10-15
影响因子：
3.7
通讯作者：
Burgess DJ
中科院分区：
文献类型：
--
作者：
Bao Q;Burgess DJ
Ophthalmic ointments are unique in that they combine features of topical drug delivery, the ophthalmic route and ointment (semisolid) formulations. Accordingly, these complex formulations are challenging to develop and evaluate and therefore it is critically important to understand their physicochemical properties as well as their in vitro drug release characteristics. Previous reports on the characterization of ophthalmic ointments are very limited. Although there are FDA guidance documents and USP monographs covering some aspects of semisolid formulations, there are no FDA guidance documents nor any USP monographs for ophthalmic ointments. This review summarizes the physicochemical and in vitro profiling methods that have been previously reported for ophthalmic ointments. Specifically, insight is provided into physicochemical characterization (rheological parameters, drug content and content uniformity, and particle size of the API in the finished ointments) as well as important considerations (membranes, release media, method comparison, release kinetics and discriminatory ability) in in vitro drug release testing (IVRT) method development for ophthalmic ointments.
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Chattaraj, SC;Kanfer, I
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Kanfer, I
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Bao, Quanying;Newman, Bryan;Burgess, Diane J.
通讯作者：
Burgess, Diane J.
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Zatz, JL