Quality by design approaches for topical dermatological dosage forms
نویسندگان
چکیده
منابع مشابه
Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms
The pharmacokinetic approach used for the BE assessment of systemically absorbed drugs is not considered appropriate to study the bioavailability (BA) and/or BE of topically applied drugs other than dosage forms such as transdermal patches and other products intended for local application which contain drugs intended for the systemic circulation. Apart from the analytical difficulty of measurin...
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ceutical dosage forms. They serve as carriers for drugs that are topically delivered by way of the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue, urethral membrane, and external ear lining (1). Because of their peculiar rheological behavior, semisolids can adhere to the application surface for sufficiently long periods before they are washed off. This property helps prolong d...
متن کاملQuality by Design for ANDAs: An Example for Immediate-Release Dosage Forms
Although we have tried to make this example as realistic as possible, the development of a real product may differ from this example. The example is for illustrative purposes and, depending on applicants’ experience and knowledge, the degree of experimentation for a particular product may vary. The impact of experience and knowledge should be thoroughly explained in the submission. The risk ass...
متن کاملChallenges obtaining a biowaiver for topical veterinary dosage forms.
Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However, the skin of domestic animals varies anatomically and biochemically and experimental approaches to assess bioequivalence (BE) in veterinary species have challenges that are not often encountered with human skin. This is especially the situation with locall...
متن کاملDiffusion of preservatives from topical dosage forms: a comparative study.
A study of the diffusion of parabens from topical formulations is presented here. In particular, four different topical formulations, namely, a water-in-oil emulsion, an oil-in-water emulsion, and two hydrophilic gels (Pemulen gel and Carbopol gel) were produced, containing a mixture of three common parabens, namely, methylparaben (MP), ethylparaben (EP), and propylparaben (PP). An analytical m...
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ژورنال
عنوان ژورنال: Research and Reports in Transdermal Drug Delivery
سال: 2015
ISSN: 2253-1580
DOI: 10.2147/rrtd.s82739