Author(s) :

Dr. Sushama G. Vaishnav, Dr. G. A. Vaishnav.

Volume/Issue :

Abstract :

Topical formulation development is governed by a number of regulatory agencies, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The three main types of topical formulations are ointments, creams, and gels. The FDA recommends that only active pharmaceutical ingredients (APIs) be included in topical formulations. These include transdermal patches, liposomal preparations, and microparticulate systems. Topical formulations are easy to use and generally welltolerated by patients. The FDA has strict guidelines for the development and testing of topical products. Failure to comply with these regulations can result in delays or rejection of your product. In this section, we share some recipes for common topical formulations, such as lotions, creams, gels, and ointments.

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