Products Applied to the Skin - Quality Attributes and Performance Tests

CDR SEMINAR SERIES
Margareth Marques

March 7, 2018

Principal scientific liaison at the Science Department at the United States Pharmacopeia. Scientific liaison to the USP Expert Committee on Dosage Forms working on general chapters for performance tests (dissolution/drug release), and for some pharmaceutical dosage forms (products applied to the skin, ophthalmic products, etc.), responsible for the USP general chapters on osmolality, titrimetry, and UV/Vis spectrophotometry. 

Dr. Marques is also responsible for developing specifications for reagents, test solutions, buffer solutions, etc., used in USP – NF monographs. She manages the USP database on chromatographic columns, the USP database on dissolution methods and the USP web site on column equivalency. She has a B.Sc. and an M. Sc. both in Pharmacy by the University of Sao Paulo, Brazil. She has a Ph. D. in Analytical Chemistry by the State University of Campinas, Brazil. She managed analytical laboratories at Ciba-Geigy, Sandoz, and Astra.

Abstract:

We will discuss the quality attributes that are typically evaluated for products applied to the skin (creams, gels, ointments, pastes, suspensions, lotions, foams, sprays, aerosols, solutions and transdermal systems). Ophthalmic products will be very briefly discusses because several of the dosage forms applied to the skin can be applied to the eye with additional quality attributes. Some of the procedures used to evaluated the in vitro release of the drugs from the dosage forms applied to the skin will be also presented.