Abstract
This chapter outlines the general product development principles and performance evaluation of different Development of dermal delivery systems mainly from a biopharmaceutics perspective. Tests for dermal drug products are divided into two categories: those that assess general product quality attributes, and those that assess product performance, e.g., in vitro release of the drug substance from the drug product. A performance test for topical drug products must have the ability to measure drug release from the finished dosage form for a quality control purpose. Product performance tests can serve many useful purposes in product development and in post-approval drug product monitoring. Product performance tests for semisolid drug products are conducted to assess drug release from the pharmaceutical dosage forms. The amount of drug that permeates over time through the skin is measured by collecting samples from the receptor phase at different time intervals and assaying the samples.
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