A Review on In-Vitro Release Testing Methods for Topical Dosage Forms

Author(s): Seelam Jayadev and Ismail. Y*


IVRT is an in-vitro release testing parameter which determines release of drug from the topical dosage form. By using this IVRT tool we can determine the product similarity between the 2 similar semisolid dosage forms (reference and test products). The similarity between the 2 formulations should be in the limit of 75%-133.33% as per the FDASUPAC- SS guidance. To check the similarity among the reference and test product we have to validate the test product. To initiate the IVRT method validation performing laboratories should be certified, equipped and chartered, maintenance and control of the study facility environment and systems. Qualification and calibration of the instruments used for the validation activity shall be certified as per the USP semi solid drug products-performance tests. To check release of API released from a dosage form a validated quantification method is required.

image 10.4303/JDAR/236274

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