In vitro release testing (IVRT) is an FDA required test used to support post-approval manufacturing changes in compliance with SUPAC-SS requirements. IVRT is used in topical generic drug development as an accepted method of comparison to brand products. During topical drug product development, IVRT may be used to profile the performance characteristics of several prototypes formulations as a screening tool.
Tergus has a large bank of 120+ vertical Franz diffusion cells to support IVRT studies. We have developed specialized testing protocols to meet the needs of clients with challenging APIs. Our team has expertise in the design of discriminatory IVRT methods.
Similar to a dissolution apparatus utilized for release evaluation of solid dosage forms, the Franz diffusion cell is used for release evaluation of semi-solids. An appropriate synthetic membrane is selected based on the API and dosage form. This membrane is mounted onto the diffusion cell, separating the donor and receptor compartments. The receptor compartment is filled with a physiologically relevant solution, such as phosphate buffered saline, or a modified media containing solvents depending on drug solubility. The donor compartment is loaded with the formulation and sample aliquots are taken from the receptor media at selected time points. After analysis of drug content, a release profile over time is obtained.
Our IVRT Services Include:
- Analytical method development, validation, and testing
- Testing to support generic product development
- BA/BE waiver
- Support scale-up for product development