In-vitro release rate testing (IVRT) is a useful performance test for topical dosage forms such as creams, ointments, gels and lacquers.

IVRT tests can be used to support product development through rapid comparative IVRT screening of multiple formulations and/or batches. Subsequently, IVRT can be used to confirm release acceptance criteria and to support stability claims. Also, IVRT can be used to compare batches when post-approval changes in composition, manufacturing process or manufacturing site are required, as per FDA’s SUPAC-SS guidance.

ASI can also perform skin permeation studies using animal or cadaver skin and Franz Diffusion Cells.

ASI has extensive experience and expertise developing and validating IVRT methods.

Well-developed IVRT methods are:

• Specific to matrix
• Sensitive to changes in formulation components and composition
• Sensitive to changes in manufacturing process
• Sensitive to particle size differences in API used to manufacture the product
• Proportional to strength

ASI offers a complete IVRT method development package that includes:

• membrane selection
• selection of receiving medium
• development of analytical methodology for the analysis of IVRT samples

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