A comprehensively validated IVRT method reliably discriminates sameness and differences between several topical clotrimazole creams

Eur J Pharm Sci. 2023 Nov 20:106649. doi: 10.1016/j.ejps.2023.106649. Online ahead of print.ABSTRACTIn vitro release testing (IVRT) has gained increasing acceptance for use as a biowaiver for topical products intended for local action. Whereas the United States Food and Drug Administration (US FDA) has issued product specific guidances (PSGs) recommending IVRT for several products, the PSG for clotrimazole cream does not include an IVRT option. However, an important requirement to include supplemental selectivity in the validation process as described in the recent FDA draft guidance on IVRT studies for topical drug products has generally been conspicuously absent in the published literature describing the application of IVRT as a biowaiver. Supplemental selectivity involves the comparison of a reference product and altered formulations containing the same strength of the active pharmaceutical ingredient (API). In order to demonstrate supplemental selectivity, cream formulation containing the same API (clotrimazole), at the same strength (1%) and in the same dosage form (cream) but manufactured using different excipients were used. This will help assess the impact that excipients may have on the release rate of clotrimazole and whether the method is capable of identifying differences in the microstructure and arrangement of matter (Q3) as an important performance parameter. In addition, products containing <30% or >40% clotrimazole to serve as negative controls were als...
Source: European Journal of Pharmaceutical Sciences - Category: Drugs & Pharmacology Authors: Source Type: research