Project Summary
This research systematically reverse-engineered the commercially available progesterone vaginal gel, Crinone®, to establish a comprehensive quality assessment and provide a scientific foundation for developing generic equivalents. Using various analytical techniques, the study characterized critical quality attributes—including globule size, crystalline state, thermal properties, rheology, and in vitro drug release—across three commercial batches. The analysis confirmed that progesterone is uniformly dispersed in the stable crystalline form (Form I) within a non-Newtonian, shear-thinning, elastic gel matrix. Crucially, all three batches demonstrated statistical equivalence in their sustained drug release profiles over 48 hours. The detailed physicochemical and functional profile obtained will be instrumental in the regulatory assessment and development of bioequivalent generic progesterone vaginal gels.
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