Recently, significant progress has been made in exploring the application of 1,2-pentanediol in bioequivalence studies of topical skin products. In response to the strict requirements of EMA's new guidelines on bioequivalence, this study innovatively uses 1,2-pentanediol as a penetration enhancer to construct a new type of reference formulation.
    Using pig ear skin as the experimental model, the study systematically investigated the effects of different concentrations of 1,2-pentanediol through Franz diffusion cells, CRS detection, tape stripping and other methods. The results showed that 20% concentration of 1,2-pentanediol can make the 90% confidence interval of the reference formulation completely exceed the 80%-125% standard by disrupting the stratum corneum lipid structure, regulating thermodynamic activity and increasing skin moisture retention, meeting EMA's guideline requirements. Meanwhile, the CRS method is highly consistent with the traditional tape stripping results with higher precision, providing a new path for non-destructive bioequivalence testing.
    1,2-pentanediol has multiple functions of preservation, moisturizing and penetration enhancement. This study verifies its feasibility in replacing the traditional dilution method to construct reference formulations. As a high-quality supplier of this raw material, Hi-Tech Spring's cosmetic-grade 1,2-pentanediol has been widely used in the beauty and pharmaceutical fields.

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