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COMPARATIVE DISSOLUTION STUDY OF A SOLID PHARMACEUTICAL FORM CONTAINING NANOSTRUCTURED LIPID CARRIER (NLC) INCORPORATING DIOSGENIN – CONVENTIONAL VERSUS BIORELEVANT DISSOLUTION MEDIA

ANCA LUCIA POP 1#, SIMONA CRIȘAN 1,2#, PAULA HENTEȘ 2, MARIANA-ANA PALI 2, IOANA LĂCĂTUȘU 3, NICOLETA BADEA 3, ANNE-MARIE CIOBANU 1, BOGDANA ADRIANA NĂSUI 4*, OVIDIU NICOLAE PENEȘ 5, DENISA IOANA UDEANU 1

1Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 6 Traian Vuia Street, 020945, Bucharest,
Romania
2R&D Center, AC HELCOR, Victor Babeș Street, 430082, Baia Mare, Romania
3The Polytechnic University of Bucharest, Faculty of Applied Chemistry and Materials Science, 1 Polizu Street, 011061, Bucharest, Romania
4Department of Community Health, “Iuliu Hațieganu” University of Medicine and Pharmacy, 6 Louis Pasteur Street, 400349, Cluj-Napoca, Romania
5Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, 37 Dionisie Lupu Street, 020021, Bucharest, Romania

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The present study aims to test the in vitro bioavailability of diosgenin (DSG) from a solid finished pharmaceutical form containing nanostructured lipid carrier (NLC) that incorporates wild yam (Dioscorea villosa L.) standardized plant extract. The dissolution study was performed in (a) conventional and (b) special dissolution media - that closely reproduce the stomach and intestinal fluids composition. DSG has revealed a high potential of bioactivities, a growing interest in various disorders - cancer, hypercholesterolemia, menopausal disorders, inflammation, and several types of infections, but with low aqueous solubility and enhanced hydrophobicity. The role of the NLC formulation is to increase the bioavailability of DSG, by transforming it into a nanoproduct. The in vitro dissolution test is the most critical for evaluating the performance of a pharmaceutical product, chosen as a defining tool in characterizing the samples in this study. Suitable conventional media were applied for the dissolution method as a routine test in the quality control of the finished product, while we have chosen biorelevant media for further testing to modulate the formulation and posology of a candidate final formula for the best in vivo bioavailability and for a better understanding of the in vivo dissolution behaviour of the dosage form containing nano encapsulated diosgenin. The recommended pharmaceutical form for products containing diosgenin encapsulated in a nano lipidic structure is gastro-resistant; the optimal absorption of the active principle takes place at the upper intestinal level.