ABSTRACT

Dissolution studies play a major role in evaluating solid dosage forms. It is one of the official tests. In- vitro-in-vivo correlation (IVIVC) is based on dissolution studies [4, 5]. Olmesartan Medoxomil (OM) is an Angiotensin-II receptor blocker given for the treatment of hypertension [10, 11]. This was selected to compare dissolution profiles of monotherapy tablets (OLMO-40) and fixed-dose combinations (FDCs): OLMO-AM (with Amlodipine), OLMO-H (with Hydrochlorothiazide), and OLMO-AH (triple combination). Method: Dissolution testing was performed using the USP apparatus type II (paddle method) at 50 rpm in 900 mL medium. The LABINDIA D5 8000-8-stage apparatus was employed. Since OM and its FDCs are enteric-coated, two buffers were used: HCl buffer (pH 1.2) and phosphate buffer (pH 6.8), maintained at 37.0 ± 0.5 °C. Samples were analysed with a UV spectrophotometer at 256 nm. Release kinetics were studied using zero-order, first-order, Higuchi, Korsmeyer-Peppas, and Hixon-Crowell models, with R² values computed in Excel. Results: Both monotherapy and FDC tablets showed rapid release of OM in phosphate buffer (pH 6.8). The dissolution profiles of OM API reference and FDC formulations were statistically compared, revealing close similarity. The release kinetics confirmed consistent drug release patterns across formulations. Conclusion: Across all biorelevant media, the in-vitro dissolution profiles of OM in the FDC tablet and the monotherapy are regarded as statistically comparable. This finding confirms the pharmaceutical equivalence between the formulations, ensuring that the superior (critical) quality attribute of API release is maintained in the combination product [17-20]. Keywords: Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide, UV-spectrophotometer, Dissolution test apparatus, Monotherapy, Fixed dose combinations
Publication date: 01/11/2026

https://www.ijbpas.com/pdf/2026/November/MS_IJBPAS_2026_10593.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.11.10593