Key result
Olmesartan fixed-dose combinations achieve ~2-fold higher drug release at 60 minutes versus monotherapy.
Why the study?
Dissolution studies evaluate solid dosage forms and support in-vitro-in-vivo correlation, prompting a comparison of dissolution profiles between olmesartan medoxomil monotherapy tablets and fixed-dose combination tablets.
In-vitro dissolution testing demonstrated comparable, rapid, diffusion-influenced release of olmesartan medoxomil in pH 6.8 phosphate buffer across monotherapy and fixed-dose combination tablets with amlodipine and/or hydrochlorothiazide, supporting their pharmaceutical equivalence.
Answers are grounded in this paper and cite their sources.
Supports pharmaceutical equivalence of olmesartan FDC; leaves open clinical relevance without in-vivo confirmation.
Dissolution studies play a major role in evaluating solid dosage forms.It is one of the official tests.Invitro-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][18][19][20].
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A 2026 study studied Hypertension. Olmesartan medoxomil fixed-dose combination tablets (with amlodipine and/or hydrochlorothiazide) vs. Olmesartan medoxomil monotherapy tablet (40 mg) was evaluated on Cumulative percentage drug release (%CDR) at 60 minutes in pH 6.8 phosphate buffer. Olmesartan medoxomil fixed-dose combination tablets demonstrated rapid in-vitro drug release in pH 6.8 buffer, reaching 75.83% to 99.71% cumulative release at 60 minutes versus 39.35% for monotherapy.
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