Key result
Novel bilayer tablet achieves rapid metoprolol release within 30 minutes and sustained indapamide release over 12 hours.
Why the study?
Effective blood pressure management often requires combination therapy, and bilayer tablet technology combines immediate-release and sustained-release layers in a single dosage form to reduce dosing frequency and enhance compliance. This study was undertaken to formulate and evaluate bilayer tablets of metoprolol tartrate and indapamide hemihydrate for hypertension management.
This in vitro pharmaceutics study developed and optimized a stable bilayer tablet combining immediate-release metoprolol tartrate and sustained-release indapamide hemihydrate, demonstrating potential as a fixed-dose combination delivery system for hypertension.
Hypertension is one of the most prevalent chronic cardiovascular disorders and is a major contributor to morbidity and mortality worldwide.Effective blood pressure management often requires combination therapy using antihypertensive agents with different mechanisms of action.Bilayer tablet technology provides an innovative drug delivery system by combining immediate-release and sustained-release layers in a single dosage form, thereby improving therapeutic efficacy, reducing dosing frequency, and enhancing patient compliance.The present study was undertaken to formulate and evaluate bilayer tablets of Metoprolol Tartrate and Indapamide Hemihydrate for the effective management of hypertension.Nine formulations (F1-F9) were prepared by the direct compression technique.The immediate-release layer containing Metoprolol Tartrate was formulated using different concentrations of Crospovidone as the superdisintegrant, while the sustained-release layer containing Indapamide Hemihydrate was formulated using Hydroxypropyl Methylcellulose (HPMC K100M) as the release-retarding polymer.The prepared powder blends were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr's compressibility index, and Hausner's ratio.The compressed bilayer tablets were further evaluated for appearance, weight variation, thickness, hardness, friability, drug content uniformity, disintegration time, in vitro dissolution, Differential Scanning Calorimetry (DSC), and accelerated stability studies.Among the prepared formulations, F9 exhibited the best overall performance with acceptable physicochemical properties, rapid release of Metoprolol Tartrate within 30 minutes, and sustained release of Indapamide Hemihydrate over 12 hours.DSC analysis confirmed the compatibility of the drugs with the selected excipients, while accelerated stability studies demonstrated that the optimized formulation remained stable under ICH-recommended storage conditions.The study concluded that the optimized bilayer tablet formulation offers an effective biphasic drug-release system with the potential to improve therapeutic efficacy and patient compliance in the long-term management of hypertension.
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A 2026 study studied Hypertension. Bilayer tablets of Metoprolol Tartrate and Indapamide Hemihydrate vs. Different formulation batches (F1–F9) varying in Crospovidone (2–12 mg) and HPMC K100M (15–55 mg) concentrations was evaluated on In vitro drug release profile and physicochemical evaluation. Optimized bilayer tablet formulation F9 achieved rapid in vitro release of Metoprolol Tartrate within 30 minutes and sustained release of Indapamide Hemihydrate over 12 hours.
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