Formulation and evaluation of extended-release tablet Losartan potassium and Lisinopril
Keywords:
Extended Release, Bilayer Tablet, Renin, TabletsAbstract
Background: The bilayer tablet concept has long been utilized to developed sustained release formulations. Bilayer tablet has a fast-releasing layer and contain second layer to sustain the drug release. A fast-releasing granules lead to sudden rise in the blood concentration. However, the blood level is maintained at steady state as the drug release from the sustaining granules.
Objective: Bilayer tablet consists of two layers of tablet in a single unit. This approach can be used for the treatment of various diseases which require not only single drug but also combination of drugs.
Method: Extended-release tablet prepared by the solvent casting method using HPMC microcryatalline cellulose ethyl cellulose prepared Bi-layer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. The prepared films were evaluated for physical appearance, thickness, weight variation, folding endurance, surface pH, tensile strength, drug content, disintegration time, in vitro drug release, and accelerated stability according to ICH guidelines.
Result: All formulations produced smooth, flexible, and uniform films with satisfactory mechanical properties. Among the prepared formulations, F5 exhibited the most desirable characteristics, including uniform drug content, excellent folding endurance, rapid disintegration, and the highest cumulative drug release. Accelerated stability studies conducted at 600±5% RH for 90 days showed no significant changes in physicochemical properties, indicating good stability of the optimized formulation.
Conclusion: The developed Loratadine extended release demonstrated rapid disintegration, efficient drug release, satisfactory mechanical strength, and excellent stability. These findings suggest that the optimized formulation represents a promising alternative to conventional oral dosage forms, with the potential to improve patient compliance and provide rapid therapeutic action in the management of allergic disorders.
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