The aim of the present study was to formulate and evaluate the mouth dissolving film of amitriptyline hydrochloride. Mouth dissolving films were prepared by solvent casting method. Different formulation batches were prepared with different concentration of HPMC E50 LV as a polymer and PEG 400 as plasticizer. The prepared films were evaluated for their weight variation, thickness, stickiness, pH, folding endurance, drug content, appearance, tensile strength, % elongation, disintegration time and dissolution study in phosphate buffer pH 6.8. Optimization of the formulation was done with the application of 32 factorial design. HPMC E50LV and PEG 400 were considered as independent factors whereas the disintegration time and % drug release in 300 sec were selected as dependent factors or responses. The data obtained showed that mouth dissolving film containing {HPMC E15 (300 mg) and PEG 400 (15% w/w of polymer)} had thickness of 0.20±0.04, weight variation 66.05±0.12, folding endurance 209±3.51, surface pH 6.8±0.52, tensile strength 525 g/mm2 and (%)elongation 20%. The disintegration time was found to be 40 seconds which was set as the major criteria for fast dissolving film. The drug content was found to be 99.11±1.03 % for the optimized batch. In-vitro drug release was found to be 96.99±0.28 % within 5 minutes. Stability study of the optimized batch reveals that there was no significance change in the release profile and disintegration time during the stability study period. Hence, a mouth dissolving film containing antidepressant drug amitriptyline hydrochloride was successfully prepared, which is expected to increase patient compliance in pediatric, geriatric and dysphagic patients.
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