The present study was aimed to formulate and evaluate mouth dissolving films of almotriptan malate using polymers HPMC E-15, HPMC E-4 and Gelatin as the film forming agents. Formulation batches were formulated using 32 full factorial designs. The fast dissolving oral films were designed using optimal design and numerical optimization technique was applied to find out the best formulation. PEG 400 was incorporated as plasticizer to improve flexibility of films. Aspartame as sweetner. Sodium starch glycolate used as a disintegrant. An attempt was made to prepare mouth dissolving films of almotriptan with the purpose of developing a dosage form for quick onset of action. The films were prepared by solvent casting method. The FTIR studies revealed that there is no physicochemical interaction between excipients and drug. They were evaluated for physicochemical characterization such as uniformity of weight, thickness, folding endurance, uniformity of drug content, surface pH, percentage elongation and tensile strength all of which showed satisfactory results. The formulations were also subjected for in vitro disintergration and in vitro drug release. Melt in mouth films of almotriptan containing single polymer HPMC E-15 showed best results, in terms of tensile strength (1.76 ± 0.11), percentage elongation (36.63 ± 0.288%), folding endurance (>300), in-vitro disintegration time (26.01 ± 0.11sec.), surface pH (6.20 ± 0.001 pH), thickness (0.096 ± 0.011mm) and percentage content uniformity (97.23 ± 0.091). Satisfactory dissolution profile was obtained with maximum release of 96% of drug within 120 sec. The stability studies showed that there was no appreciable change in parameters when stored at three different temperatures.

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DOI: 10.4103/2231-4040.197331

The present study was aimed to formulate and evaluate mouth dissolving films of almotriptan malate using polymers HPMC E-15, HPMC E-4 and Gelatin as the film forming agents. Formulation batches were formulated using 32 full factorial designs. The fast dissolving oral films were designed using optimal design and numerical optimization technique was applied to find out the best formulation. PEG 400 was incorporated as plasticizer to improve flexibility of films. Aspartame as sweetner. Sodium starch glycolate used as a disintegrant. An attempt was made to prepare mouth dissolving films of almotriptan with the purpose of developing a dosage form for quick onset of action. The films were prepared by solvent casting method. The FTIR studies revealed that there is no physicochemical interaction between excipients and drug. They were evaluated for physicochemical characterization such as uniformity of weight, thickness, folding endurance, uniformity of drug content, surface pH, percentage elongation and tensile strength all of which showed satisfactory results. The formulations were also subjected for in vitro disintergration and in vitro drug release. Melt in mouth films of almotriptan containing single polymer HPMC E-15 showed best results, in terms of tensile strength (1.76 ± 0.11), percentage elongation (36.63 ± 0.288%), folding endurance (>300), in-vitro disintegration time (26.01 ± 0.11sec.), surface pH (6.20 ± 0.001 pH), thickness (0.096 ± 0.011mm) and percentage content uniformity (97.23 ± 0.091). Satisfactory dissolution profile was obtained with maximum release of 96% of drug within 120 sec. The stability studies showed that there was no appreciable change in parameters when stored at three different temperatures.

Keywords: Almotriptan Malate, Solvent Casting method, mouth dissolving film, HPMC E-15, Migraine