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Orally disintegrating films offer advantage of patient compliance over conventional solid dosage forms. Present study aims at formulation and evaluation of orally disintegrating films of Tramadol Hydrochloride which disintegrate within 30 seconds. Polymers like modified pea starch (Lycoat RS 720) and pullulan were evaluated for film forming capacity and were found to form thin, smooth films at 25% w/w and 2% w/w concentration respectively. Two plasticizers, propylene glycol and sorbitol were evaluated. Taste masking of drug was done using sweetener, flavour and flavour extender. Drug content in both films was above 98% and found to release the drug within 15 minutes. Drug loaded films with both the polymers were stable under 25°C/60% RH and 40°C/75% RH conditions.
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Author(s): Harsha Kathpalia Bhairavi Sule Aasavari Gupte
Lycoat RS 720, Orally disintegrating film, pullulan