Abstract :

The main objective of this research work is to formulate fast dissolving films to improve the patient compliance and bioavailability of Bambuterol HCl. Bambuterol HCl undergo first-pass metabolism, the development of fast dissolving buccal films of Bambuterol HCl release the drug in the buccal cavity and absorb through the buccal region. Hence first-pass metabolism of the drug could be avoided by developing into a fast-dissolving film of Bambuterol HCl. Fast dissolving Buccal films were prepared by solvent casting method using various polymers like HPMC E15, PVP K30, PVA and PEG600 as plasticizer and saccharin as a sweetening agent and vanillin as a flavoring agent and % Drug release is calculated using the calibration curve method. Dissolution profile as studied in a USP dissolution apparatus type 1 using a pH 6.8 simulated saliva. It was investigated how factors including release profile, concentration, and polymer type affected the results. The formulation was optimized on the basis of various evaluation parameters like the Folding endurance test, Weight uniformity test, Drug content, Stability test and In-vitro drug release. Formulation  F3 successfully fast the release of drug within 6 minutes. The IR spectra showed stable properties of Bambuterol HCl in mixture of polymers used and revealed the absence of interaction between drug and selected polymer, stability studies were as per ICH guidelines and result indicated that the selected  formulation was stable.

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Keywords :

Bambuterol Hcl, HPMC E15, PVA., PVP K-30

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