DESIGN AND EVALUATION OF ORO – FLASH RELEASE FILMS OF AMLODIPINE BESYLATE

This work aimed to formulate amlodipine besylate Oro flash release films by solvent casting method. Various film forming polymers like Hydroxy propyl methyl cellulose (HPMC) E5, HPMC E15, sodium carboxymethyl cellulose, sodium alginate, xanthan gum were used and out of which HPMCE5 was found to be satisfactory. Propylene glycol was used as plasticizer at a range of 13-32%w/w of the film and 31%w/w was found to be the best concentration based on the flexibility and the strength of the film.  Optimized formulation contains HPMC E5 as a film forming agent, propylene glycol as a plasticizer, tween 80 as a surfactant, peppermint oil as flavoring agent and aspartame as sweetening agent. Films were prepared by solvent casting method and found to satisfy the mouth dissolving time and other film parameters. 1.5 x 1.5 cm of film is required to be placed on to patient tongue which gets wet by saliva, rapidly hydrates, adheres to tongue and rapidly disintegrates and dissolves to release the drug for the oro – mucosal absorption or allow for gastrointestinal absorption when swallowed. The formulated films exhibited acceptable film endurance. Time required for the film to dissolve and release is 45 seconds and 5 minutes respectively. It can be concluded from the study that the oro flash release film can be a potential novel drug dosage form for poorly water – soluble drugs