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Abstract

The prepared Novel formulation used for chronic pain management after surgery. The present investigation deals with the development and optimization of the mucoadhesive buccal tablet containing tapentadol hydrochloride with a goal to increase the bioavailabilty by avoiding the first-pass metabolism. The tablets were prepared using polycarbophil as a bioadhesive polymer to impart better mucoadhesion, Hydroxy propyl methyl cellulose (HMPC K15M) as a release retardant polymer to control the release of drug and Ethyl cellulose(EC) to act as an impermeable layer to provide the unidirectional release of drug. The optimized formulation (F5) contained 20mg of HPMC K15M and 7.5 mg of polycarbophil had shown Mucoadhesive strength (0.333 N), swelling index (43.96%) and % drug release at 5 hr. (94.97%). ex-vivo permeation was found to be 48.38% at 5 hr. The release mechanism was found to be anomalous non-Fickian type. It can be concluded that buccal route can be one of an alternative available for the administration of tapentadol hydrochloride.

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