FORMULATION AND EVALUATION OF SUSTAINED RELEASE TABLETS OF TRAMADOL HYDROCHLORIDE USING HYDROPHILIC/ HYDROPHOBIC POLYMER MATRIX SYSTEM

Tramadol Hydrochloride is an opioid analgesic drug, which has a strong analgesic action. It acts as an opioid agonist through selective binding to µ-opioid receptors. It is administered when non-steroidal anti-inflammatory drugs (NSAIDs) fail to mitigate pain. It is available as three oral formulations: (i) Tramadol Hydrochloride immediate release (IR) [Tramacon®] administered three times daily; (ii) Tramadol Hydrochloride sustained-release (SR) [Tramacip SR®]. Administered twice daily, and (iii) Tramadol Hydrochloride control release (CR) [Tramazac®] administered once daily. All three formulations are bioequivalent in terms of systemic exposure to Tramadol. The objective of the present investigation is to design and evaluate sustained release dosage form of Tramadol Hydrochloride. Because of its shorter half-life and more adverse effect Tramadol was selected as the desired candidates for the formulation of sustain release preparation.

Sustained-release tablets were prepared by direct compression method using HPMC K100M (hydrophilic polymer) and HEC (hydrophobic polymer) as matrixing agents. Total nine batches of sustained-release tablet of Tramadol Hydrochloride were formulated and evaluated with a variation in the quantities; among them, batch F8 showed the most satisfactory drug release pattern by sustaining the release of tramadol.

Keywords: Sustained release Tablets, Tramadol Hydrochloride, Hydroxy propyl methyl cellulose, Hydroxy ethyl Cellulose.