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Development and in-vitro characterization of sustained release tramadol hydrochloride by film coating technique | Abstract
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Abstract

Development and in-vitro characterization of sustained release tramadol hydrochloride by film coating technique

Author(s): Srikrishna T, Rambabu P., Sirisha D., Vaishnavi A. and M. V. Sai Lalith Kumar

Tramadol Hydrochloride is a centrally acting analgesic. Tramadol acts as a μ-opioid receptor agonist, serotoninnor epinephrine reuptake inhibitor (SNRI), NMDA receptor antagonist, 5-HT2C receptor antagonist, nicotinic acetylcholine receptor antagonist and M1 and M3 muscarinic acetylcholine receptor antagonist. The main objective of the present work was to develop sustained release film coated tablets of water soluble Tramadol hydrochloride by wet granulation. Various polymers and the combination of polymers were used for controlling the release of drug up to desired time. Sustaining the release of drug from the dosage form was useful for achieving controlled plasma level of the drug as well as improving bioavailability. The precompression parameters were evaluated for flow properties. After evaluation of post compression parameters of tablet, the in vitro release study was performed in 0.1N HCl pH 1.2 for 16 hrs. Among all formulations (F1-F10), formulation F5 was identified to be the best as it showed 99.39% drug release and sustained action for 16 hrs. The optimized formulation (F5) was kept at stability studies according to ICH guidelines for 3 months, which showed that the formulation was stable. FTIR studies showed no unacceptable extra peaks which confirm the absence of chemical interaction between the drug and polymers.