FORMULATION AND IN-VITRO EVALUATION OF TRAMADOL HYDROCHLORIDE FLOATING TABLETS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2013, Vol 4, Issue 4
Abstract
Tramadol hydrochloride is a synthetic opioid used as a centrally acting analgesic and effective in both experimental and clinical pain. The half-life of the drug is about 5.5 hours and oral dose is 50 to 100 mg every 4 to 6 hours. To reduce the frequency of administration and to improve patient compliance, a sustained-release formulation of tramadol is desirable. The directly compressible floating tablets of Tramadol HCl were formulated using varying amounts of carbopol-934, HPMC K100M, and Hibiscus rosa-sinensis polymers along with other requisite excipients. Sodium bicarbonate was incorporated as a gas-generating agent. The concentration of the polymers increased gradually to attain the optimised formulation. In-vitro drug release profile and floatational characteristics of the formulations were determined. The studies indicated successful formulation of gastroretentive compressed matrices with excellent sustained release and hydrodynamic balance. From FTIR studies no interaction was found between the Tramadol HCl and polymers. Comparison of the dissolution profiles of the optimized formulation, with optimal composition of HPMC: Hibiscus rosa sinensis; 100:100, with that of marketed formulation indicated analogy of drug release performance with each other. The optimized formulation F10 was found to exhibit first–order kinetics which shows the diffusion along with polymer relaxation and polymer erosion of drug from the tablet.
Authors and Affiliations
Narendra Palla, Valluru Rajashekar, Prashanthi Marni, Jithender Mittepalli, K. A Sridhar
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