Modified release matrix tablets of tapentadol hydrochloride were prepared with HPMC K100 M as retarding polymer by wet granulation method. The granules were evaluated for angle of repose, bulk density, tapped density, bulkiness, compressibility index and hausners ratio. The tablets were subjected to weight variation, hardness, friability and drug content test. In-vitro release studies revealed that tapentadol formulation with high proportion of HPMC K100M was able to control the drug release for 12 hours. Fitting the in-vitro drug release data to kinetic analysis, optimized formulations followed the mechanism of diffusion. All the formulations were stored at 40°C and 75% RH and subjected to stability studies upto 6 months. It showed that all the formulations are physically and chemically stable. The in-vivo studies were carried out for optimized formulation of tapentadol hydrochloride in human adult healthy subjects under two-way cross over design. The results found that tapentadol hydrochloride test product (F-8) when compared with reference product i.e. Nucynta ER met the bioequivalence criteria with respect to the rate and extent of absorption. Finally the overall objectives were fulfilled and proved in present study.
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