Y. Shiva Kumar*, Dr.T. Mangilal, Dr. M. Ravi Kumar, J. Naveen
Mouth dissolving tablets are solid dosage forms containing tapentadol as active pharmaceutical ingredient which has analgesic effect, and has superdistegrants like croscarmellose sodium and starch glycolate which disintegrates fast usually less than 60 seconds without the need of water when placed on the tongue. To prepare and evaluate tapentadol mouth dissolving tablet by using direct compression method and to determine the effect of formulation process and the excipients. Tapentadol MDT were formulated by using ingredients and superdisintegrants like sodium starch glycolate and cross carmellose.The resulting tablets were evaluated using parameters such as: hardness, friability, disintegration time in vitro, modified disintegration time, disintegration time in the oral cavity, wetting time, water absorption ratio, drug content determination, weight uniformity, and dissolution. The results showed that tapentadol mouth dissolving Tablets fulfilled the requirements for all parameters except for F1 formula that did not produce physical shape intact tablet. MDT s used higher amount of crosscarmellose showed faster disintegration time. FTIR studies and calibration curve show there is interaction between drug and excipients tablet hardness were also higher. In vitro drug release of all formulation MDTS showed fast drug release with in few sec. The study reveals that formulations prepared by direct compression F3 exhibits highest dissolution using cross carmallose sodium showed faster drug release 90.15% over the period of 50min while disintegration time of the tablet was showed 50sec in comparison to other formulations of tapentadol. Keywords: sodium starch glycolate,crosscarmellose sodium, disintegration tapentadol mouth dissolving tablets.