Formulation and Evaluation of hydrodynamically balanced system of Baclofen

Abstract

Spasticity is a feature of altered skeletal muscle performance in muscle tone involving hypertonia; it is also referred to as an unusual "tightness", stiffness, or "pull" of muscles palsy and spinal. Spasticity, a condition in which certain muscles are continuously contracted, affects over 12 million worldwide. Baclofen is the largest prescribed drug for this indication, worldwide. Even though once-daily extended release GRS is available in the market, it is very expensive as it is a coated multi-layer gas generating floating tablet. The main objective is to develop once-daily sustained release gastro-retentive floating system of Baclofen in an economical way by using HPMC and natural gums. Fourteen formulations of floating matrix tablets of Baclofen (F1 – F14) were prepared by using different polymers and additives (HPMC K100M, HPMC K15M, HPMC K4M, Guar gum Xanthan gum PEO WSR301,- 303, sodium bicarbonate, Avicel PH-102, Talc, Magnesium stearate) at different concentrations by direct compression method. The formula 11 was found to be optimum and released 98.47% of Baclofen in 24hrs. Hence, it was selected as the optimized formulation. Marketed formulation exhibited FLT of 63.67±4.01 seconds, TFT of 24 hours and released 95.07±0.41% drug in 24 hours. Finally, once-daily sustained release gastro-retentive floating tablets of Baclofen were successfully formulated in a relatively economical way when compared to the marketed formulation and found to be superior when compared to the marketed formulation

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