Formulation and Evaluation of Sotalol Gastrorententive Tablets

G. Swathi, Krishna Jyothi Kumari Bhavan, R. Sri. S
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Abstract

The objective of this study was to formulate floating tablets (GRDDS) of Sotalol using direct compression method to increase its bioavailability and the gastric residence time of the dosage form. The Sotalol tablets were prepared by direct compression method. The tablets were prepared by using different types of polymers i.e.; Sodium CMC, Chitosan and Psyllium Husk which act as a release retardant polymer. Sodium bi carbonate (NaHCO3) was used as a gas degenerating agent and MCC (Micro crystalline cellulose) was used as a diluent. The prepared formulation were subjected to some evaluation parameters like hardness, friability, weight variation, drug content, buoyancy property, drug release study etc. In the FT-IR study it was revealed that there is no interaction between the drug and excipients. The formulation which containing Chitosan polymer and Sodium bicarbonate shows good drug release pattern with less floating lag time and good floating duration. The in vitro drug release pattern of Sotalol floating tablets was fitted to different kinetic models which showed the highest regression for Higuchi order kinetics. Thus, it can be concluded that the floating drug delivery system of Sotalol using the appropriate polymers in right amount may enhance the activity of the drug by prolonging the gastric residence time or reducing the floating lag time.
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索他洛尔胃膨松片的处方及评价
本研究的目的是采用直接压缩法制备索他洛尔浮片,以提高其生物利用度和胃停留时间。采用直接压缩法制备索他洛尔片。片剂由不同类型的聚合物制备,即;CMC钠、壳聚糖和车前草壳作为缓释聚合物。以碳酸氢钠(NaHCO3)为气体降解剂,微晶纤维素(MCC)为稀释剂。对制备的制剂进行了硬度、脆性、重量变化、药物含量、浮力、释放度等评价指标的研究。在傅里叶变换红外光谱研究显示,没有相互作用之间的药物和辅料。由壳聚糖聚合物和碳酸氢钠组成的配方具有良好的药物释放模式,漂浮滞后时间短,漂浮持续时间长。索他洛尔浮片的体外释放模式符合不同的动力学模型,其中对通口级动力学的回归程度最高。由此可见,在索他洛尔漂浮给药系统中加入适量合适的聚合物,可以通过延长胃停留时间或减少漂浮滞后时间来提高药物的活性。
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