左舒必利口腔溶解片的处方及体外评价

Irfan Sohail, Noman Ahmad, Muhammad Majid, Waqas Nasir, Shan Malik, Tuseef Tahir
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引用次数: 0

摘要

目的:制备并优化左舒必利口腔溶出制剂。方法:以微晶纤维素、甘露醇、聚维酮和崩解剂乙醇酸淀粉钠为原料,采用直接压缩法制备具有d2 -多巴胺受体拮抗活性的左舒必利口腔溶片。因此,将左舒必利配制成口服溶剂型可快速缓解症状。结果:对其重量变化、药物含量、含量均匀性、硬度、脆性、体外崩解时间和体外释药量进行了评价。结果表明,超崩解剂和甘露醇的存在是理想的。结论:该制剂的分散时间小于60秒,满足体外分散的要求,最优释药时间为30 min,符合一级线性动力学。因此,研制崩解时间可接受、释药快、硬度好、可替代常规片剂的左舒必利口腔溶出片是可行的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and in vitro evaluation of mouth dissolving tablets of levosulpiride
Objective: The objective of this study was to formulate and optimize a mouth dissolving formulation of levosulpiride. Method: Levosulpiride mouth dissolving tablet having D2-dopamine receptor antagonistic activity were made by direct compression using microcrystalline cellulose, mannitol, povidone and a disintegrant sodium starch glycolate. Thus, formulating levosulpiride into amouth dissolving dosage form would provide fast relief. Results: The tablets were evaluated for weight variation, drug content, content uniformity, hardness, friability, in-vitro disintegration time and in-vitro drug release. The results show that the presence of a superdisintegrant and mannitol is desirable for orodispersion. Conclusion: Formulations satisfied the limits of orodispersion with a dispersion time of less than 60 sec, optimized drug released within 30 min and the formulations followed first order linear kinetics. So, it is feasible to formulate mouth dissolving tablets of levosulpiride with acceptable disintegration time, rapid drug release and good hardness as an alternative to conventional tablet.
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