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盐酸美克洛嗪升华速溶片的处方研发与特性研究

Formulation Development and Characterization of Meclizine Hydrochloride Sublimated Fast Dissolving Tablets.

作者信息

Vemula Sateesh Kumar, Vangala Mohan

机构信息

College of Medical and Health Sciences, Wollega University, P.O. Box No 395, Nekemte, Ethiopia; Department of Pharmaceutics, Chaitanya College of Pharmacy Education and Research, Kishanpura, Hanamkonda, Warangal, Andhra Pradesh 506001, India.

Department of Pharmaceutics, Chaitanya College of Pharmacy Education and Research, Kishanpura, Hanamkonda, Warangal, Andhra Pradesh 506001, India.

出版信息

Int Sch Res Notices. 2014 Aug 25;2014:281376. doi: 10.1155/2014/281376. eCollection 2014.

Abstract

The intention of present research is to formulate and develop the meclizine hydrochloride fast dissolving tablets using sublimation method to enhance the dissolution rate. In this study an attempt was made to fasten the drug release from the oral tablets by incorporating the superdisintegrants and camphor as sublimating agent. The prepared fast dissolving tablets were subjected to precompression properties and characterized for hardness, weight variation, friability, wetting time, water absorption ratio, and disintegration time. From in vitro release studies, the formulation F9 exhibited fast release profile of about 98.61% in 30 min, and disintegration time 47 sec when compared with other formulations. The percent drug release in 30 min (Q 30) and initial dissolution rate for formulation F9 was 98.61 ± 0.25%, 3.29%/min. These were very much higher compared to marketed tablets (65.43 ± 0.57%, 2.18%/min). The dissolution efficiency was found to be 63.37 and it is increased by 1.4-fold with F9 FDT tablets compared to marketed tablets. Differential scanning calorimetry and Fourier transform infrared spectroscopy studies revealed that there was no possibility of interactions. Thus the development of meclizine hydrochloride fast dissolving tablets by sublimation method is a suitable approach to improve the dissolution rate.

摘要

本研究的目的是采用升华法制备并开发盐酸美克洛嗪速溶片,以提高其溶出速率。在本研究中,尝试通过加入超级崩解剂和樟脑作为升华剂来加快口服片剂的药物释放。对制备的速溶片进行预压性质测试,并对其硬度、重量差异、脆碎度、湿润时间、吸水率和崩解时间进行表征。体外释放研究表明,与其他制剂相比,制剂F9在30分钟内的释放曲线较快,释放率约为98.61%,崩解时间为47秒。制剂F9在30分钟内的药物释放百分比(Q30)和初始溶出速率分别为98.61±0.25%,3.29%/分钟。与市售片剂(65.43±0.57%,2.18%/分钟)相比,这些数值要高得多。发现溶出效率为63.37,与市售片剂相比,F9速溶片的溶出效率提高了1.4倍。差示扫描量热法和傅里叶变换红外光谱研究表明,不存在相互作用的可能性。因此,采用升华法开发盐酸美克洛嗪速溶片是提高溶出速率的一种合适方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a50d/4897533/48ae270bcee7/ISRN2014-281376.001.jpg

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