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盐酸丁螺环酮口腔黏附膜的研制与统计优化

Development and Statistical Optimisation of Buspirone Hydrochloride Buccoadhesive Films.

作者信息

Nagaich Upendra, Chaudhary Vandana, Nagaich Jaya

机构信息

Department of Pharmaceutics, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh 201313, India.

Department of Pharmaceutics, B. S. Anangpuria Institute of Pharmacy, Faridabad, India.

出版信息

Int Sch Res Notices. 2014 Oct 30;2014:214026. doi: 10.1155/2014/214026. eCollection 2014.

Abstract

The aim of the present study was to prepare unidirectional buccal films of buspirone hydrochloride by solvent casting technique. Hydroxypropylmethylcellulose (HPMC K15M) and Eudragit RL-100 were used as polymers in different proportion. Polyethylene glycol 400 and sodium lauryl sulphate were used as plasticizer and permeation enhancer, respectively, in different concentration. In the formulation, total amount of polymer (X 1) and percentage of HPMC K15M (X 2) were kept as independent variables. Afterwards, statistically optimized process was carried out and two optimized formulations (OF1 and OF2) were developed. The observed results of optimized formulation were showed a greater degree of percentage of similarity with predicted values. The stability studies showed that there was no significant change found in physicochemical properties, in-vitro release, and ex-vivo diffusion studies.

摘要

本研究的目的是通过溶剂浇铸技术制备盐酸丁螺环酮的单向口腔膜。羟丙基甲基纤维素(HPMC K15M)和Eudragit RL - 100以不同比例用作聚合物。聚乙二醇400和十二烷基硫酸钠分别以不同浓度用作增塑剂和渗透促进剂。在制剂中,聚合物总量(X1)和HPMC K15M的百分比(X2)作为自变量。之后,进行了统计优化过程,并开发了两种优化制剂(OF1和OF2)。优化制剂的观察结果显示与预测值有更高程度的相似度。稳定性研究表明,在物理化学性质、体外释放和离体扩散研究中未发现显著变化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd6f/4897544/6d02d69d845b/ISRN2014-214026.001.jpg

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