升华法制备富马酸喹硫平多孔分散片的配方及评价

M. Bagade, Shete Rv, S. B. Phulzalke, B. Kate
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引用次数: 6

摘要

本研究的目的是通过升华法制备富马酸喹硫平直接可压分散片,以提高患者的依从性。采用全32因子设计,考察了两个变量的影响,即印地安414和樟脑的浓度。以铟414 (3- 5% w/w)为强力崩解剂,樟脑(5- 15% w/w)为升华剂。考察其厚度、重量变化、硬度、脆性、含量均匀性、润湿时间、孔隙度、体外崩解时间和体外释放度。体外溶出度曲线显示配方F3的溶出速度更快,出药量最大。SEM研究表明,升华剂升华后,片剂表面形成孔隙,从而提供了充分的多孔结构。这允许选择一批崩解时间理想的片剂,并提高口服给药后的溶出率。以5%的铟414 (w/w)和5%的樟脑(w/w)为原料制备的F3批崩解时间为18.66 s,溶出率提高,易碎性较好。需要进一步的研究来评估剂型在体内的表现和体内外的相关性。关键词:孔分散片,析因设计,indi414,升华,富马酸喹硫平
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation Development and Evaluation of Orodispersible Tablets of Quetiapine Fumarate by Sublimation Method
The objective of present study was to formulate directly compressible orodispersible tablets of quetiapine fumarate by sublimation method with a view to enhance patient compliance. A full 32 factorial design was used to investigate the effect of two variables viz., concentration of Indion 414 and camphor. Indion 414 (3-5 % w/w) was used as superdisintegrant and camphor (5-15 % w/w) as subliming agent. The tablets were evaluated for thickness, weight variation, hardness, friability, content uniformity, wetting time, porosity, in vitro disintegration time and in vitro drug release. In vitro dissolution profile revealed faster and maximum drug from formulation F3. SEM study show formation of pores on tablet surface after sublimation of the sublimating agent, thus providing a sufficiently porous structure. This permitted the selection of a batch of tablets with desired disintegration time and improved dissolution rate after oral administration. The F3 batch containing the Indion 414 (5%) and Camphor (5%) w/w of total formulation weight had shown good the disintegration time of 18.66 seconds and with improved dissolution rate and desirable friability. Further studies will be required to evaluate the performance of dosage form in vivo and In Vitro In vivo Correlation. Keywords : Orodispersible tablet, factorial design, Indion 414, sublimation, quetiapine fumarate
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