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使用天然超级崩解剂对醋氯芬酸速溶片进行处方开发与优化

Formulation development and optimization of fast dissolving tablets of aceclofenac using natural superdisintegrant.

作者信息

Kaur Lovleen, Bala Rajni, Kanojia Neha, Nagpal Manju, Dhingra Gitika Arora

机构信息

Chitkara College of Pharmacy, Chandigarh-Patiala National Highway, Rajpura, Patiala, Punjab 140401, India.

NCRD's Sterling Institute of Pharmacy, Nerul, Navi Mumbai 400706, India.

出版信息

ISRN Pharm. 2014 May 8;2014:242504. doi: 10.1155/2014/242504. eCollection 2014.

DOI:10.1155/2014/242504
PMID:24944837
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4040205/
Abstract

The current research work involves preparation of fast dissolving tablets of Aceclofenac by direct compression method using different concentrations of Lepidium sativum mucilage as natural superdisintegrant. A two-factor three-level (3(2)) factorial design is being used to optimize the formulation. Nine formulation batches (D1-D9) were prepared accordingly. Two factors as independent variables (X 1-amount of β-cyclodextrin and X 2-amount of Lepidium sativum mucilage) were taken with three levels (+1, 0, -1). The levels of two factors were selected on the basis of preliminary experiments conducted and their effect on three dependent variables (disintegration time, wetting time, and in vitro drug release) was studied along with their % prediction error. All the active blends were evaluated for postcompression parameters (angle of repose, Carr's index, Hausner ratio, etc.) and the tablets were evaluated for postcompression parameters (weight variation, hardness, and friability, wetting time, disintegration time, water absorption ratio, and in vitro drug release studies). The optimum batch was further used for SEM and stability studies. Formulation D5 was selected by the Design-Expert software which exhibited DT (15.5 sec), WT (18.94 sec), and in vitro drug release (100%) within 15 minutes.

摘要

当前的研究工作涉及使用不同浓度的独行菜黏液作为天然超级崩解剂,通过直接压片法制备醋氯芬酸速溶片。采用二因素三水平(3(2))析因设计来优化制剂配方。据此制备了九个制剂批次(D1 - D9)。选取两个因素作为自变量(X1 - β - 环糊精的用量和X2 - 独行菜黏液的用量),设定三个水平(+1、0、-1)。两个因素的水平是根据前期进行的预实验选定的,研究了它们对三个因变量(崩解时间、润湿时间和体外药物释放)的影响以及它们的预测误差百分比。对所有活性混合物进行了压片后参数(休止角、卡尔指数、豪斯纳比等)的评估,对片剂进行了压片后参数(重量差异、硬度、脆碎度、润湿时间、崩解时间、吸水率和体外药物释放研究)的评估。对最佳批次进一步进行了扫描电子显微镜(SEM)和稳定性研究。设计专家软件选择了制剂D5,其崩解时间(DT,15.5秒)、润湿时间(WT,18.94秒)以及在15分钟内的体外药物释放率为100%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/aa52e2882acf/ISRN.PHARMACEUTICS2014-242504.010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/5db13b0207a6/ISRN.PHARMACEUTICS2014-242504.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/656f9d44624d/ISRN.PHARMACEUTICS2014-242504.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/1e70ebcbe691/ISRN.PHARMACEUTICS2014-242504.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/89c368867679/ISRN.PHARMACEUTICS2014-242504.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/4906a8aeaef4/ISRN.PHARMACEUTICS2014-242504.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/74ac67c82b1c/ISRN.PHARMACEUTICS2014-242504.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/f310dc302edd/ISRN.PHARMACEUTICS2014-242504.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/89480eddb4b2/ISRN.PHARMACEUTICS2014-242504.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/4ef90e30f788/ISRN.PHARMACEUTICS2014-242504.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/aa52e2882acf/ISRN.PHARMACEUTICS2014-242504.010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/5db13b0207a6/ISRN.PHARMACEUTICS2014-242504.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/656f9d44624d/ISRN.PHARMACEUTICS2014-242504.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/1e70ebcbe691/ISRN.PHARMACEUTICS2014-242504.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/89c368867679/ISRN.PHARMACEUTICS2014-242504.004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/4906a8aeaef4/ISRN.PHARMACEUTICS2014-242504.005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/74ac67c82b1c/ISRN.PHARMACEUTICS2014-242504.006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/f310dc302edd/ISRN.PHARMACEUTICS2014-242504.007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/89480eddb4b2/ISRN.PHARMACEUTICS2014-242504.008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/4ef90e30f788/ISRN.PHARMACEUTICS2014-242504.009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0519/4040205/aa52e2882acf/ISRN.PHARMACEUTICS2014-242504.010.jpg

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