乙酰氯芬酸快溶片的研制及评价

Sudhir Bhardwaj, V. Jain, R. Jat, A. Mangal, Suman Jain
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引用次数: 39

摘要

快速崩解给药系统为吞咽片剂/胶囊等困难的患者提供了解决方案。选择抗炎镇痛药乙酰氯芬酸作为模型药物。该药物的水溶性较差,导致溶出率变化,因此生物利用度较差。本研究尝试用各种超崩解剂乙醇酸淀粉钠,经直接加压法制备该药的速溶片。测定其硬度、脆性、重量变化、崩解时间、吸水率、润湿时间、体外溶出度。崩解时间为12.2 ~ 27.5 s,溶出速度快。结果表明,采用选择性超崩解剂直接压片可制备出溶出性强、味掩蔽性好、患者依从性好、治疗效果好的低溶性药物。关键词:Aceclofenac;迅速瓦解;Superdisintegrants;味道掩盖
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Formulation and evaluation of fast dissolving tablet of aceclofenac
Fast disintegrating drug delivery system offers a solution for these patients having difficulty in swallowing tablets/ capsules etc. Aceclofenac (anti-inflammatory and analgesic) was selected as the model drug. The poor aqueous solubility of the drug results in variable dissolution rate and hence poor bioavailability. In the present study, an attempt had been made to prepare fast dissolving tablets of the drug using various super disintegrates sodium starch glycolate following by direct compression technique. The tablets were evaluated for hardness, friability, weight variation, disintegration time, water absorption ratio and wetting time, in vitro dissolution studies. All the formulation showed disintegration time in range of 12.2 to 27.5 second along with rapid in vitro dissolution. It was concluded that the fast dissolving tablets of the poor soluble drug can be made by direct compression technique using selective super disintegrantes showing enhanced dissolution, taste masking and hence better patient compliance and effective therapy. Keywords: Aceclofenac; Fast disintegrating; Superdisintegrants; Taste masking
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