氯雷他定口腔溶出片的处方研制与评价

A. Kalam, Lutful Kabir, S. Rahman, Abu Shara, S. Rouf
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引用次数: 2

摘要

吞咽困难(吞咽困难)在所有年龄组中都很常见,尤其是老年人和儿科。口腔溶解片剂构成了一种创新的剂型,克服了吞咽的问题,并提供了一个快速的行动。本研究采用一种特殊的制备工艺(pharmaburst technology)和一种超级崩解剂(交联蜜糖钠)制备氯雷他定口腔溶片,并对其进行了评价。采用直接压缩法制备片剂。对颗粒的休止角、容重、攻丝密度、体积、压缩性指数和hausners比进行了评价。考察其硬度、厚度、重量均匀性、脆性、润湿时间、吸水率、崩解时间和药物含量。体外释放研究采用USP-II(桨法),在900ml pH 1.2中,50rpm下进行。所制片剂的物理性质无明显变化,具有良好的物理完整性。以pharmurst B2和交联棉糖钠配制的片剂崩解时间和润湿时间较短,分别为27±0.10和38±0.13 s。最佳配方在40℃/75% RH条件下稳定性研究60天。
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 Mouth Dissolving Tablets of Loratadine
Difficulty in swallowing (dysphagia) is common among all age groups, especially in elderly and pediatrics. Mouth dissolving tablets constitute an innovative dosage forms that overcome the problems of swallowing and provides a quick onset of action. The purpose of this study was to formulate and evaluate mouth dissolving tablet of loratadine using a special preparation technology (pharmaburst Technology) with a super disintegrating agent (Croscarmellose sodium). Tablets were prepared by direct compression technique. The granules were evaluated for angle of repose, bulk density, tapped density, bulkiness, compressibility index and hausners ratio. The tablets were evaluated for hardness, thickness, uniformity of weight, friability, wetting time, water absorption ratio, disintegration time and drug content. In vitro release studies were performed using USP-II (paddle method) in 900ml of pH 1.2 at 50rpm. The physical properties of the prepared tablets did not show any significant variations and were found to have good physical integrity. Tablets prepared with pharmaburst B2 and Croscarmellose sodium showed a lesser disintegration time and wetting time of 27±0.10 and 38±0.13 seconds respectively. The best formulations were subjected to stability studies at 40oC/75% RH for 60 days.
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