Formulation and in-vitro Evaluation of Oro-dispersible tablets of Indomethacin

Gopal Pokhrel, Ganga Kunwar, Jun Devi Rai, Sheela Thapa, Sudip Dhakal, Prashant Basnet
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Abstract

Introduction: Oro-dispersible tablets are rapidly dissolved in saliva without the need for water and are beneficial for renal impaired, bedridden and psychiatric patients. Objective: The study aimed to formulate oro-dispersible tablets of indomethacin with reduced adverse effects, better patient compliance, faster action, and convenience for patients. Methods: Oro-dispersible tablets of indomethacin were prepared using three different super disintegrants; crospovidone, croscarmellose sodium and sodium starch glycolate with three different concentrations (2.5%, 5.2%, and 7.7%) by direct compression method. The prepared tablets were evaluated for pre and post-compression parameters including bulk density, tapped density, compressibility index, angle of repose, Hausner's ratio, hardness, friability, wetting time, in vitro disintegration time, and in vitro drug release. Results: The percentage of drug released in 5 minutes of all formulations of Oro-dispersible tablets of Indomethacin was found to be 74.36% to 80.16% and the percentage of drug released in 10 minutes was 96.18% to 100%. All formulations showed disintegration time in the range of 19-78 seconds. The tablets prepared with 7.7% crospovidone (F6) shows faster disintegration (19 seconds) as compared to tablets prepared with sodium starch glycolate and croscarmellose sodium. The in-vitro dissolution studies showed that tablets of formulations batch containing 7.7% crospovidone releases 100% of the drug after 10 minutes which was fast released as compared to sodium starch glycolate and croscarmellose sodium. Conclusions: Oro-dispersible tablets of indomethacin prepared with crospovidone showed better disintegration time and dissolution profile as compared to other superdisintegrants.
吲哚美辛口腔分散片的处方及体外评价
简介:oro分散片可快速溶解于唾液中,无需水,对肾功能受损,卧床不起和精神疾病患者有益。目的:研制不良反应少、患者依从性好、起效快、方便患者使用的吲哚美辛口腔分散片。方法:采用3种不同的强力崩解剂制备吲哚美辛口腔分散片;采用直接压缩法分别取2.5%、5.2%、7.7%浓度的交叉维酮、交叉卡棉糖钠和乙醇酸淀粉钠。对制备的片剂进行压前、压后参数评价,包括容重、轻叩密度、可压缩性指数、休止角、豪斯纳比、硬度、脆性、润湿时间、体外崩解时间和体外释药量。结果:吲哚美辛奥罗分散片各剂型5 min内释药率为74.36% ~ 80.16%,10 min内释药率为96.18% ~ 100%。崩解时间在19 ~ 78秒之间。以7.7%交叉维酮(F6)配制的片剂崩解速度比以乙醇酸淀粉钠和交叉维酮钠配制的片剂快(19秒)。体外溶出度研究表明,含7.7%交叉维酮的制剂批片在10分钟后释放率为100%,比乙醇酸淀粉钠和交叉卡蜜糖钠释放快。结论:与其他超崩解剂相比,与氯维酮联合制备的吲哚美辛口腔分散片具有较好的崩解时间和溶出度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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