盐酸左西替利嗪掩味或分散片的处方及体外评价

Puri Sumati, P. Dandagi, Sunita Patil, S. Gada
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引用次数: 0

摘要

采用直接压片法制备变应性鼻炎药物盐酸左西替利嗪的掩味分散片,并对其进行评价和优选。本研究使用了不同的赋形剂,并通过傅里叶变换红外光谱研究了它们与盐酸左西替利嗪的相容性。FT-IR研究结果显示,大部分辅料与左西替利嗪配伍,用于制备左西替利嗪口腔崩解片。盐酸左西替利嗪口感偏苦,采用离子交换树脂(Tulsian-339)对其进行掩味,利用药物树脂络合物制备了可分散剂量制剂。以不同浓度的乙醇酸淀粉钠、Avicel PH102、低羟基丙基纤维素为强力崩解剂,配以辅料,制备了9批(F1-F9)盐酸左西替利嗪oro分散片。对各制剂进行药物含量、重量变化、吸水率、润湿时间、体外崩解、分散时间、硬度、脆性、厚度均匀性等评价研究。体外崩解时间为28 ~ 38秒,15 min内药物完全释放。结果表明,盐酸左西替利嗪配制成可分散的剂型。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation and in vitro Evaluation of Taste-Masked Orodispersible Tablets of Levocetirizine Dihydrochloride
The main aim was to formulate and evaluate and optimize taste- masked orodispersible tablets of Levocetirizine Dihydrochloride, a drug used in Allergic Rhinitis was prepared by direct compression method. The study involved different excipients which were used for the formulation and tested for their compatibility with Levocetirizine Dihydrochloride by the FT-IR studies. Based on the results of FT-IR studies, most of the excipients were found to be compatible with Levocetirizine which was used for the preparation of Levocetirizine oral disintegrating tablets. Levocetirizine Dihydrochloride is bitter in taste so the Tulsian-339 (ion exchange resin) was used to mask the taste to formulate an orodispersible dosage formulation using drug resin complex. Nine batches (F1-F9) of oro dispersible tablets of Levocetirizine Dihydrochloride were prepared by using super disintegrants like Sodium starch glycolate, Avicel PH102 and Low Hydroxy Propyl Cellulose in variable concentrations along with excipients for the development of optimized formulation. All formulations were subjected to evaluation studies of drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, dispersion time, hardness, friability and thickness uniformity. The tablets were disintegrated in vitro within 28-38 seconds, the complete drug was released from the tablets within 15 min. The results showed that Levocetirizine dihydrochloride was successfully formulated into an orodispersible dosage form.
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