Development and Characterization of Fast-Dissolving Tablets for the Combination Therapy of Ketorolac and Rizatriptan Benzoate

IF 2.7 4区医学 Q2 PHARMACOLOGY & PHARMACY

Journal of Pharmaceutical Innovation Pub Date : 2025-10-20 DOI:10.1007/s12247-025-10156-8

Rawand Sirwan Izzalddin, Suren Azad Ramadhan, Muhannad Omer Taher, Sara Assif Younis, Nozad Rashid Hussien, Huner Kamal Omer, Diyar Salahuddin Ali

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引用次数: 0

Abstract

Background and Objective

Fast-dissolving tablets (FDTs) are uncoated tablets designed to disperse quickly in the mouth before swallowing. This study aimed to formulate and evaluate a combination of ketorolac and rizatriptan as fast-dissolving tablets for migraine treatment. The effects of different diluents and super disintegrants on wetting time, water absorption ratio, disintegration, and dissolution time were investigated using the direct compression technique.

Method

Pre-formulation studies ruled out physicochemical interactions between the drugs and excipients. Four formulations were developed with varying diluents and super disintegrants. The tablets were evaluated for organoleptic properties, weight variation, thickness, friability, hardness, disintegration time, wetting time, water absorption ratio, and stability.

Result

FT-IR analysis confirmed no interactions between the drugs and excipients. The optimized formula, F4, containing 2.5% crospovidone and 2.5% Kyron T-134, showed the best performance. It exhibited rapid drug release, with most active ingredients released within five minutes. F4 had the shortest wetting time, the fastest disintegration time (10 s), a strong stability profile, and an improved taste with strawberry flavoring.

Conclusion

A combination of Kyron T-134 and crospovidone in a 1:1 ratio provided rapid disintegration. Thus, ketorolac tromethamine and rizatriptan benzoate can be formulated as fast-dissolving tablets using direct compression, improving patient compliance in migraine treatment.

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酮咯酸与苯甲酸利扎曲坦联用速溶片的研制与表征

背景与目的速溶片（FDTs）是一种无包衣片剂，设计用于在吞咽前快速分散在口腔中。本研究旨在制定和评估酮咯酸和利扎曲坦作为偏头痛治疗的速溶片剂的组合。采用直接压缩法研究了不同稀释剂和强力崩解剂对湿化时间、吸水率、崩解时间和溶解时间的影响。方法处方前研究排除了药物与辅料之间的理化相互作用。用不同的稀释剂和强力崩解剂开发了四种配方。对其感官性能、重量变化、厚度、脆性、硬度、崩解时间、润湿时间、吸水率和稳定性进行评价。结果tft - ir分析证实药物与辅料无相互作用。以含2.5%交叉聚维酮和2.5% Kyron T-134的F4为最佳配方。它表现出快速的药物释放，大多数有效成分在5分钟内释放。F4的润湿时间最短，崩解时间最快（10 s），稳定性强，加入草莓香料后口感有所改善。结论Kyron T-134与交叉维酮以1:1的比例联合崩解，崩解速度快。因此，酮咯酸、丙二胺和苯丙酸利扎曲坦可直接压缩制成速溶片剂，提高患者对偏头痛治疗的依从性。

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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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.