Functionality evaluation of co-processed excipients as diluents in tablets manufactured by wet granulation

European Pharmaceutical Journal Pub Date : 2020-05-01 DOI:10.2478/afpuc-2020-0010

Y. Eshovo Apeji, I. Muhammad, A. Kehinde Olowosulu, G. Owoicho Okpanachi, A. Rukayat Oyi

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引用次数: 1

Abstract

Abstract Diluents are essential components of a tablet formulation. The type of diluent used in a formulation influences the quality of tablets produced from that formulation. The aim of this study was to evaluate the tableting properties of co-processed excipients (C-PEs) incorporated as diluents in tablet formulation by wet granulation. Metronidazole tablets were prepared by wet granulation incorporating different diluents that were either single component excipients (SCEs) (lactose and microcrystalline cellulose) or C-PEs (Ludipress®, StarLac®, Prosolv® and AVICEL®HFE). The granules obtained for each formulation were evaluated for particle size analysis, flow properties and compression properties. Tablets weighing 500 mg were compressed from the metronidazole granules on a Single Station Tablet Press using a 12 mm punch and die tooling system. The tablets were kept for 24 h post-production, and the properties of weight uniformity, thickness, tensile strength, friability, disintegration time and dissolution profile evaluated subsequently. Results of granule properties showed that variations in parameters evaluated was as a result of differences in the type and composition of diluent used in formulation. Compactibility and tabletability profile of metronidazole granules revealed a better performance with granules processed with C-PE based diluents compared to SCE-based diluents. Tablets formulated with C-PEs as diluents were uniform in tablet weight, disintegrated faster and yielded a faster drug release compared to tablet formulations containing SCEs as diluent. This study reveals the performance advantage of C-PEs as diluents in tablets manufactured by wet granulation and highlights the importance of rational selection of excipients during tablet formulation.

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湿法制粒片剂中共处理辅料作为稀释剂的功能评价

摘要稀释剂是片剂配方的重要组成部分。配方中使用的稀释剂类型影响由该配方生产的片剂的质量。本研究的目的是评估通过湿法制粒作为稀释剂掺入片剂配方中的共加工赋形剂（C-PE）的压片性能。甲硝唑片通过湿法制粒制备，加入不同的稀释剂，这些稀释剂是单组分赋形剂（SCE）（乳糖和微晶纤维素）或C-PE（Ludipress®、StarLac®、Prosolv®和AVICEL®HFE）。对每种制剂获得的颗粒进行粒度分析、流动性能和压缩性能评估。在单工位压片机上使用12mm冲头和模具工具系统从甲硝唑颗粒中压制重量为500mg的片剂。片剂在生产后保持24小时，随后评估重量均匀性、厚度、拉伸强度、脆性、崩解时间和溶解特性。颗粒性质的结果表明，所评估的参数的变化是由于配方中使用的稀释剂的类型和组成的差异造成的。甲硝唑颗粒的压实性和可压片性表明，与SCE基稀释剂相比，用C-PE基稀释剂处理的颗粒具有更好的性能。与含有SCE作为稀释剂的片剂配方相比，以C-PE作为稀释剂配制的片剂重量均匀，崩解更快，药物释放更快。本研究揭示了C-PE作为湿法制粒片剂稀释剂的性能优势，并强调了在片剂配方中合理选择辅料的重要性。

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

European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

0.60

自引率

0.00%

发文量

期刊介绍： European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.