Formulation and Physical Evaluation of CTM Tablets by Direct Compression Method: A Systematic Literature Review

Astriani Nurjanah, Neni Nurlelah
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Abstract

The direct compression method is one of the well-known formulation approaches in tablet manufacture. In this method, the active ingredients and additives of the formulation are mixed together and then compressed into tablets using a special device such as a compression machine. This study is a systematic review that aims to explore the formulation and physical evaluation of CTM tablets by direct compression method. The literature search process was carried out on various databases (PubMed, Web of Sciences, EMBASE, Cochrane Libraries, and Google Scholar) regarding the formulation and physical evaluation of CTM tablets by direct compression method. This study follows the preferred reporting items for systematic reviews and meta-analysis (PRISMA) recommendations. The direct compression method enables the manufacture of CTM tablets in a single production step, reducing the complexity and time required. The CTM tablet formulation process using the direct compression method involves homogeneous mixing of the raw materials and direct compression of the mixture into tablets using a compression machine. The direct compression method has advantages in production efficiency, simplicity, and cost-effectiveness, controlling the dosage of the drug contained in the tablet, and physical uniformity of the tablet. However, the direct compression method also has drawbacks, such as the risk of material segregation, difficulty in achieving controlled drug release, and the potential for direct effects on the active ingredients. Physical evaluation of tablets involves measuring the weight, thickness, and diameter of the tablets, as well as hardness or compressive strength tests to ensure the physical quality of the tablets produced. Drug release tests and dissolution tests were carried out to ensure that the CTM tablets released the drug consistently and under control according to regulatory requirements. Stability tests and chemical tests were carried out to check the physical and chemical changes of the tablets during storage and to ensure the integrity and purity of chlorpheniramine.
直接压片法中药片的处方及物理评价:系统文献综述
直接压缩法是片剂生产中常用的处方方法之一。在该方法中,将制剂的有效成分和添加剂混合在一起,然后使用压缩机等特殊装置压缩成片剂。本研究是一项系统综述,旨在探讨直接压缩法中药片的处方及物理评价。在各数据库(PubMed、Web of Sciences、EMBASE、Cochrane Libraries、Google Scholar)中进行直接压缩法中药片剂配方及物理评价的文献检索。本研究遵循系统评价和荟萃分析(PRISMA)推荐的首选报告项目。直接压缩法使中药片剂的生产在一个生产步骤,减少了复杂性和所需的时间。采用直接压缩法的中药片剂配方工艺包括原料均匀混合和使用压缩机将混合物直接压缩成片剂。直接压缩法具有生产效率高、操作简单、成本效益好、控制片剂中所含药物的用量、片剂的物理均匀性等优点。然而,直接压缩方法也有缺点,如物质分离的风险,难以实现药物的受控释放,以及对活性成分的直接影响。片剂的物理评价包括测量片剂的重量、厚度和直径,以及硬度或抗压强度测试,以确保所生产片剂的物理质量。进行了药物释放试验和溶出度试验,以确保中药片的药物释放一致,并根据法规要求进行控制。进行稳定性试验和化学试验,检查片剂在贮存过程中的理化变化,确保氯苯那敏的完整性和纯度。
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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