酮洛芬与固体制剂中使用的某些辅料的相容性研究:实验设计方法

Joanna Ronowicz-Pilarczyk
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摘要

要获得安全有效的药物剂型,就必须充分了解药物物质和辅料的物理化学特性。根据目前监管机构(EMA、FDA)关于在药物产品开发阶段实施 "设计质量 "理念的建议,本文重点介绍了实验设计方法在制剂前研究中的应用。这项工作的目的是在酮洛芬(非甾体抗炎药)与选定固体制剂辅料之间的相容性研究中实施实验设计方法。采用分数因子设计法生成酮洛芬和选定辅料的多组分混合物矩阵。为了加速化学不相容性,将收到的混合物在恒温恒湿(60°C/75% RH)环境中暴露 3 周。采用 RP-HPLC 方法研究了酮洛芬与辅料的相容性。结果表明,崩解剂的类型对酮洛芬的降解有很大影响。结果表明,酮洛芬与淀粉乙醇酸钠的混合物不相容。根据文献数据,这可能是由于结晶度降低,从而降低了酮洛芬在淀粉乙醇酸钠存在下的稳定性。其他类型辅料的影响在统计学上不显著(p > 0.05)。应用实验设计方法可以合理选择最佳辅料,因此,这种方法可以为制药业的决策提供重要支持。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Compatibility Study of Ketoprofen With Selected Excipients Used in Solid Dosage Forms: Experimental Design Approach
A good understanding of the physico-chemical characteristics of a drug substance and excipients is necessary to obtain a safe and effective drug dosage form. Based on the current recommendations of the regulatory agencies (EMA, FDA) regarding the implementation of the Quality by Design concept at the drug product development stage, this article is focused on the application of the experimental design approach at the preformulation studies. The purpose of this work was the implementation of experimental design methodology in a compatibility study between ketoprofen (non-steroidal anti-inflammatory drug) and selected solid dosage forms excipients. The fractional factorial design was used to generate a matrix of multi-component mixtures of ketoprofen and selected excipients. In order to accelerate any chemical incompatibilities, the received mixtures were exposed to elevated temperature and humidity (60°C/75% RH) in a climate chamber for 3 weeks. The ketoprofen-excipients compatibility was studied by means of the RP-HPLC method. It was confirmed that the type of disintegrant had a strong impact on ketoprofen degradation. The incompatibility in mixtures of ketoprofen with sodium starch glycolate was indicated. According to literature data, it may be the result of a decrease in crystallinity and thus a decrease in the stability of ketoprofen in the presence of sodium starch glycolate. The effects of the other types of excipients were statistically insignificant (p > 0.05). The applied experimental design methodology allowed for a rational selection of optimal excipients and thus, this approach may support significantly decision-making in the pharmaceutical industry.
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