Magnesium Stearate Fatty Acid Composition, Lubrication Performance and Tablet Properties

IF 3.4 4区 医学 Q2 PHARMACOLOGY & PHARMACY AAPS PharmSciTech Pub Date : 2024-11-05 DOI:10.1208/s12249-024-02980-x
Natalia Veronica, Paul Wan Sia Heng, Celine Valeria Liew
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Abstract

Magnesium stearate (MgSt) is a common tablet lubricant. As variations in MgSt properties are known to influence tablet attributes, the impact of MgSt fatty acid composition, particularly the significance of the stearate and palmitate contents, and its effects on tablet properties warrant further investigation. This study investigated the effect of MgSt with different stearate and palmitate contents but comparable physical properties (e.g. particle size, crystallinity, specific surface area and morphology) on lubrication performance and resulting tablet quality attributes, including mechanical strength, disintegratability and drug release. The influence of MgSt concentration and blending duration on the resulting tablet properties was also examined. Tablets produced using the lower stearate content MgSt had slightly higher tensile strength. The effect of MgSt stearate content was more apparent in the disintegration time and drug release, whereby MgSt of lower stearate content resulted in tablets with longer disintegration time and slower drug release. The lower stearate content also resulted in a lower lubrication performance, leading to a lesser reduction in tablet ejection force. As expected, a longer blending time of the tablet formulation blend with MgSt yielded tablets with reduced tensile strength, shorter disintegration time and slower drug release. Tablets with higher MgSt concentration showed a greater reduction in tensile strength, longer disintegration time and faster drug release. The study findings reinforced observations by other researchers and provided a better understanding of the fatty acid composition effects of MgSt on lubrication performance and the resulting tablet properties.

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硬脂酸镁脂肪酸组成、润滑性能和片剂性能。
硬脂酸镁(MgSt)是一种常见的片剂润滑剂。众所周知,硬脂酸镁特性的变化会影响片剂属性,因此有必要进一步研究硬脂酸镁脂肪酸组成的影响,特别是硬脂酸和棕榈酸酯含量的重要性及其对片剂特性的影响。本研究调查了硬脂酸盐和棕榈酸盐含量不同但物理性质(如粒度、结晶度、比表面积和形态)相当的 MgSt 对润滑性能和由此产生的片剂质量属性(包括机械强度、崩解性和药物释放)的影响。此外,还研究了 MgSt 浓度和混合时间对片剂性能的影响。使用硬脂酸镁含量较低的硬脂酸镁生产的片剂拉伸强度略高。硬脂酸镁含量对崩解时间和药物释放的影响更为明显,硬脂酸镁含量较低的片剂崩解时间较长,药物释放较慢。硬脂酸镁含量越低,润滑性能越差,导致药片弹射力降低。正如预期的那样,片剂配方与硬脂酸镁的混合时间越长,片剂的拉伸强度越低,崩解时间越短,药物释放越慢。MgSt 浓度较高的片剂抗张强度降低幅度更大,崩解时间更长,药物释放更快。研究结果加强了其他研究人员的观察结果,使人们更好地了解了 MgSt 脂肪酸成分对润滑性能和由此产生的片剂特性的影响。
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来源期刊
AAPS PharmSciTech
AAPS PharmSciTech 医学-药学
CiteScore
6.80
自引率
3.00%
发文量
264
审稿时长
2.4 months
期刊介绍: AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.
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