硬脂酸镁
润滑油
粘着概率
活性成分
材料科学
混合(物理)
造粒
工艺工程
复合材料
剂型
化学
色谱法
颗粒
工程类
生物
物理
吸附
解吸
有机化学
量子力学
生物信息学
作者
C. A. Gunawardana,Angela Kong,Debbie Wanapun,Daniel O. Blackwood,C. Travis Powell,Joseph F. Krzyzaniak,Myles C. Thomas,John E. Kresevic,Changquan Calvin Sun
标识
DOI:10.1016/j.ijpharm.2023.123016
摘要
The sticking of active pharmaceutical ingredient (API) to the surfaces of compaction tooling, frequently referred to as punch sticking, causes costly downtime or product failures in commercial tablet manufacturing. Magnesium stearate (MgSt) is a common tablet lubricant known to ameliorate the sticking problem, even though there exist exceptions. The mechanism by which MgSt lowers punch sticking propensity (PSP) by covering API surface is sensible but not yet experimentally proven. This work was aimed at elucidating the link between PSP and surface area coverage (SAC) of tablets by MgSt, in relation to some key formulation properties and process parameters, namely MgSt concentration, API loading, API particle size, and mixing conditions. The study was conducted using two model APIs with known high PSPs, tafamidis (TAF) and ertugliflozin-pyroglutamic acid (ERT). Results showed that PSP decreases exponentially with increasing SAC by MgSt. The composition of material stuck to punch face was also explored to better understand the onset of punch sticking and the impact of possible MgSt-effected punch conditioning event.
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