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Updated: May 25, 2025

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整合体外溶解和基于生理学的药物动力学建模用于通用药物开发:对塔克罗利木斯的无形固体分散配方的评估

Evangelos Karakitsios1, Maria-Faidra-Galini Angelerou2, Iasonas Kapralos1

  • 1Department of Pharmacy, National and Kapodistrian University of Athens, 15771 Athens, Greece.

Pharmaceutics
|February 26, 2025
PubMed
概括

基于生理学的药理动力学 (PBPK) 建模准确预测了无形固体分散 (ASD) 配方的塔克罗利斯 (Prograf) 药理动力学. 这有助于通过评估生物预测溶解方法来开发仿制药.

关键词:
无形固体分散的无形固体分散生物相关溶解试验基于生理学的生物制药模型.

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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