药片特性对光学孔径测量性能的影响
Chi Ki Leung1, Andreas Kottlan2, Rikard Heimsten3
1Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge, CB3 0AS, United Kingdom.
International journal of pharmaceutics
|April 17, 2025
概括
光学孔隙测量是一种非破坏性的方法,用于监测药品片的孔隙性. 这项研究发现,平板电脑的厚度,毛孔度和折射率显著影响测量准确度,低毛孔度的估计过高.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 平板电脑的多孔性对药物的性能至关重要,影响液体的运输,分解和溶解.
- 精确的透性监测和控制对于制药制造中的设计质量至关重要.
- 光学孔径测量提供了一种非破坏性的PAT方法,用于实时评估药片质量.
研究的目的:
- 为了介绍一篇关于光学孔径学理论的教程.
- 为了评估光学孔径测量在具有不同孔径和厚度的药物片上的性能.
- 识别影响测量准确度和精度的用户可控制的关键因素.
主要方法:
- 光学孔径测量,整合了GASMAS,PToFS,厚度测量和折射率.
- 实验设计 (DOE) 系统地研究性能.
- 将光学孔隙测量结果与名义孔隙度测量的比较.
主要成果:
- 药片厚度,多孔度,用户估计的固体折射率和测量数量是影响准确度和精度的关键因素.
- 光学孔径测量倾向于高估平板电脑的孔径,特别是在较低的孔径值 (∼0.05).
- 与名义值相比,在光学孔径测量中观察到变异性增加.
结论:
- 光学孔径测量是一种有价值的非破坏性PAT工具,用于实时释放药片的测试.
- 用户必须了解平板电脑厚度,毛孔度和折射率对测量结果的影响.
- 意识到潜在的高估和可变性对于可靠的光学孔径测量应用至关重要.
相关概念视频
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
101
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...
101
01:20Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
155
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
155
01:22Factors Influencing Drug Absorption: Physicochemical Parameters
187
The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
Enhanced drug absorption can be achieved by reducing particle sizes and increasing surface areas, thereby facilitating...
Enhanced drug absorption can be achieved by reducing particle sizes and increasing surface areas, thereby facilitating...
187
01:21Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
256
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
256
01:21Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH
799
Drug absorption within the gastrointestinal (GI) tract is a complex process influenced by several critical factors, including the site pH, the drug's dissociation constant (pKa), and the drug's lipophilicity. The GI tract exhibits a pH gradient, with an acidic environment in the stomach and a more alkaline environment in the small intestine. This pH variation directly affects the ionization state of drugs.
A drug's pKa and the pH of the gastrointestinal (GI) tract play crucial roles...
A drug's pKa and the pH of the gastrointestinal (GI) tract play crucial roles...
799
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
614
Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
614