通过光学相干断层扫描预测未涂层固体口服剂型的溶解性能
Elisabeth Fink1, Selma Celikovic2, Jakob Rehrl1
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
概括
光学连贯断层扫描 (OCT) 能够实时,在线预测平板电脑溶解. 这种非破坏性成像技术分析光散射,以预测药物释放,改进制药制造工艺.
科学领域:
- 制药技术 制药技术 制药技术
- 生物医学成像技术 生物医学成像技术
- 材料科学 材料科学 材料科学
背景情况:
- 实时预测固体口服剂型溶解对于制药生产至关重要.
- 目前的方法,如特拉赫兹和拉曼光谱,需要长时间的离线分析.
- 在线开发,用于溶解预测的快速方法仍然是一个重要的研究目标.
研究的目的:
- 引入一种新的策略,用于分析未涂层压缩片,使用光学连贯性断层扫描 (OCT).
- 通过图像分析来证明OCT在预测平板电脑溶解行为的能力.
- 为了确定海上国家和地区测量和实际溶解性能之间的相关性.
主要方法:
- 从不同生产批次的单个平板电脑获取OCT图像.
- 开发先进的图像分析指标,以量化来自OCT数据的光散射特性.
- 应用基于树的机器学习模型来预测活性药物成分 (API) 随着时间的推移而溶解.
主要成果:
- 经过OCT的图像显示了平板电脑和批量之间的微妙差异,通常是人类眼睛看不见的.
- 来自OCT图像的量化光散射指标显示了可重复性和稳定性.
- 在OCT衍生的测量和药片溶解行为之间建立了强烈的相关性.
- 机器学习模型准确地预测了特定时间点的API解散.
结论:
- 光学连贯断层扫描 (OCT) 是一种可行的非破坏性实时技术,用于在线监测平板加工过程.
- 基于OCT的图像分析为影响溶解的平板电脑特性提供了宝贵的见解.
- 这种方法为制药制造业质量控制的传统离线方法提供了一个有希望的替代方案.
相关概念视频
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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
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01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
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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...
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01:27Factors Influencing Drug Absorption: Drug Dissolution
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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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01:21Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH
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A drug's pKa and the pH of the gastrointestinal (GI) tract play crucial roles...
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01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
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01:20Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
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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...
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