实时预测涂层口服剂型的溶解概况
Stephan Sacher1, Elisabeth Fink1, Carolina Alva1
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.
International journal of pharmaceutics
|October 16, 2024
概括
光学连贯断层扫描 (OCT) 可实时监测药物涂层厚度. 这使得能够预测药片溶解的概况,提高药物产品质量和实时释放测试.
科学领域:
- 制药技术 制药技术 制药技术
- 过程分析技术 过程分析技术
- 药物输送系统是药物输送系统.
背景情况:
- 光学连贯性断层扫描 (OCT) 用于在药物涂层中进行直线监测.
- 目前的方法依赖于代表性抽样,可能无法捕捉实时过程变化.
研究的目的:
- 开发和验证一种方法,将线性OCT涂层厚度测量与平板电脑溶解型号相关联.
- 为了能够实时预测涂层口服剂型的溶解情况.
主要方法:
- 对于平板板和颗粒液床涂层工艺,建立了相关性模型.
- 使用各种工艺参数和涂料配方来评估可行性.
主要成果:
- 证明了OCT测量的涂层厚度和片剂溶解之间的成功相关性.
- 在不同条件下验证了开发的相关性模型的预测能力.
结论:
- 基于OCT的溶解预测为确保药物产品质量提供了一个新的方法.
- 该战略支持实时释放测试 (RTRT) 控制策略的实施.
相关概念视频
Theories of Dissolution: Diffusion Layer Model
698
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...
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...
698
Factors Affecting Dissolution: Particle Size and Effective Surface Area
750
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...
750
Factors Influencing Drug Absorption: Drug Dissolution
424
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...
424
Factors Influencing Drug Absorption: Pharmaceutical Parameters
121
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...
121
Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model
277
Various dissolution theories provide insight into the factors that influence the dissolution rate. Danckwerts' Model suggests that turbulence, rather than a stagnant layer, characterizes the dissolution medium at the solid-liquid interface. In this model, the agitated solvent contains macroscopic packets that move to the interface via eddy currents, facilitating the absorption and delivery of the drug to the bulk solution. The regular replenishment of solvent packets maintains the...
277
Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH
1.1K
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...
1.1K


