局部半固体剂型的合理设计-我们还有多远?
Michael E Herbig1, Dirk-Heinrich Evers1, Sascha Gorissen1
1RaDes GmbH, Schnackenburgallee 114, 22525 Hamburg, Germany.
Pharmaceutics
|July 29, 2023
概括
针对局部半固体剂型的合理配方设计利用了皮肤透科学和稳定性分析. 这种方法增强了创新和强大的药物输送系统的发展.
科学领域:
- 制药科学 制药科学
- 皮肤病学 皮肤病学
- 材料科学 材料科学 材料科学
背景情况:
- 局部半固体剂型存在独特的挑战,包括皮肤屏障相互作用,物理/化学不稳定性和感官感知.
- 目前的配方设计往往依赖于传统方法,而不是理性,基于科学的方法.
- 了解皮肤透和配方结构的进步为改进设计提供了机会.
研究的目的:
- 分析合理配方设计在工业局部药物开发中的机遇和约束.
- 讨论基于物理化学性质的药物选择模型,以加速成功.
- 审查皮肤透科学在合理配方设计中的应用.
主要方法:
- 关于皮肤透,配方设计和稳定性的科学文献的审查.
- 讨论药物候选人选择的理论和实验模型.
- 专注于用于半固体配方表征和稳定性评估的现代体质学和分析方法.
主要成果:
- 理性设计需要了解皮肤透机制和配方影响.
- 基于有利的物理化学性质的药物选择对于开发速度和成功至关重要.
- 描述应包括与监管指导方针相一致的先进的风湿学和稳定性测试.
结论:
- 将科学原则与早期的监管考虑相结合,使得成功的开发成为可能.
- 创新和强大的半固体局部配方受益于合理的设计方法.
- 优化化学稳定性和了解皮肤透是局部药物输送的关键推动因素.
相关概念视频
Factors Influencing Drug Absorption: Pharmaceutical Parameters
154
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...
154
Drug Delivery: Overview
323
The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
323
Rational Dosage Regimen: Maintenance Dose and Loading Dose
4.2K
A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
4.2K
Factors Affecting Dissolution: Particle Size and Effective Surface Area
891
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...
891
Biopharmaceutics and Pharmacokinetics: Overview
2.1K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
2.1K
Routes of Drug Administration: Overview
6.4K
Drug administration involves delivering drugs to the body through various routes, such as enteral, parenteral, and topical.
Enteral administration refers to drugs absorbed through the gastrointestinal tract. They can be swallowed (perorally), placed under the tongue (sublingually), or on the inner lining of the cheeks (buccally). Perorally administered drugs take time to be absorbed and have a slower onset of action. The rectal route is another form of enteral administration, which allows for...
Enteral administration refers to drugs absorbed through the gastrointestinal tract. They can be swallowed (perorally), placed under the tongue (sublingually), or on the inner lining of the cheeks (buccally). Perorally administered drugs take time to be absorbed and have a slower onset of action. The rectal route is another form of enteral administration, which allows for...
6.4K


