相关实验视频
Updated: Jul 3, 2025

11:06
3D Printing of Preclinical X-ray Computed Tomographic Data Sets
Published on: March 22, 2013
40.5K
3D打印在药品固体剂型开发的早期阶段的应用
Rachel L Milliken1, Thomas Quinten2, Sune K Andersen2
1School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
International journal of pharmaceutics
|February 15, 2024
概括
三维打印 (3DP) 为个性化医疗提供定制的固体口服剂型 (SODF). 虽然3DP并没有取代大规模生产,但在适应性临床试验的小批量中表现出色,解决了监管和质量控制方面的挑战.
科学领域:
- 制药技术 制药技术 制药技术
- 药物输送系统 药物输送系统
- 增材制造 增材制造 增材制造
背景情况:
- 三维打印 (3DP) 是一种新兴技术,具有量身定制固体口服剂型 (SODF) 的潜力.
- 尽管有3DP的能力,传统的药物制造仍然是行业标准.
- 预计3DP将大大有利于个性化医疗.
研究的目的:
- 审查SODFs的3DP技术的最新进展.
- 突出3DP在SODFs临床开发早期阶段的应用.
- 讨论与SODFs3DP相关的当前监管挑战和质量控制.
主要方法:
- 关于固体口服剂型3D打印技术近期进展的文献综述.
- 在早期临床研究中对3DP应用的分析.
- 审查监管方面的考虑和质量控制策略.
主要成果:
- 3DP显示了定制SODF的前景,特别有利于个性化医疗.
- 3DP不太可能取代传统的批量生产,但适用于小批量自适应制造.
- 3DP可以在早期开发阶段促进适应性临床试验设计.
结论:
- 3DP技术准备通过定制的SODF来增强个性化医疗.
- 在适应性试验的小批量生产中应用3DP是一个关键优势.
- 解决监管障碍和确保质量控制对于在制药开发中广泛采用3DP至关重要.
相关概念视频
Factors Influencing Drug Absorption: Pharmaceutical Parameters
134
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...
134
Biopharmaceutics and Pharmacokinetics: Overview
2.0K
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...
2.0K
Drug Administration and Therapy Phases: Overview
465
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
465
Preclinical Development: Overview
4.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.4K

