揭示胀和侵蚀动态:Mirabegron延长释放片的早期发展查
Ana S Sousa1,2, J Serra2, C Estevens2
1Faculdade de Farmácia, Universidade de Coimbra, Coimbra, 3000-148, Portugal.
AAPS PharmSciTech
|November 28, 2024
概括
这项研究通过检查聚合物和稀释剂对胀和侵蚀的影响来优化延长释放 (ER) 水友性矩阵片. 早期查设计对于高效的配方开发和了解药物释放机制至关重要.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 开发延长释放 (ER) 矩阵涉及预测药物释放机制的复杂挑战.
- 早期的配方开发需要有效的方法来理解关键质量属性 (CQA).
研究的目的:
- 为了研究含有mirabegron的ER水友基矩阵片的早期发展.
- 为了评估聚合物类型,稀释剂类型和聚合物数量的对片剂胀和侵蚀行为的影响.
主要方法:
- 利用72种配方的全因数设计来分析CQAs.
- 采用多变量回归分析和Vergnaud模型用于胀数据.
- 对所选配方的体外药物释放概况进行了研究.
主要成果:
- 聚合物类型,稀释剂类型和聚合物量显著影响了胀和侵蚀.
- 聚乙烯甘醇8000 (P8000) 配方与异 (G720) 或酸盐 (DXT) 相比,显示出更大的胀.
- 高分子量聚合物和特定聚合物,如基甲基纤维素 (HPMC) 和聚乙烯氧化物 (PEO) 增加了胀率,而聚乙烯醇 (PVA-80) 呈现出更高的侵蚀.
结论:
- 早期查设计对于高效的ER矩阵药片开发至关重要.
- 了解胀和侵蚀行为是优化药物释放机制的关键.
- 这种基于QbD的方法增强了对ER矩阵片剂配方的理解.
相关概念视频
Drugs for Treatment of Diarrhea-Predominant IBS
147
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
147
Drugs for Treatment of Constipation-Predominant IBS
134
Pharmacological therapies for IBS-C are designed to alleviate abdominal discomfort and enhance bowel function. In patients with IBS-C, fiber supplements may help soften stools and decrease straining, but may also lead to increased gas production and bloating. Osmotic laxatives like milk of magnesia are frequently used to soften stools and increase stool frequency in IBS-C patients. In addition, two drugs approved for use in severe IBS-C adult cases are linaclotide (Linzess) and lubiprostone...
134
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


