开发一种新的生物相当的欧美普拉产品
Gulzina Kumisbek1, David Vetchý1, Arshyn Kadyrbay2
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, 612 00 Brno, Czech Republic.
Medicina (Kaunas, Lithuania)
|March 28, 2024
概括
使用负担得起的技术开发出了一种新的通用延迟释放欧米醇配方. 这种生物等价的仿制梅保证获得高质量的药物,满足所有稳定性和生物等价性标准.
科学领域:
- 制药技术 制药技术 制药技术
- 药物开发 药物开发
- 生物等价性研究 生物等价性研究
背景情况:
- 奥梅普拉是一种常规处方的肠膜涂层药物,对于可获得的医疗保健至关重要.
- 哈萨克斯坦优先考虑当地制药生产价格实惠,高质量的药物,反映欧洲战略.
- 开发生物等价的仿制药对于扩大药物获取是必不可少的.
研究的目的:
- 开发和技术验证一种生物等价的延迟释放欧梅普拉配方.
- 为了确保通用欧梅普拉产品的质量,稳定性和生物等价性.
- 支持哈萨克斯坦当地制药制造业的举措.
主要方法:
- 实验室和生产规模的测试各种技术参数的延迟释放欧梅普拉.
- 根据ICH指南和哈萨克斯坦的气候区域II条件进行的稳定性研究.
- 在24名健康志愿者中进行生物等价性评估,比较40毫克欧梅普拉的通用配方和参考配方.
主要成果:
- 成功开发和实施一种通用肠道形式的欧梅普拉囊制造工艺.
- 配方表现出适当的溶解特征,并通过了所有加速 (6个月) 和长期 (12个月) 稳定性测试.
- 生物等价性研究证实,仿制品和参考产品之间的Cmax和AUC值是可比的.
结论:
- 已成功开发出一种生物等价的延迟释放甲醇 (20和40毫克) 通用配方.
- 该配方采用了负担得起的技术,增强了当地制药生产能力.
- 这一发展有助于确保在哈萨克斯坦提供高质量,易于获得的梅.
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