开发生物预测溶解方法,用于延长释放德斯文拉法辛片
Gustavo Vaiano Carapeto1, Marcelo Dutra Duque2, Michele Georges Issa1
1Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes 580, São Paulo 05508-080, SP, Brazil.
Pharmaceutics
|May 27, 2023
概括
使用实验设计 (DoE) 和基于生理学的生物制药建模 (PBBM) 开发了desvenlafaxine延长释放 (ER) 片的新生物预测溶解方法. 这种方法通过几乎预测生物等价性来降低仿制药开发风险.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 生物制药生物制药公司
背景情况:
- 开发仿制药品需要强大的方法来确保生物等价性.
- 德斯文拉法辛延长释放 (ER) 片对仿制药的开发构成挑战.
- 在生物等效性研究中降低产品失败的风险至关重要.
研究的目的:
- 开发一种生物预测溶解方法,用于desvenlafaxine ER片.
- 为了开发方法,利用实验设计 (DOE) 和基于生理学的生物制药建模 (PBBM).
- 为了最大限度地降低通用desvenlafaxine ER片的关键生物等价性研究失败的风险.
主要方法:
- 使用GastroPlus®开发了一个基于生理学的生物制药模型 (PBBM).
- 采用Taguchi L9设计来评估药物产品和溶解条件的影响.
- 评估了药片表面积/体积比 (SA/V) 对德斯文拉法辛释放的影响.
主要成果:
- 特定的溶解条件 (900毫升0.9%NaCl,50rpm,沉船) 被确定为生物预测.
- 对于参考药物和通用药物德斯文拉法辛 (desvenlafaxine ER) 片,已经证明了虚拟生物等价性.
- 使用通用 #3 的外部验证证实了该方法的可靠性.
结论:
- 建立了一种合理的方法来开发一种生物预测溶解方法,用于desvenlafaxine ER片.
- 开发的方法有助于有效开发仿制药产品.
- 这一策略为药物产品和溶解方法的优化提供了宝贵的见解.
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