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开发和验证内药物产品的歧视性体外释放方法
Nada A Helal1, Marilyn N Martinez2, David G Longstaff2
1Department of Pharmaceutical Sciences, Irma Lerma Rangel School of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX, USA.
Pharmaceutical research
|October 2, 2023
概括
研究人员开发了新的体外释放方法来区分乳内 (IMM) 配方. 这些方法成功地区分了具有不同物理化学特性的配方,有助于IMM药物产品的质量控制.
科学领域:
- 兽医药房 兽医药房 兽医药房
- 药物输送系统 药物输送系统
- 分析化学 分析化学
背景情况:
- 乳腺内 (IMM) 配方对于治疗牛乳腺炎至关重要.
- 目前,没有药库内体释放方法可以区分IMM配方.
- 为质量控制和可比性评估开发歧视性的体外实验方法至关重要.
研究的目的:
- 开发和优化体外释放方法,能够区分不同的乳内制剂 (IMM).
- 评估这些方法的适用性,以比较SPECTRAMAST® LC与内部仿制药的配方.
主要方法:
- 公司内部的IMM配方被合成,以模仿SPECTRAMAST® LC.
- 配方的物理化学表征包括颗粒大小,质,药物含量和沉/花率.
- 在体外释放药物时,使用USP Apparatus 1,2 (具有定制细胞/增强剂) 和4进行评估,优化了介质组成 (牛奶与缓冲),体积和旋转速度等参数.
主要成果:
- 使用USP Apparatus 2确定了两个歧视性体外系统:一个带有定制配方容器,另一个带有增强器细胞.
- 最佳条件包括每分钟125转的旋转速度和900毫升均牛奶.
- 在1小时内,SPECTRAMAST® LC表现出与类似配方 (F-01,F-02) 类似的释放配置文件,但释放速度明显快于不同配方 (F-03,F-04).
结论:
- 开发的体外释放方法有效地根据其物理化学性质区分IMM配方.
- 这些方法是IMM药物产品体外可比性评估的宝贵工具.
- 这些发现支持制定强有力的质量控制策略,用于乳内治疗.
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