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使用创新的UV-Vis反射率方法和化学计量,对制药制造的批量和连续直接压缩工艺进行分析比较

Laura Macchietti¹, Dora Melucci¹, Lorenzo Menarini²

¹Department of Chemistry "G. Ciamician", University of Bologna, 40126 Bologna, Italy.

International journal of pharmaceutics

|April 6, 2024

概括

连续制药制造与批量生产的可靠性相匹配. 紫外线-Vis反射光谱为线内分析提供了可行的替代方案,提高了药物生产的效率和降低了成本.

科学领域:

制药制造业制药制造业制药制造业
分析化学分析化学
工艺工程是过程工程.

背景情况:

行业趋势有利于制药生产的连续制造和设计质量 (QbD).
连续的流程需要实时,在线分析方法进行中间和最终产品分析.
传统的批量制造涉及过程中断和中间存储.

研究的目的:

将传统的批量制药制造工艺与连续制造方法进行比较.
评价UV-Vis反射光谱作为直接的,非破坏性的分析方法,用于在线量化.
为了比较UV-Vis反射光谱与传统的UV-Vis吸收分析.

主要方法:

一种使用 riboflavin (2% w/w) 作为活性药物成分 (API) 的替代品的模型制药配方.
批量和连续制造工艺的实施和比较.
使用UV-Vis反射光谱学和UV-Vis吸收光谱学量化 рибофлавин.

主要成果:

两种制造工艺 (批量制造和连续制造) 的可靠性都相当.
所有校准模型都实现了R2>0.9,预测的利博弗拉度处于药典限制 (±15%) 之内.
紫外线-Vis反射率光谱检测证明对 рибофлавин的量化有效,可与吸收率分析相提并论.

结论:

连续制药制造是批处理的可靠替代方案,可以节省时间和成本.
紫外线-Vis反射光谱是一种有前途的分析技术,用于制药制造中的线性工艺控制.
该研究验证了用于制药生产的连续加工和先进分析技术的可行性.

关键词:

连续的直接压缩连续的直接压缩连续混合不断的混合.连续生产过程连续生产过程.多变量分析多变量分析.制药公司制药公司紫外线Vis 反射率

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