制药片制造的生命周期评估:一个比较分析和系统模型整合框架
Flora Bouchier1, Astrid Boje2, Gavin Reynolds3
1Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
International journal of pharmaceutics: X
|October 13, 2025
概括
生命周期评估表明,直接压缩 (DC) 对于小批量是最好的,而连续直接压缩 (CDC) 对于大规模制药片制造是最碳有效的. 工艺产量显著影响环境足迹.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 可持续工程 可持续工程
- 绿色化学 绿色化学
背景情况:
- 口服固体剂 (OSD) 制造涉及多个步骤,将粉末转化为具有特定特性的片.
- 当前的OSD制造工艺设计 (例如,直接压缩,滚筒压缩,高剪切颗粒,连续直接压缩) 往往缺乏定量环境影响评估.
- 优化制药生产需要了解产品质量以及环境足迹.
研究的目的:
- 使用"摇篮到门"生命周期评估 (LCA) 量化比较不同OSD制造平台的环境可持续性.
- 分析生产规模对各种制药制造工艺碳足迹的影响.
- 确定影响环境足迹的关键因素,包括活性药物成分 (API) 贡献和工艺产量.
主要方法:
- 采用"摇篮到门"生命周期评估 (LCA) 方法来评估标准的OSD制造平台.
- 在不同的生产规模 (小批量到大批量) 中比较了环境足迹.
- 集成的LCA数据与连续直接压缩 (CDC) 过程的系统模型进行优化.
主要成果:
- 直接压缩 (DC) 为小批量产品带来了最低的碳足迹.
- 连续直接压缩 (CDC) 对于较大的批量尺寸证明是最碳效率高的.
- 配方过程的产量,特别是由于活性药物成分 (API) 的高碳足迹,对整体碳足迹产生了最显著的影响.
结论:
- 药品片的制造工艺选择应考虑生产规模和环境影响.
- 优化工艺产量对于最大限度地减少药物产品的碳足迹至关重要.
- 结合LCA和系统建模,可以指导产品质量和减少环境影响的流程优化.
相关概念视频
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
306
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
306
Factors Influencing Drug Absorption: Pharmaceutical Parameters
402
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...
402
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
149
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
149
Biopharmaceutical Factors Influencing Drug Product Design: Overview
233
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
233
Drug Dissolution: Requirements and Profile Comparison
242
The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
242
Pharmacokinetic Models: Overview
1.9K
Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
1.9K


