液体制剂策略
用于液体药物应用的制剂需要兼顾成分和生产两方面的知识。我们的液体制剂辅料产品组合种类齐全,应用广泛,可以提供各种专长和供应商合作关系,帮助广大药物制造商应对各种挑战。
优化可注射制剂的缓释
目前已知患者对注射药物的依从性低于其他剂型,特别是对于慢性疾病或病症而言。在保持治疗功效和延长释放动力学的同时减少所需的注射次数是一项挑战。开发人员试图通过开发缓释制剂来满足这些需求。
最终可注射药物制剂中使用的赋形剂需要符合相关法规的要求。因此,选择能够确保其原材料符合这些准则的供应商十分重要。这些用作赋形剂的制剂成分的制造具有合适的质量水平,可帮助药物制造商确保其在临床试验和药物商业生产中满足相关法规的要求。可生物降解的聚合物能够实现小分子注射剂的持续释放,从而有助于优化和控制释放动力学。
相关技术文章
- Media variability is a major concern for the biopharmaceutical industry. A wideranging program to evaluate and understand the variability is critical to produce consistent quality cell culture products. Raw Material Characterization (RMC) was launched to fulfill the unmet need in the industry.
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工作流程
固体制剂策略
Solid dose challenges include API solubility and final formulation API stability, controlling total cost of manufacturing, and creating a robust, homogeneous tablet free of complications during packaging or storage.
无菌过滤策略
Drug products must be free from bacteria and other microorganisms to ensure patient safety, requiring expert use of aseptic filtration for pharmaceutical products that cannot be terminally sterilize.
制成品灌装策略
The final fill process is a critical aspect of drug manufacturing, demanding careful risk mitigation in order to ensure that safe therapeutic drug products are provided to patients.
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