DEVELOP AND PRODUCE PHARMACEUTICAL DOSAGE FORMS

开发和生产药物剂型

• 批准号: 3614467
• 负责人: JOHN L LACH
• 金额: $ 36.14万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-06-16 至 1989-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3614467
• 关键词: biological products; dosage forms; drug quality /standard; neoplasm /cancer pharmacology

This contract is to provide the National Cancer Institute's Division of Cancer Treatment with dosage form development service for about five compounds per year. Studies include: solubility determinations in vehicles suitable for intravenous use, development of stability indicating assays, pH profiles to determine optimum pH for stability, pilot scale freeze drying experiments, compatability studies with container-closure systems, stability studies of drug solutions under simulated use conditions and analyses of these dosage forms. After completion of the development assignment, the contractor will devise and carry out an appropriate manufacturing procedure on production scale. Most projects will require preparation of sterile freeze dried dosage forms in batch sizes of 4000-6000 units per batch. About two batches per year will involve solid oral dosage forms(tablets or capsules). The contractor is responsible for the quality control testing of all formulation components including active ingredients, excipients, container-closure systems as well as the finished products.

该合同是为国家癌症研究所的 癌症治疗与剂型开发服务约五 化合物每年。 研究包括： 适用于静脉内使用的溶媒，稳定性指示剂的开发 测定，确定稳定性最佳pH值的pH值曲线，中试规模 冷冻干燥实验，与容器密封件的相容性研究 系统，模拟使用条件下药物溶液的稳定性研究 和这些剂型的分析。 开发完成后 承包商将设计并执行适当的 在生产规模上的生产过程。 大多数项目需要 制备批量为 每批4000-6000件。 每年约有两批涉及固体 口服剂型（片剂或胶囊）。 承包商负责 包括活性成分在内的所有制剂组分的质量控制测试 成分、赋形剂、容器密封系统以及成品 产品.