DEVELOPMENT AND PRODUCTION OF PARENTERAL DOSAGE FORMS

肠胃外剂型的开发和生产

• 批准号: 6356122
• 负责人: TIMOTHY D SMITH
• 金额: $ 90万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2002-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6356122
• 关键词: antiAIDS agent; antineoplastics; dosage forms; drug design /synthesis /production; parenteral feedings

The primary objective of this project is to develop and produce Pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer or the HIV virus. Certain agents selected by the NCI, DCTDC, Cancer and AIDS operating committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small development batches (less than 100) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch Size (10-30,000 or more) for Phase III/IV trials and Group C distribution is possible. It is estimated that the successful offerors must be prepared to supply more than five-hundred thousand parenteral dosage units each year. The capability to develop and manufacture other pharmaceutical dosage form (i.e. large volume parental, sterile emulsions, sterile micro-dispersions, etc) is desirable but not essential. Data obtained from the contract will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, and nurses and other medical personnel handling these products in a clinical setting.

该项目的主要目标是开发和生产 具有前景的新的药学上可接受的肠胃外剂型 具有抗癌或抗HIV病毒活性的药剂。 某些试剂 由NCI，DCTDC，癌症和艾滋病操作委员会选择 将作为胃肠外制剂分配用于开发和生产 产品（主要是无菌冻干产品）。 批量大小将 范围从小型开发批次（少于100个）到中间 I期和II期试验中使用的批量;然而， III/IV期试验和组的大批量（10- 30，000或更多） C分布是可能的。据估计， 必须准备提供50多万 胃肠外剂量单位。 发展能力和 生产其他药物剂型（即大体积 亲本、无菌乳剂、无菌微分散体等）是理想的 但不是必需的。从合同中获得的数据将：1）用于 支持国家癌症研究所提交的IND申请 美国食品和药物管理局，2）提供给其他 从事大规模剂型生产的NCI承包商， 这些剂型的分析评价和3）提供给 医生、药剂师、护士和其他医务人员 在临床环境中处理这些产品。