SBIR PHS-2017-1 Topic 369 : Pediatric Cancer Drug Delivery System Research and Development. POP 09/21/2017 to 6/20/2018.

SBIR PHS-2017-1 主题 369：儿科癌症药物输送系统研究与开发。

• 批准号: 9578584
• 负责人: Michael Quinn
• 金额: $ 28.94万
• 依托单位: HS-DESIGN, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-21 至 2018-06-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9578584
• 关键词: Acids; Affect; Antineoplastic Agents; Benchmarking; Caregivers; Child; Dose; Drug Delivery Systems; Formulation; Humidity; Liquid substance; Malignant Childhood Neoplasm; Measures; Microspheres; Oral; Patients; Pharmaceutical Preparations; Phase; Refrigeration; Resistance; Risk; Saliva; Skin; Small Business Innovation Research Grant; Stomach; Syringes; System; Systems Development; Testing; Texture; Toxic effect; Vial device; cancer therapy; cost; design; liquid formulation; prototype; reconstitution; systems research; usability

HS Design proposes to develop a dispensing and dosing system for multiparticulate (MP) cancer drugs. Multiparticulate drugs are ones that have been formulated into dry microspheres that do not dissolve in saliva but will dissolve in stomach acid. MP Drugs are an ideal candidate for giving to children. They can be flavorless, are non-gritty, do not require liquid reconstitution, and do not require refrigeration. They should be better tolerated by children, especially those with sensitivity to flavors or textures as can occur with some cancer therapies. MP drugs also pose a lower risk of toxicity effects from skin contact vs. liquid formulations, to patients and caregivers. A major hurdle to the use of MP drugs is the lack of precision delivery and dosing systems. HS Design proposes to develop prototype systems that can accurately measure and dose MP drugs in volumes suitable for cancer treatment. HSD will take a platform approach so the system can be tailored for a variety of pediatric cancer drugs that already have oral formulations are could soon be approved for oral use. At the end of Phase 1 prototypes will have been tested for dose accuracy and usability.

HS Design 提议开发一种用于多颗粒 (MP) 癌症药物的分配和剂量系统。多颗粒药物是被配制成干燥微球的药物，不溶于唾液，但会溶于胃酸。 MP 药物是给儿童服用的理想选择。它们可以是无味的、无砂粒的、不需要液体重构，并且不需要冷藏。儿童应该能更好地耐受它们，尤其是那些对味道或质地敏感的儿童，就像某些癌症疗法可能会出现的情况一样。与液体制剂相比，MP 药物因皮肤接触而对患者和护理人员产生毒性作用的风险也较低。使用 MP 药物的一个主要障碍是缺乏精确的输送和剂量系统。 HS Design 提议开发原型系统，能够准确测量 MP 药物并以适合癌症治疗的剂量给药。 HSD 将采用平台方法，以便该系统可以针对各种已经有口服制剂的儿科癌症药物进行定制，这些药物很快就会被批准用于口服使用。第一阶段结束时，将对原型进行剂量准确性和可用性测试。