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Novel dry particle coating technology for the development of dry powder inhalation formulations

用于开发干粉吸入制剂的新型干颗粒包衣技术

基本信息

批准号：
133333
负责人：
金额：
$ 13.36万
依托单位：
ASTON PARTICLE TECHNOLOGIES LIMITED
依托单位国家：
英国
项目类别：
Feasibility Studies
财政年份：
2018
资助国家：
英国
起止时间：
2018 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=133333
关键词：
Novel dry particle coating technology

项目摘要

The global market for treatment of asthma and COPD is estimated to be $41.7B in 2017. Dry powder inhalers (DPI) make up nearly 50% of the market by sales value (FDA, 2015). The formulation and performance of a DPI is affected by complex interactions between drug substance, excipients and inhalation device. Current technologies for developing DPIs, such as high shear blending or turbula mixing remain a black art based on trial and error, with highly variable inputs to the subsequent DPI formulation. APT offers a world’s first IP protected (WO 2016/066462A) aerosolised particle engineering technology as a one step, relatively isothermal process with controlled process parameters that produces repeatable product performance with readily available commercial excipients. APT can offer a means of streamlining preclinical formulation development, whilst simultaneously providing robust clinical test article. APT will target the market through product development fees and licensing for royalty payment. The team brings over 75 years of pharma experience and comprises of Dr Ian Smith (CEO), Dr David Wyatt (COO), Prof Afzal Mohammed (CTO), 2FTE scientists and project manager. The CEO and COO have many contacts in DPI sector including GSK, Vectura, Novartis and Mylan.

2017年全球哮喘和COPD治疗市场估计为417亿美元。干粉吸入器（DPI）占销售额的近50%（FDA，2015）。DPI的配方和性能受到原料药、辅料和吸入装置之间复杂相互作用的影响。目前用于开发DPI的技术，例如高剪切共混或双组分混合，仍然是一种基于试错的黑技术，对随后的DPI制剂具有高度可变的输入。APT提供了世界上第一个受IP保护的（WO 2016/066462 A）气溶胶化颗粒工程技术，作为一个一步，相对等温的过程，具有受控的工艺参数，使用容易获得的商业赋形剂产生可重复的产品性能。APT可以提供一种简化临床前制剂开发的方法，同时提供稳健的临床供试品。APT将通过产品开发费和特许权使用费来瞄准市场。该团队拥有超过75年的制药经验，包括Ian Smith博士（首席执行官），大卫怀亚特博士（首席运营官），Afzal Mohammed教授（首席技术官），2FTE科学家和项目经理。首席执行官和首席运营官在DPI领域有许多联系人，包括GSK，Vectura，诺华和Mylan。