3D Printing of Pharmaceutical Products for Bespoke Medicinal Delivery

用于定制药物输送的药品 3D 打印

• 批准号: 104522
• 金额: $ 83.84万
• 依托单位: FABRX LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 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=104522
• 关键词: 3D; Printing; Pharmaceutical; Products; Bespoke

"This innovation is focused on improving the production of solid-dose medicines (tablets). Currently, capitally intensive processes are used to produce large volumes of identical tablets. The applicants have identified clear market demand for a flexible point-of-dispensing, manufacturing approach such that bespoke tablet formulations can be produce on a desktop machine. Such an approach can provide greater control of the dose strength enabling medications to be personalised to recipient's needs.This team is developing such a novel 3D tablet printing ""3DP"" manufacturing and supply chain. The vision is to produce bespoke doses of personalised medicines. As an example, a long-term goal is to enable production of personalised multi-drug combinations for a patient or defined group of patients with cognitive impairment such that their entire multi-faceted dosage regimen is drastically simplified; such a ""polypill"", even in a simpler, non-personalised form, has been a long-established goal for dosing to elderly patients but the development is not feasible using standard manufacturing processes. This team's commercial goal is to create the systems and materials which enable production of validated, traceable pharmaceutical products which are suitable for human use, and commercially to establish printing as a pharmaceutical development service to companies researching personalisation of medicines.Contextually, partner 1 (Katjes Fassin) has developed a food grade 3D printing system. FabRx (the leading pharmaceutical 3D printing specialists) wishes to adopt and modify this system for use in the pharmaceutical sector. The challenge is; 1 -- limited validation of use of the types of food grade materials that form the basis of the 3DP tablets and 2 -- development of the tablet production hardware to provide in-situ confirmation of the table dose (key regulatory requirement)."

“这项创新的重点是改善固体剂量药物（片剂）的生产。目前，资本密集型工艺用于生产大量相同的片剂。申请人已经确定了对灵活的分配点制造方法的明确的市场需求，使得可以在台式机器上生产定制的片剂制剂。这种方法可以更好地控制剂量强度，使药物能够根据接受者的需求进行个性化。该团队正在开发这种新型3D打印“3DP”制造和供应链。其愿景是生产定制剂量的个性化药物。例如，长期目标是能够为患有认知障碍的患者或限定的患者组生产个性化的多药物组合，使得他们的整个多方面给药方案大大简化;这种“多药药丸”，即使是更简单的、非个人化的形式，长期以来一直是老年患者给药的目标，但使用标准生产工艺进行开发是不可行的。该团队的商业目标是创建系统和材料，使其能够生产经验证的、可追溯的适合人类使用的药品，并在商业上将打印作为一种药物开发服务，为研究药物个性化的公司提供服务。在此背景下，合作伙伴1（Katjes Fassin）开发了一种食品级3D打印系统。FabRx（领先的制药3D打印专家）希望采用和修改该系统，以用于制药行业。挑战在于，1 -对构成3DP片剂基础的食品级材料类型的使用进行有限验证，2 -开发片剂生产硬件，以提供片剂剂量的原位确认（关键监管要求）。"