New Branched Polymers Excipients and Emulsions for Enhanced Drug Delivery

许多口服药物的吸收较差，导致每次给药的剂量高于理想的剂量，以保持较低的生产成本、储存问题和制造能力。对于艾滋病毒和其他慢性病，患者需要终身致力于治疗，这意味着随着时间的推移，费用会累积。这对低收入和中等收入国家有相当大的影响，在这些国家，许多慢性传染病需要终身服药，以最大限度地减少感染患者的进一步传播，并最大限度地提高感染患者的生命质量和寿命，这对生产力和更广泛的经济考虑具有连锁反应。艾滋病毒是一个具体的例子，每个患者每天的剂量超过900毫克是很常见的，这给医疗保健提供者(通常是地方政府和国际社会)带来了相当大的成本负担，并由于成本限制而阻碍了广泛获得治疗的机会。在许多情况下，之所以需要这些高剂量，只是因为吞咽的药物中实际上有有限的量进入血液，以提供明确的药理益处。在某些情况下，滞留在肠道内并通过肠道的药物可能会给患者带来相当大的副作用，如胃肠道紊乱。在这笔赠款中，我们的目标是通过在健康志愿者中展示实际益处来发展一种新的治疗方案，并建立减少给药剂量的可能性，同时保持血液中可用药物的量，以便在口服剂量后发挥其治疗效果。这将需要充分展示将我们的新材料技术应用于制药和监管部门批准的制造工艺并使用这些材料产生新的候选疗法的潜力。在人类药代动力学评估获得批准后，一项小型研究将建立降低制药和材料行业投资风险以开发新药所需的数据。因此，这项拟议的研究大大加快了先前研究的结果，使其达到可能在世界各地提供医疗保健福利的实际影响。虽然该计划专门针对一种新的艾滋病毒药物，但我们预计经过验证的平台技术将广泛适用于各种适应症，节省治疗成本，使原本无法口服的药物能够交付，并通过高收入背景下的商业化为英国经济创造财富。

The poor absorption of many orally-dosed medicines results in the use of higher doses per administration than would be ideally delivered to maintain lower production costs, storage issues, and manufacturing capacity. For HIV and other chronic diseases, patients require a life-long commitment to therapy meaning that costs accumulate over time. This has considerable impact in low- and middle-Income countries where many chronic infectious diseases require lifelong dosing to minimise further spread and maximise the quality and length of life for infected patients, which has a knock-on effect for productivity and wider economic considerations. HIV is a specific example where doses greater than 900mg per-patient-per-day are common, leading to a considerable cost burden for healthcare providers (often local governments as well as the international community) and the prevention of wide spread access to therapy due to cost constraints. In many cases, these high doses are only required because a limited amount of the drug that is swallowed actually enters the bloodstream to provide the explicit pharmacological benefits. In some cases, the drug that stays in and passes through the gut may cause the patient considerable side-effects such as gastrointestinal disturbances. Within this grant we aim to progress a new approach to therapy formulation through to demonstration of actual benefits in healthy volunteers and establish the potential to reduce administered doses whilst maintaining the amount of drug available within the bloodstream to exert its therapeutic effect after oral dosing. This will require the full demonstration of the potential to take our new materials technology through to pharmaceutical and regulatory approved manufacturing processes and use the material to generate a new therapy candidate. After approval for human pharmacokinetic evaluation, a small study will establish the data required to de-risk pharmaceutical and material industry investment to develop new medicines. The proposed research, therefore, considerably accelerates the outcomes of previous research towards actual impact that could provide healthcare benefits around the world. While the programme is specifically targeted at a new HIV medicine, we expect the validated platform technology to be widely applicable across indications, saving costs of treatment, enabling delivery of drugs that could otherwise not be delivered orally, and generating wealth for the UK economy through commercialisation in high income contexts.