New Branched Polymers Excipients and Emulsions for Enhanced Drug Delivery

许多口服药物吸收不良，导致每次给药使用的剂量高于维持较低生产成本、储存问题和生产能力的理想剂量。对于艾滋病毒和其他慢性疾病，患者需要终身接受治疗，这意味着费用会随着时间的推移而积累。这对低收入和中等收入国家产生了相当大的影响，在这些国家，许多慢性传染病需要终生服药，以尽量减少进一步传播，并最大限度地提高受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产生了连锁反应。艾滋病毒是一个具体的例子，在这种情况下，每个病人每天服用超过900毫克的剂量是很常见的，这给医疗保健提供者（通常是地方政府和国际社会）造成了相当大的费用负担，并由于费用限制而无法广泛获得治疗。在许多情况下，之所以需要这么高的剂量，只是因为被吞下的少量药物实际上会进入血液，从而产生明显的药理作用。在某些情况下，停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。在这笔拨款中，我们的目标是通过在健康志愿者中展示实际益处来推进一种新的治疗配方方法，并建立减少给药剂量的潜力，同时保持血液中可用的药物量，以在口服给药后发挥其治疗效果。这将需要充分展示我们的新材料技术通过制药和监管批准的制造工艺的潜力，并使用该材料来产生新的治疗候选药物。在批准人体药代动力学评价后，一项小型研究将建立所需的数据，以降低制药和材料工业投资开发新药的风险。因此，拟议的研究大大加快了以往研究的成果，使其朝着可能在世界各地提供医疗保健益处的实际影响发展。虽然该项目专门针对一种新的艾滋病药物，但我们希望经过验证的平台技术能够广泛应用于各种适应症，节省治疗成本，使原本无法口服的药物得以输送，并通过在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.