New Branched Polymers Excipients and Emulsions for Enhanced Drug Delivery

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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.