Micron-scale, chemically-controlled, auto-injection systems for at-home drug delivery

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Traditional pharmaceutical drugs are small molecules that treat the symptoms of a disease. Biopharmaceuticals are larger molecules, for example, peptides, proteins and antibodies, which target the underlying mechanisms and pathways of a disease that are not accessible with traditional drugs. Recently, there have been rapid and revolutionary developments in this field of biotechnology. Therapeutic peptides, proteins and antibodies are expected to be used extensively in the coming years as vaccines and as treatments for cancer, high blood pressure, pain, blood clots and many other illnesses. However, one of the major challenges to successful clinical use of these so-called "biotech" molecules is their efficient delivery to the site of action. The body breaks these medicines down when they are swallowed and they are generally not well-absorbed into the blood. As a result, they have to be given frequently by injection, which is painful and means that these drugs are usually only administered in hospital. Long-acting formulations of small molecules, increasingly to the fore in treating HIV and TB, must also be injected. The COVID-19 pandemic has greatly increased the need for self-administration of injectables at home, away from healthcare settings, where transmission can have dire consequences and healthcare systems are backlogged. Complexities of storage, distribution and administration, needle phobia and the difficulty of domestic disposal of potentially-contaminated sharps all contribute to an urgent need for alternative delivery modes for injectable drugs/vaccines. We have developed a novel type of transdermal patch that by-passes the skin's barrier layer, which is called the stratum corneum. The patch surface has many tiny needles that pierce the stratum corneum without causing any pain - The sensation is said to feel like a cat's tongue. These needles create tiny holes in the stratum corneum, through which drugs/vaccines can enter the body from a unique reservoir system powered by simple and safe chemistry. Our unique technology could potentially revolutionise the delivery of peptides and proteins, antibodies, vaccines, as well as that of long-acting small molecules that cannot currently be delivered across the skin. In the UK, the NHS stands to benefit from at-home dosing of medicines/vaccines that normally require a healthcare worker's time and expertise. Ultimately, health-related-quality-of-life will be enhanced through improved disease control by empowered patients. At-home treatment, keeping people away from healthcare settings, will also help reduce spread of COVID-19 and other respiratory pathogens (e.g. influenza, Strep A) to vulnerable in-patients and healthcare workers whilst also, importantly, allowing NHS staff to focus on overcoming the backlog in normal diagnosis and treatment of non-COVID disease.We have attracted considerable interest and funding from industry to develop our first and second generation microneedle technologies for a range of applications. However, to facilitate the translational development of the novel third generation technology to be investigated here and maximise value to the UK, it is essential to develop methods to fully understand these new high-dose microneedles. We will ensure that their efficacy is guaranteed by employing advanced computer-guided device design and rationalisation, coupled with extensive laboratory investigation. Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits.