Optimisation of microneedle insertion and understanding the implications of repeat application as tools to support translation
Lead Research Organisation:
Queen's University Belfast
Department Name: Sch of Pharmacy
Abstract
Traditional pharmaceutical drugs are small molecules that treat the symptoms of a disease. Biopharmaceuticals are larger molecules, for example, peptides and proteins, 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 and proteins are expected to be used increasingly 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. 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. Similarly, development of blood-free diagnostic systems is a major priority.
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 either dissolve quickly, leaving tiny holes in the stratum corneum, through which medicines can enter the body, or swell, turning into a jelly-like material that keeps the holes open and allows continuous drug delivery. Our unique technology could potentially revolutionise the delivery of peptides and proteins, as well as that of long-acting small molecules that cannot currently be delivered across the skin. Notably, we have also found that our swellable microneedles can extract fluid from the skin. This permits us to monitor the levels of medicines and markers of disease without actually taking blood samples.
In the UK, the NHS stands to benefit from reduced costs due to shorter hospital stays and reduced occurrence of inappropriate dosing. Ultimately, health-related-quality-of-life will be enhanced through improved disease control, rapid detection of disease and dangerously high or low levels of medicines, facile monitoring of compliance with prescribed dosing and detection of illicit substances in addicts or vehicle drivers. Preterm neonates will derive great benefit from the marked increase in monitoring frequency permitted, as will elderly patients being treated with multiple medicines. At-home treatment/diagnosis, keeping people away from healthcare settings, will also help reduce spread of COVID-19 to vulnerable in-patients and healthcare workers.
We have attracted considerable interest and funding from industry to investigate our technologies for a range of applications. However, to facilitate the commercialisation process and maximise value to the UK, it is now essential to develop methods for rationalised skin application of the microneedles such that they are always applied to every patient in the same way every time and that their efficacy is guaranteed. We will also study, for the first time under industry-standard conditions, repeat application of our microneedles to mimic normal use and to demonstrate safety. Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits
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 either dissolve quickly, leaving tiny holes in the stratum corneum, through which medicines can enter the body, or swell, turning into a jelly-like material that keeps the holes open and allows continuous drug delivery. Our unique technology could potentially revolutionise the delivery of peptides and proteins, as well as that of long-acting small molecules that cannot currently be delivered across the skin. Notably, we have also found that our swellable microneedles can extract fluid from the skin. This permits us to monitor the levels of medicines and markers of disease without actually taking blood samples.
In the UK, the NHS stands to benefit from reduced costs due to shorter hospital stays and reduced occurrence of inappropriate dosing. Ultimately, health-related-quality-of-life will be enhanced through improved disease control, rapid detection of disease and dangerously high or low levels of medicines, facile monitoring of compliance with prescribed dosing and detection of illicit substances in addicts or vehicle drivers. Preterm neonates will derive great benefit from the marked increase in monitoring frequency permitted, as will elderly patients being treated with multiple medicines. At-home treatment/diagnosis, keeping people away from healthcare settings, will also help reduce spread of COVID-19 to vulnerable in-patients and healthcare workers.
We have attracted considerable interest and funding from industry to investigate our technologies for a range of applications. However, to facilitate the commercialisation process and maximise value to the UK, it is now essential to develop methods for rationalised skin application of the microneedles such that they are always applied to every patient in the same way every time and that their efficacy is guaranteed. We will also study, for the first time under industry-standard conditions, repeat application of our microneedles to mimic normal use and to demonstrate safety. Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits
Publications
Li H
(2024)
Design of a Novel Delivery Efficiency Feedback System for Biphasic Dissolving Microarray Patches Based on Poly(Lactic Acid) and Moisture-Indicating Silica.
in Advanced healthcare materials
Magill E
(2023)
Solid implantable devices for sustained drug delivery.
in Advanced drug delivery reviews
Description | We have shown that repeated microneedle application to the skin of mini-pigs does not cause any adverse effects and that levels of polymers deposited in skin from statistically-optimised microneedle geometries are extremely low |
Exploitation Route | This data shows that repeated application of microneedle delivery systems is likely to be safe, providing vital reassurance to companies seeking to develop microneedle products based on our novel technologies |
Sectors | Pharmaceuticals and Medical Biotechnology |
Description | We have funded partnerships with Janssen, Boston Scientific and Haleion (GSK Consumer Healthcare spin-off). Both Haleon and TSRL inc are due to conduct initial clinical trials (using microneedles manufactured by our partner LTS Lohmann and based on our intellectual property) in the second half of 2024 |
First Year Of Impact | 2023 |
Sector | Pharmaceuticals and Medical Biotechnology |
Impact Types | Economic |
Description | Delivering 5-MeO-DMT transdermally using microneedle patches |
Amount | £114,229 (GBP) |
Organisation | Beckley PsyTech |
Sector | Private |
Country | United Kingdom |
Start | 07/2022 |
End | 07/2023 |
Description | Delivering two peptides transdermally using microneedle patches |
Amount | £146,584 (GBP) |
Organisation | Janssen Pharmaceutica NV |
Sector | Private |
Country | Belgium |
Start | 06/2022 |
End | 09/2023 |
Description | Microneedle biomarker detection systems |
Amount | £100,004 (GBP) |
Organisation | Boston Scientific |
Sector | Private |
Country | United States |
Start | 11/2023 |
End | 10/2024 |
Description | Pharmacy Showcase |
Form Of Engagement Activity | Participation in an open day or visit at my research institution |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Schools |
Results and Impact | Visit by Northern Ireland school children from disadvantaged backgrounds to the university to engage with research in the pharmaceutical sciences and the pharmacy profession. A week-long course was attended by the children, all of whom have shown promise. They engage with our laboratory activities and have classes and workshops while staying on campus. If they score well on the test at the end of the week, they receive a 1-grade reduction for entry to the MPharm and BSc degrees at the School of Pharmacy. Our work features extensively in this Pathways Opportunity Programme each year. |
Year(s) Of Engagement Activity | 2022,2023,2024 |