Transdermal delivery of macromolecules mediated by microneedle arrays
Lead Research Organisation:
Queen's University Belfast
Department Name: Sch of Pharmacy
Abstract
Traditional pharmaceutical drugs are small chemical molecules that treat the symptoms of a disease. Biopharmaceuticals are large biological molecules, known as peptides and proteins and these target the underlying mechanisms and pathways of a disease. They can deal with targets in humans that are not accessible with traditional medicines. Recently, there have been rapid and revolutionary developments in this field of biotechnology. Therapeutic peptides and proteins are expected to be used extensively in coming years as vaccines and treatments for cancer, high blood pressure, pain and blood clots, as well as many other illnesses. However, one of the major challenges to successful clinical use of these 'biotech' molecules is their efficient delivery to the site of action. The body breaks these drugs 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 causes pain and means that such drugs are usually only given to people in hospital. If these new drugs could be delivered across the skin, then many of the problems associated with their administration could be overcome. However, in order to do this, it is necessary to overcome the barrier presented by the outer layer of the skin. This skin layer, known as the stratum corneum, has evolved to protect us from the external environment. It prevents entry of dirt and microorganisms, but also most medicines. In this project, a novel type of transdermal patch will be developed that will by-pass the stratum corneum barrier. On its surface will be many tiny needles that pierce the stratum corneum without causing any pain - the sensation is said to feel like a cat's tongue or sharkskin. These needles will either dissolve quickly, leaving tiny holes in the stratum corneum, which will let proteins and peptides enter the body, or swell, turning into a jelly-like material that keeps the holes open and will allow continuous drug delivery. The technology developed here is unique and could potentially revolutionise delivery of peptides and proteins. This is likely to be of great benefit to patients, as it will make these advanced medicines readily available to everybody.
Technical Summary
Advances in biotechnology have allowed the economical and large-scale production of therapeutically important peptides and proteins. One of the major challenges to successful clinical use of these 'biotech' molecules is their efficient delivery to the site of action. Due to enzymatic breakdown and poor absorption, parenteral delivery is presently the most routinely-employed method for administering macromolecular agents. Transdermal delivery offers one potential means of overcoming many of the problems associated with delivery of these drugs. Microneedle arrays are minimally invasive devices that can by-pass the stratum corneum barrier to drug diffusion. Such microneedle arrays are applied to the skin surface and painlessly pierce the epidermis, creating microscopic holes through which drugs diffuse. In this project, it is intended to develop a unique transdermal drug delivery system based on microneedle arrays. Following thorough physicochemical characterisation of candidate materials and microneedle geometries, the device will be produced and used to deliver model macromolecules across the skin.
People |
ORCID iD |
Ryan Donnelly (Principal Investigator) |
Publications
Al-Zahrani S
(2012)
Microneedle-mediated vaccine delivery: harnessing cutaneous immunobiology to improve efficacy.
in Expert opinion on drug delivery
Donnelly R
(2013)
Hydrogel-Forming and Dissolving Microneedles for Enhanced Delivery of Photosensitizers and Precursors
in Photochemistry and Photobiology
Donnelly RF
(2011)
Design, optimization and characterisation of polymeric microneedle arrays prepared by a novel laser-based micromoulding technique.
in Pharmaceutical research
Donnelly RF
(2009)
Processing difficulties and instability of carbohydrate microneedle arrays.
in Drug development and industrial pharmacy
Donnelly RF
(2013)
Hydrogel-forming microneedle arrays exhibit antimicrobial properties: potential for enhanced patient safety.
in International journal of pharmaceutics
Donnelly RF
(2017)
Vaccine delivery systems.
in Human vaccines & immunotherapeutics
Donnelly RF
(2010)
Optical coherence tomography is a valuable tool in the study of the effects of microneedle geometry on skin penetration characteristics and in-skin dissolution.
in Journal of controlled release : official journal of the Controlled Release Society
Donnelly RF
(2017)
How can microneedles overcome challenges facing transdermal drug delivery?
in Therapeutic delivery
Donnelly RF
(2009)
Microneedle arrays allow lower microbial penetration than hypodermic needles in vitro.
in Pharmaceutical research
Donnelly RF
(2010)
Microneedle-mediated intradermal nanoparticle delivery: Potential for enhanced local administration of hydrophobic pre-formed photosensitisers.
in Photodiagnosis and photodynamic therapy
Description | Discovery and development of hydrogel-forming microneedle arrays that have capabilities in delivery of biomolecules, high dose small molecules and capture of skin interstitial fluid for minimally-invasive monitoring/diagnosis |
Exploitation Route | Working with many international companies to commercialise |
Sectors | Pharmaceuticals and Medical Biotechnology |
URL | http://pure.qub.ac.uk/portal/en/persons/ryan-donnelly(7f46a524-c3a4-46a9-b347-834f0a3640f2).html |
Description | Working with a range of international companies (Teva, L'OREAL, Merck Sharp & Dohme, Johnson & Johnson, Randox, ViiV Healthcare, Janssen and Gilead) to develop commercial products. More than £8 million in additional funding has be obtained based on the findings of this grant. This technology has great potential economic and societal value |
First Year Of Impact | 2007 |
Sector | Pharmaceuticals and Medical Biotechnology |
Impact Types | Societal Economic |
Description | Collaborative Awards in Science |
Amount | £907,730 (GBP) |
Funding ID | UNS39792 |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 03/2018 |
End | 03/2022 |
Description | Delivering TAF Intadermally using Dissolving Microneedles |
Amount | £89,674 (GBP) |
Organisation | Gilead Sciences, Inc. |
Sector | Private |
Country | United States |
Start | 07/2019 |
End | 07/2020 |
Description | Design and characterisation of microneedle arrays for delivery of active cosmaceutical ingredients. |
Amount | £50,168 (GBP) |
Organisation | Beiersdorf AG |
Sector | Private |
Country | Germany |
Start | 03/2011 |
End | 05/2012 |
Description | Design and characterisation of microneedle arrays for delivery of active cosmaceutical ingredients. |
Amount | £50,168 (GBP) |
Organisation | Beiersdorf AG |
Sector | Private |
Country | Germany |
Start | 05/2011 |
End | 07/2012 |
Description | Design and characterisation of novel microneedle arrays for delivery of gene-based vaccines. |
Amount | £72,401 (GBP) |
Organisation | Touchlight Genetics Ltd |
Sector | Private |
Country | United Kingdom |
Start | 03/2013 |
End | 12/2013 |
Description | Healthcare Technologies |
Amount | £821,430 (GBP) |
Funding ID | EP/P034063/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 11/2017 |
End | 10/2020 |
Description | In vitro and in vivo safety investigations to support the commercialisation of novel microneedle arrays for transdermal drug delivery |
Amount | £95,345 (GBP) |
Funding ID | BB/FOF/287 |
Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
Sector | Public |
Country | United Kingdom |
Start | 03/2010 |
End | 07/2011 |
Description | In vivo evaluation of microneedle arrays |
Amount | £32,387 (GBP) |
Organisation | Reckitt Benckiser |
Sector | Private |
Country | United Kingdom |
Start | 03/2013 |
End | 12/2013 |
Description | In vivo evaluation of microneedle arrays |
Amount | £32,387 (GBP) |
Organisation | Reckitt Benckiser |
Sector | Private |
Country | United Kingdom |
Start | 03/2013 |
End | 12/2013 |
Description | Industrial scale microneedle design and manufacture and microneedle applicator design |
Amount | £11,600 (GBP) |
Funding ID | BB/FOF/PF/3/12 |
Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
Sector | Public |
Country | United Kingdom |
Start | 05/2012 |
End | 09/2012 |
Description | Manufacture and applicator technologies for commercialisation of polymeric microneedle arrays |
Amount | £709,446 (GBP) |
Funding ID | BB/K020234/1 |
Organisation | Biotechnology and Biological Sciences Research Council (BBSRC) |
Sector | Public |
Country | United Kingdom |
Start | 04/2013 |
End | 08/2015 |
Description | Microneedle arrays for transdermal delivery |
Amount | £140,441 (GBP) |
Organisation | Reckitt Benckiser |
Sector | Private |
Country | United Kingdom |
Start | 01/2011 |
End | 12/2013 |
Description | Microneedle arrays for transdermal delivery |
Amount | £140,441 (GBP) |
Organisation | Reckitt Benckiser |
Sector | Private |
Country | United Kingdom |
Start | 01/2011 |
End | 12/2013 |
Description | Microneedle-enhanced neonatal therapeutic drug monitoring |
Amount | £94,154 (GBP) |
Funding ID | GN2024 |
Organisation | Action Medical Research |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 01/2013 |
End | 12/2014 |
Description | Microneedle-enhanced neonatal therapeutic drug monitoring |
Amount | £94,154 (GBP) |
Funding ID | GN2024 |
Organisation | Action Medical Research |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 01/2013 |
End | 12/2014 |
Description | Microneedle-mediated enhanced Raman therapeutic drug monitoring |
Amount | £327,441 (GBP) |
Funding ID | EP/H021647/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 06/2010 |
End | 03/2014 |
Description | Nanoengineered microneedle arrays for enhanced delivery of long-acting HIV medicines |
Amount | £1,095,411 (GBP) |
Funding ID | EP/S028919/1 |
Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
Sector | Public |
Country | United Kingdom |
Start | 09/2019 |
End | 09/2023 |
Description | Ocular Research By Integrated Training And Learning |
Amount | £4,200,000 (GBP) |
Funding ID | 813440 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 08/2019 |
End | 08/2022 |
Description | Optical coherence tomographic characterisation of drug delivery systems and biomaterials |
Amount | £142,000 (GBP) |
Funding ID | WT094085MA |
Organisation | Wellcome Trust |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 05/2011 |
End | 05/2016 |
Description | Physical characterisation of microneedle arrays for cosmaceutical delivery |
Amount | £58,804 (GBP) |
Organisation | L'Oreal (Paris) |
Sector | Private |
Country | France |
Start | 01/2013 |
End | 10/2014 |
Description | Physical characterisation of microneedle arrays for cosmaceutical delivery |
Amount | £58,804 (GBP) |
Organisation | L'Oreal (Paris) |
Sector | Private |
Country | France |
Start | 02/2013 |
End | 09/2013 |
Description | Polymeric Microprojection Arrays for Transdermal Delivery of Active Pharmaceutical Ingredients. |
Amount | £92,567 (GBP) |
Funding ID | PoC21A |
Organisation | Invest Northern Ireland |
Sector | Public |
Country | United Kingdom |
Start | 03/2009 |
End | 02/2010 |
Description | Polymeric Microprojection Arrays for Transdermal Delivery of Active Pharmaceutical Ingredients. |
Amount | £92,567 (GBP) |
Funding ID | PoC21A |
Organisation | Invest Northern Ireland |
Sector | Public |
Country | United Kingdom |
Start | 03/2009 |
End | 03/2010 |
Description | The use of a novel technology platform to create a DNA vaccine for prostate cancer |
Amount | £97,070 (GBP) |
Funding ID | S12-006 |
Organisation | Prostate Cancer UK |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 08/2013 |
End | 12/2016 |
Description | The use of a novel technology platform to create a DNA vaccine for prostate cancer |
Amount | £97,070 (GBP) |
Funding ID | S12-006 |
Organisation | Prostate Cancer UK |
Sector | Charity/Non Profit |
Country | United Kingdom |
Start | 08/2013 |
End | 12/2016 |
Description | Pharmacists in Schools |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | Yes |
Geographic Reach | Regional |
Primary Audience | Schools |
Results and Impact | Over 100 workshops held in schools in N. Ireland. This led to further fudning from RCUK in the SUPI initiative and our participation at BBSRC's Great British Bioscience Festival High interest in our work and consistent application numbers to study pharmacy at QUB |
Year(s) Of Engagement Activity | 2009 |
URL | http://www.qub.ac.uk/directorates/degreeplus/RoutestoDegreePlus/RouteB/PharmacistsinSchools/ |