|
Developed by 
|
Supported by 
|
Dissolving microarray patches
Verified by the innovator, on Sep 2021Developer(s)
|
Queen's University Belfast Originator
https://www.qub.ac.uk/schools/SchoolofPharmacy/
Ireland Currently focusing on research in the field of microneedles/microarray patches, minimally-invasive patient monitoring/diagnosis, transdermal drug delivery, including biomolecules, vaccine delivery, photodynamic therapy, nanomedicine delivery, HIV treatment and prevention, delivery of therapeutics for tropical diseases and rare conditions. |
Sponsor(s)
|
EPSRC https://epsrc.ukri.org/ |
|
USAID https://www.usaid.gov/ |
Partnerships
|
|
Technology information
Type of technology
Polymer-based particles, In-situ forming gel/implant, Aqueous drug particle suspension, Transdermal patch
Administration route
Intradermal delivery of long-acting drug formulations
Development state and regulatory approval
Cabotegravir (CAB)
Pre-clinical
N/A
Description
Biocompatible polymeric microneedle system that painlessly and without drawing blood penetrates the skin's stratum corneum barrier and then dissolves to deposit long-acting drug formulations in the viable skin layers. This technology could be a replacement for long-acting intramuscular injections
Technology highlight
Avoids needle stick injuries, no cold chain required, high-dose delivery system, easy to use by patients at home, self-disabling system, with specialist disposal not required
Technology main components
Microneedles composed of FDA-approved biocompatible polymers
Information on the raw materials sourcing, availability and anticipated price
PVA and PVP, the typical dissolving polymers, are inexpensive and can readily be obtained by pharmaceutical excipient manufacturers. Sometimes, PLGA will be required to sustain release of more water soluble molecules. PLGA is more expensive, but Ashland and Evonik offer many different products with controllable biodegradation properties that are suitable for injectable products.
Delivery device(s)
No delivery device
APIs compatibility profile
API desired features
Water-soluble molecules
Unit: mg/mL
Microneedles are suitable for a wide range of therapeutic classes. Formulation can be readily adjusted as required
Water-insoluble molecules
Unit: mg/mL
Both soluble (e.g. tenofovir alafenamide fumarate) and poorly soluble (e.g. rilpivirine, cabotegravir) can be delivered. Formulations can be adjusted as needed to obtain the delivery rate desired
Small molecules
Rilpivirine, cabotegravir, tenofovir alafenamide fumarate, etravirine
Nucleic acids
DNA and RNA vaccines
Proteins
Therapeutic antibodies and single domain antibodies, protein vaccines and peptides (e.g. insulin, exenatide)
Additional solubility data
N/A
Additional stability data
N/A
API loading: Maximum drug quantity to be loaded
75-90 wt%
API co-administration
2 different APIs : At least two
LogP
Not provided
Scale-up and manufacturing prospects
Scale-up prospects
Microneedle products can now be made at scale by a number of manufacturers to GMP conditions - For example, by LTS Lohmann - https://ltslohmann.de/en/micro-array-patches/
Tentative equipment list for manufacturing
Confidential. Each manufacturer is unlikely to disclose such details without a CDA
Manufacturing
It is likely a low bioburden product will be required
Specific analytical instrument required for characterization of formulation
HPLC-MS, XRD, DSC, TGA, FT-IR, texture profile analysis, optical coherence tomography
Clinical trials
Not providedExcipients
Proprietary excipients used
PVA, PVP and, when needed, PLGA
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
No novel excipient or existing excipient used
Residual solvents used
No residual solvent used
Additional features
Other features of the technology
- Drug-eluting
- At least 1 year shelf life
Release properties
Sustained release enabled by the drug formulation - the microneedles act as a tool to place the long-acting system in the viable skin layers
Injectability
Applied to the skin and the needles penetrate the stratum corneum, then dissolve and deposit the long-acting drug formulation in the viable skin layers
Safety
No needle stick injuries. no specialised disposal required, as the microneedles dissolve in skin
Stability
Not provided
Storage conditions and cold-chain related features
No cold chain needed, as the system is dry-state and so very stable
Potential application(s)
Therapeutic area(s)
Use case(s)
Use of technology
Ease of administration
- Self-administered
Frequency of administration
Weekly, Monthly
User acceptance
Many studies have been conducted in this area - Freely available in the literature
Targeted user groups
Age Cohort- Children
- Adolescents
- Adults
- Older Adults
- Neonates
- All
Pregnant individuals
Unspecified
Lactating individuals
Unspecified
Healthy individuals
Unspecified
Comment
People in their own homes, including children
Potential associated API(s)
Rilpivirine (RPV)
Class(es)
anti-retroviral
Development stage
Pre-clinical
Clinical trial number(s)
N/A
Foreseen/approved indication(s)
HIV prevention and treatment
Foreseen user group
HIV patients and PreP patients
Foreseen duration between application(s)
1 week to 1 month
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
N/A
Cabotegravir (CAB)
Class(es)
anti-retroviral
Development stage
Pre-clinical
Clinical trial number(s)
N/A
Foreseen/approved indication(s)
HIV treatment and prevention
Foreseen user group
HIV patients and PreP patients
Foreseen duration between application(s)
1 week to 1 month
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
N/A
Tenofovir alafenamide (TAF)
Class(es)
Antiviral (NRTI)
Development stage
Pre-clinical
Clinical trial number(s)
Not provided
Foreseen/approved indication(s)
Not provided
Foreseen user group
Not provided
Foreseen duration between application(s)
Not provided
Applications to Stringent Regulatory Authorities (SRA) / regulatory approvals
Not provided
Patent info
There are either no relevant patents or these were not yet submitted to LAPaL
Supporting material
Publications
There are no publication
Additional documents
No documents were uploaded
Useful links
Access principles
|
Collaborate for developmentConsider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided |
|
Share technical information for match-making assessmentProvide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided |
|
Work with MPP to expand access in LMICsIn the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided |
Comment & Information
Microneedles aim to take the hypodermic needle out of the equation in the delivery of high-dose, long-acting drug formulations. Conditions to be managed include HIV, malaria, tuberculosis, schizophrenia and many others
Illustrations
Microneedles
Queen's University Belfast