Company insight
Microneedles – a game changer in vaccine delivery
LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.
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or several drugs, delivery by injectable has been the standard delivery route for many therapies.
However, there are very real issues with injectables specifically related to patient compliance, usability and safety for HCPs. Aversion to needles, pain and needle size are all very real concerns for many patients. Needlestick injuries (NSIs) are a source of great concern for HCPs – indeed, WHO stated in its World Health Report 2002 that 37.6% of Hepatitis B, 39% of Hepatitis C and 4.4% of HIV/AIDS in HCPs globally are due to needlestick injuries. Microneedles can reproducibly deliver APIs into the dermal and epidermal layers of the skin, which contain high densities of immune cells. The technology was first conceptualised and subsequently patented in the 1950s, but it was not until 1998 that the possibility of using microneedles for vaccination was discussed. Since that early work, the WHO has identified microneedles as a potential game changer for vaccine distribution and coverage in low to middle- income countries.
Microneedles deliver benefit to the entire healthcare ecosystem Essentially, if the API can be delivered in an injection, it can probably be delivered via microneedles. This offers a range of benefits to the entire healthcare ecosystem in terms of increased patient comfort and better compliance, a faster onset, lower overall
The manufacturing process for dissolvable microneedles.
healthcare costs through self-administration and the removal of the cold chain distribution challenges evident for some pre-filled syringes.
For pharma partners, there are specific advantages in terms of lower cost – for example, by reducing the dose (‘dose sparing’), customised design, brand differentiation, product extension and repurposing existing products into a more patient-friendly delivery mechanism.
Dissolvable microneedles are a game changer technology Uncoated dissolvable microneedles enable optimal API load without relying on liquid reservoirs. There are three key processing requirements for a homogeneous microneedle product: the homogeneity of dispensing solutions, dosing precision, and precise mould dimensions and geometry. The technology can provide for improved stability because the API is embedded homogeneously in the polymer, ensuring 100% of the drug content is dispensed. The API and polymer are mixed with a solvent, dispensed into the mould and then dried to remove the solvent. The dispensing heads deliver a precise, reproducible volume of the solution. Indeed, so precise are the dispensing heads that partners can even switch formulations and volumes within each microneedle array. Configured for the API and release option, each microneedle array can feature up to 1,000 needles per cm2
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Microneedle array from LTS – small in form, big in performance.
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with needle lengths ranging from 200μm to more than 1,000μm – 900μm being the threshold for pain sensation.
References available on request.
https://ltslohmann.de/en
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
The future potential of microneedles Microneedles have the potential to become a game changer for immunisation programmes that mostly rely on vaccine storage and transportation at 2–8°C, and trained healthcare workers to administer injectable vaccines by needle and syringe.
Microneedle technology is considered as an advantageous delivery route for existing vaccines, including influenza, tetanus toxoid, measles-rubella, Hepatitis B and inactivated poliomyelitis vaccine (IPV), as well as vaccines in development, such as inactivated rotavirus and dengue. Given the challenges currently surrounding the cold chain distribution of Covid-19 vaccines, a great deal of consideration should be given to microneedles as an efficient method to immunise mass populations. There is a growing weight of evidential data to show that the concerns around content uniformity in dissolvable microneedles have been largely eradicated. This is now a real and present opportunity for pharma partners to benefit and deliver real value across the healthcare ecosystem by overcoming the various challenges associated with conventional formulations, and offers tangible benefits for pharma partners, payers, HCPs and, of course, patients. ●
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