Developing the World’s First Suite of Products based on a Rapid-Detaching, Dissolvable Microneedle Concept
Crying children, phobic adults, and an assortment of logistics challenges. Delivering medicines via hypodermic needles is painful and complex. As the world lines up for the first Covid-19 vaccinations, everyone will revisit their personal feelings about needles.
A Journal of Advanced Nursing meta-analysis reported the “majority of children exhibited needle fear, while prevalence estimates for needle fear ranged from 20-50% in adolescents and 20-30% in young adults.” That’s a lot of people.
Pain and needle phobias aside, hypodermic needles and the drugs they deliver come with a demanding set of logistics requirements.
The Problem with the Hypodermic Model
Delivering vaccines and medicines via hypodermic needles presents a series of challenges. The needles themselves require special, safe storage to ensure sterile conditions and prevent accidental punctures. The medicines they deliver must adhere to a complex set of cold chain logistics.
Cold Chain and Drug Administration Logistics Impact Everyone
Cold chain logistics have a direct impact on everyone, especially underserved communities, developing nations, and rural populations. These at-risk communities do not necessarily have access to stable electricity, let alone specialized freezers required by some Covid-19 vaccines. Even drugs that do not require ultra-low storage temperatures need basic refrigeration. This is not universally feasible.
Developed nations also face challenges. The Guardian highlighted cold chain experiences facing General Practitioners (GPs) in Scotland. One doctor noted, “the Oxford/AstraZeneca vaccine that we’d receive, which doesn’t need ultra-low temperatures for storage, but we would have to have a vaccine fridge big and reliable enough to hold all the vials we’d need. (This isn’t a given: GPs are obliged to buy and maintain their own clinic equipment – vaccine fridges aren’t supplied by the NHS.)”
Transportation and storage of most medicines require a complex cold chain and Covid-19 vaccines have highlighted this problem. When freezers fail, drugs must be administered within a specific timeframe or it is rendered useless, as recently reported in the USA.
Adding to the list of challenges is the specialist syringes required to get the sixth dose out of the Pfizer/BioNTech vaccine. Reports from Japan note “a shortage of low “dead space” syringes – which have narrow plungers that can push out any leftover vaccine – means vaccinators in Japan will have to use mainly standard syringes that are capable of extracting only five doses per vial, or enough for 60 million people.” 12 million people will not receive existing doses as a result.
Most drugs delivered by hypodermic needles can only be given by certified medical personnel. Despite these and other limitations, the hypodermic needle model remains the dominant drug delivery mechanism.
Dissolving microneedles are recognized for efficacy, efficiency, economic delivery and, most importantly, safety.
And after usage, there is an equally important responsibility: disposal.
How Are Used Needles Disposed Of?
Used needles are biohazardous waste and must be safely and securely disposed following every injection. The World Health Organization estimated there were 16 billion injections long before the arrival of Covid-19 and vaccines. “In 2015, a joint WHO/UNICEF assessment found that just over half (58%) of sampled facilities from 24 countries had adequate systems in place for the safe disposal of health care waste.”
There is an entire industry built around hypodermic needle disposal. NeedleSmart, a UK company offering disposal solutions, claims there are over 500,000 NSI (needlestick injuries) in Germany and Spain alone. Clearly, safe disposal of needles presents a significant and costly challenge.
WikiHow asserts “millions of people use needles at home to self-inject medications for a variety of healthcare reasons. While this practice is common, surprisingly few people are given clear instructions on how to dispose of the needles once they’re used.”
The UK National Health Service recommends a sharps disposal container but notes “arrangements for disposing of full sharps bins vary depending where you live.” The EU directive applies to hospital and healthcare sector with each member country setting their regulations. Outside the healthcare environment, there appears to be little official guidance other than recommending a sharps disposal container or returning used needles to a pharmacy. The US-FDA recommends using a sharps disposal container, but municipal and state standards vary.
Dissolving microneedles resolve the biohazardous disposal issue by 100% eliminating sharps waste.
Microneedles Will Transform Drug Delivery Processes
Transdermal patches or microneedles – an array of tiny needles smaller than a hair arranged on an adhesive patch that delivers medicines – have delivered medicines since the late 70s. (For background on microneedles read this article.)
In the past decade, science and technology have partnered to create more effective products that resolve earlier issues. The focus today is mainly on the most efficacious type, dissolving microneedles.
SeriTech is developing a suite of medicinal products leveraging a revolutionary, fast-detaching, dissolving microneedle concept to solve the limitations of other microneedle patches, with a two-minute application time. No more lengthy application times and the inherent risks. The products will make breakthroughs, from vaccines to pain killers, from deep skin treatments to on-organ patches, shifting delivery mechanisms for future generations and democratize access to an array of drugs.
Best of all: microneedles are painless.
A growing body of research into microneedles concludes “transdermal drug delivery is the perfect blend of medicine and technology for a preferred alternative to conventional vaccine delivery. The publication adds an important note: “There’s evidence that transdermal microneedle methods are more effective than hypodermics for immunization.”
Ioanna Skountzou, co-principal investigator for a US National Institutes of Health project and an assistant professor in Emory University School of Medicine’s Department of Microbiology and Immunology, says: “Combined with the convenience of self-administration, painless application and absence of sharps waste, this novel immunization route could make the microneedle patch a powerful new weapon against infectious diseases.”
The list of applications for microneedles continues to grow, from tissue sampling to detecting the presence of antibodies, analyzing blood, and more. A recent article in the Journal of Controlled Release published in Science Direct notes microneedles are recognized as the new horizon for delivering immunotherapies like rheumatoid arthritis, food allergies, allergic respiratory diseases and cancer. They can be employed to deliver vaccines and for treatment of inflammatory diseases like psoriasis, acne, atopic dermatitis (eczema) and to aid in healing wounds.
SciTech Daily confirms a “microneedle patch can test for antibodies and more in the fluid between cells.” An interesting sidebar in the article notes that from an ethical basis “using this technology could limit the number of animals needed for research.”
According to Scientific American, the jury is in: “Microneedle devices could enable testing and treatment to be delivered in underserved areas because they do not require costly equipment or a lot of training to administer.”
Richard Joye, Managing Director at SeriTech and head of European operations, references a Science Direct article highlighting “improved thermostability by coated and dissolving MNs [microneedles] provides the possibility to decrease or eliminate high costs relevant to the “cold chain” for storage or transportation of vaccines. Additionally, MNA [Micro Needle Application] vaccines are advantageous to create immunization against infectious diseases (SARS and COVID-19) in that they possess a high potential for self-administration without the need for any specialized equipment or an applicator.”
Company Founder Saimai Cunvong adds the SeriTech team is excited to lead the microneedles charge. “Our technology not only resolves earlier limitations in microneedle delivery systems, it opens the world to medical equity by eliminating barriers and democratizing economic access to important medicines. And equally important, it paves the road for a reduction in biohazardous waste. Our goals are impacting people’s lives.”
The company is currently completing ‘in vivo’ testing of its IPSYLON line of dermocosmetics, based on a similar concept, however not medicinal, anticipating market introduction mid-2021. Meanwhile, the SeriTech team in Barcelona is amplifying research into delivering medicines and vaccines, with a Covid-19 microneedle vaccine in its crosshairs.
In the not-so-distant future, vaccines and other medicines, from cancer treatments and other immunotherapies, will be delivered through microneedles. SeriTech is uniquely positioned to become a world leader in this arena with its world-first, fast-detaching dissolving microneedle technology.
SeriTech aspires to bring forward the day your child will never cry out from a hypodermic needle administered in the Doctor’s office. SeriTech technology will usher in a new era where you apply a microneedle for a painless two minutes in the comfort of your home.
No complex cold chains. No biohazardous waste. No specialized training to administer the drug. No hassle. Voila! Vaccinated.