SERITECH USES A QUICKLY REMOVABLE AND DISSOLVABLE MICRONIDE FOR TRANSDERMAL DRUG DELIVERY - ONdrugDelivery (2023)

Richard Joye and Tim Morch discuss the benefits of using soluble microneedles for vaccine delivery, particularly in terms of storage and transport, and present SeriTech's soluble microneedle rapid dissociation technology, soon to be commercialized in the cosmetics sector under the brand name IPSYLON brand.

HYDRODERMAL MODEL CHALLENGES

"Cold chain shipping and storage was valued at US$13 billion (£9.5 billion) in 2017 and growing every year, especially since the creation of the SARS-CoV2 vaccine. This complex system has numerous shortcomings, with up to 40% of products in sealed bottles damaged before delivery.”

Vaccines remain one of the greatest achievements of modern medicine. However, the 150-year-old subcutaneous delivery model is undermined by cold chain logistics, waste dispensing, biohazardous waste, and needlestick injuries.

Cold chain shipping and storage was valued at US$13 billion (£9.5 billion) in 2017 and growing every year, especially since the creation of the SARS-CoV2 vaccine. This complex system has numerous shortcomings, with up to 40% of products in sealed bottles damaged before delivery. In 2005, it was estimated that more than 50% of vaccines are lost annually in the world. WHO has recently launched three new work programs to address this issue, measuring effective vaccine management, cold chain equipment and optimisation.

With the current global focus on covid-19 vaccines, ultra-cold freezers, specialized syringes, and licensed administrators, cracks in the traditional system are beginning to appear. The impact was most evident in developing countries.

These vaccine programs are expensive and time-consuming: The urgency to develop a new solution has never been greater. With a clear unmet need in the market, dissolving microneedle (dMN) technology has the potential to transform the current landscape.

REDUCTION OF COSTS, INJURIES AND WASTE

dMN technology offers a proven alternative to traditional vaccine delivery methods, reducing the need for cold chain logistics and shipping, thereby reducing storage and transportation costs. dMNs also eliminate biohazardous waste and needlestick injuries associated with hypodermic needles, as well as reduce the impact of drug waste and dose reduction issues. In addition, dMNs improve vaccine stability, reduce vaccine waste, and reduce the effort of trained personnel. These advantages make dMN vaccines an especially attractive option for use in developing countries.1

MICRO NEEDLE SOLUTION FOR VACCINES

"Unlike traditional subcutaneous injections, influenza vaccines prepared as dMN show strong heat stability. dMN patches can maintain influenza vaccine activity outside of cold chain storage, as well as when subjected to other environmental stresses.”

Vaccines prevent millions of deaths each year. More than 6.4 billion flu shots are administered annually, and the rise of covid-19 vaccines will add to that list. Most vaccines are sensitive to temperature fluctuations and must be kept in a strictly controlled cold chain until delivery. This presents challenges, especially for last-mile delivery.

Unlike traditional subcutaneous injections, influenza vaccines prepared as dMN show strong heat stability. dMN patches can maintain influenza vaccine activity outside of cold chain storage, as well as when subjected to other environmental stresses. With this in mind, it is not a meaningful step to consider a dMN vaccine that can be safely stored on a clinic or pharmacy shelf.2

Compared with vaccines administered by traditional subcutaneous injections in preclinical studies, dMN-based vaccines have shown comparable cellular and antibody responses. In some cases, these responses were actually greater and longer lasting than conventional vaccines.1Therefore, the dMN technology is likely to lead to a significant change in the way vaccines are produced, shipped, and administered.

From the patient's point of view, dMN represents a safe, simple and painless way to administer the vaccine. Most importantly, dMNs administer medications more efficiently and equitably.

SERITECH SOLUTION

"SeriTech develops products using unique technology, the world's first rapid-release dMN patch for a safe, effective and affordable alternative to traditional drug delivery. SeriTech transdermal patches can be applied in just two minutes.”

SeriTech creates innovative and effective health and skin care products for the 21st century, operating in three key areas: pharmaceuticals, therapeutics and cosmetics. SeriTech develops products using a unique technology, the first rapidly dissolving microneedle (fddMN) patch for a safe, effective, and affordable alternative to traditional drug delivery (Figure 1). SeriTech transdermal patches can be applied in just two minutes.

The SeriTech solution does not suffer from the limitations of many other dMN patches, with longer application times ranging from two to six hours. This technological innovation prevents patch movement, skin irritation, and related complications that can occur with prolonged application time.

SeriTech is also evaluating how silk proteins could enhance transdermal drug absorption by using the company's innovative proprietary process to produce pharmaceutical grade fibrin and sericin. The next generation of fddMN patches will use silk proteins and the combination will be a single IP. Silk is an attractive material because it is inherently non-toxic, biocompatible and biodegradable, self-assembling, mechanically stable, and structurally controlled.3

Sericin inhibits inflammation and has antibacterial, antioxidant, anticoagulant, and regenerative properties, and fibroin may increase the structural strength of dMN. Research on insulin delivery has shown that matrices composed of fibrous silk tips have strong mechanical strength and can achieve rapid drug dissolution and release. In addition, silk fibrin increases enzyme and protein stability, and dMN with insulin has a 20-day shelf life at room temperature.4

IPSYLON: SKIN CARE PRODUCTS FOR SKIN CARE

SeriTech brings its revolutionary patch to market with the release of IPSYLON (Figure 2). The SeriTech skincare brand will be available from the fourth quarter of 2021 in Spain and later in selected markets, following the successful completion of clinical trials. Testing this technology in commercial applications will pave the way for its use as a healthcare drug delivery device for vaccines and other medications.

IPSYLON dermocosmetic skin care products offer a package of transdermal microcarriers that deliver the active ingredient exactly to the target site. SeriTech and IPSYLON were born out of company founder Saimai Cunvong's desire to use new technologies to deliver improved products.

Each of the IPSYLON fddMN patches is designed for a specific purpose. The products are minimalist, additive-free, and contain a blend of hyaluronic acid, vitamin C, and retinal.

IPSYLON eliminates time-consuming skin care routines by providing simple, fast and effective skin care. Different shapes of pads suit the target areas: curved for the eye area or nasolabial areas or round for blackheads and acne scars. IPSYLON provides professional-quality skin care that is easy to apply at home or on the go.

IPSYLON acts on wrinkles, dark spots and age-related acne scars. The product's ingredients are specially blended to hydrate and revitalize, increasing elasticity and caring for the skin. Polymer tip arrays vary in number based on product, target area, and payload mix. "Dark Spot Corrector" and "Acne Scar Smoother" have 137 dMN, "Deep Filler" consists of long hybrid 557 dMN, and "HA Intense" and "Retinal Filler" have 607 dMN to reduce fine lines and wrinkles.

Lab results

LaboratoryliveThe analysis confirms the ease of use of SeriTech's fddMN and demonstrates the efficacy of IPSYLON products, which have been certified by Bionos Biotech (Valencia, Spain) as compliant with EU Good Clinical Practice (GCP) standards and labeled as "Dermatologically Tested", "Clinically Tested Products" and "Tolerance Tested".

The results confirm that Dark Spot Corrector significantly reduces the area of ​​dark spots and increases the uniformity of the skin. Retinal Filler patches show anti-wrinkle ability in the nasolabial region, showing a significant reduction in total skin surface area, length, depth and roughness and a significant increase in smoothness.

Gentle Acne Scar Patches show anti-roughness properties and increase skin smoothness, with a significant reduction in the roughness of the area where acne scars are visible, compared to baseline values ​​before starting treatment.

HOW SERITECH FDDMN WORKS

SeriTech's fddMN are secure and easy to use. Consisting of a microarray tip and base, the patch is shaped to better fit the target area and provide charging. The IPSYLON patch has two sides: the front, where the dMNs are located, and the back, where the fluid disconnection pad is placed. During the application, it is important to never touch the dMN on the front of the device.

To use the IPSYLON patch, follow these steps (Figure 3):

1. Gently open the sterile container.
2. Thoroughly wash the skin around the target area
3. Remove the IPSYLON patch from the sterile package
4. Check which side of the IPSYLON patch is the front and which is the back
5. Hold the IPSYLON lip patch to avoid touching the dMNs in front
6. Remove the protective plastic film from the IPSYLON patch
7. Firmly stick the IPSYLON patch on the target area and press for 30 seconds
8. Place the wet release pad on the back of the IPSYLON patch and press for two minutes to release the dMN from the patch.

After application, remove the base of the IPSYLON patch and use the same release pad to gently massage the area to facilitate the penetration and dissolution process.

"The company is investigating how to incorporate silk proteins as polymer blends into its fddMNs. Additional research includes potential applications for innovative treatments for indications such as cancer, glaucoma, diabetes, Alzheimer's disease, and asthma.”

I+D SERITECH

SeriTech's research and development team is exploring a number of pharmaceutical applications for its fddMN technology, with a focus on vaccines. The company is investigating how to incorporate silk proteins as polymer blends into its fddMNs. Additional research includes potential applications for innovative treatments for indications such as cancer, glaucoma, diabetes, Alzheimer's disease, and asthma.

The advantages of dMN compared to other methods of systemic delivery could be attractive in other biomedical applications.5Cancer research shows that transdermal drug delivery via microneedles can delay tumor onset and delay tumor growth in a therapeutic model.6SeriTech anticipates further collaboration with scientists to deliver these drugs through the fddMN platform.

BIBLIOGRAPHIC REFERENCES

1. Leone M et al, "Dissolving microneedle patches for skin vaccination." Pharm Res, 2017, Volume 34, p. 2223-2240.
2. Mistilis MJ et al, “Long-term stability of an influenza vaccine in a dissolving microneedle patch.” Drug Dev Transl Res, 2016, vol 7, p. 195–205.
3. Veiga A et al, "Recent advances in silk sericin/calcium phosphate biomaterials." Front Mater, 2020, volume 7(24), online.
4. Lau S et al, “Multilayer pyramidal microneedle dissolution pads with flexible scaffolds to improve efficient drug delivery.” J Control Release, 2017, vol 265, p. 113–119.
5. Yang J et al., "Recent Advances in Microneedles for Biomedical Applications: Drug Delivery and Beyond." Acta Pharm Sin B, 2019, volume 9(3), p. 469–483.
6. AA Ali et al, “DNA vaccination against cervical cancer. A new technological platform for RALA-mediated gene transfer through polymer microneedles”. Nanomedicine: NBM, 2017, Vol 13(3), pp. 921–932.