Using Silk Proteins to Enhance or Create Polymers for Fast-Detaching Dissolving Microneedles

In seritech Posted

Research into dissolving microneedles (dMNs) has intensified in recent years. The dissolving microneedle is acknowledged as the most effective type of microneedle compared with other methods of transdermal drug delivery methods, especially in the context of rapid, safe and effective delivery without side effects or visible signs of application.

Globally, researchers have doubled down on dissolving microneedles noting that “compared to other types of microneedles, dissolving microneedles overcome drug limitations and avoid the danger of silicon and metal needles breaking in vivo.”

With the world currently focused on vaccines, ultra-cold freezers, specialized syringes, and licensed administrators, cracks in the traditional system are beginning to appear.

Vaccines are historically credited as the one of the most successful medical interventions. However, the logistics of vaccine delivery remains largely unchanged. The vaccine lifecycle – production, shipment, and storage – is constrained by stringent cold chain requirements. A failure of any link in this chain has serious implications.

Developed nations have experienced wide-ranging challenges in delivering Covid-19 vaccines, from freezer failures to syringe limitations.

The reality facing developing nations will prove even more difficult. Less reliable infrastructures, limited access to special syringes, and a shortage of qualified healthcare specialists are likely to result in even greater dosage loss.

The Covid-19 pandemic has brought this to the forefront.

Improving Vaccine Delivery Mechanisms is Paramount

A dissolving microneedle can safely and economically deliver vaccines and other medicines, resolving a host of logistics issues while democratizing global access.

The first successful delivery of a vaccine via microneedle was reported in research over a decade go. Data indicates “vaccination by dMNs can evoke comparable or even superior responses.” However, dMNs are plagued by lengthy application times with reports that “three clinical phase 1 studies have been reported and showed that skin irritation and patch application are hurdles that need to be solved in future applications.”

SeriTech is introducing the world’s first fast-detaching, dissolving microneedle (fddMN) into medical care. This ground-breaking technology offers an application time of only 2 minutes, presenting a fundamental advance in transdermal delivery mechanisms. The company’s first commercial product line of fddMNs that deliver skin care will soon be released.

With consensus on the advantages of dissolving microneedles, the conversation – and research – has shifted to how products are manufactured, and the best materials to use in the process. It has been noted that “silk is a valuable alternative due to its excellent intrinsic properties such as non-toxicity, biodegradability, self-assembly, mechanical stability and controllable structure.”

Silk Proteins and Fast-detaching Dissolving Microneedles

SeriTech has developed an innovative, proprietary process to upcycle silk by-products that are the two proteins: fibroin and sericin. They demonstrate exceptional capabilities for use in the fast-detaching dissolving microneedle as they make effective polymerized dissolving microneedles.

Leveraging its expertise in silk proteins and microneedles, the company is developing new fddMNs with silk proteins integrated in the blend that makes the polymers. With its ability to inhibit inflammation, and known antibacterial, antioxidant, anti-coagulation and regenerative properties, sericin is a natural fit. SeriTech is undertaking further R&D and clinical trials to demonstrate the added value of silk proteins compared to other polymers.

SeriTech Founder Saimai Cunvong is enthusiastic about silk proteins. “When we started SeriTech, we knew the potential of silk proteins for medical applications. With our partners, leveraging the world’s first fast-detaching, dissolving microneedle we put our focus to vaccine and medicinal applications that use silk proteins for a healthier solution.”

The efficacy of silk proteins in dMNs is confirmed and SeriTech is currently researching implementation of silk fibroin in dissolving microneedles. A 2017 study of insulin delivery observed dMNs “composed of silk fibroin tips with the ability of robust mechanical strength, rapid dissolution and drug release.” And silk fibroin increases the structural strength of dMNs for internal applications.

Researchers report “silk fibroin enhances stabilization of enzymes and proteins,” noting the insulin loaded dMNs had a shelf life of 20 days at room temperature. US researchers highlight one of “the main advantages of silk-based MN patch delivery systems include drug stabilization in the matrices to provide shelf-stable material systems without a need for refrigeration.”

For vaccines, “dMN immunization has generated comparable or higher and more durable antibody and cellular responses than conventional immunizations in preclinical studies.”

The SeriTech Solution

SeriTech creates innovative, effective health and skin care products for the 21st century, operating in three core verticals: medicinal, therapeutic, and cosmetic products. It is encouraged by research confirming the improved stability of medicines in dMNs and evaluating how silk protein scaffolds could enhance this effect.

The company is amplifying research to identify and incorporate the best result, whether sericin, fibroin, or a blend of both silk proteins. With pharmaceutical grade sericin and fibroin to be used in fast-detaching microneedles, and other applications in gels and scaffolds, the company will integrate its core market positions.

SeriTech creates game-changing products that make a real impact: social, health, economic, and environmental.