who and how makes patches with microneedles in Russia




RSkolkovo resident and co-founder of a beauty startup BLÓM Vasily Zvezdin – about how modern patches with microneedles are created and what determines their effectiveness.

Please tell us more about the idea of ​​launching patches with microneedles in Russia and the implementation of the idea.

We originally developed a vaccine delivery solution. You have to understand that we were not the first to come up with microneedles. This is the merit of two outstanding minds: Professor Mark Prauzdnitz from the USA and Rien Donnelly from Ireland. We, like hundreds of scientists in more than 14 universities, 23 private companies and an endless number of laboratories, are improving this technology to solve specific problems of delivering active ingredients.

Now there is no question who is the first. It is important who will offer the best solution. Compared to Western researchers, we were able to develop the development to our own production in a short time, in about 5 years. And at the same time, we did not have $ 400 million, like a conventional Korean company. We just started from what others consider impossible. Soon many will be able to produce needles, but the challenge is different: to make them different in size, in patch area, in modification. And when, from 2020, the EU tightens control over the turnover of these products, then there will be strict control over the declared effects. We are already ready for this.

At the development stage, the most difficult thing was not to stop and not give up. We did not start in Cambridge, although the development team had experience working with leading universities in the USA and Europe.

When you feel limited in material resources, will and imagination become the key fuel.

You said that you started from what others consider impossible. What exactly are the differences between BLÓM patches and other similar tools?

Microneedle platform DDMN (Detachable Dissolving Microneedles), which forms the basis of BLÓM patches, was developed in Russia (RF patent No. 2652567). The plant for the production of funds is also located in Russia (unlike any other patches that have been present in the Russian and EU markets since 2014). The development of any other patches with microneedles, most often based on the microtyps platform (these are essentially not needles, but sharp droplets), which now exist on the Russian market, is the merit of Professor Hyungil Jung. Regardless of where they are finally packaged and who imports them, they are manufactured at JuVic Biotech Co’s plant in South Korea.

The second difference is the technology itself, which provides the effect in 25 minutes, and not in 2-4 hours, as it was before. For example, this allowed BLÓM to find a solution for patches that can be applied in the morning to correct puffiness. All other patches in the world must be kept on the face for at least 2 hours to get the effect. In addition, the microneedles that we are developing enter the epidermis up to the basement membrane, ensuring the delivery of active ingredients. On the packaging, everyone who brings needles to Russia speaks about this, but no supplier has clinical protocols confirming this thesis.

It’s like rockets: many countries have them, and for an ordinary person they all look the same, only the rockets of not every country can deliver astronauts to the ISS.

How is the effectiveness of patches checked during the development phase? How are they tested?

If we are talking about developing a platform, then there are several stages here. First, clinical specialists decide whether this problem can be corrected with microneedles or, for example, to introduce an active component, determine the required depth and time of component release. Next, mathematical modeling of deformation, dissolution or detachment (depending on the platform) and distribution of the active component in the skin is performed. After that – standard protocols on the effectiveness of insertion of needles into ex vivo skin (skin of volunteers after plastic surgery). We do not work with animals.

After a series of protocols for assessing stability and security, we turn to work with volunteers. The minimum sample of volunteers is from 80 people.

In production, the quality assessment is carried out by phased internal control, from this month the final units of the technical control department are fully automated. Machine vision and rejection protocols allow us to view 100% of the products.

Now BLÓM is two types of patches: with hyaluronic acid and caffeine. What is the best way to use them, and will there be a wow-effect with a single application (or do you need a course)?

The worse the condition of the epidermal layer of the skin and microcirculation, the higher the chance to see the wow effect. If you are a 19-year-old beauty lover with freshly chipped skin, the chance is zero. The main task of microneedles with hyaluronic acid is to reach the basal layer between the dermis and the epidermis and provide its biochemical correction through mechanical action and nutrition (here the hyaluron acts as food for cells).

Biochemical correction should take at least 20 days. And if you remember that the stratum corneum is formed in 28 days, then the final action will be visible in 40 days.

Deep wrinkles cannot be straightened by microneedles; a deeper level of penetration is needed. It is worth waiting for an increase in hydration after the normalization of the epidermis, and not measure with a hygrometer how much the skin is sweating after the procedure.

If we talk about edema, then the effect is possible immediately if the cause of the edema is associated with a violation of local microcirculation. But in no case with chronic kidney disease and dysmetabolic disorders.

When conducting clinical studies, about 20% of respondents saw changes after the first procedure, cosmetologists noted changes in the same group in 42% of cases. Profilometry indicated a stable change of 98%. After the third procedure, the volunteers noted a visible improvement in texture of 76%.

So we have determined the optimal value in 4-6 procedures, then the effect will be stable.

For girls of what age will such patches be most effective?

We have established the greatest efficiency in correcting epidermal wrinkles for girls aged 45-60 + years. At the age of 25+, microneedle patches act as a means of preventing age-related changes: they increase the barrier function of the skin and its physiological density in the upper layers of the dermis.

What other components, besides hyaluronic acid and caffeine, work in patches?

We mainly use two types of hyaluronic acid and one water-soluble active in BLÓM solutions. Low molecular weight hyaluronic acid (50 kDa) is located at the tip with the active component and dissolves much faster, and a 400 kDa hyaluron is located closer to the base.

It is also important to understand that we are not limited by the ability to simply change the active components, now solutions are being prepared for other areas of the face and body! But this requires a change in the shape of the patches, and most importantly, the size and fit of the needles, which we are actively working on now.

Interview and text: Yulia Kozoliy