FuTai Tech Combines Iontophoresis with Hydrogel Technology for Non-Invasive, High-Concentration Transdermal Drug Delivery

Iontophoresis refers to the process by which drug ions accelerate their migration under the influence of an externally applied electric field. As an advanced iteration of traditional transdermal drug delivery, iontophoresis represents the fourth major route of administration, following oral, injectable, and nebulized inhalation methods. Futai Technology’s iontophoresis technology achieves high-concentration transdermal drug delivery while effectively eliminating the risk of skin burns. This technology is applicable across various sectors, including medical treatment, consumer healthcare, and consumer goods.Futai Technology has developed a range of cosmetic and anti-aging ingredients, including peptides, vitamins, and NMN (Nicotinamide Mononucleotide), for use in lifestyle beauty products. In the medical field, the company has initiated the regulatory filing and registration of active medical devices. It utilizes tranexamic acid and glutathione gel patches as adjunctive therapies for the treatment of melasma, and lidocaine gel patches as rapid topical anesthetics for dermatology departments and medical aesthetic institutions.

Iontophoresis technology is founded on the principles of electrochemistry. Charged electrodes repel ions with the same charge, while electrodes with the opposite charge on the other side attract ions with the opposite charge. By placing two electrodes with opposite charges on either side of the administration site and activating the power source, charged ions undergo redox reactions at the electrode with the same charge, utilizing ion flow to maintain circuit continuity. Under the influence of an electric field, drug ions exhibit directional movement, while the solvent generates directional flow, forming electroosmotic flow. Additionally, the electric field enhances skin permeability, facilitating the passage of drug ions through biological barriers into systemic circulation. Drug delivery can be rapidly terminated by simply switching off or removing the iontophoretic delivery system, thereby achieving intelligent and controllable administration.

As an intelligent and efficient "active" permeation mode, iontophoresis offers numerous advantages, including avoidance of the first-pass effect, improved patient compliance, enabling transdermal delivery of drugs that are generally not absorbable via this route (such as peptides and steroids), and providing continuous drug delivery at a therapeutic rate to minimize the risks of over- or under-dosing.

Currently, marketed transdermal drug delivery products are primarily available in the United States, Japan, and the European Union. Approved indications for transdermal patches are concentrated in the fields of neuropsychiatry, anti-inflammatory and analgesic therapy, cardiovascular diseases, and hormonal disorders.

According to a report by LeadLeo Research Institute, the market size of transdermal preparations in China increased from RMB 2.77 billion in 2015 to RMB 4.33 billion in 2019, with a compound annual growth rate (CAGR) of 17.5%. However, drug delivery therapy combining gel technology with iontophoresis remains a gap in the domestic market. Futai Technology, established in 2017, aims to fill this void.

Futai Technology focuses on the research, development, and application of innovative non-invasive transdermal drug delivery technologies. Driven by iontophoresis technology and leveraging extended applications of dermal health research, the company provides technical support and customized project services to industries including healthcare, medical aesthetics, technological beauty, lifestyle beauty, and daily chemicals. It operates a GMP-compliant production base and R&D center spanning over 6,000 square meters in Jiading, Shanghai.

According to Xu Lixia, founder of Futai Technology, the development of iontophoresis drug delivery systems requires not only the interdisciplinary integration of polymer science, chemistry, and electrical engineering, but also ensures therapeutic-grade drug permeability, stable and efficient permeation rates, as well as reliable gel adhesion to skin at various anatomical sites. Numerous factors influence the efficacy of iontophoretic drug delivery, including but not limited to: drug-related properties such as concentration, relative molecular mass, molecular size, charge, and polarity; operational parameters such as on/off control, current density, current waveform, administration duration, and electrode materials; and biological factors, primarily skin condition and pH at the application site.

Furthermore, the current intensity of iontophoresis limits the quantity and area of drug permeation. Achieving a higher drug loading capacity requires greater output current, which consequently increases the output voltage. However, this can lead to skin polarization, resulting in erythema and burns. Similar marketed products abroad have been subject to continuous recalls due to device instability. Balancing “higher current intensity and enhanced transdermal efficiency” with “the safety tolerance of human skin” has thus become another significant challenge in research and development.

Based on a comprehensive analysis of domestic and international technical products and in-depth clinical observations, Futai Technology has innovatively integratedIontophoresis TechnologyandGel Technologycombined to create a uniquePatented Transdermal Iontophoresis Drug Delivery System(Patent No.: 201810456482.X). Its highlights are mainly reflected in three aspects.

First, the proprietary smart hydrogel preparation technology (encapsulation technology) is combined with transdermal delivery technology to ensure drug permeability and penetration rate.Futai Technology employs patch-based drug delivery, utilizing controlled-release hydrogels as a transdermal delivery platform for drugs and active ingredients. This approach ensures the complete and effective encapsulation and preservation of drug molecules. By combining hydrogels with transdermal technology and leveraging their high-efficiency transport capability for active ingredients, the system prevents ingredient degradation and enables more uniform and stable transdermal absorption. Furthermore, the hydrogel matrix enhances the local retention of drug components on the skin, thereby doubling the therapeutic efficacy.

Second, it breaks through the traditional 600 Da limit, increasing the molecular weight of drugs that can penetrate the skin to 5,000 Da and boosting the penetration dose by 30-fold.Futai Technology’s transdermal iontophoresis drug delivery system innovates physical stratum corneum penetration-enhancement technology. By combining gel technology with MF2P iontophoresis delivery technology, it breaks through the 600 Da molecular weight limit for transdermal drug permeation, enabling effective delivery of molecules up to 5,000 Da. This increases the delivered dose by 30-fold, allowing for higher drug loading and enhanced transdermal absorption rates.

Third, it addresses issues associated with traditional iontophoresis, such as burns, pain, and dose control, while enabling non-invasive, high-concentration transdermal drug delivery.Futai Technology encapsulates active pharmaceutical ingredients (APIs) within a gel matrix, imparting polarity to the APIs under an electric field. Leveraging the repulsive force between like charges, the system facilitates the penetration of skin barrier channels, thereby achieving precise and efficient drug delivery. This therapeutic approach ensures safety, accurate dosing, and prolonged pharmacological effects. It is widely applicable in various scenarios, including medical aesthetics, lifestyle beauty treatments, topical anesthesia, and clinical medical practice.

Market Application Prospects of Futai Technology’s Transdermal Delivery Technology

The system has filed six invention patent applications, including two certified international invention patents and one certified Chinese invention patent; patents in the European Union, the United States, and Japan are currently under examination.

In terms of application advancements, Futai Technology is currently focusing primarily on medical applications and dermatological aesthetics.

In terms of medical applications, pharmaceuticals such as tranexamic acid and glutathione have been selected. The company plans to collaborate with pharmaceutical manufacturers to modify dosage forms and innovate their applications, thereby replacing certain injectable treatments. Meanwhile, the company will also proactively identify other drugs with advantages in transdermal delivery to conduct targeted research and development for personalized drug administration.

In the field of medical aesthetics, the company initiated relevant experiments in 2022 and achieved substantial progress. The team has completed clinical trials on lidocaine administration to the human face. The results demonstrate that Futai Technology’s patented transdermal iontophoresis drug delivery system can achieve non-invasive, painless full-face anesthesia within 15 minutes. By combining currently available lidocaine gel products with iontophoresis technology, the application time can be significantly reduced. The medical device product, an iontophoresis delivery instrument, has already begun the regulatory filing process.

Currently filed cosmetic products include the peptide-infused anti-aging series and the L-ascorbic acid (L-VC) infused whitening series, primarily targeting professional beauty salon channels and the consumer goods market.

Xu Lixia introduced to VCBeat that, in terms of commercialization, Futai Technology has partnered with medical aesthetics clinic chains in the lifestyle beauty sector and will continue to refine its products to accelerate commercial rollout. Regarding product ecosystem development, the company will increase R&D investment to achieve precise, information-driven, data-based monitoring and interaction, as well as visualized drug delivery presentation. In the medical field, it will expedite the research and development of medical devices, medical consumables, and reformulations of suitable pharmaceuticals.

Reference: "Research Progress on Iontophoresis Drug Delivery Technology"