—— On April 24, the clinical application of dexmedetomidine hydrochloride micro-roneedle patch submitted by Guangzhou Xinji Pharmaceutical was successfully approved and officially entered the clinical trial stage. This is the first drug microneedle clinical license in China, which means that the domestic microneedle drug delivery has entered a new stage, and is also an important milestone in the development of drug delivery technology in China.
The approved dexmedetomidine hydrochloride micro-roneedle patch by Guangzhou Xinji Pharmaceutical was applied for preoperative sedation in children. According to the "Preoperative Antianxiety Expert Consensus (2021)", the incidence of preoperative anxiety is as high as 25%~80%, and the incidence of preoperative anxiety in young children is higher. With years of accumulated experience in microneedle technology platform, the R & D team of Xinji Pharmaceutical has successfully developed a microneedle patch, which is quickly released and highly effective after percutaneous delivery in a painless or slightly painful way, filling the gap in the clinical needs of the majority of pediatric patients.
Dr. Wu Chuanbin, Chairman of Guangzhou Xinji Pharmaceutical, said that the approval of microneedin hydrochloride is only the beginning, and the platform has provided several product lines, including medicines for children and the elderly; different needs for topical and systemic drugs; cancer, osteoporosis and metabolic diseases. In the future, Xinji Pharmaceutical industry will accelerate the promotion of more microneedle projects into clinical research, and promote the development of the microneedle preparation field in China. Dr. Wu Chuanbin said, " Xinji Pharmaceutical will continue to dig the application potential of microneedle technology, and also welcome to cooperate with all sectors of the industry to promote the industrialization of microneedle, so that this drug delivery technology will benefit more patients.”
Microneedle patches were first clinically approved
Soluble microneedle is an advanced drug delivery system, which uses biodegradable polymer material as the main material of microneedle, through precision manufacturing technology to integrate hundreds of micron scale fine tips in the form of an array on a base of about 1 square centimeter. When applied to the skin, the tip of the drug enrichment can directly puncture the stratum corneum layer, quickly dissolve and release the drug in the skin, avoid the first pass effect of the drug and enhance the effect of drug absorption.
In 2020, microneedle delivery technology topped the top ten new technologies that are expected to change the world in 2020 by the authoritative American popular science magazine Science American. However, so far, the global microneedle in the drug field is still in the research stage, there is still no drug microneedle on the market. From the perspective of industrial development, the approval of the clinical application of dexmedetomidine hydrochloride microneedle patch, which means that the development of China's microneedle technology has officially entered the ranks of advanced countries and entered a new stage, and further enhanced the competitiveness of China in the field of drug delivery technology, which is of a milestone significance.
New forms of drug administration may change the pattern of drug delivery
Compared with traditional percutaneous preparations, soluble microneedles can directly penetrate the skin stratum corneum barrier and deliver the drug to the epidermis or superficial dermis, which can be quickly absorbed into the blood, greatly improving the bioavailability and efficacy of the drug. Compared with general subcutaneous injection, soluble microneedles are only micron size, which is painless or slightly painful when used, which reduces patient injection pain and improves patient compliance. In addition, soluble microneedles also have the advantages of avoiding liver first pass effect and easy to use.
Soluble microneedle application widely, can be suitable for small molecule drugs, peptides, protein, mRNA, vaccines, and other drugs of structure, so also gradually become the domestic and foreign research and development in recent years, the current foreign research and development hot focus on tumor, diabetes, osteoporosis, skin diseases, medical diagnosis and other fields.
Although soluble microneedle has many advantages compared with traditional administration, but soluble microneedle technology in drug preparation application level has high technical barriers: need to ensure that soluble microneedle tip part can completely into the human skin, achieve rapid dissolution, to package or mixed drug ingredients to release quickly. This process has high requirements for the mechanical strength, dissolution speed and content uniformity of microneedles.
After years of painstaking research, Guangzhou Xinji Pharmaceutical has overcome a number of key technical difficulties of soluble microneedles, and has more than 30 microneedles related patents, which has laid a solid foundation for the industrialization of soluble microneedles.
