Shinshin Pharmaceutical Completes Preparation for Dissolving Microneedle Production Process... "Expansion to Obesity Treatments and More"

Transdermal drug delivery platform company Shinshin Pharmaceutical announced on the 30th that it has completed the production process setting for soluble microneedles and has started pilot product production for approval from the Ministry of Food and Drug Safety (MFDS).

During the process setting, Shinshin Pharmaceutical was responsible for formulation research, while Nicomedical improved the production process. Through formulation research, Shinshin Pharmaceutical maximized the productivity of soluble microneedles. The drug loaded by Shinshin Pharmaceutical is characterized by its stability at high temperatures, as it is less sensitive to temperature compared to other drugs, allowing for a significant reduction in production time.

Shinshin Pharmaceutical plans to complete the pilot production of microneedles within this month and begin the full-scale preparation process for the MFDS drug approval application. Along with establishing the production process, the company is concurrently setting up test methods that meet MFDS approval guidelines and has entered the final stages. The company explained that the goal is to complete tests for approval requirements, such as skin permeability tests for the pilot product, by August.

A Shinshin Pharmaceutical official stated, “Through cooperation with Nicomedical, we have completed the process setting for pilot product production, and after prototype testing, we plan to proceed with the MFDS approval process in earnest, including non-clinical trials. In the development of microneedle drugs, delivering the drug at a consistent rate is key, and since this was confirmed during the formulation design process, we expect to obtain MFDS approval smoothly,” emphasizing.

He added, “We plan to develop microneedle-based obesity treatments centered on our proprietary drug delivery rate control technology, ‘Microsphere,’ and composition patents for drug administration. After the launch of the first microneedle drug, we will diversify our therapeutic portfolio,” he added.

Shinshin Pharmaceutical is developing microneedle drugs using TDDS (transdermal drug delivery system) technology. Microneedles have the advantage of delivering high molecular weight drugs that are difficult to deliver with conventional patches, making them a next-generation formulation attracting attention from global biotech companies. Shinshin Pharmaceutical has independently developed Microsphere technology, which reduces the size of existing drugs and converts them into an amorphous form. Microsphere not only controls the delivery rate of drugs loaded onto microneedles but also improves drug solubility and bioavailability.

This content was produced with the assistance of AI translation services.