Debuting at CPHI China 2023, Singmed Shows the Innovative Power of Chinese Drug Delivery Technology
On June 19, the 21st International Convention on Pharmaceutical Ingredients and Intermediates (CPHI China 2023) was grandly opened in Shanghai New International Expo Center.
As a leading innovative design, development and manufacturing enterprise of drug delivery devices in China, Suzhou Singmed Medical Device Science & Technology LTD. (referred to as "Singmed") debuted with five innovative products including soft spray inhalation delivery devices(SMI), demonstrating the breakthrough and innovative strength of Chinese enterprises in the field of complex drug delivery devices.
CPHI China is an annual global pharmaceutical event, providing a platform for the exhibition and exchange of new technologies, new devices, new products and new development trends of Chinese pharmaceuticals. The exhibition covered 15 segments related to the whole pharmaceutical industry chain, attracting over 3,000 manufacturers from different segments.
As the only professional enterprise in China focusing on the development of complex drug delivery devices, Singmed attracted the attention of numerous pharmaceutical domestic and overseas professionals at the exhibition.
Founded in 2016, Singmed focuses on the three core drug delivery fields of pulmonary drug delivery, nasal drug delivery and ophthalmic drug delivery, concentrates on the innovative design and manufacturing of drug delivery devices, provides one-stop solutions for the development and manufacturing of drug delivery system devices and microfluidic chips, and provides integrated services for the generic drug market and innovation of drug-device combination preparations.
In 2021-2022, two dry powder inhalation devices independently developed by Singmed: Tiotropium Bromide Inhalation Powder Single-dose Capsule Type (generic Spiriva® HandiHaler® device), Umeclidinium Bromide and Vilanterol Trifenatate Multi-dose Type (generic Diskus® device) has achieved the first in China which passed the vivo consistency evaluation (official Bioequivalence Evaluation) by NMPA.CDE, thus achieving the breakthrough of zero BE of DPI devices in China..
At CPHI China 2023, Singmed exhibited five major products of self-developed and manufactured SMI device, wafer, silicon-based atomization chips, generic Diskus inhaler and generic Breezhaler inhaler.
Soft Mist Inhaler
The Soft Mist Inhaler (SMI) presented at this exhibition is one of the outstanding innovative products of Singmed. As a updated generation of inhalers for respiratory medications, the pocket-sized device is designed to produce an inhalable aerosol that can be inhaled once and is designed to enhance the efficiency of drug delivery to the lungs, reduce the need for patient coordination and inspiratory force, and improve patient experience and convenience.
The SMI applies an innovative aerosol technology that converts the drug solution into a soft mist made up of two liquid jets that rotate and flow through each other via a precisionly-designed two-channel nozzle. This kind of soft mist has the characteristics of low velocity, high cohesion, long residence time and small particle size, which is conducive to the distribution of drugs in the lungs. Compared with other inhalers, it has advantages in pulmonary deposition rate, oropharyngeal deposition rate, regional distribution, dose consistency, respiratory parameters, and patient satisfaction. The device is able to improve the deposition of drugs in target areas of the lungs, such as small airways, thereby improving treatment effectiveness and reducing side effects.
It is worth mentioning that based on the integrated service of "device, drug and clinical", the SMI devices Singmed has developed with Chinese head pharmaceutical companies (such as: Tiotropium Bromide spray) passed the in vivo consistency clinical evaluation (pre-BE) of CDE in 2021, becoming the first SMI device development company in China to break through the monopoly of SMI delivery technology and successfully pass the in vivo consistency clinical evaluation.
Wafer and Silicon-based Atomizing Chips
The wafer and silicon-based atomization chips on display at CPHI China also demonstrate Singmed's leading technology in the manufacturing of parts for SMI devices. Singmed is the first company in China equipped with the technology to commercialize silicon-based atomizing (soft mist) chips at scale. It is understood that Singmed Industrial Manufacturing Center has 2000 square meters of GMPD/C level injection molding and assembly purification workshop, commercial silicon atomization chip production workshop, with world-class production equipment, from wafer production to atomization chip testing, and then to SMI parts manufacturing, to achieve the technological breakthrough of commercial mass production such as medical silicon chip design and cutting process atomized chips. Singmed has truly achieved scale manufacturing and one-stop production, and truly demonstrated the miracle of precision industry.
Achievements and Vision
As a professional medical device enterprise focusing on the development and manufacturing of complex drug delivery devices in China, Singmed has broken through the technical barriers of several drug delivery devices, and conducted independent intellectual property research and development in the core technology areas of drug delivery system structure design, development and manufacturing of silicon based atomization chip, precision mold and automation, and has been providing innovative and generic drug-device combination preparation market with integrated service solutions of structural design, patented FTO, tolerance analysis, medical materials, precision molds, process validation, precision injection molding, product validation and product assembly.
Mr. Albert Zhao, founder and executive director of Singmed, said at the exhibition that the patent barriers and technical barriers of drug delivery devices have become a major difficulty in the imitation and innovation of drug-device combination products. Singmed perceived this pain point at the beginning of its establishment, and will continue to provide one-stop solutions for the imitation and innovation of drug-device combination products through the organic integration of "device, drug and clinical" in the future, and help Chinese pharmaceutical companies accelerate the localization of inhaled preparations with technological innovation and large-scale manufacturing advantages.
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