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Avito (Shanghai) Pharmaceutical Technology Co., Ltd
Avito Dodecylphosphatidylcholine (DPC) completes DMF filing
Date: 2025-10-23Read: 0
Recently, Avito Dodecylphosphatidylcholine (DPC, for injection) has successfully been registered and published as an active pharmaceutical ingredient (DMF) by the US FDA (DMF registration: 042280).
This registration is another important milestone after the completion of CDE registration (CDE registration number: F20250000363) on July 11, 2025. This move marks the comprehensive alignment of DPC's quality system with international standards, providing solid compliance support for pharmaceutical companies at home and abroad committed to the research of nasal brain drug delivery systems, significantly accelerating the development and application process of innovative nasal formulations.
Partial information on Avito Dodecylphosphatidylcholine (DPC)
BAQSIMI ® It's the first one tooonlyA nasal powder spray of hyperglycemia administered by nose, approved by the US FDA as early as 2019, is used for emergency treatment of severe hypoglycemia in diabetes patients aged 4 years and over, and has becomethe first oneApproved glucagon therapy for emergency treatment of severe hypoglycemia. Its innovation lies in the fact that as a ready to use dry powder preparation (no need for reconstitution), it is passively absorbed through the nasal mucosa, allowing patients to complete the administration without the need for inhalation, greatly improving the convenience of use in emergency situations.
It is worth noting that the market value of this star product is highly recognized: in April 2023, Eli Lilly and Company announced BAQSIMI ® Global equity sold to Amphistar for $1.075 billion; In June 2024, the product was officially approved for market by the China National Medical Products Administration (product name: Glucagon Nasal Powder Mist), marking its comprehensive coverage in major global pharmaceutical markets.
Table 1 BAQSIMI ® Drug Information
Figure 2 BAQSIMI ® Original image of prescription information
Dodecylphosphatidylcholine (DPC), as a zwitterionic compound, has a similar structure to lauroyl lysophosphatidylcholine but is more stable to hydrolysis, which gives it a unique advantage in nasal formulations. At BAQSIMI ® The mechanism of action of DPC is mainly reflected in two aspects:
◇ Enhance mucosal permeability: By regulating the tight junctions of nasal mucosal cells, improve the paracellular permeability of hydrophilic compounds, thereby enhancing the absorption efficiency of glucagon in the nasal cavity.
◆ Stable drug structure: As a phospholipid surfactant, DPC can form micelles in solution, efficiently encapsulating glucagon. Compared with other phospholipid materials such as DLPG and DDPC, DPC can reduce the formation of bilayer liposomes, avoid a decrease in drug encapsulation efficiency, and ensure the stability of the formulation.
Table 2 BAQSIMI ® relatedZhuanLiinformation
Avito has always been committed to providing high-quality excipient support for the research and development of high-end formulations. If you need more information about DPC (for injection), please feel free to contact us through the following methods, and we will provide you with professional services as soon as possible!