Pharmaceutical compositions comprising viloxazine and methods of making the same

By adding antioxidants and optimizing the immediate-release and sustained-release layer structures in the veloxacin drug composition, the problem of excessive nitrosamine impurities was solved, the stability and safety of the drug were improved, and the dissolution behavior was made similar to that of the reference formulation.

CN122440593APending Publication Date: 2026-07-24SUZHOU NHWA PHARM RES CO LTD +1
View PDF 0 Cites 0 Cited by

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SUZHOU NHWA PHARM RES CO LTD
Filing Date
2026-01-21
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Existing veloxacin formulations generate nitrosamine impurities during preparation and storage, exceeding safety limits and affecting the stability and safety of the drug. Current technologies have not effectively addressed this issue.

Method used

By adding antioxidants, such as ascorbic acid or its salts, to the veloxacin pharmaceutical composition, combining sustained-release materials and pore-forming agents, optimizing the structure of the immediate-release and sustained-release layers, forming an isolation layer to control the formation of nitrosamine impurities, and preparing the pharmaceutical composition through specific ratios and processes.

Benefits of technology

It effectively reduces the formation of nitrosamine impurities, improves the stability and dissolution behavior of the drug and its similarity to the reference preparation, meets regulatory requirements, and ensures the safety and efficacy of the drug.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure FT_1
    Figure FT_1
  • Figure FT_2
    Figure FT_2
  • Figure SMS_6
    Figure SMS_6
Patent Text Reader

Abstract

The application provides a pharmaceutical composition of venlafaxine hydrochloride, which comprises a pill core, a quick-release layer and a slow-release layer, and optionally further comprises an isolation layer and / or a protective layer, wherein the quick-release layer contains an antioxidant. The pharmaceutical composition provided by the application has good stability, can effectively inhibit the growth of nitrosamine impurities in the process of preparation and the process of storage of the preparation, has little influence on related substances, has good storage stability of the product, and has beneficial effects such as similar dissolution of the preparation to a reference preparation. The application further provides a preparation method of the pharmaceutical composition, which is simple in operation and suitable for industrial application.
Need to check novelty before this filing date? Find Prior Art