Good news has recently arrived. The pharmaceutical excipient docusate sodium/sodium benzoate (F20250000020) of Jiudian Hongyang has had its registration status changed to "A" at the Center for Drug Evaluation (CDE) of the National Medical Products Administration. It has been successfully approved for marketing and is qualified for compliant commercial supply.

Docusate sodium/sodium benzoate is a co-processed pharmaceutical excipient prepared from docusate sodium and sodium benzoate by a proprietary process. It allows the two components to be distributed uniformly at the microscopic level and avoids the segregation or non-uniform content that may occur with conventional physical blending. It effectively addresses long-standing industry difficulties with neat docusate sodium, including high hygroscopicity, caking, strong electrostatic behavior, poor powder-processing performance, and unsuitability for direct compression.

Docusate sodium/sodium benzoate combines several functions, including those of a wetting agent, solubilizer, disintegrant, and glidant. As a highly efficient surfactant, docusate sodium can markedly improve the surface wettability of poorly soluble drugs, effectively increase the dissolution rate and the extent of dissolution, and at the same time optimize powder flowability and compressibility, matching the process requirements of a range of solid dosage forms. As a carrier and preservative, sodium benzoate can further improve powder stability and formability and confer good preservative and antimicrobial properties on the excipient, improving both the physical stability and the storage stability of the preparation.

With its strong overall performance, docusate sodium/sodium benzoate is widely suitable for oral solid dosage forms such as tablets and capsules. It can effectively optimize the forming process and improve formulation stability and medication safety. The product has a wide range of applications and broad market prospects.

The successful change of docusate sodium/sodium benzoate to status "A" is another important breakthrough for Jiudian Hongyang in high-end pharmaceutical excipients. Going forward, Jiudian Hongyang will continue to deepen its work in high-end APIs and excipients, focus on clinical needs and industry difficulties, increase investment in research and development, continue to broaden its product line, and strengthen its core competitiveness.