High-stability mometasone furoate cream and processing technology thereof

By employing a dual-emulsification system process, and utilizing components such as gallic acid, aluminum starch octenyl succinate, lanolin, and modified silicone oil, the stability and user experience issues of mometasone furoate cream were resolved, achieving uniform stability and sustained-release effect at both high and low temperatures.

CN121910657APending Publication Date: 2026-04-24JIANGSU SEMPOLL PHARMA
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Patent Information

Application Number
CN202610077635.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-01-21
Publication Date
2026-04-24

AI Technical Summary

Technical Problem

Existing mometasone furoate cream formulations struggle to balance stability and user experience, exhibiting issues such as excessively high viscosity, sticky texture, difficulty in spreading evenly, and a tendency to crystallize during low-temperature storage. Current technologies, by adding stabilizers, may increase the risk of skin irritation.

Method used

The process employs a dual emulsification system, using gallic acid to maintain an acidic environment and scavenge free radicals, adding aluminum starch octenyl succinate to adjust viscosity, using lanolin and modified silicone oil to improve matrix stability, and glycyrrhizic acid to modify soybean lecithin to enhance emulsification performance, forming W/O and O/W/O structures, and using titanium dioxide and other excipients to improve stability.

Benefits of technology

It significantly improves the stability and bioavailability of creams, prevents crystallization, improves spreadability and skin feel, reduces drug irritation, and achieves uniform stability and sustained-release effect at high and low temperatures.

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Abstract

The invention discloses high-stability mometasone furoate emulsifiable paste and a processing technology thereof, and relates to the technical field of emulsifiable paste preparations. A double-emulsification-system preparation process is adopted, the stability of the cream is remarkably improved, firstly, main drug active ingredients are prepared into submicron emulsion through dispersion and homogenization to form a first emulsification system (W / O) to play a role in primary protection, secondly, dispersion is added into a water phase to form an oil-in-water particle structure, and then the dispersion and an oil phase are emulsified to form a second emulsification system (O / W / O) to play a role in secondary protection. The mometasone furoate emulsifiable paste with high stability is prepared by adding auxiliary materials such as titanium dioxide and starch aluminum octenylsuccinate, so that the bioavailability of mometasone furoate is improved; by cooperating with excellent oxidation resistance of 4-vinyl guaiacol, gallic acid and glycyrrhizic acid, the oxidation resistance of the cream is remarkably improved, and the long-acting stability of the cream is further ensured.
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