Salmeterol sulfate sustained-release tablet and its preparation process

By combining a drug-ion exchange resin complex with a hydrophilic gel matrix material, along with gradient temperature-controlled drying and step-curing treatment, the problems of burst release and stability of salbutamol sulfate sustained-release tablets were solved, achieving stable release and low impurity content, making it suitable for industrial production.

CN122440575APending Publication Date: 2026-07-24SUZHOU HOMESUN PHARMA CO LTD
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Patent Information

Application Number
CN202610579592.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-04-29
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Existing salbutamol sulfate sustained-release tablets have several problems, including burst release at the initial stage of drug release, release behavior being greatly affected by gastrointestinal pH and enzymes, high-temperature drying in the preparation process affecting drug stability, and the inability of a single sustained-release mechanism to achieve continuous release for 24 hours.

Method used

By combining a drug-ion exchange resin complex with a hydrophilic gel framework material, and through gradient temperature-controlled drying and step-curing treatment, combined with dual controlled-release coating technology, the drug release rate and impurity level can be controlled simultaneously.

Benefits of technology

It achieves stable and sustained drug release, inhibits burst release, reduces impurity content, improves batch-to-batch stability and clinical drug safety, and is suitable for industrial production.

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Abstract

The application discloses a salbutamol sulfate sustained-release tablet and a preparation process thereof. The preparation process comprises the following steps: drug micronization treatment, drug and ion exchange resin compounding, granulation with hydrophilic gel matrix material, gradient temperature control drying, total mixing after whole granulation, tabletting, double controlled-release coating, ladder solidification treatment and screening and packaging. Through the synergistic sustained-release effect of the ion exchange resin and the hydrophilic gel matrix material, the double controlled-release coating and the ladder solidification process, the application effectively inhibits drug burst release, realizes smooth and long-lasting release, reduces impurity content, and improves product stability and batch reproducibility. The obtained sustained-release tablet releases 20%-40% in 2 hours and 80% or more in 8 hours in a pH 6.8 phosphate buffer, and the quality is controllable, so the sustained-release tablet is suitable for industrial production.
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Citation Information

Patent Citations

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