A stable oral pharmaceutical liquid preparation of an antispasmodic agent
A stable and palatable oral suspension of drotaverine for infants and young children is achieved through a drotaverine-resin complex with safe excipients, addressing taste and chemical instability issues, ensuring effective and safe administration.
JP2025524203APending Publication Date: 2025-07-25DROTASTAR LLC
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Patent Information
- Application Number
- JP2025504798
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-07-29
- Filing Date
- 2023-07-28
- Publication Date
- 2025-07-25
AI Technical Summary
Technical Problem
Current drotaverine formulations are not suitable for infants and young children due to their bitter taste and chemical instability, and there is a lack of a stable, palatable, and safe oral suspension for this age group.
Method used
A stable oral suspension formulation of drotaverine or its salts, using a drotaverine-resin complex with a specific ratio, combined with safe excipients like sorbitol, glycerin, and natural sweeteners, and ion exchange resins to mask bitterness and ensure chemical stability.
Benefits of technology
The formulation provides a chemically stable, palatable, and safe oral suspension for infants and young children, ensuring accurate dosing, ease of administration, and flexibility, while maintaining drug efficacy and safety.
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Abstract
The present invention provides an oral suspension formulation of drotaverine or a salt thereof, methods for producing them, and their use in therapy.
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