Tranexamic Acid Oral Solution Stability and Taste
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Solution Overview
Problem
Current tranexamic acid oral rinse compositions are not stable for long-term shelf storage and exhibit discoloration, along with bitterness issues that limit their use, particularly in dental procedures for patients with bleeding disorders.
Innovation Solution
An aqueous pharmaceutical composition comprising tranexamic acid, water, a non-ionic surfactant, a preservative, a viscosity enhancer, a thickening agent, a pH adjuster, a sweetener, and a flavoring agent, which maintains at least 90% of tranexamic acid in undegraded form after storage for several months and improves taste characteristics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If tranexamic acid is formulated in oral rinse compositions, then it can be used for topical administration to reduce bleeding during dental procedures, but the composition is not stable for long-term shelf storage and exhibits discoloration
Solution Approach 1:
The patent optimizes the pH of the oral rinse composition to a specific range (pH 3.0-5.0) to enhance stability and prevent discoloration of tranexamic acid during shelf storage, while maintaining its effectiveness for topical administration to reduce bleeding during dental procedures
Solution Approach 2:
The patent formulates a composite oral rinse composition containing tranexamic acid combined with specific excipients and buffering agents that work synergistically to improve shelf stability and prevent discoloration, enabling long-term storage while maintaining topical efficacy
2Reliability
If tranexamic acid oral rinse compositions are formulated, then they can be used to reduce bleeding during dental procedures, but they exhibit bitterness that limits their use
Solution Approach 1:
The patent introduces flavoring agents and sweeteners as intermediary substances that mask the bitter taste of tranexamic acid, making the oral rinse more palatable and improving patient compliance without compromising the hemorrhage prevention effectiveness
Solution Approach 2:
The patent optimizes the concentration of tranexamic acid and combines it with flavor-modifying agents to reduce perceived bitterness while maintaining the therapeutic dose required for effective hemorrhage control during dental procedures
Data Source
AI summary
Methods and compositions are provided for treating a patient having a bleeding disorder during or after a dental procedure to reduce bleeding or need for factor replacement therapy. Aqueous pharmaceutical compositions are provided comprising tranexamic acid, sodium carboxymethyl cellulose, Tween® 20, and menthol wherein the composition exhibits good long term stability, little to no discoloration over time, and reduced bitterness compared to a control solution of tranexamic acid and water.