Sofpironium Bromide Formulation Viscosity Stability
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Solution Overview
Problem
Existing pharmaceutical formulations containing sofpironium bromide for external application face challenges in maintaining viscosity stability over time, particularly in non-aqueous or low water content formulations, leading to undesirable changes in patient experience and formulation characteristics.
Innovation Solution
A pharmaceutical formulation with sofpironium bromide, water-soluble polymers, and ethanol, maintained at a pH of 5.2 or lower, which suppresses viscosity decrease over time, ensuring stable and effective topical application for conditions like hyperhidrosis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If water-soluble polymers are added to non-aqueous or low water content formulations containing sofpironium bromide, then viscosity is improved, but viscosity decreases over time during storage
Solution Approach 1:
The patent applies parameter changes by controlling the pH of the formulation to be 5.2 or lower. This pH parameter control prevents the degradation of water-soluble polymers in non-aqueous or low water content formulations, thereby maintaining viscosity stability over time during storage. The specific pH threshold of 5.2 is identified as the critical parameter that resolves the contradiction between initial viscosity improvement and long-term viscosity maintenance.
2Ease of operation
If external formulations are designed with appropriate viscosity, then patient feeling of use is improved, but viscosity changes over time affecting retentivity
Solution Approach 1:
The patent uses parameter changes by establishing pH control at 5.2 or lower as the key mechanism to maintain viscosity consistency over time. This ensures that formulations designed with appropriate viscosity for good patient feeling of use and spreadability will maintain their rheological properties during storage, preventing dripping and adhering to clothes issues.
3Stability of the object's composition
If cellulose polymers are blended into high water content formulations, then viscosity is increased, but viscosity decreases over time due to polymer degradation
Solution Approach 1:
The patent applies parameter changes by controlling pH to 5.2 or lower, which prevents the degradation of cellulose polymers in high water content formulations. This pH parameter control resolves the contradiction by maintaining both the initial viscosity increase from polymer addition and the long-term viscosity maintenance during storage.
Data Source
AI summary
A pharmaceutical formulation for applying as an external application to the surface of the human body, in which decrease of viscosity during long-term storage is suppressed, and which contains sofpironium bromide, a water-soluble polymer, and ethanol, has a pH of 5.2 or lower, and is a uniformly dispersed, and non-aqueous formulation or low water content formulation with a water content of 5% or lower.