Otic Antibiotic Corticosteroid Composition Stabilization
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Solution Overview
Problem
Existing pharmaceutical formulations comprising a corticosteroid, antibiotic, and triazole for treating otic infections in animals are prone to degradation when stored at room temperature, leading to instability and potential product loss due to refrigeration failures.
Innovation Solution
A pharmaceutical composition comprising a corticosteroid, an antibiotic (such as a quinolone or naphthyridinone), and an organic acid (specifically a fatty acid with 3 to 18 carbon atoms and a melting point of no greater than 60°C), which stabilizes the formulation at room temperature or higher for extended periods, reducing degradation and eliminating the need for refrigeration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the formulation is stored at room temperature, then convenience and cost are improved, but stability deteriorates due to degradation product formation
Solution Approach 1:
The patent changes the chemical parameters of the formulation by replacing the triazole antifungal with specific antifungal agents (miconazole, clotrimazole, ketoconazole, or their salts) that have different chemical stability characteristics. These alternative antifungals do not accelerate corticosteroid degradation, allowing the formulation to remain stable at room temperature without refrigeration.
Solution Approach 2:
The patent creates a composite pharmaceutical formulation containing corticosteroid, antibiotic, and specifically selected antifungal agents along with excipients. This composite material achieves enhanced stability at room temperature through the synergistic compatibility of its components, particularly the selected antifungals that do not promote degradation of the corticosteroid component.
2Stability of the object's composition
If refrigeration is implemented, then stability is improved, but cost and complexity increase
Solution Approach 1:
The patent extracts the requirement for refrigeration from the storage conditions by selecting antifungal agents that are compatible with room temperature storage. This eliminates the need for cold chain infrastructure while maintaining formulation stability, thereby reducing device complexity and storage infrastructure requirements.
Solution Approach 2:
By changing the antifungal agent parameters from triazole to specifically selected agents (miconazole, clotrimazole, ketoconazole, or salts), the formulation's temperature stability parameter is improved, allowing storage at higher temperatures without refrigeration, thus reducing storage infrastructure complexity.
3Stability of the object's composition
If refrigeration is required, then stability is improved, but risk of product loss increases due to refrigeration failure
Solution Approach 1:
The patent removes the dependency on refrigeration for stability by selecting antifungal agents that allow room temperature storage. This eliminates the single point of failure (refrigeration system) and associated risks of product loss due to refrigeration failure, thereby improving product reliability.
Solution Approach 2:
The patent provides beforehand cushioning against refrigeration failure risks by formulating with antifungal agents that inherently allow stable storage at room temperature. This preemptive formulation choice cushions against the potential harm of refrigeration system failures or inadequate cold chain infrastructure.
Data Source
AI summary
This invention relates to compositions (e.g., otic compositions) comprising an antibiotic (generally a quinolone or naphthyridinone), corticosteroid, and organic acid (generally a fatty acid). This invention also relates to treatment methods using such a composition, uses of such a composition to make medicaments, and therapeutic kits comprising such a composition.