Sotalol Oral Solution Composition for Extended Stability
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Solution Overview
Problem
Existing oral formulations of sotalol hydrochloride, such as extemporaneously prepared suspensions, have limited stability and are unsuitable for patients who cannot swallow solid dosages, necessitating improved stability for commercial use.
Innovation Solution
Development of stable oral solutions comprising sotalol hydrochloride with specific osmolality, pH, and optional excipients, which maintain stability for over 4 months, including formulations without polymers like xanthan gum.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If extemporaneous oral suspensions are prepared for patients who cannot swallow solid dosages, then accessibility to treatment is improved, but stability is reduced to only 3 months
Solution Approach 1:
The patent changes the physical form parameter from suspension to solution, and optimizes chemical parameters including pH (4.0-6.0), osmolality (200-400 mOsm/kg), and composition (using citric acid, sodium citrate, sucralose, and sodium benzoate) to achieve enhanced stability of greater than 4 months while maintaining ease of administration for patients who cannot swallow tablets
2Stability of the object's composition
If oral suspensions are prepared with polymers like xanthan gum, then viscosity and stability are improved, but complexity of formulation increases
Solution Approach 1:
The patent extracts and eliminates polymer excipients like xanthan gum from the formulation, achieving stability through a simplified solution containing only essential components: sotalol hydrochloride, water, citric acid, sodium citrate, sucralose, and sodium benzoate, thereby reducing formulation complexity while maintaining stability
Solution Approach 2:
The patent changes the formulation approach by eliminating polymers and instead optimizing pH (4.0-6.0) and osmolality (200-400 mOsm/kg) parameters to achieve stability without requiring complex excipients, resulting in a simpler formulation
Data Source
AI summary
The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.