Sodium Deoxycholate Formulation pH Stabilization
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Solution Overview
Problem
Aqueous solutions of sodium deoxycholate at low concentrations are prone to precipitation, limiting their shelf life and requiring frequent dilution before use, which is not ideal for routine administration in fat removal treatments.
Innovation Solution
Maintaining the pH of sodium deoxycholate solutions between 8.0 and 8.5 inhibits precipitation, stabilizing the formulation and extending its shelf life, allowing for effective and safe fat removal without the need for frequent dilution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If aqueous solutions of sodium deoxycholate are prepared at low concentrations, then the formulation is more dilute and easier to administer, but precipitation occurs rapidly limiting shelf life
Solution Approach 1:
The patent applies parameter changes by adjusting the pH of the aqueous solution to a specific range (pH 8.0-8.5) to prevent precipitation of sodium deoxycholate. This chemical parameter modification allows low concentration formulations to remain stable over extended periods, resolving the contradiction between dilution and shelf life.
2Ease of operation
If aqueous solutions of sodium deoxycholate are prepared at low concentrations, then the formulation requires less dilution before use, but precipitation occurs limiting storage stability
Solution Approach 1:
By changing the pH parameter to the optimal range of 8.0-8.5, the formulation achieves both ease of administration (low concentration) and storage stability (no precipitation). This parameter optimization allows the solution to remain stable during storage while requiring minimal or no dilution before use.
3Stability of the object's composition
If the pH of sodium deoxycholate solution is maintained at 8.0 to 8.5, then precipitation is inhibited and shelf life is extended, but the formulation requires precise pH control
Solution Approach 1:
The patent identifies pH 8.0-8.5 as the optimal range that prevents precipitation while maintaining formulation stability. By targeting this specific parameter range, the invention achieves extended shelf life without requiring overly complex control systems, as the pH range provides a buffer zone for stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The stabilization of sodium deoxycholate solutions at pH 8.0 to 8.5 prevents precipitation for extended periods, enhancing storage stability and maintaining the active ingredient's concentration, thus improving the efficacy and safety of fat removal treatments.
Implementation Method 1
aqueous solutions of sodium deoxycholate at low concentrations are prone to precipitation... Maintaining the pH of sodium deoxycholate solutions between 8.0 and 8.5 inhibits precipitation
Data Source
AI summary
The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.