Acidified Crotoxin Formulation for Long-Term Potency Stability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for Crotoxin purification and storage are inefficient, leading to losses and reduced activity, and existing formulations are not stable for long-term storage or room temperature use, posing challenges for clinical administration and waste reduction.
Innovation Solution
A formulation of Crotoxin in a saline solution with a pH of 1.5 to 4.5, using HCl for acidification, and including benzalkonium chloride as a preservative, ensures stability and biological activity, allowing easy handling and reduced waste.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If Crotoxin is stored in conventional formulations, then it requires complex storage conditions and handling procedures, but this leads to significant drug material loss and increased waste
Solution Approach 1:
The patent changes the pH parameter of the formulation to an acidic range (pH 3.0-5.0) and modifies the buffer composition to create a stable environment for Crotoxin that maintains potency without requiring complex refrigerated storage, thereby reducing handling complexity and preventing drug material loss
2Reliability
If Crotoxin is purified using conventional methods, then some purity is achieved, but the activity is reduced by heat process and not all Crotoxin is recovered
Solution Approach 1:
The patent replaces the conventional heat-based purification method with a pH-based precipitation and filtration system that uses acidic buffer conditions to precipitate impurities while maintaining Crotoxin activity, thereby improving recovery efficiency without compromising reliability
3Duration of action of stationary object
If Crotoxin formulation is designed for long-term stability, then storage duration is extended, but the formulation complexity increases
Solution Approach 1:
The patent creates a composite formulation system combining Crotoxin with specific buffer components (acetate buffer, citrate buffer), preservatives (benzalkonium chloride, thimerosal), and stabilizers that work synergistically to provide long-term stability through simple refrigerated storage conditions without increasing formulation complexity
Data Source
AI summary
A highly stable acidifed formula of Crotoxin comprising saline and benzalkonium chloride, and optionally Thiamine, is disclosed that facilitates the therapeutic use of Crotoxin. Also disclosed is a method of preparing a highly stable formula of Crotoxin.