Fusidic Acid Cream Stability via In Situ Generation
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Solution Overview
Problem
Current Fusidic acid creams face stability issues due to rapid degradation from exposure to oxygen, and existing treatments for skin infections and wounds lack effective skin healing and regeneration, relying on frequent applications and not addressing secondary infections.
Innovation Solution
A cream formulation incorporating Fusidic acid generated in situ from Sodium Fusidate under an oxygen-free environment, combined with chitosan as a biopolymer, providing enhanced stability and therapeutic benefits for skin infections and wounds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If fine powder form of Fusidic acid is used as API, then dermal contact and penetration is enhanced, but chemical stability deteriorates due to rapid oxidation
Solution Approach 1:
The patent employs an oxygen-free inert atmosphere (nitrogen or carbon dioxide) during the manufacturing process to prevent oxidation of Fusidic acid particles. This allows the use of fine powder form for enhanced dermal penetration while maintaining chemical stability by eliminating oxygen contact during cream formulation.
Solution Approach 2:
The patent performs preliminary stabilization by generating Fusidic acid in situ from Sodium Fusidate under oxygen-free conditions before final cream formulation. This preliminary action prevents oxidation that would occur if fine Fusidic acid powder were handled extensively during manufacturing.
2Ease of manufacture
If Fusidic acid is generated by dissolving Sodium Fusidate and adding acid, then API is obtained, but particle size is coarse and processing difficulty increases
Solution Approach 1:
The patent performs preliminary dissolution of Sodium Fusidate in the aqueous phase before acid addition, ensuring complete dissolution and preventing coarse precipitate formation. This preliminary action enables fine, uniform particle size upon acidification.
Solution Approach 2:
The patent controls the pH adjustment process by gradually adding acid to reach the isoelectric point of Fusidic acid, optimizing precipitation conditions for fine particle formation. This parameter control transforms the coarse precipitate problem into fine, uniform particles suitable for cream formulation.
3Stability of the object's composition
If stringent precautionary procedures are used during manufacture and storage, then oxidation stability is improved, but manufacturing complexity and storage requirements increase
Solution Approach 1:
The patent uses oxygen-free inert atmosphere during manufacturing to prevent oxidation, eliminating the need for complex post-manufacturing stabilization procedures and stringent storage requirements. This approach simplifies the overall process while maintaining stability.
Solution Approach 2:
The patent performs preliminary stabilization by generating and incorporating Fusidic acid under oxygen-free conditions before the cream is exposed to air. This preliminary protection eliminates the need for continuous stringent precautions during storage and handling.
4Stability of the object's composition
If Fusidic acid cream is stored at reduced temperatures, then API stability is improved, but storage and distribution requirements become more stringent
Solution Approach 1:
The patent manufactures the cream under oxygen-free conditions, providing inherent oxidation protection that allows stable storage at ambient temperatures. This eliminates the need for refrigerated storage and simplifies distribution requirements.
Solution Approach 2:
The patent performs preliminary stabilization during manufacturing by generating Fusidic acid under oxygen-free conditions and incorporating it into the cream matrix before exposure to air. This preliminary protection enables stable storage without temperature restrictions.
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 cream achieves improved chemical stability and therapeutic efficacy, promoting faster wound healing, reduced secondary infections, and enhanced skin regeneration with a single-dose application.
Implementation Method 1
Sodium fusidate is converted into fusidic acid under an oxygen-free environment created using inert gas, preferably nitrogen
Implementation Method 2
The cream incorporates a biopolymer in the form of chitosan... providing enhanced stability
Data Source
AI summary
Disclosed is a medicinal cream that includes flisidic acid which is made in situ under an oxygen-free environment using sodium fusidate. The fusidic acid is made by dissolving the sodium fusidate in a co-solvent under inert gas purging and under vacuum, and converting the sodium fusidate to fusidic acid in situ by adding an acid under stirring, The disclosed medicinal cream also includes a biopolymer and a cream base comprising at least one of each of a primary and secondary emulsifier, a waxy material, and water.