Dermaceutical Cream Stability via Inert Atmosphere Conversion
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Solution Overview
Problem
Current Fusidic acid creams are unstable due to rapid oxidation during manufacture and storage, leading to a significant reduction in potency, which compromises their effectiveness and shelf life.
Innovation Solution
Converting Sodium Fusidate into Fusidic acid in an oxygen-free environment to create a more stable cream formulation with improved chemical stability and finer particle size, enhancing dermal penetration and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If Fusidic acid is used in fine powder form to enhance dermal contact and penetration, then the surface area for skin interaction is increased, but the exposure to molecular Oxygen during manufacture and processing increases, leading to rapid oxidation and reduction in potency
Solution Approach 1:
The patent applies inert atmosphere by conducting the conversion of Sodium Fusidate to Fusidic acid in an oxygen-free environment using inert gases such as nitrogen or carbon dioxide. This prevents oxidation of the Fusidic acid during manufacture while maintaining the fine powder form for enhanced dermal contact and penetration.
2Quantity of substance
If Fusidic acid is converted from Sodium Fusidate by dissolving in aqueous phase and adding acid, then Fusidic acid can be obtained, but the precipitate has coarse and uneven particle size that is difficult to process into cream form
Solution Approach 1:
The patent changes the physical-chemical parameters by converting Sodium Fusidate to Fusidic acid in an oxygen-free environment and controlling the precipitation process to produce fine, uniform particles. The use of inert atmosphere and controlled conversion conditions ensures consistent particle size distribution suitable for cream formulation.
3Reliability
If Fusidic acid is stored and handled with standard precautions, then it can be processed, but stringent controls are required including storing at 2°C to 8°C in air-tight containers, increasing manufacturing complexity
Solution Approach 1:
The patent eliminates the need for stringent cold storage and air-tight container requirements by conducting the entire conversion and formulation process in an inert atmosphere. This maintains Fusidic acid stability while significantly simplifying manufacturing and storage conditions.
4Productivity
If Fusidic acid is exposed to Oxygen during manufacture and handling, then processing can proceed, but degradation due to oxidation occurs, reducing API potency by 7.7% to 11% within three months
Solution Approach 1:
The patent maintains an oxygen-free inert atmosphere throughout the conversion and formulation process, preventing oxidation degradation while allowing efficient processing. This eliminates the trade-off between productivity and substance loss by creating conditions where both can be optimized.
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 maintains stability and potency throughout its shelf life, providing effective treatment for bacterial skin infections with improved dermal compatibility and therapeutic efficacy.
Implementation Method 1
a serious shortcoming of the fine size of Fusidic acid particles is that it presents an enormous surface area for contact and reaction with molecular Oxygen during manufacture, handling, and processing of the cream. This has serious implications to its chemical stability and results in rapid reduction in potency of the API (Fusidic acid) in the final cream formulation. Degradation due to oxidation is a major cause of instability of currently available Fusidic acid creams.
Data Source
AI summary
The invention discloses a dermaceutical cream containing steroids and an antibacterial agent in the form of Fusidic acid, which Fusidic acid is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The cream of the present invention contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, and steroids in a cream base comprising an acid, a co-solvent, an emulsifier and a waxy material along with water, preferably purified water.