Extended-Release Potassium Citrate Wax Matrix Tablet Production
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Solution Overview
Problem
The preparation of extended-release potassium citrate tablets is complex due to the high solubility of potassium citrate, requiring the use of a hydrophobic wax matrix, and existing methods involve heating carnauba wax until it liquefies, which is time-consuming and difficult to handle.
Innovation Solution
Heating the potassium citrate-carnauba wax mixture to a temperature below the liquefaction point of carnauba wax, forming granules that can be directly processed into tablets, eliminating the need for melting and cooling, and allowing for a simpler production process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If carnauba wax is heated until it liquefies to produce extended-release potassium citrate tablets, then the extended-release profile and abrasion resistance are improved, but the production time increases and the process complexity increases
Solution Approach 1:
The patent changes the temperature parameter from above the melting point of carnauba wax to below the melting point (specifically maintaining temperature between 55-60°C, below the 80-90°C melting point). This parameter change allows the wax to remain in a solid or semi-solid state during mixing, eliminating the time-consuming melting and cooling steps while still achieving proper granulation and extended-release profile.
2Reliability
If carnauba wax is heated until it liquefies to produce extended-release potassium citrate tablets, then the extended-release profile and abrasion resistance are improved, but the process complexity increases
Solution Approach 1:
The patent changes the temperature parameter to remain below the melting point of carnauba wax during the mixing process. This eliminates the need for separate melting and cooling steps, simplifying the overall process while still achieving adequate granulation, extended-release profile, and abrasion resistance through the modified mixing conditions.
3Duration of action of moving object
If the amount of carnauba wax is increased to extend the release of potassium citrate, then the extended-release profile is improved, but the tablet size increases making it unacceptable for swallowing
Solution Approach 1:
The patent changes the temperature parameter during mixing to below the melting point of carnauba wax. This parameter change improves the efficiency of the wax as an extended-release agent, allowing achieving the same extended-release profile with lower wax content (below 25% w/w), thus maintaining acceptable tablet size for swallowing.
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
This method reduces production time and simplifies the manufacturing process while maintaining the same dissolution profile and abrasion characteristics as tablets produced by fully melting the wax, ensuring compliance with USP 35 dissolution specifications and acceptable tablet hardness and abrasion.
Implementation Method 1
The potassium citrate-carnauba wax mixture is heated to a temperature below the temperature at which carnauba wax liquefies
Implementation Method 2
The cooled granulate can then be fed directly into a comminuting machine for size reduction
Data Source
AI summary
The present invention relates to a method for producing extended-release potassium citrate tablet containing camauba wax, wherein the method comprises heating the potassium citrate-carnauba wax mixture to a temperature below the temperature at which carnauba wax liquefies. This invention simplifies the production of extended release potassium citrate wax-matrix tablet.