Diclofenac Salt Patch Solvent System for Homogeneity
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Solution Overview
Problem
Existing processes for preparing anti-inflammatory and analgesic patches face challenges with long solubilization times and precipitation phenomena, especially when handling large volumes, leading to incomplete solubilization and dishomogeneity of the final product.
Innovation Solution
Adding the diclofenac salt as a solution in a 1:1 ratio of water and propylene glycol to the mixture of components, rather than solely in water, to enhance solubility and stability, preventing precipitation and ensuring homogeneity regardless of quantity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the entire quantity of DHEP salt is added to the mixture in aqueous solution, then the solubility is improved, but the solubilization time increases and precipitation occurs with larger volumes
Solution Approach 1:
The patent introduces propylene glycol as an intermediary solvent to facilitate the dissolution of DHEP salt. By using a mixed solvent system (water and propylene glycol in 1:1 ratio), the patent achieves faster solubilization and prevents precipitation without requiring excessive dissolution time, thus resolving the contradiction between solubility and processing time.
Solution Approach 2:
The patent changes the solvent parameters by switching from pure aqueous solution to a mixed solvent system containing propylene glycol. This parameter change (solvent composition) enables the DHEP salt to dissolve more rapidly and remain stable in larger volumes, eliminating precipitation issues while maintaining high solubility.
2Quantity of substance
If the entire quantity of DHEP salt is added to the mixture in aqueous solution, then the solubility is improved, but component precipitation occurs leading to dishomogeneity
Solution Approach 1:
Propylene glycol acts as an intermediary substance that prevents the precipitation of DHEP salt and other components. By incorporating propylene glycol into the solvent system, the patent maintains component homogeneity throughout the mixture, avoiding the dishomogeneity that would result from precipitation in pure aqueous solutions.
Solution Approach 2:
The patent employs a composite solvent system combining water and propylene glycol in a 1:1 ratio. This composite solvent approach creates a stable medium that accommodates DHEP salt and other formulation components without precipitation, ensuring uniform distribution and homogeneity in the final product regardless of volume.
3Productivity
If larger volumes are processed at industrial production stage, then productivity is improved, but solubilization time increases and stability is compromised
Solution Approach 1:
The patent modifies the solvent parameters by introducing propylene glycol to the aqueous system. This parameter change enables the solution to maintain stability in larger volumes processed at industrial scale, preventing precipitation and ensuring consistent composition without requiring extended solubilization times, thus supporting high productivity.
Solution Approach 2:
Propylene glycol serves as a stabilizing intermediary that prevents component separation and precipitation in large-volume industrial batches. By incorporating this intermediary substance, the patent ensures solution stability remains consistent regardless of processing volume, allowing high productivity without compromising product quality.
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 approach prevents precipitation and ensures sufficient time stability of the solution, making it suitable for industrial-scale production by maintaining solubility and homogeneity, even with larger volumes.
Implementation Method 1
adding, always in an aqueous solution, the entire quantity of DHEP salt to the mixture of components
Implementation Method 2
avoid for example component precipitation phenomena, particularly of the active principle
Data Source
AI summary
The present invention relates to a process for preparing a pharmaceutical composition with anti-inflammatory and analgesic activity for administration via a patch for external use, its components including as active principle a salt of diclofenac, 2[(2,6-dichlorophenyl)amino]benzene-acetic acid, with a cyclic organic base chosen from hydroxyethylpyrrolidine or hydroxyethylpiperidine characterized in that said active principle is added to a mixture of one or more of said components, in the form of a solution in water and propylene glycol in a ratio of about 1:1 parts by weight.