Salfaprodil Freeze-Dried Injection pH Control for Uniform Crystals
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Solution Overview
Problem
Conventional freeze-drying techniques for salfaprodil injection result in non-uniform crystals, poor stability, precipitation, and poor re-solubility due to differences in crystallization of active ingredients, leading to defects like apparent layering and impurities.
Innovation Solution
A preparation method involving dissolving salfaprodil in water for injection, filtering with specific membranes, adjusting pH with alkaline substances, sterile filtration, and controlled freeze-drying to achieve a uniform, stable, and soluble freeze-dried powder injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional freeze-drying techniques are used for salfaprodil injection, then the preparation process is simple, but the crystals are non-uniform and the product has poor stability with precipitation and apparent layering
Solution Approach 1:
The patent applies preliminary action by adjusting the pH of the solution to 7.5-8.5 using sodium hydroxide solution before freeze-drying. This pre-adjustment ensures optimal crystallization conditions during the freeze-drying process, resulting in uniform fine crystals without precipitation or layering, while maintaining a relatively simple preparation process.
2Ease of operation
If conventional freeze-drying is used, then the process is straightforward, but the product shows poor re-solubility and apparent layering
Solution Approach 1:
The patent applies parameter changes by optimizing the pH parameter to 7.5-8.5 through sodium hydroxide adjustment. This specific pH range ensures that salfaprodil forms uniform fine crystals during freeze-drying that maintain high re-solubility and stability after reconstitution, eliminating apparent layering and precipitation issues while keeping the process straightforward.
3Reliability
If conventional freeze-drying techniques are applied, then no special pH adjustment is needed, but impurity content increases and stability decreases
Solution Approach 1:
The patent applies preliminary action by performing pH adjustment to 7.5-8.5 with sodium hydroxide solution before the freeze-drying step. This preliminary pH optimization prevents impurity formation and ensures high product stability during and after freeze-drying, while adding only one simple adjustment step to the manufacturing process.
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 method produces a visually clear, off-white powder with fine particles, high solubility, low impurity content, and good stability, maintaining consistent parameters after a 6-month accelerated test.
Implementation Method 1
filtering the solution
Implementation Method 2
adjusting pH filtrate with alkaline substance water solution
Implementation Method 3
freeze-drying the solution to obtain salfaprodil freeze-dried powder injection
Implementation Method 4
freeze-drying the solution
Data Source
AI summary
A salfaprodil freeze-dried powder injection, and a preparation method thereof and the use thereof are proposed. The preparation method may include adding salfaprodil into water for injection, filtering after the salfaprodil is completely dissolved, and adjusting pH of filtrate with an alkaline substance water solution. The method may also include adding the injection water to achieve a constant volume, filling with an inert gas for protection, and performing sterilization and filtration to obtain a salfaprodil solution, which is then freeze-dried to obtain the salfaprodil freeze-dried powder injection.