Soluble Inositol Phosphate Salt Recrystallization for High Purity
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Solution Overview
Problem
There is a need for industrially scalable, reproducible, and safe processes to produce high-purity soluble salts of inositol phosphate, particularly Na6IP6, suitable for therapeutic applications, as existing methods result in impure and insoluble forms that are inadequate for intravenous administration.
Innovation Solution
A recrystallization process involving dissolving the IP salt in water, converting to a suspension, washing with an alcohol solution, and drying to obtain a purified IP salt, combined with ion exchange and alkoxide separation steps, to achieve high-purity soluble salts like Na6IP6.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If phytin (Ca-Mg salt of IP6) is used as the starting material, then the source material is readily available and cost-effective, but the product is insoluble in water and inadequate for intravenous administration
Solution Approach 1:
The patent applies parameter changes by converting the insoluble Ca-Mg salt (phytin) into soluble monovalent cation salts through chemical transformation. Specifically, phytin is treated with strong acids (HCl, H2SO4, or HNO3) to release IP6, which is then neutralized with monovalent bases (NaOH, KOH, or NH4OH) to produce soluble sodium, potassium, or ammonium salts of IP6. This chemical parameter transformation resolves the solubility issue while maintaining the therapeutic benefits of IP6.
Solution Approach 2:
The patent uses strong acids (HCl, H2SO4, HNO3) as intermediary substances to convert the insoluble phytin into soluble IP6 forms. These acid intermediaries facilitate the release of IP6 from its insoluble Ca-Mg salt form, enabling subsequent conversion to medically acceptable soluble salts suitable for intravenous administration.
2Productivity
If existing extraction and precipitation methods are used to prepare IP6 salts, then the process is simple and fast, but the product contains impurities (proteins, carbohydrates, metals) and achieves insufficient purity
Solution Approach 1:
The patent systematically removes impurities through multiple extraction and separation steps. After acid treatment and neutralization, the solution undergoes filtration to remove insoluble impurities, followed by concentration and precipitation steps that separate pure IP6 salt from soluble impurities. The use of alcohol precipitation and controlled crystallization further purifies the product by selectively precipitating IP6 salt while leaving other impurities in solution.
Solution Approach 2:
The patent applies preliminary action by treating the crude IP6 extract with acids before neutralization to convert it into a pure form. This pre-treatment step with strong acids ensures complete dissolution and conversion of phytin, followed by careful neutralization that prevents re-precipitation of impurities. The sequential preparation of reagents and controlled addition rates are preliminary actions that ensure high purity from the outset.
3Manufacturing precision
If ion exchange columns are used to extract IP6, then purification can be achieved, but the process becomes complex and less suitable for industrial scale-up
Solution Approach 1:
The patent replaces the mechanical/physical ion exchange column system with a chemical solution-based approach. Instead of using complex ion exchange resins and column systems, the invention uses straightforward acid-base chemistry: treating the extract with strong acids to release IP6, then neutralizing with monovalent bases to form soluble salts. This chemical substitution simplifies the equipment requirements while maintaining high purification effectiveness, making the process more suitable for industrial scale-up.
4Productivity
If hydrolysis under pressure is used to recover IP6, then extraction efficiency is improved, but the process requires harsh conditions and additional equipment
Solution Approach 1:
The patent changes the physical parameters of the extraction process by using strong acids at ambient or moderate temperatures instead of requiring high-pressure hydrolysis conditions. The use of concentrated HCl, H2SO4, or HNO3 enables efficient IP6 release from phytin without the need for pressure vessels or specialized high-temperature equipment, thereby maintaining high extraction efficiency while simplifying the equipment requirements.
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 process yields high-purity soluble IP salts, such as Na6IP6, suitable for pharmaceutical compositions that are stable at room temperature and effective in treating ectopic calcifications.
Implementation Method 1
dissolving the IP salt in water to obtain an IP solution
Implementation Method 2
converting the IP solution to an IP suspension
Implementation Method 3
washing the IP suspension with an alcohol solution to obtain a solid
Implementation Method 4
drying the solid to obtain the purified (i.e., recrystallized) IP salt
Implementation Method 5
contacting the IP solution with an ion exchange medium
Data Source
AI summary
The present invention provides processes for preparing soluble salts of inositol phosphate characterized by a low level of impurities. Processes for preparing soluble salts (e.g., alkali-metal or ammonium) of inositol phosphates (e.g., hexasodium or dodecasodium salts), and of inositol hexaphosphate in particular (e.g., Na6IP6 and Na12IP6), are described. Also provided are pharmaceutical compositions, methods of use, combination treatments, kits, and articles of manufacture comprising soluble salts of inositol phosphates prepared according to the method of the invention.