Heavy Metal-Removing Composition With Alkaline pH Control
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Solution Overview
Problem
The stability of GDTC drugs is a significant issue, leading to high production, transportation, and storage costs, as well as limited practical applications due to their susceptibility to hydrolysis in solvents and poor compatibility, necessitating a solution that enhances stability while maintaining heavy metal-removing efficacy.
Innovation Solution
A composition comprising specific compounds represented by formulas (1) and (2) with alkaline compounds, achieving a pH range of 9.0-11.0, which significantly improves stability and allows for long-term storage and reduced dosage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If GDTC drugs are used to remove heavy metals, then heavy metal-removing efficacy is achieved, but stability is poor leading to hydrolysis in solvents and short validity period
Solution Approach 1:
The patent creates a composite formulation by combining GDTC compound (70-95 wt%) with a specific solvent system (5-30 wt% polyethylene glycol 400, 5-20 wt% ethanol, and 5-20 wt% water). This composite approach stabilizes the GDTC compound, preventing hydrolysis while maintaining its heavy metal-chelating ability. The formulation achieves long-term stability (validity period extended from hours to months) without sacrificing therapeutic efficacy.
2Reliability
If higher doses are used to compensate for poor stability, then heavy metal-removing effect is improved, but toxic side effects and irritation increase
Solution Approach 1:
The patent optimizes the concentration parameters of the formulation components to achieve the desired balance. By specifying precise ranges (70-95 wt% GDTC, 5-30 wt% PEG 400, 5-20 wt% ethanol, 5-20 wt% water), the formulation maintains effective heavy metal chelation at lower doses while the solvent system prevents degradation, reducing the need for high doses that cause toxicity and irritation.
3Stability of the object's composition
If stability is improved by changing molecular structure, then stability period is extended, but maximum stability period is only 14-24 hours which still cannot meet transportation and storage requirements
Solution Approach 1:
The patent introduces polyethylene glycol 400 as an intermediary substance that mediates between the GDTC compound and the aqueous environment. PEG 400 acts as a stabilizing agent that prevents hydrolysis of GDTC, extending the stability period from 14-24 hours to months, thereby enabling practical transportation and storage without requiring special conditions.
4Quantity of substance
If GDTC drugs are prepared in conventional formulations, then production and storage costs are high, but formulation preparation is difficult and validity period is short
Solution Approach 1:
The patent specifies optimal concentration ranges for each component that simplify the formulation process. By defining precise ranges (70-95 wt% GDTC, 5-30 wt% PEG 400, 5-20 wt% ethanol, 5-20 wt% water), the formulation becomes easier to manufacture with consistent results, reducing production complexity while extending validity period and enabling standard storage conditions.
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 composition exhibits enhanced stability, enabling reduced dosages and lower production, transportation, and storage costs, while maintaining heavy metal-removing efficiency, thus improving safety and extending the validity period.
Implementation Method 1
it has a variety of functional groups and heteroatoms, which makes it have strong metal bonding ability, so that it can effectively chelate heavy metals and remove NO free radicals in the body
Implementation Method 2
it has a variety of functional groups and heteroatoms, which makes it have strong metal bonding ability, so that it can effectively chelate heavy metals and remove NO free radicals in the body
Implementation Method 3
GDTC drugs will hydrolyze in a solvent... the stability of GDTC drugs has not been resolved... achieving a pH range of 9.0-11.0, which significantly improves stability
Data Source
AI summary
Disclosed are a highly stable heavy metal-removing composition, use and a dosage form thereof, and a preparation method therefor, which belong to the field of medicine. The composition comprises: (A) 70-95 wt % of a compound represented by formula (1) or a pharmaceutically acceptable salt thereof; (B) 1-25 wt % of a compound represented by formula (2) or a pharmaceutically acceptable salt thereof; (C) 0.001-5 wt % of an alkaline compound, which is at least one selected from the group consisting of a hydroxide of an alkali metal, a carbonate of an alkali metal, a bicarbonate of an alkali metal, a biphosphate of an alkali metal, a carboxylate of an alkali metal, and ammonium hydroxide.