Water-Soluble Strontium L-Lactate for Neutral pH Absorption
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Solution Overview
Problem
Current strontium salts used for treating bone and cartilage disorders are water-insoluble, making them less effective in neutral stomach fluids, particularly for individuals with gastrointestinal issues like acid reflux, as they require acidic conditions to release the strontium ion for absorption.
Innovation Solution
Development of a pharmaceutical quality strontium L-lactate composition that is water-soluble, prepared through careful selection of raw materials and controlled reaction conditions to prevent racemization, ensuring high bioavailability and safety by minimizing metal contaminants and using methods compliant with Good Manufacturing Practices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If water-insoluble strontium salts are used, then they can be administered orally for treating bone disorders, but they require acidic stomach conditions to release strontium ions, making them ineffective for individuals with gastrointestinal issues like acid reflux
Solution Approach 1:
The patent changes the solubility parameter of strontium salts by selecting specific salts (strontium L-lactate, strontium L-citrate, strontium L-malonate) that are water-soluble, allowing them to release strontium ions in neutral pH conditions without requiring acidic stomach environment
Solution Approach 2:
The patent uses L-lactate, L-citrate, or L-malonate as intermediary compounds that form water-soluble complexes with strontium ions, enabling these ions to be released in neutral pH conditions and absorbed effectively in the gastrointestinal tract
2Productivity
If high temperatures are used to accelerate strontium salt formation, then reaction yield and purity are improved, but racemization of L-lactate may occur, reducing product quality
Solution Approach 1:
The patent optimizes the temperature parameter by conducting reactions at controlled temperatures (0-25°C) that are sufficient to achieve complete reaction and high yield while preventing racemization of the L-lactate stereocenter
Solution Approach 2:
The patent implements monitoring of reaction progress and pH control during the neutralization process to ensure complete reaction occurs without exceeding temperature or pH thresholds that would cause racemization
3Ease of manufacture
If conventional strontium salt preparation methods are used, then production is simplified, but metal contaminants and impurities are not adequately removed, compromising pharmaceutical quality
Solution Approach 1:
The patent employs extraction techniques using organic solvents (ether, ethyl acetate, or methyl tert-butyl ether) to remove metal contaminants and impurities from the aqueous reaction mixture, separating them into the organic phase while retaining the strontium L-lactate in the aqueous phase
Solution Approach 2:
The patent uses chelating agents (EDTA or DTPA) as intermediary compounds that selectively bind to metal contaminants, forming water-soluble complexes that can be easily separated from the desired strontium L-lactate product
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 water-soluble strontium L-lactate composition effectively releases strontium ions in neutral solutions, enhancing bioavailability and therapeutic efficacy, particularly for individuals with gastrointestinal issues, while minimizing adverse effects and maintaining stability over extended use.
Implementation Method 1
The water-soluble strontium L-lactate composition effectively releases strontium ions in neutral solutions
Implementation Method 2
reaction by neutralization of aqueous solutions of pharmaceutical quality L-lactic acid with pharmaceutical quality strontium carbonate
Data Source
AI summary
The present application relates to strontium L-lactate compositions and methods of use. The methods and compositions disclosed herein are particularly useful for providing bioavailable strontium to mammals and treating or preventing symptoms of bone and/or cartilage disorders.