Low-Purity Soy Phosphatidylserine Cochleates for Drug Delivery
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Solution Overview
Problem
Non-purified soy phosphatidylserine (NSPS) has not been used to form cochleates, requiring a purification process to achieve at least 75% purity for cochleate formation, limiting its application in drug delivery.
Innovation Solution
Utilizing low purity soy phosphatidylserine (40-74% by weight) to form cochleates, incorporating multivalent cations and optionally bile salts, to create stable lipid-based cochleates that can be loaded with biological actives for oral or parenteral administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If non-purified soy phosphatidylserine is used to form cochleates, then the purification process is avoided and cost is reduced, but the cochleate formation is prevented due to insufficient purity
Solution Approach 1:
The invention changes the purity parameter threshold from the conventional requirement of at least 75% purity to a lower threshold of 40-74% purity, demonstrating that cochleate formation can occur with non-purified or low-purity soy phosphatidylserine. This parameter change enables the use of cost-effective non-purified soy PS while maintaining functional cochleate structure and drug delivery capability
Solution Approach 2:
The invention utilizes non-purified soy phosphatidylserine, which is a cheaper alternative to purified phosphatidylserine, to form functional cochleates. By accepting the lower purity level (40-74%), the process becomes more cost-effective while still achieving the desired drug delivery function, effectively replacing the need for expensive purification processes
2Manufacturing precision
If purification process is applied to soy phosphatidylserine, then the purity is enhanced to at least 75%, but the manufacturing complexity and cost increase
Solution Approach 1:
The invention extracts and removes the unnecessary purification step from the conventional cochleate formation process. By demonstrating that cochleates can form with non-purified soy phosphatidylserine (40-74% purity), the process eliminates the complex purification operations while maintaining functional integrity, thereby simplifying manufacturing
3Ease of manufacture
If low purity soy phosphatidylserine is used, then cost is reduced and purification is avoided, but the stability and reliability of cochleate formation may be compromised
Solution Approach 1:
The invention creates a functional copy of the cochleate structure using non-purified soy phosphatidylserine that mimics the properties of purified phosphatidylserine-based cochleates. The low-purity soy PS (40-74%) produces cochleates with comparable stability, drug encapsulation capacity, and release characteristics, thereby achieving cost reduction without sacrificing reliability
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 improved cochleates provide effective drug delivery with reduced toxicity, enhancing bioavailability and efficacy against fungal and bacterial infections, particularly with amphotericin-B and amikacin, and maintaining stability for prolonged periods.
Implementation Method 1
Cochleate delivery vehicles are stable phospholipid-cation precipitates composed of simple, naturally occurring materials, for example, phosphatidylserine and calcium
Implementation Method 2
The bilayer structure of cochleates provides protection from degradation for associated, or 'encochleated,' molecules. Since the entire cochleate structure is a series of solid layers, components within the interior of the cochleate structure remain substantially intact
Data Source
AI summary
Unpurified or low pure soy phosphatidylserine is used to make cochleates. The cochleates contain about 40-74% soy phosphatidylserine, a multivalent cation and a biological active. A preferred cochleate contains the antifungal agent amphotericin B.