Nano-resin particles for pharmaceutical use
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Solution Overview
Problem
Current ion exchange resins in the micrometer size range are not suitable for pharmaceutical use due to high levels of water and organic extractable impurities when reduced to the nanometer range, leading to safety concerns and instability, particularly causing mucosa and skin irritation.
Innovation Solution
Development of nano-sized ion exchange resin particles with a particle size distribution of 200 nanometers to 900 nanometers and low levels of water and organic impurities, achieved through a process involving washing, wet milling, purification, and drying, which prevents the formation of fine particles less than 50 nanometers that cause membrane clogging and impurity issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ion exchange resins are reduced to nanometer size range, then pharmaceutical suitability is improved, but water extractable impurities increase to unacceptable levels
Solution Approach 1:
The patent applies parameter changes by precisely controlling the particle size distribution parameters (D90 between 200-900 nm, D10 not less than 50 nm) to achieve a specific nano-size range that provides pharmaceutical suitability while limiting impurity generation. This parameter optimization resolves the contradiction by finding the optimal size window where benefits are maximized and harms are minimized.
2Productivity
If ion exchange resins are reduced to nanometer size range, then drug delivery efficiency is improved, but organic extractable impurities increase to unacceptable levels
Solution Approach 1:
The patent controls the particle size distribution parameters (D90 between 200-900 nm, D10 not less than 50 nm) to achieve optimal drug delivery efficiency while limiting organic impurity generation. This precise parameter control resolves the contradiction between productivity improvement and harmful factor reduction.
3Area of stationary object
If very fine particles less than 50 nanometers are present, then surface area for drug adsorption is increased, but membrane clogging occurs during purification
Solution Approach 1:
The patent sets the D10 parameter to not less than 50 nm, which establishes a lower bound on particle size that prevents excessive fineness. This parameter control maintains sufficient surface area for drug adsorption while preventing membrane clogging during ultrafiltration, resolving the contradiction between adsorption efficiency and manufacturing ease.
Solution Approach 2:
The patent converts the potential harm of fine particles causing membrane clogging into a beneficial control mechanism by specifying D10 not less than 50 nm. This specification prevents the formation of problematic ultra-fine particles while maintaining the advantages of nano-sizing, effectively using the constraint as a quality assurance feature.
4Reliability
If resin particles are milled to reduce size, then pharmaceutical applicability is improved, but particle breakdown forming impurities increases
Solution Approach 1:
The patent optimizes the particle size distribution parameters (D90 between 200-900 nm, D10 not less than 50 nm) to achieve pharmaceutical applicability while minimizing particle breakdown impurities. This parameter control ensures that milling is sufficient to reach nano-size for pharmaceutical use but not excessive to cause significant material degradation.
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 resulting nano-resin particles are safe for pharmaceutical use, with water extractable impurities below 1% and organic impurities below 3 ppm, suitable for drug delivery via various routes, including topical, ophthalmic, and dermal applications, ensuring effective and stable drug release without adverse reactions.
Implementation Method 1
drugs are adsorbed onto the surface of the resin particles
Data Source
AI summary
The present invention relates to nano-resin particles that are suitable for pharmaceutical use and their use in the pharmaceutical field. The present invention provides nano-sized resin particles having a particle size distribution characterized in that D90 value is between 200 nanometers to 900 nanometer and D10 value is not less than 50 nanometers, wherein the nano-resin particles are in pure form and safe for pharmaceutical use. The present invention further relates to pharmaceutical compositions comprising these purified nano-resin particles and their use in the treatment of diseases.The present invention further provides a process for preparing purified, nano-sized resin particles that are suitable for pharmaceutical use, the process comprising steps of: (i) washing an ion exchange resin and suspending in an aqueous liquid, (ii) subjecting the suspension of (i) to wet milling for a period such that the particles have a particle size distribution characterized in that the D90 value is between 200 nanometers to 900 nanometers and D10 value is not less than 50 nanometers, (iii) subjecting the suspension of (ii) to purification to remove impurities, (iv) drying the purified suspension to obtain nano-resin particles in the form of dry powder.