Continuous API Impregnation on High Surface Area Carriers
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Solution Overview
Problem
Current methods for continuously impregnating high surface area porous carriers with active pharmaceutical ingredients (APIs) face challenges in achieving high API loadings with homogeneous distribution and consistent particle size, especially for high dose products, leading to difficulties in scalability and increased processing time.
Innovation Solution
A continuous impregnation process involving the controlled dispensing and mixing of an API solution with high surface area porous carriers, followed by solvent evaporation, allows for high API loadings and uniform distribution within a short contact time, utilizing a continuous impregnation device that efficiently handles high surface area carriers with specific surface areas of at least 400 m2/g.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multi-pass impregnation is used to increase drug loading, then API loading increases, but solubility enhancement decreases for loadings beyond about 10%
Solution Approach 1:
The patent utilizes high surface area porous carriers (with surface area ≥400 m2/g) that can accommodate high API loadings while maintaining pore structure integrity. The porous structure allows capillary absorption of API solution and maintains drug solubility enhancement even at loadings beyond 10% through optimized pore size distribution and surface area characteristics.
Solution Approach 2:
The patent changes key parameters including using carriers with specific surface area ≥400 m2/g, optimizing pore size distribution, and controlling API solution concentration and contact time. These parameter changes enable achieving high API loadings (20-50%) while maintaining solubility enhancement through optimized carrier properties rather than relying on multiple impregnation passes.
2Reliability
If carriers with large surface area are used to achieve high API loadings, then dissolution enhancement is achieved, but carriers become cohesive and very difficult to fluidize
Solution Approach 1:
The patent applies local quality modification by controlling the distribution of high surface area porous carrier particles within the formulation. It uses a combination of carrier particle sizes and optimizes the local concentration of high surface area carriers to achieve adequate dissolution enhancement while maintaining overall formulation fluidization capability through lower surface area carriers or optimized packing arrangements.
3Manufacturing precision
If batch mode impregnation is used for high surface area porous carriers, then homogeneous impregnation is achieved, but process time increases significantly as scaling up
Solution Approach 1:
The patent transitions from batch to continuous impregnation mode, where API solution is continuously supplied and carrier material continuously passes through the impregnation zone. This continuous operation maintains homogeneous impregnation through controlled residence time and continuous mixing, while dramatically reducing total process time compared to batch cycles that require complete drainage and drying between passes.
Solution Approach 2:
The patent performs preliminary classification and sorting of porous carrier particles by size and surface area before impregnation. This preliminary action ensures that only carriers with optimal properties (surface area ≥400 m2/g, appropriate pore size) are subjected to impregnation, enabling more efficient continuous processing and reducing the time required to achieve homogeneous impregnation compared to treating all carriers uniformly in batch mode.
4Quantity of substance
If high surface area porous carriers are used, then high API loadings are achieved, but consistent particle size distribution before and after impregnation becomes difficult to maintain
Solution Approach 1:
The patent segments the porous carrier population into different size fractions and surface area categories before impregnation. By separating carriers into distinct size classes and treating them through controlled impregnation conditions, the process maintains particle size distribution consistency while achieving high API loadings on the high surface area fraction. The segmented approach prevents excessive swelling or aggregation that would occur if all carriers were treated uniformly.
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
This process enables high API loadings and improved content uniformity, reducing the amount of carrier material needed, enhancing dissolution profiles, and facilitating scalable production with consistent particle size distribution, making high dose products more manageable and effective.
Implementation Method 1
contacting a porous carrier with the at least one API of step (a) in a contactor to form an API-impregnated porous carrier
Implementation Method 2
drying the at least one API-impregnated porous carrier
Data Source
AI summary
The disclosed technology relates to a continuous impregnating process of active pharmaceutical ingredients (API) onto porous carriers, a continuous impregnation process for making impregnated porous carrier particles and pharmaceutical dosage forms comprising impregnated porous carrier particles, impregnated porous carrier particles and pharmaceutical dosage forms comprising impregnated porous carrier particles prepared by the continuous impregnation process.