Automated Dissolution and Permeation Testing System
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Solution Overview
Problem
Current pharmaceutical testing systems lack a reliable method to perform both dissolution and permeation testing simultaneously, which is necessary for in-vitro in-vivo correlation (IVIVC), and existing methods are often cumbersome or inhumane, such as using animal studies for permeation testing.
Innovation Solution
An automated dissolution and permeation testing system that recreates the flow of a pharmaceutical from the stomach to the intestines using a man-made intestinal membrane, integrating temperature-controllable testing cell units with syringe pump arrangements for fluid circulation and analysis, allowing for simultaneous dissolution and permeation testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional glass bottles with intestinal membrane are used for permeation testing, then permeation data can be obtained, but too many variables adversely affect the permeation information
Solution Approach 1:
The patent combines dissolution testing and permeation testing into a single integrated system. The dissolution apparatus includes a dissolution vessel connected to a permeation cell with an artificial intestinal membrane, allowing both dissolution and permeation measurements to be obtained simultaneously from the same setup, thereby reducing the number of separate variables and improving data reliability.
Solution Approach 2:
The dissolution testing system is designed to perform multiple functions: it conducts dissolution testing of the pharmaceutical product while simultaneously performing permeation testing through the artificial intestinal membrane. This multi-functional approach eliminates the need for separate testing systems and reduces experimental variables.
2Measurement precision
If animal studies are used for permeation testing, then permeation data can be obtained, but the method is inhumane and should be replaced
Solution Approach 1:
The patent uses an artificial intestinal membrane that replicates the permeation characteristics of the actual intestinal wall. This artificial membrane serves as a copy or model of the biological membrane, allowing permeation data to be obtained without using real animals, thus eliminating animal suffering while maintaining scientific validity.
3Adaptability or versatility
If separate dissolution and permeation testing systems are used, then each test can be performed independently, but no reliable system exists to perform both tests simultaneously
Solution Approach 1:
The patent integrates dissolution testing and permeation testing into a single system. The dissolution vessel is directly connected to the permeation cell, allowing the same apparatus to perform both tests simultaneously on the same pharmaceutical product, thereby achieving versatility without requiring separate systems.
4Productivity
If manual sampling and analysis methods are used, then flexibility is maintained, but the process is time-consuming and less efficient
Solution Approach 1:
The system includes automated sampling mechanisms where the dissolution media and permeation fluid are automatically sampled at predetermined time intervals. The system automatically analyzes the concentration of pharmaceutical in both compartments and calculates permeation parameters, eliminating manual intervention and significantly reducing testing time.
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
Enables efficient and humane simultaneous dissolution and permeation testing, providing accurate data for IVIVC, reducing variables and the need for animal testing, and allowing for quicker adjustment of testing parameters.
Implementation Method 1
a membrane between the first and second chambers
Implementation Method 2
the flow of release of a pharmaceutical from the stomach to the intestines
Implementation Method 3
A first flow control arrangement, e.g., a syringe pump arrangement, is coupled to the first connecting means and operatively circulates dissolution media into and out of the first chamber
Implementation Method 4
controllable mixing means for mixing the fluid flowing into and out of the second chamber
Implementation Method 5
temperature-controllable testing cell units
Data Source
AI summary
Combined dissolution rate and permeation rate testing apparatus includes temperature-controllable testing cell units arranged on a housing frame. Each testing cell unit includes a donor chamber receivable of dissolution media, a receptor chamber receivable of bodily fluid, gaskets that retain a membrane between the two chambers, and controllable mixers that mix the fluid in the receptor chamber. A flow control arrangement operatively circulates dissolution media through the donor chamber and enables sampling of the dissolution media. Another flow control arrangement operatively circulates bodily fluid through the receptor chamber. An analysis unit analyzes dissolution media removed from the donor chamber and bodily fluid removed from the receptor chamber to provide data about dissolution of a pharmaceutical product dissolved in the dissolution media and permeation of the pharmaceutical product through the membrane into the bodily fluid.