Dissolution Testing Apparatus with Nested Optical Monitoring
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Solution Overview
Problem
Conventional dissolution testing systems face issues with inaccurate results due to secondary dissolution during sample transfer, disruption of vessel hydrodynamics, and the inability to handle diverse dosage forms in a single test run, along with cumbersome monitoring and manipulation of vessels.
Innovation Solution
A dissolution testing apparatus with a transparent tank design featuring coaxially arranged cylindrical body portions, multiple dissolution vessels, a heater assembly, and an optical monitoring system with cameras for precise monitoring and manipulation, allowing for efficient agitation and temperature control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If large-volume samples (10 ml) are transferred using pumps and tubing, then samples can be transferred to analytical equipment, but secondary dissolution occurs during transfer resulting in inaccurate dissolution rate values
Solution Approach 1:
The invention extracts only the necessary portion of the sample (500 µl) from the dissolution vessel using a sampling probe, rather than transferring large volumes (10 ml) with pumps and tubing. This minimizes the sample volume subjected to transfer processes that cause secondary dissolution, thereby maintaining measurement precision while still obtaining sufficient material for analysis.
Solution Approach 2:
The sampling probe acts as an intermediary device that directly accesses the dissolution vessel contents without requiring large-volume transfer through pumps and tubing. This intermediary approach enables precise sample extraction while avoiding the harmful transfer process that causes secondary dissolution.
2Quantity of substance
If large-volume samples (10 ml) are withdrawn at a transfer rate of 10 ml per minute, then samples can be transferred to analytical equipment, but vessel hydrodynamics are disrupted for the entire transfer time
Solution Approach 1:
The invention extracts only 500 µl of sample directly from the dissolution vessel using a sampling probe, reducing the withdrawal time from approximately 1 minute (for 10 ml at 10 ml/min) to a few seconds. This minimal extraction time prevents significant disruption of vessel hydrodynamics while still obtaining sufficient sample for analysis.
3Quantity of substance
If multiple large samples are withdrawn from the dissolution vessel, then sufficient samples can be obtained for analysis, but the sample media volume in the test vessel must be replenished to maintain adequate volume for proper agitation
Solution Approach 1:
The invention extracts only small volumes (500 µl per sample) compared to conventional methods (10 ml per sample), enabling multiple samples to be withdrawn without depleting the dissolution media volume. This eliminates the need for complex replenishment procedures while maintaining adequate volume for proper agitation throughout the test.
4Temperature
If dissolution vessels are arranged inside a tank with monitoring devices from outside, then temperature control can be maintained, but monitoring and manipulation of vessels become cumbersome and less precise
Solution Approach 1:
The invention places monitoring devices (cameras, lights) and manipulation tools (sampling probe, injection needle) inside the tank, nesting them within the temperature-controlled environment. This allows precise monitoring and manipulation of vessels while maintaining temperature control, as the devices operate within the same thermal zone rather than from outside the tank.
Solution Approach 2:
The sampling probe and injection needle act as intermediaries that can be precisely positioned inside the tank to access individual vessels. These tools enable accurate sample withdrawal and media injection while maintaining temperature control, overcoming the limitations of external monitoring devices.
5Reliability
If prior art systems are configured for specific dosage form types, then testing of that specific type can be performed, but the system cannot handle all possible dosage forms within a single test run
Solution Approach 1:
The invention creates a universal testing system that can handle all dosage forms (tablets, capsules in baskets, sinkers, floating capsules) within a single test run. The standardized sampling probe and injection needle work equally well with all dosage form types, eliminating the need to reconfigure the system for different dosage forms while maintaining reliable testing for each type.
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 precise monitoring and manipulation of vessels, reduces secondary dissolution errors, and facilitates testing of various dosage forms in a single run without disrupting vessel hydrodynamics, improving the accuracy and efficiency of dissolution testing.
Implementation Method 1
a heater assembly arranged to heat test media in the vessels to a predefined temperature
Implementation Method 2
a tank which has a circular cylindrical outer body portion with a transparent side wall and a circular cylindrical inner body portion with a transparent side wall
Data Source
Figure 1~2
Figure 3~5
AI summary
An apparatus (1 ) for dissolution testing comprises a tank (2) having a circular cylindrical outer body portion (21 ) with a transparent side wall and a circular cylindrical inner body portion (22) with a transparent side wall, wherein the inner body portion (22) is coaxially arranged with respect to the outer body portion (21 ) such that an outer interior (23) having a ring-shaped cross section is defined between the outer body portion (21 ) and the inner body portion (22) and an inner interior (24) having a circular cross section is defined inside the inner body portion. The apparatus (1 ) further comprises a plurality of dissolution vessels (4) arranged in the outer interior (23) of the tank and a heater assembly being arranged to heat a test media in the vessels (4) to a predefined temperature. The apparatus (1 ) according to the invention allows for a comparably precise monitoring of vessels (4) inside the tank (2) and/or an appropriate manipulation of the vessels (4) inside the tank (2).