Nested Vessel Apparatus for Simultaneous Dissolution and Permeability Testing

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Solution Overview

Problem

Current methods for combined dissolution and permeability assessments in pharmaceutical compounds are complex, inefficient, and often fail to predict in vivo behavior accurately, leading to issues such as batch variability and formulation issues during drug development.

Innovation Solution

A method and apparatus for simultaneously measuring dissolution and permeability using a nested vessel configuration with a permeable membrane, allowing for the assessment of absorption potential through concentration profiling and flux measurement, which can be scaled to meet compendial requirements and enhance predictability of in vivo performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional separate dissolution and permeability testing methods are used, then each parameter can be measured with standardized protocols, but the overall evaluation process becomes complex and time-consuming

Engineering Contradiction:
Improvemeasurement accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines dissolution and permeability testing into a single integrated apparatus where the dissolution vessel contains both the dissolution medium and the permeability measurement components. The permeability membrane is positioned within the dissolution vessel, allowing simultaneous measurement of dissolution rate and permeability in one system, thereby reducing overall complexity while maintaining measurement accuracy for both parameters.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The dissolution vessel is designed to serve multiple functions: it contains the dissolution medium, houses the permeability membrane, and enables both dissolution rate measurement and permeability assessment. This multi-functional design eliminates the need for separate apparatuses and reduces the complexity of the overall evaluation system.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If combined dissolution and permeability assessment systems are implemented, then comprehensive evaluation can be performed, but the system complexity and difficulty of operation increase

Engineering Contradiction:
Improveevaluation comprehensivenessVSAvoidoperation simplicity
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

By merging dissolution and permeability measurement capabilities into a single apparatus with a unified operation interface, the system achieves comprehensive evaluation without proportionally increasing operational complexity. The integrated design allows researchers to conduct both assessments using the same protocols and操作流程, simplifying operation while maintaining comprehensive evaluation.

Inventive Principle:
Principle #5Merging (Combining)

3Productivity

If multiple vessels and complex configurations are used for combined assessment, then both dissolution and permeability can be measured simultaneously, but throughput decreases

Engineering Contradiction:
Improvetesting throughputVSAvoidsystem configuration
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The integrated apparatus allows simultaneous measurement of dissolution and permeability in a single system, effectively doubling the throughput capability compared to sequential testing. By eliminating the need for separate vessels and operations, the system can evaluate more samples concurrently, improving productivity without requiring complex multi-vessel configurations.

Inventive Principle:
Principle #5Merging (Combining)

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 approach simplifies the evaluation of both dissolution and permeability properties, increases throughput, and provides more accurate predictions of in vivo absorption, reducing batch variability and improving formulation development.

Implementation Method 1

allowing for the assessment of absorption potential through concentration profiling and flux measurement

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentUS10228358B2Apparatus and method for the assessment of concentration profiling and permeability rates
Publication Date: 2019.03.12 PION INC
  • US10228358B2 patent drawing
  • US10228358B2 patent drawing
  • US10228358B2 patent drawing

AI summary

An apparatus for the combined assessment of dissolution and permeability relies on a receiver chamber that is contained within a donor chamber. A membrane is provided between the two chambers. Measurements can be taken to determine solute amounts of a drug introduced in the donor chamber and amounts of permeated solute in the receiver chamber. Also described are techniques for the assessment of a dissolution rate and total amount of dissolved compound, together with their effect on absorption potential of a compound or a compound product as well as approaches for evaluating in vivo relevant differences between formulations of a compound through their effect on the absorption potential of the compound.