Pharmaceutical Mixture Evaluation via Stain-Based Imaging

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current methods for assessing the physical makeup and distribution of pharmaceutical mixtures are slow and expensive, making it challenging to ensure the quality and manufacturability of pharmaceutical products, particularly in identifying issues related to particle sizes and distributions within heterogeneous mixtures.

Innovation Solution

A method and apparatus that utilize image enhancement agents, such as stains, to obtain images of pharmaceutical mixtures, allowing for the derivation of component distribution information, which can be applied to both active and inactive ingredients, enabling quick and cost-effective quality control and monitoring of pharmaceutical manufacturing processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If Raman mapping or imaging spectroscopy is used to assess mixture heterogeneity, then measurement precision is improved, but loss of time and cost increase significantly

Engineering Contradiction:
Improvemixture heterogeneity assessmentVSAvoidanalysis time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent uses disposable stains instead of expensive, time-consuming spectroscopic equipment. The stains are applied to tablet surfaces to visualize component distribution, providing rapid assessment without the need for costly Raman mapping or imaging spectroscopy instruments. This disposable staining approach eliminates the time and cost burden of sophisticated analytical equipment while still achieving the goal of assessing mixture heterogeneity.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent replaces complex spectroscopic measurement systems with a simple chemical staining mechanism. Instead of using Raman spectroscopy or imaging spectroscopy to detect component distribution, the invention uses stains that chemically interact with specific components to create visible patterns. This substitution of mechanical/optical measurement systems with chemical visualization methods dramatically reduces analysis time and cost while maintaining the ability to assess mixture heterogeneity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If Raman mapping is used to obtain detailed distribution information, then measurement precision is improved, but device complexity and cost increase

Engineering Contradiction:
Improvecomponent distribution mappingVSAvoidanalytical equipment
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent employs inexpensive, disposable stains to achieve component distribution mapping without requiring complex analytical equipment. The stains are applied directly to tablet surfaces and visualized using simple imaging methods, replacing the need for expensive Raman mapping equipment. This approach provides the necessary distribution information while eliminating the complexity and cost of sophisticated spectroscopic instruments.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The invention substitutes complex spectroscopic measurement systems with simple chemical staining and visual imaging. Instead of using Raman mapping equipment to detect and map component distributions, the patent uses stains that selectively color different components, allowing distribution patterns to be observed with basic imaging devices. This mechanical substitution dramatically simplifies the analytical system while maintaining the capability to assess component distribution.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If visual inspection of white powder mixtures is used, then ease of operation is improved, but measurement precision deteriorates due to inability to visualize distribution

Engineering Contradiction:
Improvevisual inspectionVSAvoiddistribution visualization
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent applies stains that produce color changes when they interact with specific components in the white powder mixture. These color changes make previously invisible component distributions visible to the naked eye or simple imaging devices. The stains selectively color different components (such as active ingredients versus excipients), transforming the invisible heterogeneity of white powder mixtures into visible patterns that can be easily inspected and assessed for uniformity.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The patent introduces stains as intermediary substances that facilitate the visualization of component distribution. These stains act as mediators between the invisible chemical components and human vision or simple imaging devices. The stains selectively bind to or react with specific components, creating visual contrast that reveals the spatial distribution of ingredients in the mixture, thereby enabling easy visual inspection with improved measurement precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 allows for rapid and inexpensive assessment of pharmaceutical mixture quality, enabling real-time monitoring and correction of manufacturing defects, reducing waste and improving the consistency of pharmaceutical products.

Implementation Method 1

The stain can have an affinity for one or more of the inactive ingredients. The stain can have an affinity for one or more of the active ingredients.

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

The step of applying can apply a fluorescent stain as the image enhancement agent.

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS8004662B2Pharmaceutical mixture evaluation
Publication Date: 2011.08.23 MALVERN INSTRUMENTS
  • US8004662B2 patent drawing
  • US8004662B2 patent drawing
  • US8004662B2 patent drawing

AI summary

A method of obtaining information about a heterogeneous pharmaceutical mixture is disclosed. This method involves applying an image enhancement agent, such as a stain, to the mixture. An image of the mixture can then be obtained, and information about a distribution of components of the mixture in the image can also be obtained based on spatial information derived from the application of the image enhancement agent.