Pharmaceutical Disintegration Testing With Automated Image Endpoint Detection
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Solution Overview
Problem
Conventional disintegration testing of pharmaceutical dosage units relies heavily on human observation, which is time-consuming, prone to errors, and subjective, and existing automated solutions can interfere with disintegration processes.
Innovation Solution
An apparatus and method using a computer system with motion sensors, capture devices, and data communications interfaces to automate the disintegration testing process, determining disintegration times by analyzing image data and background differentials to ensure accuracy and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If human operators perform visual observation to determine disintegration endpoints, then subjective judgment is applied, but measurement precision and reliability deteriorate due to human error and distraction
Solution Approach 1:
The patent replaces the mechanical human visual observation system with an automated image capture and analysis system. A camera captures images of the dosage unit in the immersion fluid, and computer software automatically analyzes these images to detect disintegration endpoints, eliminating human error and subjectivity entirely.
Solution Approach 2:
The patent introduces an intermediary automated system between the dosage unit and the human operator. The image capture device and analysis software serve as intermediaries that objectively record and interpret disintegration events, providing reliable data to human operators without requiring their direct visual observation.
2Productivity
If human operators manually record disintegration times, then flexibility in observation is maintained, but productivity deteriorates due to time-consuming manual processes
Solution Approach 1:
The system enables self-service automation where the image capture device and software automatically perform the entire disintegration monitoring and recording process without human intervention. The system captures images at specified intervals, automatically analyzes them to detect disintegration endpoints, and records the results, freeing human operators from manual recording tasks entirely.
Solution Approach 2:
The automated system maintains continuous monitoring of the disintegration process through periodic image capture, ensuring that disintegration events are detected immediately when they occur. This continuous automated observation eliminates the time loss associated with manual checking and recording, significantly increasing testing throughput.
3Extent of automation
If electronic contacts or probes are used to detect disintegration, then automation is achieved, but the dosage unit disintegration process is interfered with
Solution Approach 1:
Instead of directly contacting the dosage unit, the system creates visual copies (images) of the dosage unit at various time points. The camera captures light reflected from or transmitted through the dosage unit, creating image copies that can be analyzed computationally without physically touching or interfering with the actual dosage unit disintegration process.
Solution Approach 2:
The patent uses light and image capture technology as intermediaries to detect disintegration without direct contact. The camera system captures optical information about the dosage unit's state, and software analyzes these optical signals to determine disintegration endpoints, eliminating the need for physical contacts that would interfere with the disintegration process.
Data Source
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AI summary
Embodiments of the present invention provide an apparatus and method for determining whether a dosage unit of a pharmaceutical drug disintegrates in an immersion fluid of a disintegration tester within a prescribed time limit and to record and transmit to human-accessible output devices the times required. In one implementation, the apparatus comprises a computer system, a motion sensor, a capture device, a fastener for attaching the capture device and motion sensor to the reciprocating arm of the disintegration tester, and one or more data communications interfaces to carry commands and data between the computer system, the motion sensor and the capture device.