Gastroretentive Dosage Form Mechanical Collapsing System
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Solution Overview
Problem
Expandable gastroretentive dosage forms face challenges in maintaining stable physical properties during shelf life, affecting their ability to expand into effective shapes for stomach retention and controlled drug release.
Innovation Solution
A portable device and method for preparing gastroretentive dosage forms that allow transitioning between collapsed and expanded configurations, using an assembly unit with a mechanical system to lock the dosage form into a collapsed configuration using an erodible confining element, enabling self-preparation and extended gastric retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If expandable gastroretentive dosage forms are prepared in advance in collapsed configuration, then they are ready for immediate administration, but the elastic materials deteriorate during shelf life and lose their ability to expand properly
Solution Approach 1:
The system separates the dosage form into two independent components: an expandable gastroretentive dosage form (without elastic materials) and an erodible confining element (capsule). This segmentation allows the dosage form to be stored in its expanded, stable configuration without elastic materials, while the confining element maintains the collapsed state during storage. Upon ingestion, the confining element erodes, releasing the pre-expanded dosage form.
Solution Approach 2:
The dosage form is pre-expanded into its effective acting shape before storage, eliminating the need for elastic materials to maintain collapse during shelf life. The confining element is designed to erode in the stomach, automatically releasing the pre-prepared dosage form without requiring additional preparation steps at the point of care.
2Duration of action of stationary object
If the dosage form is kept in expanded configuration for storage, then shelf life is extended, but the dosage form cannot be easily administered
Solution Approach 1:
An erodible confining element (capsule) is used to encapsulate the pre-expanded dosage form. This flexible, biodegradable shell allows the dosage form to be stored in its expanded configuration while maintaining a compact, swallowable form during administration. The capsule erodes in the stomach, automatically releasing the dosage form without requiring patient manipulation.
3Adaptability or versatility
If elastic materials are used to maintain collapsed configuration, then the dosage form can be stored ready for use, but the physical properties deteriorate over time
Solution Approach 1:
The elastic materials are completely removed from the system. Instead, the dosage form is prepared without elastic components and stored in its expanded configuration. The confining element is designed to erode away, releasing the dosage form without requiring elastic materials to maintain any configuration during storage.
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
The solution extends the shelf life of gastroretentive dosage forms by allowing on-demand preparation, maintaining stability and effectiveness, and ensuring prolonged gastric retention for controlled drug release.
Implementation Method 1
The retention mechanism may be an erodible confining element. For example, the collapsed GRDF may be encapsulated into a capsule.
Implementation Method 2
the gastroretentive dosage form expands in the stomach into an effective acting shape suitable for stomach retention
Implementation Method 3
a mechanical system configured for, upon operation of an actuation mechanism: (a) transitioning said gastroretentive dosage form into the collapsed configuration
Data Source
AI summary
The present disclosure provides a device for self-preparation of a gastroretentive dosage form being capable of transitioning between a collapsed configuration and an expanded configuration, the device comprising an assembly unit including: a compartment configured for accommodating the gastroretentive dosage form in the expanded configuration; and a mechanical system configured for, upon operation of an actuation mechanism: (a) transitioning said gastroretentive dosage form into the collapsed configuration; and (b) locking said collapsed gastroretentive dosage form into the collapsed configuration; wherein the device is configured for being portable.