Capsule Surface Texture for Accidental Ingestion Deterrence
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Solution Overview
Problem
Current capsule technologies for oral administration lack effective deterrence against accidental ingestion and ease of opening, particularly in sprinkle-type forms, which are desirable for geriatric and pediatric subjects with swallowing difficulties.
Innovation Solution
The development of a hard capsule with a sensory trigger featuring protrusions or bands on its surface, providing visual, tactile, and taste deterrents, designed to prevent ingestion and facilitate easy opening by enhancing grip and surface area for better handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the capsule is designed for oral administration with smooth surface, then it is easy to manufacture and swallow, but it provides no deterrence against accidental ingestion and is difficult to open
Solution Approach 1:
The capsule surface is modified locally by adding sensory triggers (protrusions, ridges, or textured patterns) only in specific areas rather than changing the entire capsule structure. This allows the capsule to maintain its basic swallowability while providing tactile and visual deterrence against accidental ingestion, and simultaneously improving grip for opening operations.
Solution Approach 2:
The sensory triggers are designed with asymmetric features such as uneven protrusions, ridges, or textured patterns that create distinct tactile sensations. This asymmetry makes the capsule uncomfortable to swallow accidentally while providing natural grip points for intentional opening, resolving the contradiction between deterrence and ease of opening.
2Ease of operation
If the capsule locking force is reduced for easier opening, then it becomes easier to open for geriatric and pediatric subjects, but it may become too easy to open accidentally
Solution Approach 1:
The sensory triggers are applied in advance to the capsule surface before use. These pre-applied tactile features serve as preliminary guides for proper handling, ensuring that the capsule is gripped correctly at the right location for opening, thereby preventing accidental opening while maintaining ease of intentional opening.
Solution Approach 2:
The sensory triggers act as an intermediary element between the user's fingers and the capsule's locking mechanism. By providing intermediate grip points and tactile feedback, they enable controlled application of opening force without directly compromising the locking mechanism's security, thus preventing accidental opening while facilitating intentional opening.
3Object-affected harmful factors
If the capsule surface is modified with sensory triggers, then it provides visual and tactile deterrence to ingestion, but it increases manufacturing complexity
Solution Approach 1:
The capsule manufacturing process is segmented into distinct stages: basic capsule formation, application of sensory triggers, and final assembly. This segmentation allows the use of standard capsule-making equipment for the main body, with the sensory triggers applied as a separate, simplified step, thereby minimizing overall manufacturing complexity while achieving the desired deterrence effect.
Solution Approach 2:
The sensory triggers are implemented by modifying surface parameters (texture, protrusion height, ridge patterns) of the capsule shell material rather than changing the fundamental material composition or capsule structure. This parameter-based approach allows for easy adjustment of deterrence characteristics while maintaining compatibility with existing manufacturing processes and materials.
Data Source
AI summary
A comestible dosage form article, in the form of a hard capsule, for administration to a target subject, the dosage form comprising at least one body and at least one cap telescopically engageable with the body, the cap and the body being separable such to allow dispensing of a contents therefrom. The capsule comprising a sensory trigger over at least a portion of the outer surface of the capsule arranged to provide a visual, taste, and/or tactile deterrence to ingestion thereof.