Tamperproof Oral Dosage Form with Elastic Locking Shells
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Solution Overview
Problem
Existing tamperproof dosage forms face limitations in providing true resistance to tampering, especially under torsion, and are costly to produce, with methods like shrink-wrapping and gelatin coatings leading to contamination issues and restricted compositional characteristics.
Innovation Solution
A tamperproof dosage form design featuring elastic shells with locking protrusions and recesses that snap into place, eliminating the need for adhesives and providing enhanced mechanical locking, combined with a controlled release profile and visual tamper indication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If shrink-wrapping shells over tablets is used, then some tamper resistance is provided, but the shells can still be removed and the method has limited applications
Solution Approach 1:
The shell is segmented into multiple sections with locking protrusions and recesses distributed around the circumference, allowing the shell to be divided into manageable segments that can lock onto corresponding features on the tablet, providing both tamper resistance and adaptability to different tablet types
Solution Approach 2:
The locking mechanism uses localized protrusions and recesses at specific positions on the shell and tablet, creating targeted engagement points that provide secure locking while allowing the rest of the shell to maintain flexibility and adaptability to different tablet geometries
2Reliability
If gelatin banding or dot application is combined with shrink-wrapping, then some tamperproofness is achieved, but the dosage forms suffer from tampering upon twisting and have limited compositional flexibility
Solution Approach 1:
The locking mechanism relies on mechanical geometry (protrusions and recesses) rather than material properties like gelatin adhesion, allowing the shell to be made from various materials including pullulan, celluloses, and enteric polymers without compromising tamperproofness, thus achieving both security and compositional flexibility
3Ease of manufacture
If mechanical connection with snap-fit is used between core and shells, then assembly is simplified, but the components disconnect upon sufficient force without apparent damage
Solution Approach 1:
The locking protrusions and recesses are designed with asymmetric geometries where the protrusion fits into the recess in one direction but cannot be easily removed in the opposite direction without significant force, providing secure locking that resists tampering while maintaining simple assembly
Solution Approach 2:
The shell is pre-formed with locking protrusions and recesses during manufacturing, so that when the shell is placed over the tablet, the locking engagement occurs automatically without requiring additional assembly steps, simplifying manufacture while ensuring reliable tamper resistance
4Reliability
If coating tablets by dipping into gelatinous composition is used, then tamperproofness is provided, but the process is costly and may bring contamination issues
Solution Approach 1:
The locking functionality is extracted from the coating process and integrated directly into the shell structure through molded protrusions and recesses, eliminating the need for separate gelatinous coating steps, thereby reducing manufacturing cost and eliminating contamination risks while maintaining tamperproofness
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 achieves a tamperproof dosage form with high resistance to opening and torsion forces, ensuring secure medication delivery while maintaining cost-effectiveness and avoiding contamination, with improved compositional flexibility and visual tamper detection.
Implementation Method 1
at least a portion of the shells proximal to the locking protrusions is elastically deformable and arranged such that each one locking protrusion is snapped into each one of the locking recesses once inserted over a predetermined portion of the core to provide a locking force
Data Source
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AI summary
A tamperproof dosage form article comprising: a core, wherein the core comprises a first end and a second end; a first shell on at least a portion of the first end of the core; a second shell on at least a portion of the second end of the core; wherein the first and second shells comprise one or more locking protrusions extending along at least a portion of the circumference and inner surface of the shells, and the core comprises one or more locking recesses, and wherein at least a portion of the shells proximal to the locking protrusions is elastically deformable and arranged such that each one locking protrusion is snapped into each one of the locking recesses once inserted over a predetermined portion of the core to provide a locking force between the core and the shells.