Tamper-Resistant Oral Dosage Form with Inert Core
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Solution Overview
Problem
Solid oral pharmaceutical dosage forms are vulnerable to tampering through splitting, crushing, or chewing, leading to issues such as overdosing, underdosing, and abuse, particularly with controlled release formulations, which can compromise the integrity of the dosage and result in toxic plasma levels or illicit use.
Innovation Solution
A solid oral dosage form comprising an inert tamper-resistant core surrounded by a coating containing the active agent, which provides a breaking strength of at least 400 Newtons, making it difficult to split, crush, or chew, and includes additional aversive agents to deter abuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the dosage form is made easier to split or divide, then patient compliance and cost containment are improved, but dosing accuracy and therapeutic safety deteriorate
Solution Approach 1:
The dosage form is divided into multiple discrete units (e.g., multiple tablets per blister pack, each tablet representing a specific dose fraction) that can be easily separated without requiring physical splitting. This allows patients to take the exact number of units needed while maintaining dosing precision, as each unit is pre-formulated with the correct amount of active ingredient.
2Reliability
If the dosage form is made more resistant to tampering, then abuse potential and dosing errors are reduced, but ease of splitting and patient compliance deteriorate
Solution Approach 1:
By providing multiple pre-divided units in a single packaging, the need for patients to physically split tablets is eliminated. Each unit is individually wrapped or positioned to allow easy removal without breaking, maintaining both tamper resistance (as each unit is sealed) and ease of use (as patients can simply take the required number of whole units).
Solution Approach 2:
Multiple dosage units are nested within a single outer packaging structure (blister pack or container), allowing the dosage form to provide both protection/tamper resistance at the outer level and easy access to individual units at the inner level. The outer packaging can be secured while each inner unit remains easily removable.
3Speed
If controlled release dosage forms are split or crushed, then immediate availability of active agent is achieved, but controlled release integrity is compromised leading to toxic plasma levels
Solution Approach 1:
The controlled release formulation is divided into multiple separate units, each maintaining its own controlled release mechanism. This prevents the compromise that occurs when a single controlled release tablet is split or crushed, as each unit remains intact and functional. If immediate availability is needed, multiple units can be administered separately without destroying the controlled release property of any individual unit.
4Reliability
If the dosage form is made more difficult to tamper with, then abuse deterrence is improved, but manufacturing complexity increases
Solution Approach 1:
Rather than making each individual tablet extremely difficult to tamper with (which would require complex coatings, matrices, or structures), the invention uses segmentation to provide multiple units in a secure packaging system. The tamper resistance is achieved at the packaging level rather than requiring complex modifications to each tablet, thus maintaining manufacturing simplicity while improving abuse deterrence.
Data Source
AI summary
Disclosed in certain embodiments is a solid oral dosage form comprising: (a) an inert tamper resistant core; and (b) a coating surrounding the core, the coating comprising an active agent.