Abuse Deterrent Dosage Form with Functional Score and Effervescent System
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current abuse deterrent solid dosage forms that incorporate high molecular weight polymers for immediate release formulations are unsuitable due to their difficulty in being crushed or split, compromising the functionality of scores intended for dosing regimen evaluation.
Innovation Solution
A pharmaceutical solid dosage form comprising at least one active pharmaceutical ingredient, a low molecular weight hydrophilic polymer, a high molecular weight hydrophilic polymer, and an effervescent system, designed to maintain immediate release and abuse deterrent properties while allowing functional scoring for splitting into equal portions with minimal mass loss.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If high molecular weight hydrophilic polymers are included in the dosage form to provide abuse deterrent properties, then the dosage form becomes difficult to crush and pulverize, but the release of the active ingredient is retarded, making it unsuitable for immediate release formulations
Solution Approach 1:
The patent segments the polymer system into two distinct components: low molecular weight hydrophilic polymer (e.g., Povidone K30) and high molecular weight hydrophilic polymer (e.g., Macrogol). The low molecular weight polymer ensures rapid drug release by forming a porous structure, while the high molecular weight polymer provides abuse deterrent properties through gel formation. This segmentation allows both contradictory requirements to be satisfied simultaneously.
Solution Approach 2:
The patent creates a composite material system combining two polymers with different molecular weights and functions. The low molecular weight polymer (Povidone K30, Mw=40,000 g/mol) provides immediate release characteristics, while the high molecular weight polymer (Macrogol, Mw=6,000 g/mol) provides abuse deterrent properties. The synergistic interaction between these two polymers resolves the contradiction between rapid release and abuse deterrence.
2Object-affected harmful factors
If abuse deterrent features are incorporated into solid dosage forms by increasing crushing strength, then the dosage form becomes difficult to crush, but the score functionality is compromised, making it difficult to break into smaller portions
Solution Approach 1:
The patent applies local quality by creating different mechanical properties in different regions of the dosage form. The bulk of the tablet has high crushing strength due to the high molecular weight polymer providing gel formation and structural integrity, making it resistant to crushing and pulverization. However, at the score line, the tablet is designed to have reduced strength to facilitate clean breaking. This local differentiation allows the tablet to be both abuse-deterrent and easily splittable at the score.
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 dosage form achieves rapid API release and resistance to crushing or pulverization, maintaining abuse deterrent features and allowing precise dosing without forming fine powders, thus preventing inhalation or injection abuse.
Implementation Method 1
an effervescent system
Implementation Method 2
at least one low molecular weight hydrophilic polymer, at least one high molecular weight hydrophilic polymer
Data Source
AI summary
The present disclosure provides an immediate release, abuse deterrent pharmaceutical solid dosage form comprising at least one functional score. In particular, the immediate release, abuse deterrent solid dosage form comprises at least one low molecular weight hydrophilic polymer, at least one high molecular weight hydrophilic polymer, and an effervescent system.