Abuse-Proof Solid Pharmaceutical Composition via Viscosity Control
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Solution Overview
Problem
Existing abuse-proof pharmaceutical compositions fail to prevent parenteral administration of active ingredients with potential for abuse, as they either form injectable solutions or agglomerates when dissolved in water, posing challenges for individuals with swallowing difficulties and not effectively deterring misuse.
Innovation Solution
A solid pharmaceutical composition combining silica and guar flour, with an active ingredient and a water-soluble diluent, that dissolves in a glass of water but forms a non-injectable gel or viscous solution when added to a hypodermic syringe, preventing parenteral administration and misuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If gelling or thickening agents are added to the pharmaceutical composition, then parenteral administration is prevented, but the composition becomes impossible to administer orally to individuals with swallowing difficulties
Solution Approach 1:
The invention changes the concentration parameter of the gelling agent based on the volume of water used. When dissolved in a glass of water (large volume), the gelling agent concentration is low enough to allow easy dissolution and oral administration. When dissolved in a syringe volume (small volume), the concentration becomes high enough to form a non-injectable gel, thus preventing abuse while maintaining accessibility for legitimate use.
Solution Approach 2:
The invention creates a dynamic system where the physical state of the composition (soluble vs. gel-forming) changes based on the volume of water added. This dynamic behavior allows the same composition to be easily administered orally when prepared correctly, while automatically becoming non-injectable when attempt is made to prepare it for parenteral administration.
2Ease of operation
If the composition is made soluble in water for oral administration, then it can be easily taken orally, but it can also be easily extracted and administered parenterally for abuse
Solution Approach 1:
The invention applies preliminary anti-action by incorporating a gelling agent that preemptively prevents parenteral administration. The gelling agent is present in the composition before use, and when the composition is dissolved in a small volume of water (syringe volume), the gelling agent activates to form a gel structure that physically blocks parenteral injection, thus counteracting the abuse risk before it can occur.
Solution Approach 2:
The invention utilizes parameter changes where the same soluble composition exhibits different physical properties based on the water volume parameter. In large volumes (oral administration), the composition remains soluble and easily administrable. In small volumes (parenteral preparation), the composition forms a gel with high viscosity, making injection impossible. This parameter-dependent behavior simultaneously achieves oral solubility and parenteral prevention.
3Object-affected harmful factors
If a gelling agent is used to prevent abuse by injection, then parenteral administration is deterred, but the composition may form agglomerates when dissolved in water
Solution Approach 1:
The invention carefully selects and adjusts the concentration parameter of the gelling agent to achieve optimal performance. The gelling agent is present at a concentration that is sufficient to form a non-injectable gel when dissolved in small volumes, but low enough to prevent agglomerate formation when dissolved in larger volumes of water for oral administration. This precise parameter control resolves the contradiction between abuse prevention and solution stability.
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 composition effectively prevents parenteral administration by forming a high osmolarity viscous solution when dissolved in a small volume of water, thereby deterring abuse while allowing oral administration in a larger volume, and maintaining aesthetic acceptability.
Implementation Method 1
guar flour in an amount of from 100 mg to 300 mg
Implementation Method 2
forming a not injectable gel and/or viscous solution
Implementation Method 3
silica in an amount of from 10 mg to 1000 mg
Implementation Method 4
forming a high osmolarity viscous solution
Data Source
AI summary
The present invention relates to an abuse-proof solid pharmaceutical composition comprising an active ingredient with potential for abuse, silica in an amount of from 10 mg to 1000 mg, guar flour in an amount of from 100 mg to 300 mg, and a water soluble diluent in an amount of from 500 mg to 5000 mg.