Abstract
Prescription drug abuse has become a worldwide public health issue. Of particular concern is the dose-dumping effect caused by co-ingestion of ethanol which leads to premature rapid release of the drug load. Also, medications can be crushed and dissolved in ethanol for extraction to allow for parenteral routes of administration. To combat this abuse, the pharmaceutical industry has begun to develop dosage forms that are abuse deterrent. In this study, we investigated the use of a cone-and-plate rheometer to evaluate the rheological properties of polyethylene oxide (a common excipient in abuse deterrent dosage forms) in water-alcohol mixtures. This polymer prevents rapid drug dissolution in alcohol by forming a viscous gel in the presence of solvents to discourage intravenous abuse. Our results showed that 2% w/v polyethylene oxide in hydro-alcoholic solvents behaved non-Newtonian. Rheograms showed a non-linear profile where apparent viscosity was decreased as a function of increasing shear rate, and was fit to a Herschel-Bulkley fluid model. The greater viscosities seen in test solutions at low shear rates may prevent rapid ethanol dissolution of drug, and provide difficulty when dissolving a product in hydro-alcoholic solutions. However, high shear rates such as that seen in rapid mixing or in a needle and syringe are likely to adversely affect the deterrence capacity of polyethylene oxide in solutions.
Highlights
With the widespread prevalence of prescription drug abuse, the introduction of abuse-deterrent and tamper-resistant medications into the marketplace has never been more important
One common method of their abuse is the extraction of the active drug from the dosage form using aqueous or hydro-alcoholic solutions in an attempt to make a concentrated solution of the drug for parenteral use [1,2]
Our results show that if the solutions are agitated or mixed, there would be a substantial decrease in solution viscosity that may possibly negate the deterrence capacity of the Polyethylene Oxide (PEO)
Summary
With the widespread prevalence of prescription drug abuse, the introduction of abuse-deterrent and tamper-resistant medications into the marketplace has never been more important. Co-ingesting certain medications with ethanol can lead to accelerated dissolution and rapid absorption of the drug into the blood stream to produce euphoric effects This is important for long-acting and extended release dosage forms where rapid release of a large drug load can be dangerous and even fatal [3]. A formulation can be made to change its physical properties upon being mixed with ethanol or aqueous solutions to form a mixture that is incapable of being drawn into a syringe or passed through a filter before being injected This may be accomplished with the use of gelling or viscosity modifying agents that trap the drug or increase the internal friction of the extract to an extent that it prevents syringeability and filtration. Various hydrophilic and ethanol soluble polymers can be used for this purpose in formulations to prevent parenteral abuse [5]
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