Development and Characterization of Abuse-Deterrent Tablets Using Chlorpheniramine Maleate as a Surrogate
Abstract
Background and Objectives: Drug abuse has become a worldwide problem associated with increased addiction and death, which led to encouraging the Food and Drug Administration and many companies to develop formulations that can prevent or decrease abuse. This study aimed to develop abuse-deterrent formulations using chlorpheniramine maleate as a model drug. The formulations were evaluated for their ability to resist crushing and injection, which are common methods of drug abuse. Method: The direct compression method was used to prepare tablets. Polyethylene oxide was used as a polymer at two concentrations (40% and 80%) and two molecular weights (300,000 and 4,000,000). Neusilin US2 and microcrystalline cellulose were added as tablet diluents. Half of the formulations were heat-treated in an oven at 80 C. A full factorial experimental design was developed using Minitab software, resulting in 16 formulations. Results: The results showed that both the grade and concentration of Polyethylene oxide, along with oven heating, significantly affect almost all the tested properties of the tablets. However, altering the type of diluent only impacts some tablet properties, such as hardness. Conclusion: This study has shown the feasibility of using polyethylene oxide at a different grade to prepare abuse-deterrent dosage forms. Furthermore, the utilization of a diluent such as neusilin in the preparation of tablets introduces challenges in terms of crushing; this could help reduce drug abuse.
References
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