Evaluation of Powder Drug Layering Technique as Possible means of Abuse Deterrent Formulation

Abstract

Abuse and misuse of prescription opioids is a significant public health concern. The strategies used to confer abuse-deterrent properties on opioid abuse deterrent formulations (ADFs). The objective of this study was to develop techniques for an abuse deterrent (AD) platform utilizing the Granurex process. For the preparation of abuse deterrent extended release formulation core material was layered with dry active pharmaceutical ingredient with the help of Granurex technology and after the drug layering suitable polymeric coat was applied to make formulation crushed resistance and resistance to dose dumping. Formulation optimization was accomplished by utilizing full factorial design of experiments to determine the effect of the three formulation factors: Ethyl cellulose 45 cps, white wax and carbopol 974P NF; each of which was studied at three levels on crushed resistance (CR) attributes of the produced extended release pellets. Suitable formulation ingredients were employed as carrier matrices and processing aids. All of the formulations were evaluated for the crushed resistance and dose dumping attributes, such as crushing strength, extraction studies of drug in different levels of solvents and particle size . All of the design of experiments formulations demonstrated sufficient hardness and elasticity, and could not be reduced into fine particles , which is a desirable feature to prevent snorting. In addition, all of the formulations exhibited good gelling tendency in water with minimal extraction of drug in the aqueous medium. Moreover, Carbopol 974P NF, in combination with white wax, could be utilized to produce pellets with crushed resistance potential. Granurex has been demonstrated to be a viable technique with a potential of develop novel AD formulations.