Date of Award
M.S. in Pharmaceutical Science
Michael A. Repka
The purpose of the current study was to formulate hot melt extruded (HME) abuse deterrent pellets of acetaminophen(APAP), a model drug with the aid of high molecular weight hydroxypropyl methylcellulose (HPMC 4M ) and gelling agents (starch, pectin and carbopol). The formulated HME pellets were assessed for their abuse-deterrence (AD) potential using Category- 1 laboratory in-vitro evaluation standards. The pellets were examined for the particle size reduction (PSR), extraction in small volume, syringeability, thermal manipulation and dissolution for evaluating the resilience of the AD properties. Though, most of the formulation showed complete particle size reduction after grinding, grounded pellets were able to show AD properties. The drug extraction was < 30% in 10 mL of different level of solvents (Level 1- DI water, Level 2- 40% ethanol, Level 3- 100% Ethanol) under static, agitation, and thermal manipulation conditions with an incubation time of 30 min. The grounded pellets formed gel under agitation condition with every level of the solvent. The HPMC 4M/ Low Methoxy pectin formulation showed lowest extraction of drug from grounded pellet using all levels of solvents and using thermal manipulation conditions among all formulations. These studies support the abuse deterrent potential of HPMC 4M and pectin against intravenous abuse.
Raje, Vishvesh, "Abuse deterrent formulation using Hot Melt Extrusion Technology" (2021). Electronic Theses and Dissertations. 2129.