Development, optimization, and in vitro assessment of abuse-deterrent formulation.

Abstract

Drug abuse and misuse have been a public health issue for many years. To curb this problem, abuse-deterrent formulations (ADFs) have been developed. The present research aimed to develop an ADF using a simple yet effective, scalable, and cost-effective technique. The combination of hydrophobic and hydrophilic materials was used to develop the ADF. The hydrophilic drug molecule was coated with a hydrophobic wax material (hydrogenated castor oil-HCO). This hydrophobic coating retards drug extraction and release from the crushed formulation. A hydrophilic polymer, polyethylene oxide (PEO), was included in ADF. It provides mechanical strength to the formulation and deters from physical manipulation. It can also form a gel-like structure by rapid uptake of solvent, which deters -intravenous abuse. In this research, HCO was explored as a hydrophobic material. A 32 full factorial design was utilized to optimize the formulation, in which the quantity of HCO and PEO has a significant impact on the abuse-deterrent features of the formulation. The optimized formulation was tested using a range of real-life conditions. Stability study proves that the prepared formulation is stable at accelerated and long-term conditions for 6 months.