Prescription opioid abuse also known as opioid epidemic has been an ever-growing problem in the United States. It has been associated with numerous emergencies and mortality with significant burden on healthcare system. Amongst various approaches proposed by FDA, development of an abuse deterrent formulation is one of the key strategies to address this opioid crisis. Existing abuse deterrent technologies have several deficiencies which enable abusers to manipulate/bypass it. The proposed study aims to develop and optimize an abuse-deterrent immediate release bilayer film (ADRIFT). A novel material with distinct process engineering was employed to achieve immediate drug release with nasal/intravenous abuse deterrent properties. Drug layer (DL) composed of a rapidly soluble film forming polymer - polyvinyl alcohol (PVA) while various solvent system and biocompatible polymers were screened to incorporate sodium polyacrylamide starch (KPX) in abuse deterrent layer (AL). Mechanical analysis of ADRIFT suggested that individual excipients played significant role in improving the mechanical strength of ADRIFT. Spontaneous formation of highly viscous gels in different solvents and resistance to mill into fine powder support the injection and snorting abuse deterrent potential, respectively. Immediate release (>85% release) was achieved in < 30mins, indicating that there was no interference between either of the layers towards their specific purposes. Hence, our novel yet simple ADRIFT oral film technology could potentially be useful in manufacturing immediate release abuse-deterrent formulation of opioid drugs.
Keywords: Abuse deterrent formulation; Bilayer film; Biorelevant media; Oral film; Sodium polyacrylamide starch.
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