Pavan Kumar Nukala

Bioduro San Diego, USA

Title: Development of Multi-dose oral abuse deterrent formulation of loperamide using hot melt extrusion

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Biography

Dr. Pavan Kumar Nukala is an experienced scientist in the development of solid oral dosage forms. Dr. Nukala, uses his expertise in various techniques like solid dispersion, hot melt extrusion, 3D printing for solving complex issues in formulation development. During his doctoral training at St. John’s University, Dr. Nukala received lot of recognition for his research work on developing abuse deterrent formulations. He is one (among five) of the recipient of IPEC graduate student award in 2019, additionally he is also a recipient of NJPhast Graduate student scholarship for the year 2019. Currently he serves as a reviewer in five peer reviewed journals and working as a formulation development scientist at Bioduro San Diego USA.

Abstract

Loperamide, an over the counter anti-diarrheal drug, also infamously referred to as “poor man's methadone”. Due to the ease of availability and low price, people/patients abuse it by consuming more than 30 tablets to achieve euphoric effect and to combat opioid withdrawal. But supratherapeutic doses of loperamide result in severe respiratory depression, cardiac dysrhythmia and mortality. To address this issue, we developed a unique and innovative technology to deter multi-dose oral abuse. The concept is to design a tablet which can immediate release loperamide in diarrheic patients (single tablet) while stops loperamide release in case of intentional multi-dose ingestion. Loperamide was molecularly dispersed into gastric soluble cationic polymers – Eudragit® EPO and Kollicoat® Smartseal 100P using hot melt extrusion to obtain filament. Filaments were milled and compressed into tablets ((Eudragit® EPO (SJU1) and Kollicoat® Smartseal (SJU2)) with optimized amount of L-Arginine. Dissolution in 250?mL of Fasted state simulated gastric fluid (FaSSGF) revealed that single tablet of Imodium® (marketed formulation) and SJU1 showed >85% of release within 15?min. Most importantly, in multi-unit dissolution (15 tablets), Imodium® exhibited >90% release but SJU tablets showed <2% of drug release thus demonstrating its ability to deter multi-dose oral abuse.