ARx Demonstrates Ability To Eliminate Toxic Metabolites With Thin Film Technology
Dissolution Testing of a Fast-Dissolving Oral Vardenafil Free Base Film
July 23, 2018
AAPS Pharm Sci360
October 29, 2018

ARx Demonstrates Ability To Eliminate Toxic Metabolites With Thin Film Technology

ARx partners with Clients to develop novel drug products with specific delivery objectives such as rapid onset, controlled release, and avoidance of the first pass metabolism. In this specific case, ARx was approached by a Client with an active pharmaceutical ingredient (API) that produced a toxic metabolite when undergoing the first pass metabolism. The metabolite caused a pivotal clinical trial program with an oral tablet to be abandoned due to safety concerns. Through its partnership model and leveraging its knowledge in thin film formulations and mucosal delivery, ARx developed a pre-clinical prototype that demonstrated 0% of the metabolite was found after sixty (60) minutes of delivery, and that the film was able to enhance onset and bioavailability with only 25% of the tablet API loading.

ARx Case Study 1 Metabolites June 2018