Dissolution Study of Investigational Tablet of 5mg Oxycodone HCl/25mg Dextromethorphan HBr to Determine a Release Profile

Abstract

Objectives: To standardize six tablets that share a statistically insignificant in vitro dissolution profile consisting of an experimental mixture of oxycodone HCl paired with dextromethorphan. We wanted to see if the release dynamics were not statistically different in an aqueous environment utilizing testing via USP Apparatus II (rotating paddles) in order to establish a drug release profile. Methods: Six experimental formulation tablets of oxycodone/DM were placed in separate dissolution vessels. The medium contained 900ml of water (standard media per USP) at 37°C (standard temperature per USP). Samples were taken at the 1, 2, 4, 6, 8, and 24 hour time periods and quantified using HPLC. The aim of this experiment was not meant to simulate an in vivo environment but simply to gain preliminary data for future research. Results: A one-sample t-test was used to calculate significant differences between the release profiles of oxycodone and dextromethorphan. We found that the release of all 6 tablets were not significantly statistically different for active ingredients, oxycodone and dextromethorphan. This data validated our hypothesis that the six experimental tablets would release the active ingredients over a 24-hour period at very similar and statistically insignificant rates. Implications: We now have a tablet formulation that can be replicated and used for further research including animal studies, and possibly human clinical trials, in order to develop a new pharmacotherapeutic approach for pain management.