OxyPerine INNOGLOBO/I/81/AAOA/2022

Project Goal

The aim of the project is to develop an innovative pharmaceutical form of oxycodone combined with organic Mg2+ ions and a substance preventing/difficulting the recreational use of oxycodone by administering it through the oral mucosa, nasal route, or intravenously. Medicinal products containing 5, 20, and 40 mg of oxycodone are being developed. The key innovation of this pharmaceutical form will be the addition of substances preventing the recreational use of oxycodone through administration via the oral or nasal mucosa, as possible with commercially available traditional pharmaceutical forms.

This feature/innovation is crucial for the American market for which the medicinal product is being developed. The project focuses on conducting preclinical studies, the result of which will enable the relatively simple registration of a new medicinal product both in the American and Polish markets without the need for comprehensive clinical trials.

Project Assumptions

The project will focus on the following tasks:

• Development of a pharmaceutical form in the form of a hard tablet weighing approximately 1g.
• Development of a set of analytical methods enabling the analysis of both active substances and impurities in the API, the complex medicinal product, and release profiles.
• Conducting stability tests in a non-GMP standard, necessary to determine the quality and safety of the medicinal product.
• Conducting tests using an animal model to confirm the efficacy of the developed innovative drug.

Project co-financed from the State budget.

Agreement No. INNOGLOBO/I/81/AAOA/2022, implemented under the 1st Competition of the INNOGLOBO Program.

Total project cost: 1,764,184.49 PLN

Amount of co-financing: 1,411,347.60 PLN