Since 2009, in direct reaction to the surge in prescription opioid drug product abuse, the FDA requires risk evaluation and mitigation strategies (REMS) for all long-acting and extended-release opioid products. Many new technologies have been developed to make abuse susceptible oral drug products resistant to tampering and extraction. Common approaches include making the drug unpleasant and irritating when inhaled or injected, or causing it to lose activity when crushed.
Anchored by its well-known EUDRAGIT® product portfolio, Evonik develops polymeric coatings and matrix systems that provide reliable and targeted controlled release of active pharmaceutical ingredients from oral dosage forms (capsules, tablets). The primary functionalities include delayed and extended release, moisture protection, taste masking and solubility enhancement. In recent years, there has been an increased interest in using EUDRAGIT® polymers in new applications such as developing oral dosage formulations for abuse resistance and deterrence.
Evonik envisions use of our EUDRAGIT® polymers in developing advanced solutions for abuse deterrent technology in pharmaceutical applications. We intend to deploy our existing polymeric materials and competencies to advance such technologies. Your challenge is to provide an innovative idea (not already patented or published) for developing tamper-resistant and abuse-deterrent oral dosage formulations using EUDRAGIT® polymers.
Top solvers from this challenge may be invited to interview for internship or entry-level positions with Evonik.
Propose a new means to make medications tamper resistant or abuse-deterrent using EUDRAGIT® polymers:
2. Propose an idea that utilizes EUDRAGIT® polymers and other approved ingredients for pharmaceutical use for developing tamper-resistant and abuse-deterrent oral dosage formulations. Other delivery technologies or approved excipients can be used in combination with EUDRAGIT®.
3. Give an explanation of how your use of EUDRAGIT® polymers could potentially make a medication tamper resistant (we recommend that you submit a concept diagram and schematic as supporting materials as a .doc, .docx, and .pdf.)
4. (Optional) Sketches, drawings, CAD renderings, mock-ups, videos, or any other visuals that better explain your submission.
Things to consider:
- Winning solutions should be innovative and easily implemented in large-scale manufacturing.
- Please see the additional terms and conditions for this challenge under "Additional Materials" below.
- Select submissions received by Tuesday May 31st will be eligible for review & feedback from the Evonik team prior to final award judging.
- Submissions should be focused on the formulation aspects of an EUDRAGIT(r) based system. Please select additional ingredients from the attached FDA list of approved inactive ingredients for drug products."