Innovative dissolution-permeation approach for biopharmaceutical evaluation of hard-to develop oral medicines

The major project activities: 1. Assembly of the dissolution-permeation setup, with the RSU equipment: USP2 apparatus, peristaltic pumps and permeation chambers. 2. Development of the novel dissolution-permeation approach, and its verification via permeation across biorelevant artificial membranes (with and without the mucus-imitating layer), and ex vivo GIT membranes. 3. Investigation of the methodology, using poorly soluble/poorly permeable model drugs (naproxen, itraconazole, and metformin) Data obtained will include combined dissolution-permeation(release) profiles (concentration over time) of model drugs (and their formulations) from different aqueous media, across different membranes, into different acceptor media. Dissolution-permeation profiles will be published as three datasets. Based on the experimental results, the innovative compendial dissolution-permeation methodology will be established. Results will be communicated via the article publication and scientific conference presentation. This novel methodology, when applied in biopharmaceutical research will target multiple global current pharmaceutical drug development problems, by: • Improvement in the oral formulations’ bioavailability • Reduction of the investments and increase in the success rate of clinical studies • Improvement in therapeutical outcomes of drug treatment • Reduction of the drug doses required to achieve therapeutical effect