Deanna Mudie, principal scientist at Lonza looks at how to increase the robustness of oral drug products and accelerate their development with biorelevant dissolution media.
Oral delivery is a common route of administration for pharmaceutical drug products. To be effective, oral drug products must dissolve in gastrointestinal (GI) fluids and permeate across the GI membrane. Depending upon the drug and formulation properties and physiology of the target patient population, these processes can determine how quickly the drug appears in the bloodstream 1, 2. For efficient development of robust drug products, developers need rapid, accurate methods to evaluate how the interplay between formulation and GI physiology will affect drug-product performance.
In vitro dissolution testing is the gold standard for assessing oral performance throughout the drug product lifecycle 3. In vitro dissolution testing falls into three categories: (1) quality control (QC); (2) biorelevant; and (3) clinically relevant, with potential overlap between the three 4. Whereas QC testing is used for such purposes as detecting drug-product changes during manufacturing, biorelevant testing is used to guide formulation selection and clinically relevant testing is used to link in vitro and in vivo pharmacokinetic data 4. By using dissolution media to support biorelevant dissolution testing, drug developers may have success facilitating right-first-time pre-clinical and clinical formulations, and ultimately enable low cost and high speed to patients.