Many new active pharmaceutical ingredients (APIs) suffer from poor gastro-intestinal solubility in their crystalline form. This low solubility can prevent the drug from reaching its effective dose and lead to a significant pill burden for the patient, driving a need for bioavailability enhancement technologies. Formulating an amorphous solid dispersion (ASD) is one way to overcome these challenges. By solubilizing the API in a polymer with molecular level mixing, the API is prevented from returning to its lower solubility crystalline form.
In a webinar hosted by Lonza, Allison DuRoss, Sr. Engineer, Product Development, Amanda Pluntze, Scientist III, Research & Development and David Lyon, Ph.D., Senior Research Fellow, are talking about Lonza's ‘right first time’ strategy, utilizing material-sparing and time-saving methods to swiftly advance molecules from development to commercialization.
During the development of an ASD-based drug product, Lonza focuses on meeting 3 key criteria:
- Comprehensive: Ensuring the right questions are being asked, appropriate data is being collected, and that data is reliable and accurate
- Quick-to-Clinic: Advancing molecules through the development pipeline efficiently and quickly
- Material-Sparing: Conserving material and preventing unnecessary waste
Comprehensiveness is the top priority, ensuring decisions that advance a project are rooted in sound scientific foundations. Performing material-sparing studies efficiently without waste is the next strategic focus, so long as comprehensiveness is not compromised.
This whitepaper will highlight some of Lonza’s material-sparing and time-saving methods applied across the development process. Specifically, the selection of the ASD manufacturing technology and scale-up to the final drug product.