The Changing Landscape of Solid Oral Dosage Forms
Oral solid dosage forms are a dynamic and ever-changing landscape, driven primarily by new, more potent chemical entities (NCEs) that require particularly specific formulations. In this episode of the Drug Solutions podcast, Deepak Thassu, VP R&D and Regulatory Submission, LGM Pharma, and Marco Gil, Senior VP Sales and Marketing, Hovione, discuss how, in addition to NCEs, older APIs and more established ones are finding renewed life because these APIs are continually being improved to have higher potency at lower doses, changing the way their formulation is handled. Looking to the future, the bio/pharma industry is also tackling the problem of converting large molecule (biologic) drugs into orally administered doses, rather than parenterally administered, for better compliance with patients. Among the issues addressed are:
- The latest developments in solid oral dosage technology and methodologies
- What remain the greatest challenges in formulating APIs for oral administration of solid doses
- How the industry is tackling the problem of improving bioavailability through better oral solid dosage formulations/technologies, etc.
- Some “best practice” approaches to formulating oral solid dosage products
About the speaker
Deepak Thassu, Vice President R&D and Regulatory Submissions, LGM Pharma, joined LGM in 2020 to lead the company’s integrated R&D and Regulatory Submissions teams for CDMO clients. He launched commercial products with several US and European patents and managed submissions for NDAs, ANDAs, BLAs and medical devices. Prior to joining Nexgen in 2015 to lead the R&D and Regulatory groups, Deepak was Managing Director at Actavis, Chief Scientific Officer and Vice President of Pharmaceutical Development at PharmaNova, Chief Scientific Officer and Senior Vice President of Pharmaceutical Development at Holopack International, and Associate Director of global pharmaceutical development and technology at UCB Pharma. He received his Masters in Pharmacy from the University of Saugor and his Ph.D. and postgraduate training from the University of Cincinnati in Pharmaceutical Sciences. He holds an MBA from Cornell University, in General Business Administration and Finance, and Queen’s University.
Marco Gil, senior vice president of sales and marketing, Hovione, graduated from the chemical engineering department of the Technical University of Lisbon, where he also obtained a doctorate in chemistry in 2006. In 2007, he joined the R&D department of Hovione as a particle scientist. design disciplines. The focus of his work was the application of particle engineering technologies to improve the bioavailability of poorly water-soluble drugs. In May 2011, he was appointed Director of R&D Process Chemistry and was responsible for a group of scientists dedicated to the development and scale-up of chemical processes for the production of active ingredients. He held several management responsibilities, including General Manager of Hovione’s US site operations and trade-related functions. He is the author of more than 15 scientific articles in peer-reviewed journals and book chapters, co-author of two patents and invited speaker at more than 10 international conferences.
About the Drug Solutions Podcast
Pharmaceutical technology features the Drug Solutions podcast, where editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share their insights on your biggest questions, from technologies to strategies to regulations related to drug development and manufacturing.
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