Developing a modified release formulation is a common request. Often, modified release (MR) formulations offer patient compliance, marketing and exclusivity/patent benefits over immediate-release versions. What isn’t as obvious is that MR dosage forms present their own unique set of complications around excipient selection.
There are specific strategic decisions to be made concerning the desired in vivo behavior and final dosage form that critically impact formulation strategy and polymer selection. For example, do you want a tablet or capsule? Sustained release or pulsatile? Is an initial burst release of the drug desirable or not? Is there a specific zone in the GI tract where the drug should or should not release?
These decisions all have a significant impact on polymer (and other excipients) selection. In this webinar, panelists will discuss the most common polymers used in modified release oral solid dosage form development. The speakers will distinguish between tablets and capsules, and matrix and reservoir control strategies. The speakers will discuss the different grades of some common polymers and how those differences impact performance. Finally, the speakers will touch on some other excipients that are commonly used in conjunction with controlled-release polymers to modify the performance or processing.
Register for this webinar to learn more about polymer selection for modified release medications.
Richard Sidwell, Ph.D., Vice President and Chief Scientific Officer, Recro
Richard Sidwell is responsible for Recro®’s overall scientific strategy for the CDMO business. He has worked at the Gainesville site since 2003, experiencing its evolution from Elan Drug Technologies to Alkermes in 2011 and finally to Recro in 2015. While at Recro, Richard has been instrumental in leading and building the CDMO’s product development team, which focuses on bringing innovative solutions to its clients.
With over 25 years of pharmaceutical development experience, Richard is recognized as a thought leader in pharmaceutical formulation and process development for oral solid dosage forms, multi-particulate controlled release formulations, and abuse-deterrent formulations for controlled substances. Richard holds multiple patents and publications in these areas.
Richard earned his Ph.D. in pharmaceutics from the University of Georgia; Master of Science degree in health physics from the Georgia Institute of Technology; and Bachelor of Science degree in physics from Oglethorpe University. He is an active member of the American Association of Pharmaceutical Scientists (AAPS).Message Presenter
Charles Vesey, R.Ph., M.S., Formulation Technologies Manager, Colorcon, Inc.
Charles Vesey has more than 20 years of experience in oral solid dosage form development and is currently a formulation technology manager in the market development group at Colorcon, Inc., located in Harleysville, Pennsylvania. Charles received both his Bachelor in Pharmacy and Masters in Pharmaceutics from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia.
Charles began his career at Colorcon as a research associate in the global technology development group, where he focused on film-coating formulation, raw material qualification, process optimization, and scale-up. His current work is in the area of drug product design to make better tasting medicines for pediatric and geriatric populations to help positively impact patient compliance. More broadly, Charles’ interests include formulation and process troubleshooting of oral solid dosage forms with emphasis on multiparticulate controlled release products.
Charles has contributed numerous research publications and conference presentations in the area of modified release technologies. He is a member of the American Pharmacists Association (APhA), a licensed pharmacist in the Commonwealth of Pennsylvania, and a United States Pharmacopeia (USP) Expert Committee Member (volunteer).Message Presenter
Who Should Attend?
This webinar will appeal to senior professionals from pharmaceutical companies interested in developing new modified release formulations.
- Formulation Development
- Analytical Development
- Regulatory Affairs CMC
What You Will Learn
After this webinar, participants will be able to:
- Recognize the most common polymers used in formulating modified release oral solid dosage forms
- Determine best practices for polymer selection for matrix vs. reservoir systems and achieving different types of modified release goals
- Understand the characteristics of different polymer grades and how they affect the finished product dissolution performance
- Identify some of the other excipients that are useful in modified release dosage forms to either modify the dissolution release profile or improve processing
Recro provides oral solid dosage form development, regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. Specializing in modified release oral solid dose and DEA controlled substances, Recro has the experts to deliver our clients’ most complex pharmaceutical development and manufacturing projects in our best-in-class facilities, totaling 120,000 square feet of manufacturing space in Gainesville, Georgia.
Colorcon is a world leader in the development, supply, and technical support of formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical and nutritional industries. Our best-in-class products and technologies are complemented by our value-added services, supporting all phases of solid dose design, development, and manufacture.