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Opportunities and Challenges in Formulation Development of Fixed-Dose Combination Products
Development of fixed-dose combination of two or three drug molecules is a common development strategy in many Pharma companies to improve patient compliance as well as to increase the patent life of a compound. Though the concept looks simple, but bringing two or three chemical compounds together in one pill poses several challenges in terms of chemical and physical stability and processing challenges as well in-vivo PK performance.

This presentation will focus on understanding the various formulations and processing challenges, which could be encountered during fixed-dose combination development. Several aspects of fixed-dose combination development, such as selection of excipients, dissolution method development as well as process selection will be elaborated. Several opportunities and tips to address the challenges will be presented with few concrete examples.

Dr. Sudha Vippagunta
Dr. Sudha Vippagunta is a Principal Fellow in Pharmaceutical and Analytical Development (PHAD), Novartis in East Hanover, New Jersey. She received a Ph.D. from the University of Nebraska Medical Center in Omaha, Nebraska and joined Novartis in 2000.

Dr. Vippagunta has extensive experience in product development from early phase to launch of the product using roller compaction and hot-melt extrusion technologies. Over the years, Dr. Vippagunta has contributed significantly to the development of solid dispersions and fixed-dose combinations at Novartis. Her work has improved oral bioavailability of poorly water-soluble compounds and has led to the development of compounds that otherwise would have been difficult to develop. In addition, Dr. Vippagunta has contributed to the development and marketing of many double as well as triple fixed-dose combinations of products that present challenges in achieving bioequivalence (BE) due to their variable pharmacokinetic properties or significant food effect.

DIRECTIONS TO: Somerset Holiday Inn
Take Exit 10 from any direction on I-287 and follow the signs for the Somerset Holiday Inn.
February 16, 2012
Registration: 5:30 PM
Dinner: 6:30 PM
Presentation: 7:30 PM
Sponsors:
Senopsys
Somerset Holiday Inn
195 Davidson Ave.
Somerset, NJ 08873
Phone: 732-356-1700

Registration
Make reservations via our website www.njphast.org. You can also prepay by using PayPal. Payment on the day of the events can only be made using cash, check, or money order. Credit cards or debit cards will not be accepted.
Fees:
  • Registered on-line and paid online by PayPal: $65.00
  • Registered at meeting (walk-in): $75.00 - CASH OR CHECK ONLY
  • Between positions/Retirees/Students with ID: $40.00 WITH ADVANCED REGISTRATION ONLY
(If paying via PayPal, hit the "CONTINUE" button to enter your credit card information.)
ADVANCED REGISTRATION WILL END AT 7:00 PM ON TUESDAY, FEBRUARY 14. AFTER THAT TIME YOU MUST REGISTER IN PERSON FOR THE $75.00 WALK-IN FEE - CASH OR CHECK ONLY - NO EXCEPTIONS