This webinar will examine the rational use of biopharmaceutical principles to design a drug product that will optimize drug delivery to achieve the therapeutic objectives of the drug.
Why Should You Attend:
Bioavailability is a measurement of the rate and extent of active drug that becomes available at the site of action. For oral drug products, the drug must be absorbed systemically to achieve the desired therapeutic effect. Biopharmaceutics links the physical and chemical properties of the drug substance and the dosage form to clinical performance. Application of biopharmaceutics allows for the rationale design of drug products.
This webinar will demonstrate how biopharmaceutics may be used in the rational design of a drug product to achieve a desired therapeutic objective. Furthermore, the webinar will discuss the measurement of drug product performance, in vitro, including drug dissolution and in vitro in vivo correlation.
Participants will be introduced to the basic concepts of biopharmaceutics and apply these principles to the design of finished dosage forms (drug products). Participants will learn how the physicochemical properties of the drug substance and the formulation of the drug product affect drug product performance. In addition, participants will consider the rate-limiting steps in drug absorption, the quantitative measurement of in vitro performance using dissolution and drug release testing and the determination of In Vitro-In Vivo Correlation.
Topics
Biopharmaceutic Factors and Rationale for Drug Product Design
Rate-Limiting Steps in Drug Absorption
Physicochemical Properties of the Drug
Formulation Factors Affecting Drug Product Performance
Drug Product Performance, In Vitro: Dissolution and Drug Release Testing
Compendial Methods of Dissolution
Alternative Methods of Dissolution Testing
Dissolution Profile Comparisons
Meeting Dissolution Requirements
Problems of Variable Control in Dissolution Testing
Performance of Drug Products: In Vitro-In Vivo Correlation
Approaches to Establish Clinically Relevant Drug Product Specifications
Drug Product Stability
Considerations in the Design of a Drug Product
Drug Product Considerations
Instructor
Leon Shargel, Ph.D., R.Ph., is Manager and Founder of Applied Biopharmaceutics LLC, a pharmaceutical consulting company and holds academic appointments as Affiliate Professor, School of Pharmacy, Virginia Commonwealth University. Prior to forming his own company, Dr. Shargel was Vice President, Biopharmaceutics, Sandoz (formerly, Eon Labs). He has over 35 years' experience in both academia and the pharmaceutical industry. Dr. Shargel has lectured widely on pharmacokinetics, bioavailability and generic drug product development.
He has over 200 publications including a leading textbook,
"Applied Biopharmaceutics &
Pharmacokinetics." Dr. Shargel received a B.S. in Pharmacy from the University of Maryland and a Ph.D. in Pharmacology from the George Washington University Medical Center. He is a member of various professional societies including the American Association Pharmaceutical Scientists (AAPS), American Pharmacists Association (APhA) and the American Society for Pharmacology and Experimental Therapeutics (ASPET).