Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance - Webinar (Recorded)

Overview
Biopharmaceutics is the study of the physicochemical properties of the drug and the drug product and links these properties to drug product quality and drug product performance. Biopharmaceutics has a crucial role in establishing a link between the in vivo product performance such as bioavailability, onset of drug action, safety and efficacy to the drug product. Both in vitro (e.g., dissolution) and in vivo methods (e.g., bioavailability and bioequivalence) are applied to evaluate drug product quality and drug product performance. Systemic drug absorption from a drug product consists of a succession of rate processes including (1) disintegration of the drug product and subsequent release of the drug, (2) dissolution of the drug in an aqueous environment, and (3) absorption of the drug across cell membranes into the systemic circulation.

The slowest step in a series of kinetic processes is called the rate-limiting step. Dissolution is a dynamic process by which a solid drug substance becomes dissolved in a dissolution medium. Developing a discriminating dissolution method and setting the appropriate product specifications is critical in assuring that the manufacture of the dosage form is consistent and successful throughout the product’s life cycle. Clinically relevant specifications are those specifications that assure consistent safety and efficacy profile. Clinically meaningful dissolution method and specifications will minimize the variability to the patient and, therefore, will optimize drug therapy.

An in vitro-in vivo correlation (IVIVC) establishes a relationship between a biological property of the drug (such as a pharmacodynamic effect or plasma drug concentration) and a physicochemical property of the drug product containing the drug substance, such as dissolution rate. A validated IVIVC enhances drug product understanding and provides justification of manufacturing changes during drug product development. The use of biopharmaceutic tools such as dissolution and bioavailability and bioequivalence studies are very important in assuring consistent drug product performance.

Why you should Attend
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.

Areas Covered in the Session

• Biopharmaceutic Factors and Rationale for Drug Product Design
• Biopharmaceutics and Drug Absorption Process
• Rate-Limiting Steps in Drug Absorption
• Relationship of the Active Drug Substance and Formulation Factors Affecting Drug Product Performance
• Drug Product Performance, In Vitro: Dissolution and Drug Release Testing
• In Vitro-In Vivo Correlation
• Biopharmaceutics in Drug Product Design

Who Will Benefit
Pharma (brand) and Generic Drug Companies
Faculty and Students in the Department of pharmaceutical sciences, at various colleges of pharmacy

Speaker Profile
Leon Shargel, Ph.D., R.Ph., is Manager and Founder of Applied Biopharmaceutics LLC, a pharmaceutical consulting company and is an 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).