Optimization of Drug Formulations Using In Vitro-In Vivo Modeling with STELLA®

Learn new techniques for investigating possible bioavailability outcomes based on dissolution study data

COURSE DESCRIPTION

This course has been specifically designed to provide participants with “hands on” applications of STELLA® in the optimization of in vitro-in vivo relationships (dissolution-bioavailability correlates) drug formulation development. STELLA® (isee Systems, Inc.) is a powerful, graphic, object-based, model-building tool used to simulate various systems and processes. Methods for generating and supporting dissolution specifications, especially in the context of minor scale-up and post-approval changes (SUPAC) as defined in recent FDA guidances, will be thoroughly examined.

Although a comprehensive understanding of pharmacokinetic principles (as per Kemic’s “PHARMACOKINETICS: Essential Theory …” course) would be desirable, participants lacking formal training in pharmacokinetics will still benefit from the techniques and concepts presented in this course.

* Participants should supply their own computer (PC or Mac) and are encouraged to bring data from their specific R & D activities for analyses during the course.

Participants will have the option to separately purchase at a special discount price the STELLA® software which will be provided for use during the course.

PARTIAL COURSE CONTENTS

  • Introduction to STELLA® and use of numerical techniques to simulate rate processes
  • Review of pertinent pharmacokinetics
  • Development of pharmacokinetic models in STELLA® (single and multiple dose simulations)
  • Optimization of dissolution profiles to obtain a specific pharmacokinetic response prior to defining the in vitro-in vivo relationship
  • Estimation of bioavailability parameters from dissolution profiles prior to defining an in vitro-in vivo relationship
  • Methods to evaluate the in vivo-in vitro relationship
  • Optimization of a formulation’s dissolution profile after establishing the in vitro- in vivo relationship
  • Potential applications of STELLA® related to SUPAC

PRINCIPAL INSTRUCTOR > Arthur B. Straughn, Pharm.D.
NOTE:  Please contact us about arranging a special in-house presentation to suit your organization’s specific requirements.