Advanced Dissolution

Course Description

The USP dissolution and drug release tests are in vitro performance tests that are applicable to many dosage forms such as tablets, capsules, suspensions, transdermal patches, suppositories, etc. These tests are important components of the specifications that establish the quality and safety of the drug product.

Who Should Participate

Scientists, Chemists and Laboratory technicians who perform dissolution testing in the lab, QC, as well as Product Development professional who review dissolution data

Format

Traditional classroom

Duration

2 days

Fee

$1495.00

Registration

Call Marc Finn at 215-442-1500 or send email to

Learning Objectives

Understand physicochemical principles affecting dissolution and drug release
Describe official USP dissolution apparatus, methods and non-official methods for drug release testing
Gain a study design for the development and validation of a dissolution method
Contrast discriminating and non-discriminating drug dissolution methods
Fully understand proper protocol for computation and interpretation of dissolution data
Develop specifications/tolerances for the drug product based upon a set of dissolution data
Compare dissolution profiles in vitro/in vivo correlations and regulatory aspects of dissolution and drug release tests
Demonstrate problem solving and trouble-shooting capabilities related to all aspects of dissolution testing by way of case studies