Dissolution Testing of Oral Solid Dosage Forms
The module looks at dissolution testing as a proxy for the bioavailability of a drug in human body. It also provides an overview of the components and operation of the dissolution apparatus
Introduction to dissolution and disintegration
Historical timeline of dissolution test
Significance in patient safety
Introduction to oral dosage forms, and their classification based on solubility and permeability
Drug dissolution rate and tests
Regulatory expectations
Different dissolution apparatus from USP1 to USP7 and their usage as defined by USP
Procedures specific to USP1, USP2, and USP3
Drug properties and properties and settings of the apparatus that can impact drug dissolution rate
Best practices while performing the test
Why it matters
Understanding how a drug releases its active ingredient in the human body is critical for accurate designs of drug delivery mechanisms. Another frequent problem faced by pharmaceutical manufacturers is how to optimize the amount of drug available to the body (bioavailability). Any inadequacies in bioavailability can mean ineffective treatment or dangerous side-effects. In-vitro dissolution tests is a crucial aid in determining bioavailibility.
Who is it for
This module is relevant to quality control and quality assurance team members who conduct and evaluate the results of dissolution tests.
