• 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 expecatations
  • 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

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

What's inside

  • 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 expecatations
  • 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

Additional information

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.

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.