Why Test?

From a manufacturing objective, the aim is to:

"Manufacture a dosage form in such a way that the active ingredient is released from the dosage form in a predicatable way and within a reasonable time in order for it to be absorbed by the body". Drugs also need to be released in the right area of the body - in the intestine instead of the stomach for example.

Most routine dissolution testing is used to confirm the statement above. 

When a dosage form is manufactured, there are a number of parameters which need to be checked:

• That the active ingredient is released in the predicted way
• That the manufactured batch is the same as previous batches and falls within the required levels.
• That he product can be stored for the specified shelf life without deterioration
• To ensure that the dosage form does not break up in transit
• To confirm that the drug is stable over time.

The Dissolution Test is a very useful tool and the only standardised way to generate scientific data that enables comparison

In addition, standardised testing promotes globalisation and harmonisation and also acts as a referee to identify mis-branded or substandard products

Application of dissolution data

Testing the dosage form from production to the end of its shelf life produces data that

• Confirms immediate quality control
• Ensures that the drug is still pharmaceutically active throughout its shelf life
• Includes stability testing within well defined and strict criteria for each drug
• Validates the manufacturing process and confirms therapeutic equivalence

What is tested:

Dissolution testing is appropriate to a wide range of products:

• ‘Traditional’ pharmaceuticals
• Dietary supplements
• Veterinary drugs
• Other ‘remedies’

Next Page:  Theoretical Concepts of Dissolution