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

Dissolution testing was initially developed for oral dosage forms, but the role of the test has now been extended to drug release studies on various other forms such as topical and transdermal systems and suppositories.

 

What is tested:

Dissolution testing is appropriate to a wide range of products:

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