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’