2019-09-20 09:00
(534 d 15:50 ago)

Posting: # 20635
Views: 1,279

 Dissolution Media for Comparative Dissolution Study [Dissolution / BCS / IVIVC]


In the US FDA Recommended Dissolution Methods, it shows product-specific dissolution methods.

When searching for a product, it shows specifically the dosage form, USP apparatus, speed, medium, volume, and recommended sampling time.

1) Can be applied also for comparative dissolution studies?
If yes,
can we only conduct under the number of media that is stated in the 'Medium' column from the FDA Dissolution Method search result for the product? Usually in the case of comparative dissolution study for ORAL dosage forms, international guidelines specifically state to conduct under at least 4 pH media.
For example, if the search results only show 1 media. Can we conduct the comparative dissolution study with only 1 media?

If no,
which and how many media to use for injectables?
In the case of oral dosage form, the recommended 4 pH media is based on the actual pH levels of the gastric juices and barriers that the product goes through. Injectables have a completely different administrative route and the recommended 4 pH media does not seem to be appliable for this. How can we set up which and how many media to be used for comparative dissolution studies of injection products?

Thank you.

Edit: Category changed; see also this post #1[Helmut]
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