BCS III Classification [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – USA, 2018-04-20 08:09  – Posting: # 18704
Views: 5,982

Dear All,

I have a question concerning the criterion for classification of a pharmaceutical product as Class III. Some text would say there are two criteria namely: High Solubility and Low Permeability. However some other text would add a third criterion: Very Rapid Dissolution.

Which is correct? If the later is correct, then where do we classify a product with High Solubility, Low Permeability and Rapid Dissolution (ie 85% of the API does not go into solution within 15 minutes but will within 30 minutes or even beyond)?

Similarly, for BCS class I, must all products under this class be Rapidly Dissolving? If so, then how do we classify a product that's Highly Soluble, Highly Permeable and Moderately Dissolving (85% of API dissolves beyond 30 minutes across all physiologic pH.

Regards

Scopy

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
20,034 posts in 4,233 threads, 1,378 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 01:51 CET

Maturity is the capacity to endure uncertainty.    John Finley

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5