Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-19 01:17 CEST (UTC+2h)
Anand
Junior

India,
2017-10-30 06:50

Posting: # 17946
Views: 1,578
 

 Discriminatory Dissolution Media [Dissolution / BCS / IVIVC]

Dear All,

Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.

Thanks & Regards,
A.A
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2017-10-30 10:42

@ Anand
Posting: # 17949
Views: 1,337
 

 Formulation-dependent

Hi Anand,

» Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.

That’s not possible. Discriminatory in vitro conditions depend on the properties of formulations. You have to develop ones which are discriminatory for your product.
  • Produce a target batch (expected to be BE to the reference) and two side batches (expected to fail on the lower and upper end).
  • Perform a small 3-way in vivo study.
  • Find in vitro conditions which discriminate between batches. Ideally full IVIVC or at least matching rank order.

Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,384 posts in 3,905 threads, 1,172 registered users;
online 13 (1 registered, 12 guests [including 11 identified bots]).

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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