Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-11-18 22:20 CET (UTC+1h)
 
Anand
Junior

India,
2017-10-30 06:50

Posting: # 17946
Views: 607
 

 Discriminatory Dissolution Media [Dissolution / BCS / IVIVC]

Dear All,

Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.

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

@ Anand
Posting: # 17949
Views: 545
 

 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.

[image]All the best,
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
17,482 Posts in 3,743 Threads, 1,085 registered users;
27 users online (0 registered, 27 guests).

I have had my results for a long time:
but I do not yet know how I am to arrive
at them.    Carl Friedrich Gauss

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