Anand
☆    

India,
2017-10-30 07:50
(2341 d 06:14 ago)

Posting: # 17946
Views: 4,097
 

 Discriminatory Dissolution Media [Dissolution / BCS / IVIVC]

Dear All,

Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.

Thanks & Regards,
A.A
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2017-10-30 11:42
(2341 d 02:22 ago)

@ Anand
Posting: # 17949
Views: 3,246
 

 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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
81 visitors (0 registered, 81 guests [including 7 identified bots]).
Forum time: 14:04 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5