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Back to the forum  Query: 2017-11-22 10:25 CET (UTC+1h)
 
Anand
Junior

India,
2017-10-30 06:50

Posting: # 17946
Views: 632
 

 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: 568
 

 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]Regards,
Helmut Schütz 
[image]

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