Anand
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India,
2017-10-30 07:50
(2362 d 17:42 ago)

Posting: # 17946
Views: 4,169
 

 Discriminatory Dissolution Media [Dissolution / BCS / IVIVC]

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Dear All,

Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.

Thanks & Regards,
A.A
 
Helmut
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Vienna, Austria,
2017-10-30 11:42
(2362 d 13:50 ago)

@ Anand
Posting: # 17949
Views: 3,301
 

 Formulation-dependent

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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.
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