Log in
RegisterFormulation-dependent [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2017-10-30 11:42 (3155 d 22:06 ago) – Posting: # 17949
Views: 4,645
Hi Anand,
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.
❝ 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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Discriminatory Dissolution Media Anand 2017-10-30 06:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Formulation-dependentHelmut 2017-10-30 10:42
Ing. Helmut Schütz