Log in
RegisterIVIVC [Dissolution / BCS / IVIVC]
❝ ❝ Is there any calculations or methods for estimating BE based on vitro dissolution studies in multi pH, except f1, f2.
❝
❝ It’s only possible to predict BE if you have established an in vivo-in vitro-correlation (IVIVC). Such a correlation may (!!) exist only if the release from the formulation is the rate-limiting step of the in vivo absorption processes. Therefore IR formulations are no candidates at all!
Dear Helmut,
Thank you very much for your immediate reply. This question related to MR product and find the below vitro release results in multi pH. Let me know the chances of bioequivalence.
Multi Ph dissolution study for Gliclazide Mr-30 vs Reference product
Media TIME (hr) Cumulative release Test ptd Cumulative release Reference
0.1 N HCL 0 0 0
0.5 7.2 4.29
1 10.51 8.03
1.5 15.51 14.52
2 17.76 19.77
pH 4.5 3 29.91 48.95
pH 6.8 4 43.5 72.56
6 70.52 87.16
8 82.63 94.74
12 95.03 94.98 with regards,
Srinivasu
Edit: Table coded; tabs are collapsed to a single blank! Please use the preview before submitting your post in the future. [Helmut]
Complete thread:
- Based on Vitro dissolution study in multi pH srinivasu 2010-06-12 11:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IVIVC Helmut 2010-06-12 12:32
- IVIVCsrinivasu 2010-06-12 12:53
- No prediction of BE from dissolution Helmut 2010-06-12 16:04
- No prediction of BE from dissolution Dr_Dan 2010-06-14 09:30
- About desire Helmut 2010-06-15 12:43
- About desire Dr_Dan 2010-06-15 16:02
- About desire ElMaestro 2010-06-17 00:03
- About desire Helmut 2010-06-15 12:43
- No prediction of BE from dissolution Dr_Dan 2010-06-14 09:30
- No prediction of BE from dissolution Helmut 2010-06-12 16:04
- IVIVCsrinivasu 2010-06-12 12:53
- IVIVC Helmut 2010-06-12 12:32
Ing. Helmut Schütz