comparative dissolution profile between various strengths [Dissolution / BCS / IVIVC]

posted by Falisa_Mustafa – Malaysia, 2010-08-09 06:34 (5802 d 09:33 ago) – Posting: # 5743
Views: 8,347

Good day everyone.

I have few queries regarding CDP, in support of a BE study as follows:
  1. If the dissolution medium for QC test contains surfactant, and CDP need to be conducted in other medium such as in pH 1.2, 4.5 and 6.8 (to compare dissolution of other strengths), can surfactant be included in that medium or the dissolution run need to be done without surfactant?

  2. Is it possible/acceptable if the CDP between various strengths failed to show f2 value within 50-100, but dissolution is >80% in 15 minutes? How should we proceed with the results presented?

  3. Can we use different batch from the batch used to perform BE study to conduct CDP?

Hope someone can help me to clarify on these matter as i'm still very 'green' in this BABE field.

TQ & kind regards,
Falisa

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
344 visitors (0 registered, 344 guests [including 15 identified bots]).
Forum time: 16:07 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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