BE of solutions [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2018-06-21 13:33 (859 d 07:38 ago) – Posting: # 18942
Views: 29,235

Hi Outlaw Torn,

» » […] dissolution testing is possible but technically demanding.
» If you can elaborate, it would be great. If not, that's okay too. :-D

Dissolution is not my cup of tea. Only a few examples dealing with suspensions, e.g., this one:

A suspension sample equivalent to a typical dose (5 mL) was taken on a weight basis using a suitable syringe–cannula system, and quantitatively transferred to the dissolution vessel midway between the surface of the dissolution medium and the top of the rotating blade. To calculate the exact weight of suspension added to the vessel, syringe and cannula were weighed at three stages: empty, filled with the suspension, and after the sample was expelled into the dissolution vessel.

But in Dissolution Technologies we find:

Questions and Answers February 2017
Q How is the sample prepared, and how it is it added to the dissolution equipment for dissolution testing of a dry syrup for oral suspension?
A […] If a product, powder or granule, when reconstituted as directed in the instructions to the patient, results in a solution, no dissolution test is required.

(my emphasis)

» I'm still trying to wrap my head around whether there is the need to do dissolution testing in syrups.
» Also, Appendix III seems to imply that only solid dosage forms are eligible for BCS-based biowaivers. Is that your understanding?

After reading it again, yes. This leaves us with nobody’s answer about solutions:No idea what “other data” are. When it comes to similarity of excipients see the GL’s Appendix III, Section IV.2.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,474 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time: Tuesday 20:12 CET (Europe/Vienna)

No computer has ever been designed
that is ever aware of what it’s doing;
but most of the time, we aren’t either.    Marvin Minsky

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