yuvaneshwari
☆    

India,
2019-04-18 11:12

Posting: # 20188
Views: 1,529
 

 Is FDA dissolution database more preferable to product specific FDA BE guidance? [Dissolution / BCS / IVIVC]

For a Oral solid dosage form [tablet and suspension], FDA dissolution database is recommending dissolution to be done at 25 degrees whereas, product specific FDA guidance for the same product is mentioning 37 degrees.

Which temperature should i need to adapt and follow for generic development ?


Edit: Please follow the Forum’s Policy[Helmut]
Vineeth KE
☆    

India,
2019-04-25 13:15

@ yuvaneshwari
Posting: # 20229
Views: 1,170
 

 Is FDA dissolution database more preferable to product specific FDA BE guidance?

» For a Oral solid dosage form [tablet and suspension], FDA dissolution database is recommending dissolution to be done at 25 degrees whereas, product specific FDA guidance for the same product is mentioning 37 degrees.
»
» Which temperature should i need to adapt and follow for generic development ?

For development purpose, it is advisable to follow 37 degrees, as it mimics in-vivo condition (For oral solid dosage form).

If the drug release is affected by temperature (due to API solubility/Surfactant Solubility in dissolution media/API degradation/gelling of excipients or any other reasons), it is better to consider the worst case scenario (25 or 37degrees).

For submission purpose, we need to evaluate in both the conditions as mentioned in FDA-Dissolution database & FDA-Product specific guidance.
Activity
 Admin contact
20,641 posts in 4,327 threads, 1,437 registered users;
online 47 (0 registered, 47 guests [including 10 identified bots]).
Forum time: 23:51 CEST (Europe/Vienna)

In general, scientific progress calls for no more
than the absorption and elaboration of new ideas 
and this is a call most scientists are happy to heed.    Werner Heisenberg

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