jag009
★★★

NJ,
2021-07-06 19:19
(20 d 06:42 ago)

Posting: # 22462
Views: 213
 

 Bracketing approach for multiple strenght product EMA [Regulatives / Guidelines]

Hi all,

For drug product which have multiple strengths (lets say 3), my thinking is to run a BE study comparing highest and lowest strength, and present dissolution similarities between the three strengths + a formulation composition table showing that the formulations are proportional.

Question: What if the product release > 85% within 15 mins? If so then one can't use dissolution to demonstrate similarity.

The product is BCS class 2.

Thx

J
dshah
★    

India,
2021-07-17 11:44
(9 d 14:16 ago)

@ jag009
Posting: # 22474
Views: 87
 

 Bracketing approach for multiple strenght product EMA

Dear J!
If the dissolution is more than 85% in 15 min, then F2 would not be applicable. However, for multimedia dissolution for a BCS class II drug, there is a high possibility that in at least one media, the dissolution would be slower and thus F2 can be applied.
Regards,
Dshah
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