luvblooms
★★  

India,
2014-10-14 12:52
(3454 d 02:55 ago)

Posting: # 13698
Views: 1,642
 

 Tablet Scoring: A must for Generic Companies? [Regulatives / Guidelines]

Dear All

Today I had an interesting conversation with one of our formulation guy
Formulation Guy: If an Innovator have a score line does generic product needs to have score line too?

Me: Yes you have to, other wise how you will go for dose titration if required.

Formulation Guy: Fine. Agreed but what if the innovator is available in different other strengths which are equivalent to the strength of broken tablet? For eg. If RLD is 400 mg MUPS tablet with a score line which can break it in two parts of 200 mg each. But Innovator is also available in 200 mg individual strengths (with a score line to divide it in 100 mg), 100 mg (with a score line to divide it in 50 mg) and 50 mg (with a score line to divide it in 25 mg strength which is not used for titration). Even in that condition do a generic company who want to make it in form of let's say matrix tablet need to have a score line and also to meet all the criteria?

Me: :lookaround: (Never thought about that)

But I think his question is valid as later on when we discussed the formulation strategy I realized that the technique proposed is more reproducible and well controlled to meet dissolution and other QTTP specs.

Is it must to have score line or if I have a well controlled BE product which is meeting all the criteria except the scoring, I can file the same to FDA.

Gurus any idea?
Any one came across some situation?

~A happy Soul~
jag009
★★★

NJ,
2014-10-14 18:54
(3453 d 20:53 ago)

@ luvblooms
Posting: # 13704
Views: 1,335
 

 Tablet Scoring: A must for Generic Companies?

Hi Bloom,

I spoke with my formulators here and they all said "As long as the RLD is scored, you have to be scored."

Not sure if that helps...

John
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
103 visitors (0 registered, 103 guests [including 11 identified bots]).
Forum time: 14:48 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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