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: (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?
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: (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~
~A happy Soul~
Complete thread:
- Tablet Scoring: A must for Generic Companies?luvblooms 2014-10-14 10:52 [Regulatives / Guidelines]
- Tablet Scoring: A must for Generic Companies? jag009 2014-10-14 16:54