Log in
Register|
govardhanpillari ☆ India, 2009-03-13 14:12 (6311 d 16:06 ago) Posting: # 3364 Views: 6,458 |
|
|
Dear All, We have developed one formulation for canada market, strengths is 150 & 300 mg, This is linear drug and comes under BCS III. we have done the comparative dissolution for both 150 and 300 mg and we did BE for 300 mg, we got the results very closely! Now the problem is with 150 mg. The dissolution of our test 150 mg formulation is not matching with the RLD 150 mg (both F1 and f2 is failing). But test formulation is dose propotional and it is perfectly matching the dissolution (getting f2 around 85 in b/t 150 mg Vs 300 mg test. My question is doest it mandatory to match the dissolution of lower strengths with RLD lower strengths for canada submission? Please suggest me Thanks in advance... Regards, PGR |
|
irinad ☆ 2010-08-01 21:12 (5805 d 10:06 ago) @ govardhanpillari Posting: # 5707 Views: 4,726 |
|
|
❝ Now the problem is with 150 mg. The dissolution of our test 150 mg formulation is not matching with the RLD 150 mg (both F1 and f2 is failing). But test formulation is dose propotional and it is perfectly matching the dissolution (getting f2 around 85 in b/t 150 mg Vs 300 mg test. 1. Doing the dissolution test, was it used the paddle method or the basket method? What rpm? 50, 100, 150? 2. What shape has the 150mg RLD tablet; has it the same shape as your 150mg formulation? is the 150mg RDL tablet larger that your formulation? Regards Irina |
Ing. Helmut Schütz