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RegisterCarbamazepine 200mg, IR tablets [Dissolution / BCS / IVIVC]
USP dissolution test 2:
two-point dissolution specification, one at 15 min. and and the other at a later point
"Between 45% and 75% of the labeled amount is dissolved in 15 min" is a claim regarding the safety of the Carbamazepine 200mg, immediate release tablets?
More than 75% carbamazepine dissolved at 15 min. would represent a warning on the rate of potential absorption?
Is the 2-point dissolution requirement correlated with formulations considered to be Narrow Therapeutic Index Drugs?
Thank you
Irina
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf
two-point dissolution specification, one at 15 min. and and the other at a later point
"Between 45% and 75% of the labeled amount is dissolved in 15 min" is a claim regarding the safety of the Carbamazepine 200mg, immediate release tablets?
More than 75% carbamazepine dissolved at 15 min. would represent a warning on the rate of potential absorption?
Is the 2-point dissolution requirement correlated with formulations considered to be Narrow Therapeutic Index Drugs?
Thank you
Irina
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070237.pdf
Complete thread:
- Carbamazepine 200mg, IR tabletsirinad 2010-05-24 17:32
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