A BCS Class III API pharmaceutical product is formulated as…
A BCS Class III API pharmaceutical product is formulated as a test tablet containing a different binder from the reference product. The comparative dissolution testing shows rapid, not very rapid, dissolution (i.e. 85 % in 30 min) in all three media (pH 1,2, 4,5, 6,8) of both test and reference products. What is the biowaiver status of this product?
Read DetailsA batch of immediate-release tablets has a dissolution speci…
A batch of immediate-release tablets has a dissolution specification of Q = 80 % in 30 minutes: (15)The % dissolved at 30 minutes is measured as follows: Tablet % Dissolved S1 (6 tablets) 82, 79, 84, 81, 78, 80 S2 (6 tablets) 83, 85, 79, 80, 81, 82 S3 (12 tablets) 80, 79, 81, 82, 78, 83, 80, 81, 82, 80, 79, 81 Tasks:Calculate the mean % dissolved at tier (S2, S3 as required).Determine whether and at what stage the batch meets the dissolution specification.Explain the regulatory implications of your findings at each tier.
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