Dissolution test performed for
1) To differentiate between formulations and to evaluate the
potential effect of the formulation and other processes variables on drug
bioavailability.
2) To ensure bioequivalence from batch to batch.
3) To ensure that the preparation comply with product
specification, as it is a requirement for regulatory approval of marketing for
the registered product.
4) To indicate the performance of the preparation under the in
vivo conditions. (It is possible to correlate dissolution rate of a drug with
its bioavailability)
No comments:
Post a Comment