USP apparatus I and II are gold standard methodologies for determining the in vitro dissolution profiles of test drugs.
A new supplier provided two batches of API (AS-1 and AS-2) that gave noncomplying results of dissolution testing of the drug product, tablet sample, TS-1, and boundary results of dissolution testing of tablet sample TS-2.
This can be explained by the following: at the initial stage of dissolution test, in presence of high concentration of HPMC, the fast water uptake capacity leads to rapid formation of a strong gel layer with a longer diffusion path which could cause a reduction in the drug release [ 41].
The obvious and simple option for improvement of dissolution testing of drugs with low solubility (such as atorvastatin) would be modification of the method by employing higher (unphysiological) medium volumes in the individual compartments, which would prevent early saturation of medium with the tested API.
As a result, an increase in drug release rate was noticed from PEC-based LSS of IDM (F2) with a DE% of 23.66 after 30 min of dissolution test in pH 6.8.
It can be seen that an amount of 67.10% of drug content was released with a DE% of 20.07 after 30 min of dissolution test in pH 6.8.
An example of application of experimental design methodologies to the set up of dissolution test conditions for a new ketoprofen oral extended-release dosage form is presented.
After 1, 2, 4, 12, and 24 hours of dissolution test, the sustained release matrix tablet of F2 released 11.28 (less than 15%), 18.94 (less than 35%), 22.63 (less than 55%), 25.6 (less than 75%), and 54.79 (less than 85%) of its drug content, respectively.
It is clear that F2 matrix exhibited the highest drug release as 32.89% of IDM was released after 2 hours of dissolution test in pH 6.8.
The percentage of drug release at the end of 24 hrs of dissolution test (pH 6.8) ranged from 82% (F1) to 28% (F6) with P < 0.0001.
