Typically, the rotation speed for USP Apparatus 2 is between 25 and 75 rpm. Can we increase this rotation speed to improve the accuracy of the dissolution method? I am working with a fixed combination product, and one of the drug substances has very low solubility in aqueous solvents.
In my openion, you should make it at intermediate speed .. If it is a high speed, it would reinforce to dissolve more and if it is a forthy material it would make foam. If you uses a low speed , you would slow the rate of dissolution of the soluble one in aqeuous medium. Generally, if you make a dissolution study you should done at intermediate speed.
It may be worth doing a robustness test on your samples. altering the rotation speed and analysing the effects of increasing or decreasing this parameter. what is the low solubility compound? also increasig the rotational speed may increase the disintegration of the formulation but will most likely not translate directly into an increase in solubility
dissolution apparatus are the artificial stomach nature u must use avg stiring speed in it how normal moment will happens in stomach by that u will get the accurate results what tablets will undergoing in body
as per my knowledge and experience avg speed is recommended
The quick answer would be; try the disolution at slow, intermediate and quick speed (25,50,75 rpm) and see the results in the dissolution curves obtained (Concentration versus time). Choose the speed that is the most adequate for the results you are looking for. The correct speed must correlate which in vivo pharmacokinetic experiments in the best of cases. High speeds mask the real release rate differences between different formulations and could give you wrong conclusions.
Agree with Luis about selecting the speed which is adequate for your objective.
Are you comparing Generic & Innovator formulations, or are you comparing different formulations of same drug, or for IVIVC?
I concur with Luis Estrada. There is a limitation in the use of dissolution testing to predict in vivo performance. We used to think that the GIT is filled with fluids but recent GIT transit monitoring of dosage forms using MRI techniques revealed otherwise. Instead the GIT is filled with pockets of air. Hence we have to relook at better designing such surrogate experiments for predicting in vivo performance of solid dosage forms. However, pH of media used is very important from my experience in acieving bioequivalence. For immediate release products, 1.2 and 4.5 are critical to be used for in vitro comparing 2 products of the same drug.
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