Why are the people doing dissolution studies in USP dissolution apparatus only? Why we need USP apparatus? What is the important role of USP Dissolution apparatus in Dissolution studies, if we do same study in simple 1 litre beaker, is it publishable or not.?
Refer to my most contribution, "Crystal Engineering of Green Tea Epigallocatechin-3-gallate (EGCg) Cocrystals and Pharmacokinetic Modulation in Rats". We describe a simple solubility study without using a USP apparatus. Although publishable without it, a USP dissolution apparatus is certainly preferable for accurate in vitro to in vivo predictions. Best, Adam
According to FDA guidelines there are 7 type of official dissolution apparatus available for different kind of dosage forms. Dissolution helps to predict in vitro release profile of drug. Drug dissolution can be used to check batch to batch variability (a routine quality control test) and is important as formulation development tool. Some of applications are:
Selection of salt forms, polymorphs and particle size
Selection of dosage forms
Selection of route of administration
Optimization of manufacturing process
Selection of excipients
Formulation optimization
IVIVC
Doing dissolution in a beaker is not official method however researchers do report such methods for nanoparticles, nanosuspensions etc. and several research paper report doing dissolution in a beaker
Pharmacopiea apparatus are standardized, so that experiments could be reproduced easily by others and compared to their own results or with other studies. Moreover, hydrodynamics and stirring device are optimized with these apparatus contrary to beaker. But dissolution kinetics, if they are well described, can probably be done in a beaker for publication purpose.
Ordinarily in pharma testing 500 or 900 ml (more common) of buffer is chosen, kept at a temperature of either 25, or 37 deg C (more common) with tolerances +/- 0.5 deg C. The amount of drug should be the same as the intended applied dose. Typical stirring speeds are 50 or 100 rpm. If the drug isn't fully released (dissolved), meaning you are not seeing near 100% recovery, within the time frame you are testing for (e.g. after 6 or 10 hours), then an additional stirring period at 250 rpm is needed. Its called the infinity time point, where the sample is stirred at 250 rpm for 30 or 60 minutes.
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