How is the sample prepared, and how it is it added to the dissolution equipment for dissolution testing of a dry syrup for oral suspension?
I would think the preparation would be the same as directed on the label (example; dilute in a glass of water and stir). In essence you want to prove your API operates in vitro (dissolution) the same as in vivo.
equivalent wt of preparation (keeping % purity of drug in calculation) should be prepared in buffer and evaluated as per the official procedure
No, I think you must put the amount of dry powder equivalent to a unit dose into the basket of the USP 1 Dissolution apparatus, and count the time since you immerse the basket into the dissolution médium. You can performa dissolution profile taking samples at 5, 10, 15, 20 and 30 minutes and see the results to determine which is the correct time in which the drug is disolved in the medium more than 80%.
Another option is to prepare the oral suspensión as is indicated in the label and take an aliquot of the prepared suspension equivalent to the unit dose, pour into the vessel with dissolution media in Apparatus 2 (palets) and count the time from the moment of addition. You can try both and see wich is the procedure that best fit your needs.
Dear Luis, can you please support the 80% requirement for dissolution that you referred in your comment? Why 80%? Is it 80'% or 80%(Q)? Thanks in advance, Luis
Dear Vipul,
Despite not common (and it is not a general requirement for "oral suspensions" or "powder for oral suspensions" in the major pharmacopoeias - PhEur, Ph.Int, USP - some particular cases include the dissolution testing, for instance the USP "Fluconazole for Oral Suspension" which states "Sample solution: Reconstitute the suspension according to the label instructions, Weight, and transfer an amount of the reconstituted suspension equivalent to one dose to the vessel. At the time specified withdraw 10mL of the solution under test, and pass through a suitable filter of 0.45-µm pore size.".
This particular monograph states apparatus II (paddle) at 50rpm for 30 min using water as dissolution medium. The acceptance limit is 85%(Q). Both the apparatus, speed, medium and acceptance limit (both dissolution extent and time) are chosen taking into consideration the particular product. For oral suspensions or powder for oral suspensions I am not familiar with the use of the "rapidly dissolving" and/or "very rapidly dissolving" terminology, common used when referring to unit solid dosage forms.
Regards, Luis
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