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Hello Forum,
I am interested to know why the FDA has of late been recommending 500
ml of dissolution medium as opposed to the 900 ml recommended in
pharmacopoeias.
Can anyone suggest a reason?
Nisha K R
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The following message was posted to: PharmPK
I think that FDA recommend 500 ml rather than 900 in a way to mimic the
case in-Vivo, taking into consideration that it is published that the
gastric content it is a roung 50 ml, add to that 240-250 ml water, so
500 closer to the real case.
but note: for Class II drugs (according to the BCS), which show poor
solubility, it is recomendied to use higher dissolution volume, that to
have good discrimination between formulation (due to the low satiration
solubility)
Alaa kilany
R&D scientist
Hikma pharma
Amman-Jordan
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