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RegisterFed dissolution with 20% glucose [Dissolution / BCS / IVIVC]
Dear All,
We are planning to conduct an in vivo bioequivalence study under fed conditions. The drug product is administered with 250mL of water with 20% glucose in it.
We would like to design an in-vitro dissolution experiment to mimic the above conditions. My team is of the opinion that 20% glucose gets diluted upon reaching the GIT, hence, in-vitro experiment can be designed with 15% glucose or even less.
Did anyone come across any publications that has information related to this? Kindly share your thoughts as well.
Thank You,
Y
We are planning to conduct an in vivo bioequivalence study under fed conditions. The drug product is administered with 250mL of water with 20% glucose in it.
We would like to design an in-vitro dissolution experiment to mimic the above conditions. My team is of the opinion that 20% glucose gets diluted upon reaching the GIT, hence, in-vitro experiment can be designed with 15% glucose or even less.
Did anyone come across any publications that has information related to this? Kindly share your thoughts as well.
Thank You,
Y
Complete thread:
- Fed dissolution with 20% glucoseyuva 2024-07-11 08:55
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Ing. Helmut Schütz