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Dear All,
Could anyone please let me know the BE procedures for oral solid
dosage liposome products as all of us know the standard BE procedures
available for IR/SR products.
I would be so hankful for the great help in this regard.
Regards
Bollu Prasad
Nicholas Piramal India Liited,
Hyderabad.
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The following message was posted to: PharmPK
Hi,
Were you thinking of any particular product? As far as I know there
are no solid oral liposome products. I don't think that there are any
generic liposome products. There is a draft FDA guidance on
liposomes but it does not address BE. The topic of BE for liposomal
products is on the FDA's list of Critical Path Initiatives for generic
products. It wouldn't be unreasonable to expect that a guidance is
created in the next few years.
Regards
Mark Milton
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Hi Bollu,
There is a very good presentation by Kofi Kumi from FDA regarding the
main issues that FDA will be looking at when a liposomal product is to
demonstrate bioavailability. Here is the link:
http://www.fda.gov/ohrms/dockets/ac/01/slides/3763s2_10_KUMI/sld001.htm
I hope this helps.
Murad
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The following message was posted to: PharmPK
Dear Bollu,
You may have to determine the plasma concentrations of both the
released and the encapsulated amounts of the drug because Liposomal
formulations are highly unstable.
Refer to articles related to AmBisome (perhaps the 1st Liposomal
formulation with anti-fungal Amphotericin B). You can find good Info.
Regards,
Santosh Tata
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