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The following message was posted to: PharmPK
hello sir,
I am right now working on Fenofibrate formulation.
I have seen that the marketed products of fenofibrate
includes both tablets and capsules. However, it is
seen that tablets are available in strength of 54mg
and 160 mg, whereas capsules are available in strength
of 67mg and 200mg.
i would like to know the rationale behind the
difference in the dose strength.
can you help me out with this?
yours truly
ashok
[Just a guess but could it be MWt differences between salts? - db]
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The following message was posted to: PharmPK
Dear Ashok,
The bioavailability of fenofibrate is highly dependent on the particle
size
of the API and on the formulation itself.
Although both the formulations i.e. tablets and capsules (by the
innovator)
claims to contain micronized API; but there is a significant difference
in
the formulation (& process) of these dosage forms. The tablet
formulation
(54 mg and 160 mg) is so designed as to have a higher bioavailability
and is
therefore bioequivalent to the capsule formulation (67 mg and 200 mg)
in fed
conditions. Hence you would find that the tablets are recommended to be
given only after meals.
For more details on the formulations, you may go thru the respective
patents.
Hope this clarifies your query.
Regards,
Hitesh Maheshwari
Hikma Pharmaceuticals,
Amman-Jordan
[Interesting, that was my second choice - db]
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The following message was posted to: PharmPK
fenofibrate as such is not available as salt form.Both
tablets and capsules contains fenofibrate as such.
the dose of fenofibrate was initially 300mg/day but it
was reduced to 200mg/day as it was found that the 67mg
of micronised drug was bioequivalent to 100mg of plain
drug.
However both tablets and capsules have the micronised
form and still there is a difference of strength
between the two.
I cannot figure out this problem.
ashok
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