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Dear All
Can somebody help me in interpretation of Supac Guideline in view of
following
We have a Hard Gelatin Capsule with API 25% and PGS (Filler, only one
excipient) 75% to a fill weight of 270mg.
In view of Supac-I a total of 5% change is permissible in filler.
In our formulation on changing filler concentration total weight of
product also changes leading to change in % filler e.g.
Existing Weight
API - 70mg (25.9%)
PGS - 200 mg (74.1%)
Total Fill Weight - 270mg
Proposed Weight
API - 70mg (29.2%)
PGS - 170 mg (70.8%)
Total Fill Weight - 240mg
We have conducted BE with existing weight, can we claim Biowaver with
new proposed weight as per Supac-I.(% Filler difference in two
formulations is less than 5%)
We could not find guidance wrt total weight change which is 11.1% in
this case.
Regards
Vijender Gupta
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Dear Vijender,
You are right that this case is unusual and there is no guideline
existing to deal with such a situation. But I think that if you can
limit the total weight change in your formulation to less than equal 10%
(243 to 245mg) then even w. r. t total weight change you will be with in
SUPAC level II. This means that you would be able to avoid repeating bio
just by providing dissolution comparison of the previous and the new
formulation.
Hope this helps.
Regards
Manoj K. Paruthi
Sr. Manager, R&D
Hikma Pharmaceuticals Plc.
Amman, Jordan
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You may be more on the "safe side" to follow the SUPAC II Guidelines:
You can increase the total capsule weight to 250 mg just by
increasing the PGS filler by another 10 mg added to amount you
suggsted in the modified formulation. This way you will still be
within the 10% allowed by SUPAC II. In the absence of an explanatory
guideline to address th difference between following SUPAC i and
SUPAC II and any resulting conflicts, I think this suggestion would
be the most prudent.
I hope this helps.
Murad
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The following message was posted to: PharmPK
Dear Vijander
I think you can'nt go like that, Supac level I allows you to change
+/- 5 %
of the total target weight which in this case is 13.5 mg more or
less. You
can still go at Supac level II which allows 10% change ie 26 mg but that
depends upon your actives physicochemical properties to satisfy the
dissolution requirement.
Pankaj Gupta
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