Bioequivalence and Bioavailability Forum • IVIVC question

jag009
★★★

NJ,
2012-08-16 22:18
(5052 d 22:22 ago)

Posting: # 9074
Views: 5,236

IVIVC question [Dissolution / BCS / IVIVC]

Hi everyone,

Suppose you run a 4-way crossover study for IVIVC development. The treatments are 3 Test ER formulations with different release rates and an IR Tablet. The dose of the IR is lower than the test formulations due to safety issues. When you carry out the IVIVC development, you normalize the IR dose to that of the test ER formulations assuming the kinetic is linear.

Question...What if AUC from the IR after dose normalization, is smaller than the AUC from the 3 test formulations? Can you still do an IVIVC? If you try to generate in-vivo absorption profiles of the ER based on deconvolution using the IR data to serve as the unit impulse function, then the in-vivo absorption profile would go beyond 100%.

Thanks,
John

Chiku
☆

India,
2012-08-22 10:04
(5047 d 10:37 ago)

@ jag009
Posting: # 9089
Views: 4,146

IVIVC question

Post reply

Hi

IR dose is normalised to unit dose/ 1 mg dose. Idea of having rapid release UIR is to get the pure distribution and eliminination charecteristics of drug without any interferance of absorption (true A, B alpha and Beta value) so if UIR is true then absorption wont go beyond the 100 %.

AUC of IR might be lower of SR formulation that happens but this does not prevent to develop IVIVC.

If drug is soluble then try taking fourth arm of IV formulation to get better IVIVC.

Regards

Chiku :-)