HIV
and Hepatitis.com Coverage of the 14th
Annual Conference on Retroviruses and Opportunistic Infections (14th CROI) February
25 - 28, 2007, Los Angeles, CA
Bioequivalence
of Pilot 100 mg Tablet Formulations of Ritonavir to the Marketed Soft Gel Capsule
Abbott is developing
a 100-mg ritonavir (RTV; Norvir) tablet formulation that would not require refrigeration.
Other formulation objectives include bioequivalence to the marketed soft gel capsule
(SGC), chemical and physical stability over a range of temperature and humidity
conditions, and acceptable size.
Researchers
at Abbott Labs assessed the bioavailability of 3 prototype tablet formulations
(forms A, B, and C) with limited stability evaluations administered as a 100-mg
dose. Results of this pharmacokinetic study were reported in a late breaker abstract
at the 14th CROI in Los Angeles.
"RTV
prototype tablet formulations A and B met bioequivalence criteria with respect
to RTV Cmax, AUCt, and AUCinf and warrant further development," according
to Dr. Cai of Abbott Laboratories who presented the data at the 14th CROI. "Long-term
stability evaluations under a variety of temperature and humidity conditions and
additional bioavailability studies are ongoing to guide selection of a formulation
suitable for registration," he added.
Reference Y
Cai, C Klein, U Roggatz, and others. Bioequivalence of Pilot Tablet Formulations
of Ritonavir to the Marketed Soft Gel Capsule at a Dose of 100 mg. 14th Conference
on Retroviruses and Opportunistic Infections. Los Angeles. February 25-28, 2007.
Abstract 52LB (oral).
