Heat-stable Norvir tablet is equivalent to capsule

Abbott Laboratories presented pivotal data at the 2008 International AIDS Conference, in Mexico City, showing that its investigational Norvir (ritonavir) tablet and the current soft-gelatin capsule provide similar levels of the drug in the blood. The novel heat-stable Norvir tablet will not require refrigeration, making it more convenient for patients to use, particularly in developing countries where the majority of people with HIV live, noted the US health care major.

"The heat-stable formulation of ritonavir may help to further expand protease inhibitor-based highly-active antiretroviral therapy in regions where the need for refrigeration of HIV medicines is a major barrier to treatment and care," said Pedro Cahn, president of the International AIDS Society.

The study compared the bioavailability of the 100mg ritonavir tablet to that of a 100mg soft-gelatin capsule under non-fasting conditions. The ritonavir tablet demonstrated similar bioavailability to the current soft-gelatin capsule, and was generally well tolerated. In this study, performed in 93 healthy adult volunteers, the safety profiles of the two formulations were similar, with no serious adverse events reported, said Abbott, adding that the data presented will form the basis of upcoming regulatory submissions.