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| |  New Kaletra Tablet Promises Fewer Pills, Smoother Pharmacokinetics: Presented at IAS-HIV By Ed Susman RIO DE JANEIRO, BRAZIL -- July 29, 2005 -- A new formulation of Kaletra (lopinavir/ritonavir) will provide extra convenience for patients taking one of the most popular protease inhibitor treatments for HIV infection. "The benefits of the new tablet formulation include reduced pill count, room temperature storage, lack of a significant food effect, and lower variability of lopinavir levels compared to the soft gelatin capsule," said George Hanna, MD, global project head of the Antiviral Global Project Team at Abbott Laboratories, Abbott Park, Illinois. In an oral presentation here July 27th at the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment (IAS-HIV), Dr. Hanna explained why the company sought to change the formulation of Kaletra and what it may mean to consumers. Dr. Hanna said that Abbott had tried to change the formulation of the soft gelatin capsules but was stymied until recent advances created melt extrusion (Meltrex) technology. "Lopinavir/ritonavir is currently available as 133.3/33.3 mg soft gelatin capsule or 80/20 mg/mL liquid formulation," Dr. Hanna said. "It requires refrigerated storage prior to dispensing and it is recommended to be taken with food in order optimize lopinavir exposure." Most common dosing schedules involve 6 capsules a day. With the new technology, tablets containing 200 mg of lopinavir and 50 mg of ritonavir will make it possible to take 4 tablets a day. Dr. Hanna and colleagues evaluated the efficacy of the new formulation in 141 healthy volunteers recruited to take the 4 tablets a day and undergo a battery of pharmacokinetic tests to assess the bioavailability of the new product. The lopinavir concentration profile for both the gelatin capsule and the tablet were superimposable, as was the concentration profile for ritonavir, he said. Similarly, the profiles overlapped if the pill was taken with a meal, without a meal, with a moderate fat meal, or with a high fat meal. The area under the curve and maximum concentrations were also similar whether eating a meal or not or whether having a high fat meal or a low fat meal. Dr. Hanna also said that the new tablet showed about an 18% increase in lopinavir bioavailability relative the soft gelatin capsule. The tablet was safe and well tolerated and appeared to reduce the incidence of gastrointestinal effects compared with the sift-gel capsule, he added.
[Presentation title: Significantly Reduced Food Effect and Pharmacokinetic Variability With a Novel Lopinavir/Ritonavir Tablet Formulation. Abstract WeOa0206]
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