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Pharma & Bio Ingredients
The tablet formulation of Kaletra was developed using the proprietary Meltrex(TM) melt-extrusion technology and is designed to offer patients a number of new benefits not available with the current Kaletra capsules, including:
• Fewer tablets per dose as part of their treatment regimen;
• No required refrigeration, before or after dispensing (unlike the
current soft capsule formulation, which requires refrigeration); and
• Can be taken with or without food.
"Abbott has a long legacy of providing innovative treatment options to the HIV community, including improved formulations for existing products," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "As we celebrate 10 years of protease inhibitor availability, which revolutionized HIV therapy, the Kaletra tablet offers the next step in the development of treatments directly tailored to patient needs by providing a more convenient version of the leading prescribed PI for the treatment of HIV in the European Community."
The positive opinion for the tablet formulation of Kaletra was based upon data from pharmacokinetic studies. Abbott's tablet submission was filed as a line extension to the EMEA on May 19, 2005. The United States Food and Drug Administration (FDA) approved the Kaletra tablet on October 31, 2005.
The new formulation of Kaletra will provide patients with a tablet composed of 200 mg lopinavir and 50 mg ritonavir, as compared to the current soft capsule, which contains 133.3 mg lopinavir and 33.3 mg ritonavir. While the total daily dose of Kaletra (800 mg lopinavir/200 mg ritonavir) is unchanged, the number of Kaletra pills patients need to take is reduced to four tablets from six soft capsules per day. The standard daily doses of the new tablet formulation and the current capsules provide similar drug levels in the blood.
