Bristol-myers Squibb & Gilead Sciences, Inc.

Gilead Sciences, Inc.

Taiyin Yang

Reza Oliyai

Mark Michael Menning

Terrence C Dahl

Robert L Jerzewski

Munir A Hussain

Robert A Lipper

In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.

Unitary pharmaceutical dosage form

In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, componentcomprising tenofovir DF (and, optionally, emtricitabine) and componentcomprising efavirenz, wherein componentsandare in a stabilizing configuration. In preferred embodiments componentis made by dry granulation.

This invention is directed to a composition comprising dry granulated tenofovir DF and emtricitabine, and a method for making same. Dry granulation was unexpectedly found to be important in preparing a tenofovir DF containing composition suitable for inclusion in a combination dosage form containing emtricitabine, efavirenz and tenofovir DF.

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Monte Sereno, CA, United States of America

Taiyin Yang