Other

Lek Pharmaceuticals D.d.

Sandoz Ag

Uros Klancar

Andreas Hotter

Igor Legen

Andrea Thaler

Polona Smrdel

Biljana Jankovic

Luka Peternel

Andrija Lebar

Tijana Stanic Ljubin

Zdenka Jerala-Strukelj

Klemen Naversnik

Zrinka Abramovic

The invention relates to novel hydrates of dolutegravir sodium and to processes for their preparation. Furthermore, the invention relates to a novel crystalline form of dolutegravir sodium, which is a useful intermediate for the preparation of one of the novel hydrates. In addition, the invention relates to the use of the novel hydrates for the production of pharmaceutical compositions. Finally, the invention relates to pharmaceutical compositions comprising an effective amount of the novel hydrates, to oral dosage forms comprising said pharmaceutical compositions, to a process for preparing said oral dosage forms, and to the use of said pharmaceutical compositions or dosage forms in the treatment of retroviral infections such as HIV-1 infections. 

Hydrates of dolutegravir sodium

The present invention relates to a pharmaceutical composition, preferably a pharmaceutical dosage form, comprising at least two separate compartments, wherein one compartment contains a composition comprising metformin or a pharmaceutically acceptable salt thereof and wherein another compartment contains a composition comprising sitagliptin. The present invention also relates to a process for preparing dosage forms comprising metformin or a pharmaceutically acceptable salt thereof and sitagliptin or a pharmaceutically acceptable salt thereof, the process comprising the steps of: The present invention also refers to a process for preparing dosage forms comprising at least one compartment comprising metformin or a pharmaceutically acceptable salt thereof and sitagliptin or a pharmaceutically acceptable salt thereof, the process comprises providing a composition containing metformin or a pharmaceutically acceptable salt thereof, and sitagliptin or a pharmaceutically acceptable salt thereof, and a matrix agent. Moreover, the present invention related to a dosage form obtained by said process, and to the use of said dosage form for the treatment of diabetes.

Pharmaceutical compositions comprising a combination of metformin and sitagliptin

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Ljubljana, Slovenia

Uros Klancar