Lek, Tovarna Farmacevtskih in Kemicnih Izdelkov, D.d.

Lek Pharmaceuticals D.d.

Judita Sirca

Bojan Kofler

Vlasta Humar

Ljubomira Barbara Rebi{haeck Over (c)}

Peter Venturini

Miha Tomaz Jaklic

Helena Suklje-Debeljak

Milojka Mohar

There is disclosed a method for stabilizing active substances that are unstable in acidic medium, unstable when stored for longer periods of time in the presence of water and at the same time sensitive to heating, by means of anhydrous granulation of active substances and dried pharmaceutically acceptable auxiliary substances for the preparation of pellet cores or granules. All pharmaceutically acceptable auxiliary substances employed are dried before use so that their weight loss at drying is less than 1.0% of the total weight of the pharmaceutically acceptable auxiliary substance, preferably less than 0.5%. Organic solvents used in process of anhydrous granulation should contain less than 0.2% of water. A novel pharmaceutical formulation with controlled release of active substances that are unstable in acidic medium, unstable when stored for longer periods of time in the presence of water and at the same time sensitive to heating, is disclosed as well.

Pharmaceutical formulation with controlled release of active substances

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Ljubljana, Slovenia

Judita Sirca