Abstract: The presented invention relates to a lyophilized pharmaceutical formulation comprising copanlisib salt and a bulking agent selected from lactose or trehalose and to a process for preparation thereof.

Abstract: The present invention relates to a liquid pharmaceutical composition suitable for parenteral administration comprising: a) pemetrexed diacid; b) at least one organic amine; c) at least one antioxidant; d) 10-200 mg/ml of propylene glycol; and e) one or more parenteral solvents, wherein the preparation thereof is conducted in an atmosphere of inert gas and wherein the organic amine(s) is present in an amount sufficient to reach a pH of the composition in the range from 8.3 to 9.1.

Abstract: The present invention relates to a liquid pharmaceutical composition suitable for parenteral administration comprising: a) pemetrexed diacid; b) at least one organic amine; c) at least one antioxidant; d) 10-200 mg/ml of propylene glycol; and e) one or more parenteral solvents, wherein the preparation thereof is conducted in an atmosphere of inert gas and wherein the organic amine(s) is present in an amount sufficient to reach a pH of the composition in the range from 8.3 to 9.

Abstract: The present invention relates to arginine salt of pemetrexed of formula (1), particularly to a stable solid form thereof, and to pharmaceutical compositions comprising such salt.

Abstract: The present invention relates to a liquid pharmaceutical composition suitable for parenteral administration comprising: a) pemetrexed diacid; b) at least one organic amine; c) at least one antioxidant; d) 10-200 mg/ml of propylene glycol; and e) one or more parenteral solvents, wherein the preparation thereof is conducted in an atmosphere of inert gas and wherein the organic amine(s) is present in an amount sufficient to reach a pH of the composition in the range from 8.3 to 9.1 The invention further relates to the use of said liquid pharmaceutical composition as medicament in the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

Abstract: The present invention relates to arginine salt of pemetrexed of formula (1), particularly to a stable solid form thereof, and to pharmaceutical compositions comprising such salt.

Abstract: The present invention relates to a liquid pharmaceutical composition suitable for parenteral administration comprising: a) pemetrexed diacid; b) at least one organic amine; c) at least one antioxidant; d) 10-200 mg/ml of propylene glycol; and e) one or more parenteral solvents, wherein the preparation thereof is conducted in an atmosphere of inert gas and wherein the organic amine(s) is present in an amount sufficient to reach a pH of the composition in the range from 8.3 to 9.1 The invention further relates to the use of said liquid pharmaceutical composition as medicament in the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

Abstract: The present invention relates to a liquid pharmaceutical composition suitable for parenteral administration comprising: a) pemetrexed diacid; b) at least one organic amine; c) at least one antioxidant; d) 10-200 mg/ml of propylene glycol; and e) one or more parenteral solvents, wherein the preparation thereof is conducted in an atmosphere of inert gas and wherein the organic amine(s) is present in an amount sufficient to reach a pH of the composition in the range from 8.3 to 9.1 The invention further relates to the use of said liquid pharmaceutical composition as medicament in the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

Abstract: The present invention relates to arginine salt of pemetrexed of formula (1), particularly to a stable solid form thereof, and to pharmaceutical compositions comprising such salt.

Abstract: The present invention relates to a solid pharmaceutical composition comprising pemetrexed and a solubilizing amount of meglumine or tromethamine. The composition is sufficiently stable for purpose of making pharmaceutical formulations, particularly lyophilized formulations, and is sufficiently soluble in water for purposes of using in parenteral administration.

Abstract: A pharmaceutical composition, intended particularly for potential administration and for treatment of tumor diseases sensitive to oxaliplatinum, comprises oxaliplatinum as the active compound, a pharmaceutically acceptable aqueous solvent and a stabilizing agent in stabilizingly effective amount. The stabilizing agent includes at least one compound selected from the group consisting of acids derived from neutral alcoholic sugars, lactones of these acids and salts of these acids. In a method of producing such a pharmaceutical composition, oxaliplatinum is dissolved in an aqueous solvent, whereupon to the obtained oxaliplatinum solution is added at least one acid derived from a neutral alcoholic sugar and/or at least one lactone of these acids and/or at least one salt of these acids, and optionally the pH value of the solution is adjusted by addition of an alkali metal hydroxide and/or an alkali earth metal hydroxide to pH 3.5-6.

Abstract: The invention relates to a method of producing dosage units of a solid drug form containing as the active substance warfarin sodium salt in an amount of 1 to 10 mg and having high degree of content uniformity satisfying the Bergum criterion, wherein an aqueous solution of warfarin sodium salt and/or its clathrate which optionally contains in the dissolved state one of the pharmaceutically acceptable excipients co-forming the solid drug form to be prepared but not all the pharmaceutically acceptable excipients co-forming the solid drug form to be prepared, is brought into contact with solid particles of at least one pharmaceutically acceptable excipient co-forming the solid drug form to be prepared, whereupon optionally the particles are dried and optionally mixed with a required amount of solid particles of the remaining pharmaceutically acceptable excipients co-forming the solid drug form to be prepared, and the thus-obtained particulate mixture is formulated into dosage units of the solid drug form.

Abstract: The invention relates to a pharmaceutical composition prepared by freeze-drying in vacuo, containing oxaliplatin as the active component and a pharmaceutically acceptable carrier, wherein the carrier is at least one alcoholic sugar of non-animal origin, the weight ratio of oxaliplatin to the alcoholic sugar of non-animal origin or alcoholic sugars of non-animal origin being 1:3 to 1:7. The invention also relates to the method of manufacturing of said composition and to the use of this composition in the treatment of tumors sensitive to oxaliplatin.

Abstract: The invention relates to a stabilised pharmaceutical composition comprising a pharmaceutically active substance poorly soluble in water, a solubilising agent with a low content of both basic and acidlic compounds and a polar organic solvent, in particular a stabilised injection concentrate, methods for preparing such stabilised pharmaceutical compositions and the use of a solubilising agent with a low content of both basic and acidic compounds to stabilise pharmaceutical compositions for pharmaceutically active substances.