Abstract: The present invention relates to a crystalline form of darolutamide and to a process for its preparation. Furthermore, the invention relates to a pharmaceutical composition comprising said crystalline form of darolutamide, preferably in a predetermined and/or effective amount, and at least one pharmaceutically acceptable excipient. The present invention also relates to 5 pharmaceutical compositions comprising darolutamide at a high drug load. The pharmaceutical composition of the present invention can be used as a medicament, in particular for the treatment of prostate cancer.

Abstract: The present invention relates to a pharmaceutical composition containing rifaximin in the form of two different polymorphs as well as a method of preparing the same.

Abstract: The present invention is directed to an injection syringe comprising an injectable composition, the composition comprising a penicillin, salt or prodrug thereof, one or more pharmaceutically acceptable excipients, and water, wherein the composition is free of a preservative agent. In other aspects, the invention relates to a process for producing the injection syringe, and a kit comprising the injection syringe.

Abstract: The present invention relates to a pharmaceutical composition containing rifaximin in the form of two different polymorphs as well as a method of preparing the same.

Abstract: The present invention is directed to an injection syringe comprising an injectable composition, the composition comprising a penicillin, salt or prodrug thereof, one or more pharmaceutically acceptable excipients, and water, wherein the composition is free of a preservative agent. In other aspects, the invention relates to a process for producing the injection syringe, and a kit comprising the injection syringe.

Abstract: The present invention relates to an oral solid dosage form, in particular a tablet, comprising macitentan free base polymorphic form I.

Abstract: The invention relates to a pharmaceutical composition consisting of ceftaroline fosamil acetic acid solvate and arginine, both having a specific particle size distribution, wherein said pharmaceutical composition is stable and does not segregate into an inhomogeneous mixture.

Abstract: Edoxaban is factor X inhibitor useful for the treatment or the prevention of thrombosis or embolism. A pharmaceutical composition comprising Edoxaban, or a pharmaceutically acceptable salt thereof, a water soluble vinylpyrrolidone polymer selected from the group consisting of povidone and copovidone, and a cellulose ether, and not comprising a sugar alcohol, having good dissolution and bioavailability is provided. A process for its preparation, a dosage form comprising such composition, and the use of said pharmaceutical composition and dosage form as a medicament are also disclosed.

Abstract: The present invention relates to an oral solid dosage form, in particular a tablet, comprising macitentan free base polymorphic form I.

Abstract: The present invention provides a pharmaceutical formulation prepared as dry syrups representing mere powder mixtures of beta-lactam antibiotics as active pharmaceutical ingredients and excipients without applying any other process steps than simple mixing of dry powder, whereby the pharmaceutical formulation combines two essential properties for processability and dosability: good flowability and high stability against segregation.

Abstract: The present invention provides a pharmaceutical formulation prepared as dry syrups representing mere powder mixtures of beta-lactam antibiotics as active pharmaceutical ingredients and excipients without applying any other process steps than simple mixing of dry powder, whereby the pharmaceutical formulation combines two essential properties for processability and dosability: good flowability and high stability against segregation.

Abstract: The present invention relates to pharmaceutical tablets comprising amorphous compound I in the form of its free base or pharmaceutically acceptable salts of compound I.

Abstract: The present invention relates to pharmaceutical tablets comprising amorphous compound I or pharmaceutically acceptable salts thereof, and an inert organic carrier.

Abstract: The present invention relates to an oral solid dosage form, in particular a tablet, comprising macitentan free base polymorphic form I.

Abstract: The present invention relates to an oral solid dosage form, in particular a tablet, comprising sorafenib tosylate polymorphic form III.

Abstract: The present invention relates to an oral solid dosage form, in particular a tablet, comprising sorafenib tosylate polymorphic form III.

Abstract: In a solid pharmaceutical preparation containing water-soluble salts of levothyroxine and/or liothyronine as active ingredients, the water activity of said pharmaceutical preparation is adjusted to values of below 0.4 and, preferably, 0.1 to 0.3, measured at room temperature.

Abstract: The present invention relates to a combination of pharmaceutical compositions adapted for oral administration one of which comprises a pharmaceutically active ingredient being acid resistant, and the other of which comprises a pharmaceutically active ingredient being acid labile. Said combination is in the form of a kit of parts which is administered in such way as to use food intake to optimize absorption of both the acid labile and the acid resistant active ingredient. Consequently, the kit of parts of the present invention when administered according to the invention provides improved bioavailability of both the acid-resistant and acid-labile active ingredient.

Abstract: In a solid pharmaceutical preparation containing water-soluble salts of levothyroxine and/or liothyronine as active ingredients, the water activity of said pharmaceutical preparation is adjusted to values of below 0.4 and, preferably, 0.1 to 0.3, measured at room temperature.

Abstract: The present invention relates to a new crystalline form of cefdinir and processes for the preparation thereof. Furthermore, the present invention relates to pharmaceutical compositions comprising said new crystalline form of cefdinir and to processes for preparing these compositions.