Abstract: The present invention relates to a tablet for oral administration containing valsartan and sacubitril, preferably as sodium salts or as a complex of valsartan disodium and sacubitril monosodium, preferably LCZ696. The tablet is prepared by dry-granulation or direct compression and contains a mesoporous inorganic stabilizer, e.g. mesoporous silica (Syloid®).

Abstract: The present invention relates to a gastro-resistant pharmaceutical composition comprising a solid solution prepared by hot-melt extrusion, whereby the solid solution contains posaconazole, an enteric polymer and a non-enteric polymer. The composition is preferably a granulate material that can be filled into a capsule or compressed into a tablet.

Abstract: A pharmaceutical composition, which is an oral solid dosage form, containing a pharmaceutical agent comprising a dialkylamino- or a trialkylamino-group and one or more pharmaceutically acceptable excipient(s), wherein over a period of 2 weeks at 60° C. under open exposure (at any humidity between 30 and 75% rH), or 6 months at 40° C./75% rH in the primary packaging, or 6 months at 25° C./60% rH in the primary packaging the concentration of the corresponding N-nitroso-derivative of the pharmaceutical agent remains below 50 ppm (relative to the weight of the free base of the pharmaceutical agent in the pharmaceutical composition).

Abstract: The present invention relates to a solid unit dosage form for oral administration (tablet or granules) containing a solid dispersion of valsartan and sacubitril in a polymeric matrix. The solid dispersion is prepared by hot-melt extrusion and may contain the active ingredients preferably in a non-crystalline state. LCZ696, (pseudo)polymorphic forms thereof as well as the individual drugs, e.g. valsartan disodium and sacubitril monosodium, may be subjected to the hot-melt extrusion process.

Abstract: The present invention relates to a crystalline form of amifampridine phosphate having an irregular or plate-like, not needle-like crystal habit and to a process for its manufacture.

Abstract: The present invention relates to a gastro-resistant pharmaceutical composition comprising a solid solution prepared by hot-melt extrusion, whereby the solid solution contains posaconazole, an enteric polymer and a non-enteric polymer. The composition is preferably a granulate material that can be filled into a capsule or compressed into a tablet.

Abstract: The present invention relates to a gastro-resistant pharmaceutical composition comprising a solid solution prepared by hot-melt extrusion, whereby the solid solution contains posaconazole, an enteric polymer and a non-enteric polymer. The composition is preferably a granulate material that can be filled into a capsule or compressed into a tablet.

Abstract: A dry powder inhalation device is disclosed. In one optional aspect, the device includes a housing, a base plate, a receptacle for a medicament and a mouthpiece. The base plate is engageable with the housing to form a main space with a main air inlet. The mouthpiece includes an inner conduit connected to its outlet and is engageable with the base plate to fluidly connect the inner conduit to the receptacle. The receptacle is fluidly connected to the main space, so that upon inhalation by a user, air can be drawn through the main air inlet into the main space and onward through the receptacle into the inner conduit. The mouthpiece and the base plate form an auxiliary space with an auxiliary air inlet, wherein the auxiliary space is fluidly connected to the main space.

Abstract: The present invention relates to a solid unit dosage form for oral administration (tablet or granules) containing a solid dispersion of valsartan and sacubitril in a polymeric matrix. The solid dispersion is prepared by hot-melt extrusion and may contain the active ingredients preferably in a non-crystalline state. LCZ696, (pseudo)polymorphic forms thereof as well as the individual drugs, e.g. valsartan disodium and sacubitril monosodium, may be subjected to the hot-melt extrusion process.

Abstract: The present invention relates to a tablet for oral administration containing valsartan and sacubitril, preferably as sodium salts or as a complex of valsartan disodium and sacubitril monosodium, preferably LCZ696. The tablet is prepared by dry-granulation or direct compression and contains a mesoporous inorganic stabilizer, e.g. mesoporous silica (Syloid®).

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.

Abstract: The present invention relates to a gastro-resistant pharmaceutical composition comprising a solid solution prepared by hot-melt extrusion, whereby the solid solution contains posaconazole, an enteric polymer and a non-enteric polymer. The composition is preferably a granulate material that can be filled into a capsule or compressed into a tablet.

Abstract: The present invention relates to a simple, robust and effective process for preparing a dry powder inhalation formulation containing at least one drug, preferably a highly active drug, more preferably Tiotropium bromide or Tiotropium bromide monohydrate, and a lactose carrier. The process is characterized in that a three-layered composition containing a drug layer in between layers of the lactose carrier is mixed and the obtained preblend is mixed with additional lactose carrier. The process combines a simple manufacturing procedure with an excellent content uniformity obtained over a wide range of mixing parameters.

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.

Abstract: A transdermal patch includes a protective layer, a matrix layer, an adhesive layer, and a cover layer. The cover layer is at least partially bi-elastic, and the adhesive layer comprises an acrylic copolymer having hydroxyl functional groups. The matrix layer comprises a physiologically effective amount of buprenorphine or pharmaceutically acceptable salts thereof.

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.

Abstract: The present invention relates to a method for the preparation of polyquaternium-1, wherein an aprotic polar solvent is used as the reaction medium, and a solid polyquaternium-1 having a low degree of polydispersity.

Abstract: A transdermal patch includes a protective layer, a matrix layer, an adhesive layer, and a cover layer. The cover layer is at least partially bi-elastic, and the adhesive layer comprises an acrylic copolymer having hydroxyl functional groups. The matrix layer comprises a physiologically effective amount of buprenorphine or pharmaceutically acceptable salts thereof.

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.