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: Provided is an apparatus for simulating the function of a human stomach and/or intestine. The apparatus comprises a flexible vessel (10; 100), and a plurality of constriction mechanisms (20), wherein each of the constriction mechanisms (20) is disposed annularly around the outer circumference of the vessel (10; 100), and an inner diameter of each of the constriction mechanisms (20) is variable such that the vessel (10; 100) can be locally and annularly constricted.

Abstract: A pharmaceutical composition comprising an ester of 4-(1-hydroxy-1-methylethyl)-2 propyl-1-[[2?-(1H-tetrazol-5-yl)[1,1?-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid characterized in that when exposed to 75% relative humidity at 40° in open dish for one month the total amount of related substances does not increase more than 1% is described.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.

Abstract: Provided is an apparatus for simulating the function of a human stomach and/or intestine. The apparatus comprises a flexible vessel (10; 100), and a plurality of constriction mechanisms (20), wherein each of the constriction mechanisms (20) is disposed annularly around the outer circumference of the vessel (10; 100), and an inner diameter of each of the constriction mechanisms (20) is variable such that the vessel (10; 100) can be locally and annularly constricted.

Abstract: The invention relates to a pharmaceutical composition, which comprises at least one active agent and which further comprises a binder and/or a retarding agent, wherein the binder swells in an acidic medium, and the retarding agent retards the release of the active agent in an acidic or alkaline medium.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.

Abstract: A sustained release pharmaceutical composition comprising coating comprising at least one water-insoluble permeable polymer and at least one water soluble polymer and homogenous cores containing only tolterodine or a salt thereof and microcrystalline cellulose is described.

Abstract: Self-microemulsifying drug delivery systems and microemulsions used to enhance the solubility of pharmaceutical ingredients comprising a polyoxyethylene sorbitan fatty acid ester emulsifier; a fatty acid ester co-emulsifier and an oil.

Abstract: This invention relates to sustained release pharmaceutical compositions comprising O-desmethyl-venlafaxine, in particular to sustained pharmaceutical compositions comprising O-desmethyl-venlafaxine orotate and/or O-desmethyl-venlafaxine glucuronate.

Abstract: The present invention describes in an embodiment a coating composition which contains in a film coating an active pharmaceutical ingredient, which is defined by a low water solubility of about 10 mg/ml or lower as measured in water at 20° C. at about pH 7, or which is defined by presenting a dispersed state when placed in water at 20° C. at about pH 7, and a co-polymer of polyvinyl alcohol with polyethylene glycol. Preferably the active pharmaceutical ingredient has been applied dispersed in an aqueous coating vehicle onto a core which optionally comprises a same or different active pharmaceutical ingredient.

Abstract: The present invention relates to a stable pharmaceutical composition that includes sirolimus. The pharmaceutical composition includes sirolimus in the amorphous form, a fatty acid ester, such as glyceryl behenate, and a pharmaceutically acceptable polymer wherein the fatty acid ester is present at a concentration of less than 10% w/w compared to the total weight of the composition.

Abstract: A dry formulation or granulation of eprosartan mesylate is described which comprises eprosartan mesylate in particulate form with a particle size, wherein at least 65 v/v % eprosartan mesylate particles fall in a particle size range of from 2 to 27 ?m. In another aspect, a dry formulation or granulation of eprosartan mesylate comprises eprosartan mesylate combined with an excipient which at least comprises a PEG having molecular weight in the range of 400 to 20000 and mannitol. Further described is a single dosage pharmaceutical formulation such as tablet obtained from such a dry formulation or granulation of eprosartan mesylate by direct compression or dry granulation. A dry formulation or granulation of eprosartan mesylate, or a process for the preparation thereof is also described, which comprising eprosartan mesylate in particulate form mixed with one or more excipients or additives in a way that a limited water activity is obtained.

Abstract: A tablet comprising eprosartan mesylate in only one form of either anhydrous or dihydrate form is described. In another aspect, a tablet is disclosed comprising eprosartan mesylate obtainable by direct compression, wherein eprosartan mesylate is provided in one primary form of being either anhydrous or dihydrate to the extent that the eprosartan mesylate shows a dissolution profile with a variability of dissolution from the different tablet samples of a set of below 30%, preferably below 20% and more preferably below 10% relative standard deviation at all time during dissolution, measured using USP apparatus 2, placing the tablets in 1000 ml 0.1 M hydrochloric acid at 37±0.5° C. with paddle speed of 50 rpm.

Abstract: Self-microemulsifying drug delivery systems and microemulsions used to enhance the solubility of pharmaceutical ingredients comprising a polyoxyethylene sorbitan fatty acid ester emulsifier; a fatty acid ester co-emulsifier and an oil.

Abstract: The invention relates to a pharmaceutical composition, which comprises at least one active agent and which further comprises a binder and/or a retarding agent, wherein the binder swells in an acidic medium, and the retarding agent retards the release of the active agent in an acidic or alkaline medium.

Abstract: A pharmaceutical composition comprising an ester of 4-(1-hydroxy-1-methylethyl)-2 propyl-1-[[2?-(1H-tetrazol-5-yl)[1,1?-biphenyl]-4-yl]methyl]-1H-imidazole-5-carboxylic acid characterized in that when exposed to 75% relative humidity at 40° in open dish for one month the total amount of related substances does not increase more than 1% is described.

Abstract: A sustained release pharmaceutical composition comprising coating comprising at least one water-insoluble permeable polymer and at least one water soluble polymer and homogenous cores containing only tolterodine or a salt thereof and microcrystalline cellulose is described.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.