Abstract: The present invention relates to an oral dosage form containing rifaximin in form beta, wherein the oral dosage form provides delayed release of the active pharmaceutical agent. Further, the invention relates to the preparation of an oral dosage form, preferably a tablet.

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 a stable polymorph of rifaximin and a wicking agent as well as a method of preparing the same.

Abstract: The present invention relates to an oral dosage form containing rifaximin in form beta, wherein the oral dosage form provides delayed release of the active pharmaceutical agent. Further, the invention relates to the preparation of an oral dosage form, preferably a tablet.

Abstract: The present invention relates to a pharmaceutical composition containing a stable polymorph of rifaximin and a wicking agent as well as a method of preparing the same.

Abstract: A solid pharmaceutical composition comprising a solid composition, wherein the solid com-position comprises sofosbuvir and at least one pharmaceutically acceptable matrix compound, wherein at least 99 weight-% of the sofosbuvir comprised in the solid composition are present in amorphous form, at least 99 weight-% of the solid composition consist of the sofosbuvir and the at least one matrix compound, wherein the solid composition contains the sofosbuvir in an amount of at least 25 weight-%, or at least 30 weight-%, or at least 35 weight-%, or at least 40 weight-% or at least 50 weight-% or at least 55 weight-% or preferably at least 5 weight-% based on the combined weight of the sofosbuvir and the at least one matrix com-pound, wherein in the adsorption-desorption isotherm of the at least one pharmaceutically acceptable matrix compound, the desorption mass difference minus the adsorption mass dif-ference at 75% relative humidity and 25° C. is less than 0.

Abstract: The present invention relates to novel pharmaceutical compositions comprising Ledipasvir and Sofosbuvir as well as to methods for their preparation.

Abstract: The invention relates to a capsule comprising an inlet and an outlet connected by a passage, in which a dissolvable blocking element and a composition to be orally administered are arranged. The blocking element is fluid permeable and, in a non-dissolved condition, is arranged in the passage to block delivery of the composition to an outlet of the passage. The invention further relates to a method for releasable sealing a capsule comprising a composition to be orally administered, comprising the steps of providing the composition chamber in a passage and filling composition into the composition chamber. The passage formed by the capsule is occluded with a blocking element and the blocking element comprises dissolvable material and has a fluid permeable structure.

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: A device for oral application of a substance, comprising an inner tube surrounding a first volume an outer tube surrounding a second volume, the second volume comprising a cavity section adjoining an inlet opening of the outer tube being adapted for containing the substance, a separation area arranged in the second volume, the separation area adjoining the cavity section and the first volume, and a selective connecting passage between the cavity section and a pressure compensation space to selectively enable a flow of the substance from the cavity section though the first volume. A kit-of-parts, comprises the inventive device a predefined amount of a substance being contained in a receptacle or the cavity section, and instructions for the use of the substance. Methods for filling the inventive device as well as to a method for oral application using the inventive device are provided.

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 invention relates to a device for oral application of a composition. The device comprises recess having an outer rim encompassing the recess. Within the recess, a composition is arranged. The composition comprises a gelling agent and an active agent. A cover member is attached to the rim and completely covers the recess. Thus, the cover member, together with the recess, retains the composition within the recess. The cover member has an outer surface opposed to an inner surface adjoining the recess. In order to allow preparation of the composition by adding water without the risk of losing some of the composition during preparation, the cover member comprises one or more openings for providing fluidic connection between the inner surface and the outer surface. Through this opening, water can enter for preparing the composition meanwhile the cover retains all composition within the recess. The invention further relates to a method for manufacturing the device.

Abstract: A novel process for preparing stable granulate which comprises amoxicillin trihydrate and a sugar, and to novel stable granulate comprising amoxicillin trihydrate and the sugar as well, for reconstitution with water into fine stable homogeneous aqueous suspension is described. The novel process omits preliminary process step for preparing fine particle size of micronized amoxicillin trihydrate used subsequently in the granulation process known in the art, for example grinding or micronizing of said antibiotic. In a preferred aspect of the invention the novel stable granulate comprises amoxicillin trihydrate and the sugar, preferably sucrose, free of any pharmaceutically acceptable excipient. Novel granulate, which is easily dissolved in water to form smooth aqueous suspension immediately, is used for treating bacterial infections in humans or animals, especially in pediatric patients and in the geriatrics.

Abstract: An oral suspension comprising (a) an antibiotic composition which comprises coated micropellets and optionally one or more excipients, (b) additional excipients, and (c) a solvent, wherein said coated micropellets comprise (i) a core comprising at least one antibiotic; (ii) an inner coating comprising at least one cellulose polymer which is not an enteric coating polymer; and (iii) an outer coating comprising at least one enteric coating polymer, wherein said coated micropellets have a mean particle size of about 100 ?m to about 650 ?m. The oral suspension of the invention is characterized by a lack of bitter taste.

Abstract: The invention relates to a device for oral application of a composition. The device comprises recess having an outer rim encompassing the recess. Within the recess, a composition is arranged. The composition comprises a gelling agent and an active agent. A cover member is attached to the rim and completely covers the recess. Thus, the cover member, together with the recess, retains the composition within the recess. The cover member has an outer surface opposed to an inner surface adjoining the recess. In order to allow preparation of the composition by adding water without the risk of losing some of the composition during preparation, the cover member comprises one or more openings for providing fluidic connection between the inner surface and the outer surface. Through this opening, water can enter for preparing the composition meanwhile the cover retains all composition within the recess. The invention further relates to a method for manufacturing the device.

Abstract: The invention relates to a capsule comprising an inlet and an outlet connected by a passage, in which a dissolvable blocking element and a composition to be orally administered are arranged. The blocking element is fluid permeable and, in a non-dissolved condition, is arranged in the passage to block delivery of the composition to an outlet of the passage. The invention further relates to a method for releasable sealing a capsule comprising a composition to be orally administered, comprising the steps of providing the composition chamber in a passage and filling composition into the composition chamber. The passage formed by the capsule is occluded with a blocking element and the blocking element comprises dissolvable material and has a fluid permeable structure.

Abstract: The present invention relates to a pharmaceutical composition for oral administration suitable for the preparation of a ready-to-use suspension comprising coated particles comprising an active substance having an unpleasant and/or bitter taste, such as clarithromycin, and a suspension base comprising an osmotically active substance capable of providing a high osmolality to the admixture of the suspension base with an aqueous suspending medium in the ready-to-use suspension. Said ready-to-use suspension maintains its palatability over a prolonged period of time by those defined osmotic conditions.

Abstract: A device for oral application of a substance, comprising an inner tube surrounding a first volume an outer tube surrounding a second volume, the second volume comprising a cavity section adjoining an inlet opening of the outer tube being adapted for containing the substance, a separation area arranged in the second volume, the separation area adjoining the cavity section and the first volume, and a selective connecting passage between the cavity section and a pressure compensation space to selectively enable a flow of the substance from the cavity section though the first volume. A kit-of-parts, comprises the inventive device a predefined amount of a substance being contained in a receptacle or the cavity section, and instructions for the use of the substance. Methods for filling the inventive device as well as to a method for oral application using the inventive device are provided.

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: A novel process for preparing a stable granulate, which comprises a mixture of amoxicillin trihydrate and amoxicillin sodium, by means of extrusion granulation of amoxicillin trihydrate with an aqueous solution of sodium hydroxide, sodium bicarbonate, sodium carbonate and mixture thereof or with an aqueous solution of sodium salt of (C1-8) organic acid as a sodium source to form a moist extruded mass, which is granulated through a sieve and dried the obtained granulate, is disclosed. Alternatively, a novel process for preparing a stable granulate comprising pure amoxicillin sodium may be obtained according to the above extrusion granulation process as well. In a further aspect the present invention relates to a novel stable granulate comprising the mixture of amoxicillin trihydrate and amoxicillin sodium or alternatively, to a novel stable granulate comprising pure amoxicillin sodium, whenever prepared according to the above described process.