Abstract: The invention relates to a pharmaceutical composition, comprising or consisting of: 10 to 30 weight percent of at least a pharmaceutically active amount of a pharmaceutical substance selected from the group comprising statins, in particular water-insoluble, oxidatively degradable statins, preferably cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, or combinations thereof, 30 to 70 weight percent of lactose hydrate, 2 to 15 weight percent of microcrystalline cellulose, 5 to 25 weight percent of a partially water-soluble starch, 0.2 to 4 weight percent of at least one alkali and/or alkaline-earth salt of stearic acid and/or stearyl fumaric acid, wherein the composition contains no antioxidatively active substances such as chain terminators, reductants, free-radical scavengers, and complexing agents.

Abstract: The present invention relates to a method for analyzing glycans of a recombinant glycoprotein in a liquid sample of a mammal. Specifically the method comprises a step of affinity purifying the recombinant glycoprotein from the sample, enzymatically releasing a glycan containing fragment from the immobilized glycoprotein, adding a reference standard containing isotopically labeled glycans, fluorescently label the glycans and analyzing the glycans using LC-MS. The present invention also relates to a method further comprising analyzing the glycans of the immobilized recombinant glycoprotein fragment, further comprising a pre-clearing step of the liquid sample, and releasing the glycans from the immobilized recombinant glycoprotein fragment.

Abstract: The present invention relates to a solid oral pharmaceutical composition comprising vortioxetine hydrobromide in a matrix formed from at least one polyethylene oxide and optionally one or more further matrix forming polymers.

Abstract: The invention relates to a pharmaceutical composition for oral administration comprising or consisting of (i) 10 to 30% weight, of at least one pharmaceutically active substance selected from the group consisting of water-soluble, oxidatively-degradable statins, preferably atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or a combination thereof, (ii) 0.01 to 3% weight, of a first anti-oxidatively active substance (A1), (iii) 0.01 to 3% weight, of a second anti-oxidatively active substance (A2) that differs from the first anti-oxidatively active substance (A1), and (iv) 60 to 85% weight of at least one additive, selected from the group consisting of filler, binder, flow-regulating agent, disintegrant and anti-blocking agent or a combination thereof, and the use of the pharmaceutical composition in medicine.

Abstract: The present invention is related to a pharmaceutical formulation comprising a biopharmaceutical drug, said composition further comprising at least one mono- or dicarboxylic acid with a backbone of 2-6 C-Atoms, or at least one salt thereof.

Abstract: The use of anthranilic acid (2-AA) to label N-glycans prior to separation using a reversed-phase liquid chromatography (RP-LC) column under acidic conditions using formic acid is described herein. Negatively charged 2-AA offers stronger retention on the reversed phase column than 2-aminobenzamide (2-AB) in RP-LC and allows efficient ionization and detection of 2-AA labeled N-glycans. The acidic conditions used for the RP-LC leads to an efficient separation of acidic 2-AA N-glycans carrying terminal sialylation without the need for an ion-pairing reagent. The method and compositions described herein may be used with RP-nano-LC-MS and a 96-well plate sample preparation, which allows attomolar sensitivity and high throughput.

Abstract: The present invention is directed to a tablet comprising at least one bitter tasting and/or mucosa numbness causing pharmaceutically active compound; and at least one zinc salt. In addition, the present invention relates to the use of a zinc salt to reduce or mask the bitter taste of or the numbness of the mucosa caused by pharmaceutically active compounds.

Abstract: The invention relates to a pharmaceutical composition, comprising or consisting of: 10 to 30 weight percent of at least a pharmaceutically active amount of a pharmaceutical substance selected from the group comprising statins, in particular water-insoluble, oxidatively degradable statins, preferably cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, or combinations thereof, 30 to 70 weight percent of lactose hydrate, 2 to 15 weight percent of microcrystalline cellulose, 5 to 25 weight percent of a partially water-soluble starch, 0.2 to 4 weight percent of at least one alkali and/or alkaline-earth salt of stearic acid and/or stearyl fumaric acid, wherein the composition contains no antioxidatively active substances such as chain terminators, reductants, free-radical scavengers, and complexing agents.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The invention relates to a pharmaceutical composition for oral administration comprising or consisting of (i) 10 to 30% weight, of at least one pharmaceutically active substance selected from the group consisting of water-soluble, oxidatively-degradable statins, preferably atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or a combination thereof, (ii) 0.01 to 3% weight, of a first anti-oxidatively active substance (A1), (iii) 0.01 to 3% weight, of a second anti-oxidatively active substance (A2) that differs from the first anti-oxidatively active substance (A1), and (iv) 60 to 85% weight of at least one additive, selected from the group consisting of filler, binder, flow-regulating agent, disintegrant and anti-blocking agent or a combination thereof, and the use of the pharmaceutical composition in medicine.

Abstract: The present invention relates to diester prodrugs of cilazaprilate which undergo enzymatic cleavage to release the active metabolite cilazaprilate that is used for the treatment of hypertension and congestive heart failure. Furthermore the diester prodrugs of cilazaprilate possess all the properties necessary to be topically administered, preferably via transdermal therapeutic systems.

Abstract: The present invention relates to diester prodrugs of cilazaprilate which undergo enzymatic cleavage to release the active metabolite cilazaprilate that is used for the treatment of hypertension and congestive heart failure. Furthermore the diester prodrugs of cilazaprilate possess all the properties necessary to be topically administered, preferably via transdermal therapeutic systems.

Abstract: The invention relates to a process for the preparation of granules comprising an oily substance. It relates also to granules for a pharmaceutical formulation and to a tablet as a product of further processing.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The present invention is related to a pharmaceutical formulation comprising a biopharmaceutical drug, said composition further comprising at least one mono- or dicarboxylic acid with a backbone of 2-6 C-Atoms, or at least one salt thereof.

Abstract: The invention is concerned with a transdermal therapeutic system (TTS) comprising buprenorphine and a method of manufacturing such a TTS. The transdermal therapeutic system is used for the transdermal administration of buprenorphine and analogues thereof. In particular, the invention relates to the use of a transdermal therapeutic system (TTS) for analgesic purposes. The TTS according to the invention comprises a transdermal drug delivery composition comprising buprenorphine and an adhesive component, which is a mixture of a crosslinked and a non-crosslinked acrylic polymer and a penetration enhancer comprising a keto acid.

Abstract: The invention relates to a pharmaceutical film formulation comprising one or more bitter-tasting drug(s) or pharmaceutically acceptable salts thereof, one or more film formers, a bitterness masker containing one or more inorganic and/or organic salt(s) and at least two monocyclic monoterpenes, and one or more sweetening agent(s).

Abstract: The invention relates to a process for preparing a composition, more particularly a pharmaceutical composition for oral administration, comprising the steps of forming a suspension of at least one pharmaceutical ingredient and a solvent or solvent mixture, the at least one pharmaceutical ingredient being insoluble or poorly soluble in the solvent or solvent mixture, the step of adding at least one gel former to the suspension, the at least one gel former being swellable in the solvent or solvent mixture, and, optionally, the step of swelling the suspension.

Abstract: The invention relates to a method for the solvent-free preparation of a homogenizate, especially for implants or microparticles, wherein one or more polymers and one or more active constituents, as raw materials, are homogenized together below the glass transition temperature of the polymer(s) and, when homogenization is complete, brought to room temperature.

Abstract: The present invention is directed to a tablet comprising at least one bitter tasting and/or mucosa numbness causing pharmaceutically active compound; and at least one zinc salt. In addition, the present invention relates to the use of a zinc salt to reduce or mask the bitter taste of or the numbness of the mucosa caused by pharmaceutically active compounds.