Holzkirchen, Germany
Holzkirchen, Germany

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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. The methods allow for the use of a small sample volume and the possibility to operate with high throughput, such as in a 96-well plate sample preparation and are therefore suited to measure pharmacodynamics parameters of a recombinant glycoprotein in a mammal in clinical or pre-clinical studies.


The present invention relates to a solid oral pharmaceutical composition comprising an inert core comprising, preferably consisting of, at least one acidic reacting compound, and a coating comprising vortioxetine hydrobromide and at least one pharmaceutically acceptable polymer and a method for enhancing the solubility and bioavailability of vortioxetine hydrobromide.


The present invention relates to a solid pharmaceutical composition comprising atorvastatin or a salt thereof, in particular to a composition having the total weight of less than or equal to 600 mg and a tablet comprising said composition. The present invention furthermore relates to a process for the preparation of solid composition comprising atorvastatin or a salt thereof and its use as a medicament, especially for the treatment of hypercholesterolemia or hyperlipidemia.


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.


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.


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 agents.


The present invention relates to a pharmaceutical orodispersible film composition which comprises buprenorphine in the form of particles having a maximum particle diameter Dv90 of at most 20 micrometer, and the process of preparation thereof.


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. The methods allow for the use of a small sample volume and the possibility to operate with high throughput, such as in a 96-well plate sample preparation and are therefore suited to measure pharmacodynamics parameters of a recombinant glycoprotein in a mammal in clinical or pre-clinical studies.


Patent
Hexal Ag | Date: 2015-12-14

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.


The present invention relates to a method for manufacturing an ingestible film, an apparatus for manufacturing an ingestible film, an ingestible film and a pharmaceutical dosage form comprising the same. The method comprises providing a matrix comprising at least a solvent and a polymer; a film forming step of forming a wet film from said matrix; a heating step of heating said wet film by radiation originating from a radiation source to obtain a heated wet film having a temperature of at least 22C; and a drying step of drying said heated wet film using a drying means.

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