Hexal AG

Holzkirchen, Germany
Holzkirchen, Germany
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Patent
Hexal AG | Date: 2017-07-26

The present invention relates to a method for analysing protein variants of a recombinant protein of interest, such as antibodies or Fc-fusion proteins, in a liquid sample of a mammal. Specifically the method comprises a step of affinity purifying the recombinant protein of interest from the sample together with an internal standard, and analyzing the protein variants using an analytic separating method such as HPLC, capillary electrophoresis or MS. This method is particularly suited to measure pharmacokinetic parameters of a recombinant protein of interest, such as a biopharmaceutical, in a mammal in clinical or pre-clinical studies. It allows 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. It also provides high sensitivity and allows analysis of protein variants individually.


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 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 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.


Patent
Hexal Ag | Date: 2015-07-16

The present invention relates to orodispersible films comprising a plant extract and to film forming suspensions comprising a plant extract. Further, the present invention relates to processes for preparing the orodispersible films and the film forming suspensions.


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 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 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.

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