Holzkirchen, Germany
Holzkirchen, Germany

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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 is related to methods of preparing a pharmaceutical formulation comprising a biopharmaceutical drug, which methods allows the modulation of immune responses related to the administration thereof. The formulation comprises a buffer comprising hexanedioic acid or at least one salt thereof, and/or citric acid or at least one salt thereof. The present invention further relates to method of using hexanedioic acid or at least one salt thereof, and/or citric acid or at least one salt thereof, to modulate the immunogenicity of a pharmaceutical formulation, to a pharmaceutical formulation as such, and to methods of modulating or determining immune responses related to the administration of a pharmaceutical formulation (FIG. 4).


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.


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.


Patent
Hexal AG | Date: 2014-04-23

The present invention uses 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. 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 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: 2014-05-21

The present invention relates to an orodispersible film composition comprising a therapeutically effective amount of at least one active pharmaceutical ingredient, a gelling agent, at least one flavoring agent selected from natural citrus fruit derived oil or a mixture of two or more natural citrus fruit derived oils, wherein said composition does not comprise an artificial flavoring agent. The present invention also relates to a method of preparation of said composition, and an orodispersible film comprising said composition. The orodispersible film composition is particularly useful as a medicament.


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.


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 is provided. The method comprises providing a matrix comprising at least a solvent and a polymer; a film forming step of forming a wet film from the 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 22 C.; and a drying step of drying the heated wet film using a drying means.


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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