Nijmegen, Netherlands
Nijmegen, Netherlands

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The present invention relates to a method to determine the potency of a batch of glatiramer acetate comprising stimulating human monocytic cell line cells with an effective amount of interferon gamma (IFN), exposing said cells to said batch of glatiramer acetate, and determining the viability of said cells induced by glatiramer acetate.


The present invention relates to a method to determine the potency of a batch of glatiramer acetate comprising stimulating human monocytic cell line cells with an effective amount of interferon gamma (IFN), exposing said cells to said batch of glatiramer acetate, and determining determining the number of metabolically active cells induced by glatiramer acetate.


Patent
Synthon B.V. | Date: 2013-12-19

The present invention relates to a tablet composition comprising a therapeutically effective dose of cinacalcet hydrochloride having a particle size distribution D_(90 )equal to or less than 30 m in an amount of from 40% to 60% by weight based on the total weight of the composition, and one or more pharmaceutically acceptable excipients.


The present invention relates to a solid pharmaceutical composition comprising pemetrexed and a solubilizing amount of meglumine or tromethamine. The composition is sufficiently stable for purpose of making pharmaceutical formulations, particularly lyophilized formulations, and is sufficiently soluble in water for purposes of using in parenteral administration.


The present invention relates to a method to determine the potency of a batch of glatiramer acetate comprising stimulating human monocytic cell line cells with an effective amount of interferon gamma (IFN), exposing said cells to said batch of glatiramer acetate, and determining the expression of the monocyte anti-inflammatory cytokine sIL-1Ra or the viability of said cells induced by glatiramer acetate.


Patent
Synthon B.V. | Date: 2014-10-01

Crystalline aripiprazole Type II can be formulated into pharmaceutical tablets having reduced dissolution profile variability upon storage.


The present invention relates to stable pharmaceutical compositions comprising ivabradine hydrochloride polymorph IV, characterized in that the composition is stabilized by a moisture barrier with a WVTR of less than 0.35 g/m^(2)/day at 38 C./90% RH. The invention further relates to the use of said composition as a medicament, particularly in the treatment of stable angina pectoris and chronic heart failure.


Patent
Synthon B.V. | Date: 2015-05-27

The present invention provides a pharmaceutical composition comprising a solid composite consisting essentially of lenalidomide and a sulfonated copolymer of styrene and divinyl benzene and processes to prepare said composition. The composition according to the invention may be used as medicament, particularly for the treatment of multiple myeloma.


The present invention relates to stable pharmaceutical compositions comprising ivabradine hydrochloride polymorph IV, characterized in that the composition is stabilized by a moisture barrier with a WVTR of less than 0.35 g/m^(2)/day at 38C/90% RH. The invention further relates to the use of said composition as a medicament, particularly in the treatment of stable angina pectoris and chronic heart failure.


Patent
Synthon B.V. | Date: 2014-10-29

A process for purifying copolymer peptides such as COP-1 polypeptides by ultrafiltration can be improved by treating the polypeptide solution with an acid before or during the early stages of the ultrafiltration. Adding the acid and/or forming acid addition salts of the polypeptide before ultrafiltration is conducted permits for faster ultrafiltration. Likewise, adding the acid in the ultrafiltration process but before polypeptide precipitation or clogging occurs can also improve the efficiency / convenience of the ultrafiltration step.

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