Synthon BV

Nijmegen, Netherlands

Synthon BV

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: 2017-05-10

The invention relates to a process for making a microcrystalline dimethyl fumarate comprising a step of providing a solution of dimethyl fumarate in methanol and combining the solution with water under precipitation of microcrystalline dimethyl fumarate.


Patent
Synthon BV | Date: 2017-06-28

The present invention relates to a process for making crystalline lenalidomide form A of formula (1), characterized by a XRPD powder diffraction pattern comprising the peaks at about 7.89, 4.35, 14.83, 15.81, 16.23, 20.12, 23.78, 24.09, 25.96 degrees 2 theta, when measured with CuK1 radiation ( = 1.54060 ), the process comprising: 1. Reduction of 3-(4-nitro-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-piperidinedione of formula (2) with a reducing agent in a mixed solvent comprising a mixture of C1-C3 aliphatic alcohol and N,N-dimethylformamide or N,N-dimethylacetamide, wherein the content of N,N-dimethylformamide or N,N-dimethylacetamide in the mixed solvent is between 20-40% (v/v), 2. Isolation of lenalidomide form.


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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