Abstract: The present invention relates to crystalline brexpiprazole having a particle size distribution (PSD) characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m. The present invention also relates to a pharmaceutical composition comprising a crystalline brexpiprazole having a PSD characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m, and to an aqueous suspension comprising said crystalline brexpiprazole. The present invention also relates to a composition comprising a crystalline brexpiprazole having a PSD characterized by a d(90) of 30 ?m to 100 ?m, by a d(10) of at least 1.0 ?m, and by a d(4,3) of at least 15.0 ?m, wherein said composition is essentially free from secondary particles of brexpiprazole.
Abstract: The present invention belongs to the field of pharmaceutical industry and relates to a pharmaceutical composition comprising an intragranulate phase and an extragranulate phase, wherein the pharmaceutically active ingredient (API) 2-({6-[(3R)-3-aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile or a pharmaceutically acceptable salt thereof, is present in the intragranulate phase, wherein said intragranulate phase is free from microcrystalline cellulose. Further, the present invention relates to a process for preparing the same.
Type:
Application
Filed:
June 16, 2016
Publication date:
May 17, 2018
Applicant:
Hexal Aktiengesellschaft
Inventors:
Thomas Kohr, Christian Wawra, Marco Marchesan
Abstract: The present invention relates to a sustained-release pharmaceutical formulation, in particular a multiple unit pellet tablet (MUT) formulation for oral administration comprising a plurality of sustained-release pellets. The invention further relates to sustained-release pellets wherein the active agent is an opioid. The sustained-release pellets are suitable for the preparation of a multiple unit pellet tablet formulation.
Type:
Application
Filed:
December 18, 2012
Publication date:
December 11, 2014
Applicant:
Hexal Aktiengesellschaft
Inventors:
Patrick Rother, Andreas Krekeler, Theresa Taeubrich, Christian Wawra, Ingeborg Mohry
Abstract: The invention describes a container (1) for separating tumour cells, in particular disseminated tumour cells (9), from a biological sample, with a closed end and an end which can be opened (2, 3). It contains a thixotropic substance (4) with a specific density selected from a range with a lower limit of 1.055 g/cm3, preferably 1.057 g/cm3, in particular 1.060 g/cm3, and an upper limit of 1.070 g/cm3, preferably 1.069 g/cm3, in particular 1.065 g/cm3, and optionally a separation medium (5) in the form of a density gradient with a specific density selected from a range with a lower limit of 1.060 g/cm3, preferably 1.065 g/cm3, in particular 1.070 g/cm3, and an upper limit of 1.085 g/cm3, preferably 1.080 g/cm3, in particular 1.075 g/cm3.