Nanoformulations of methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3 -yl]pyrimidin-5-yl} carbamate

A stable nanosuspension comprising nanoparticles of methyl {4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl}carbamate of the formula (I)

• in crystalline form of modification I, characterized in that the x-ray diffractogram of the compound exhibits peak maxima of the 2 theta angle at 5.9, 6.9, 22.7, and one or more stabilizer(s) in a dispersing agent,
• wherein the one or more stabilizer(s) is selected from the group consisting of polyvinylpyrrolidone (PVP) in combination with sodium dodecylsulfate (SDS), vinylpyrrolidone-vinyl acetate copolymer, ethylene oxide-propylene oxide block copolymer, sodium dodecylsulfate (SDS), hydroxypropylmethylcellulose (HPMC), polysorbate, hydroxypropylcellulose (HPC), polyoxyl-35 castor oil, polyoxyl 15 hydroxystearate, Na-desoxycholate, and combinations thereof,
• the maximum concentration of the one or more stabilizer(s) is the solubility limit of the stabilizer(s) in the suspension,
• the dispersing agent is selected from the group consisting of water, primary, secondary, and tertiary alcohols, and polyvalent alcohols,
• the nanoparticles have an average particle size, expressed as d50, of 500 nm or less, and
• the average particle size, expressed as d50, remains at 500 nm or less at storage for at least one week at a temperature of at least 40° C.