US 11,723,867 B2
Method for preparing pharmaceutical composition and pharmaceutical composition
Markus Nuopponen, Helsinki (FI); Huang Xiang, Changshu (CN); Haiqiu Song, Suzhou (CN); Yulong Wang, Changsha (CN); and Yanxin Liu, Changsha (CN)
Assigned to UPM_KYMMENE CORPORATION, Helsinki (FI)
Filed by UPM-Kymmene Corporation, Helsinki (FI)
Filed on Sep. 9, 2020, as Appl. No. 17/15,298.
Claims priority of application No. 19397527 (EP), filed on Sep. 13, 2019.
Prior Publication US 2021/0077403 A1, Mar. 18, 2021
Int. Cl. A61K 9/14 (2006.01); A61K 9/16 (2006.01); A61K 31/7048 (2006.01)
CPC A61K 9/1652 (2013.01) [A61K 9/1694 (2013.01); A61K 31/7048 (2013.01)] 17 Claims
 
1. A method for preparing a pharmaceutical composition, the method comprising:
providing pharmaceutical compound having a solubility in water of 1 mg/ml or less at 25° C. in a solvent comprising an organic solvent enabling solubilizing the pharmaceutical compound at least partly into the solvent,
providing an aqueous dispersion of nanostructured cellulose, and
adding the pharmaceutical compound in the solvent to the aqueous dispersion of nanostructured cellulose acting as an anti-solvent to obtain a supersaturated concentration of the pharmaceutical compound allowing the pharmaceutical compound to form nuclei at the supersaturated concentration, and then continue to grow by nucleation into nanoparticles in an anti-solvent recrystallization process to provide nanosized pharmaceutical particles having an average diameter of 50 nm or less,
to provide a pharmaceutical composition having a water content in the range of 92-99.95% (w/w),
wherein the nanostructured cellulose comprises nanofibrillar cellulose which, when dispersed in water, provides a zero shear viscosity in the range of 1000-100000 Pa·s, and a yield stress in the range of 1-50 Pa, determined by rotational rheometer at a consistency of 0.5% (w/w) by weight in aqueous medium at 22° C.±1° C.