US 10,376,467 B2
Process for reconstitution of a solid form of a pharmaceutical composition
Xavier Payet-Burin, Villard Bonnot (FR)
Appl. No. 15/112,046
Filed by UCB BIOPHARMA SPRL, Brussels (BE); and EVEON, Montbonnot-Saint-Martin (FR)
PCT Filed Jan. 20, 2015, PCT No. PCT/EP2015/050988
§ 371(c)(1), (2) Date Jul. 15, 2016,
PCT Pub. No. WO2015/107214, PCT Pub. Date Jul. 23, 2015.
Claims priority of application No. 14305070 (EP), filed on Jan. 20, 2014.
Prior Publication US 2016/0331682 A1, Nov. 17, 2016
Int. Cl. A61K 9/19 (2006.01); A61K 9/00 (2006.01); A61K 47/60 (2017.01)
CPC A61K 9/0095 (2013.01) [A61K 9/19 (2013.01); A61K 47/60 (2017.08)] 19 Claims
OG exemplary drawing
1. A process for reconstitution of a solid form of a pharmaceutical composition, comprising the following in succession:
(i) providing the solid form of the pharmaceutical composition in a sealed container, the pressure within the container being an initial pressure comprised between 0.5 Pa and 1.2×105 Pa;
(ii) at a first time point, introducing a solvent into said sealed container and maintaining the resulting pressure pr within the container for a controlled time; and
(iii) at a second time point, before reconstitution is complete, increasing the pressure within the container to a controlled pressure higher than pr until complete reconstitution.