US 10,888,500 B2
Particle size stabilization process
Josep Terradas Camins, Castellbisbal-Barcelona (ES); Josep Maria Carulla Oliver, Castellbisbal-Barcelona (ES); Silvia Donnici Garcia, Castellbisbal-Barcelona (ES); David Gomez Lamarca, Castellbisbal-Barcelona (ES); Maria Jose Martinez Velon, Sant Joan Despi-Barcelona (ES); and Emma Recio Soler, Sant Joan Despi (ES)
Assigned to INKE, S.A., Castellbisbal (ES)
Appl. No. 16/321,034
Filed by INKE, S.A., Castellbisbal-Barcelona (ES)
PCT Filed Jul. 25, 2017, PCT No. PCT/EP2017/068707
§ 371(c)(1), (2) Date Jan. 27, 2019,
PCT Pub. No. WO2018/019803, PCT Pub. Date Feb. 1, 2018.
Claims priority of application No. 16382374 (EP), filed on Jul. 29, 2016.
Prior Publication US 2019/0175451 A1, Jun. 13, 2019
Int. Cl. A61J 3/02 (2006.01); A61K 9/00 (2006.01); A61K 9/14 (2006.01); A61K 31/40 (2006.01); A61K 31/4015 (2006.01); A61K 45/06 (2006.01)
CPC A61J 3/02 (2013.01) [A61K 9/0075 (2013.01); A61K 9/14 (2013.01); A61K 31/40 (2013.01); A61K 31/4015 (2013.01); A61K 45/06 (2013.01)] 18 Claims
1. A process for obtaining stable glycopyrronium bromide, comprising the following steps:
a) micronizing glycopyrronium bromide to obtain a particle size distribution (PSD) characterized by a D90 of equal to or below about 10 μm; and
b) curing the micronized glycopyrronium bromide by maintaining the product for at least 2 hours at a temperature of between 125° C. and 160° C.;
wherein the micronization of glycopyrronium bromide in step a) is carried out in the absence of excipients and other active ingredients; and
wherein the curing step b) is carried out under a pressure of below 1 atm.