US 11,813,360 B2
Carrier particles for dry powder formulations for inhalation
Tomaso Guidi, Parma (IT); Amrit Paudel, Parma (IT); Sarah Elizabeth Zellnitz, Parma (IT); and Joana Filipa Fernandes Teixeira Pinto, Parma (IT)
Assigned to CHIESI FARMACEUTICI S.p.A., Parma (IT)
Appl. No. 17/262,802
Filed by CHIESI FARMACEUTICI S.p.A., Parma (IT)
PCT Filed Jul. 24, 2019, PCT No. PCT/EP2019/069943
§ 371(c)(1), (2) Date Jan. 25, 2021,
PCT Pub. No. WO2020/020957, PCT Pub. Date Jan. 30, 2020.
Claims priority of application No. 18186078 (EP), filed on Jul. 27, 2018.
Prior Publication US 2021/0290540 A1, Sep. 23, 2021
Int. Cl. A61K 9/16 (2006.01); A61K 9/00 (2006.01); A61K 47/14 (2017.01); A61P 11/00 (2006.01)
CPC A61K 9/1623 (2013.01) [A61K 9/0075 (2013.01); A61K 9/1682 (2013.01)] 11 Claims
 
1. A pharmaceutical composition comprising one or more active ingredients in physical admixture with spray-congealed carrier particles consisting of mannitol, wherein:
the pharmaceutical composition is in the form of a dry powder for inhalation;
the pharmaceutical composition is formulated so that the one or more active ingredients are delivered in a single dose of 800 micrograms to 1 mg per actuation of an inhaler during use;
the particles have a mass diameter of 30 to 300 micrometers;
the particles a shape factor of 0.80 to 1.15; and
the particles are obtained by a process comprising:
i) heating mannitol until completely melted;
ii) spraying the molten mannitol through a pressure nozzle into a spray congealing chamber to obtain droplets;
iii) cooling the droplets to induce solidification and particle formation;
iv) separating the obtained particles; and
v) conditioning the particles.