US 12,168,011 B2
Formulation production process
Peter Lionel Spargo, Canterbury (GB); Phillip A. Haywood, Buntingford (GB); and Edward James French, Canterbury (GB)
Assigned to Verona Pharma PLC, Cardiff (GB)
Filed by Verona Pharma PLC, Cardiff (GB)
Filed on Jan. 25, 2024, as Appl. No. 18/422,922.
Application 18/422,922 is a continuation of application No. PCT/GB2023/050372, filed on Feb. 20, 2023.
Claims priority of application No. 2202297 (GB), filed on Feb. 21, 2022.
Prior Publication US 2024/0165117 A1, May 23, 2024
Int. Cl. A61K 31/519 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 9/0075 (2013.01); A61K 9/1682 (2013.01)] 25 Claims
 
1. A method for producing a sterile liquid pharmaceutical composition comprising sterile ensifentrine particles suitable for administration by inhalation, the method comprising:
(a) heating ensifentrine particles at a temperature of from 100° C. to 220° C. to obtain the sterile ensifentrine particles, wherein the heating produces less than a 0.5% w/w increase in total impurities; and
(b) combining the sterile ensifentrine particles with a sterile liquid vehicle to produce the sterile liquid pharmaceutical composition suitable for administration by inhalation.