	US 12,409,180 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 Nov. 13, 2024, as Appl. No. 18/946,234.
Application 18/946,234 is a continuation of application No. 18/422,922, filed on Jan. 25, 2024, granted, now 12,168,011.
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 2025/0064814 A1, Feb. 27, 2025
This patent is subject to a terminal disclaimer.
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)]

14 Claims

1. A sterile liquid pharmaceutical composition comprising sterile ensifentrine particles suitable for administration by inhalation, wherein the composition is produced by a method comprising:

(a) dry heating ensifentrine particles as a dry powder at a temperature of from 145° C. to 175° C. for 45 minutes to 160 minutes to obtain the sterile ensifentrine particles, and

(b) combining the sterile ensifentrine particles with a sterile liquid vehicle to produce the sterile liquid pharmaceutical composition suitable for administration by inhalation;

wherein the dry heating produces less than a 0.5% w/w increase in total impurities.