	US 12,433,889 B2
	Compositions of clofazimine, combinations comprising them, processes for their preparation, uses and methods comprising them
Thomas Hofmann, Doylestown, PA (US); Stefan Ufer, Raleigh, NC (US); and Kevin Stapleton, Laguna Beach, CA (US)
Assigned to Mannkind Corporation, Westlake Village, CA (US)
Filed by MannKind Corporation, Westlake Village, CA (US)
Filed on Sep. 19, 2023, as Appl. No. 18/470,331.
Application 18/470,331 is a continuation of application No. 17/181,448, filed on Feb. 22, 2021, granted, now 11,793,808.
Prior Publication US 2024/0000779 A1, Jan. 4, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/498 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 31/47 (2006.01); A61K 47/02 (2006.01); A61K 47/26 (2006.01)

CPC A61K 31/498 (2013.01) [A61K 9/008 (2013.01); A61K 9/10 (2013.01); A61K 31/47 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01)]

27 Claims

1. A pharmaceutical composition comprising:

a) a therapeutically effective dose of clofazimine or a pharmaceutically acceptable derivative or salt thereof;

b) a nonionic surfactant with a hydrophilic-lipophilic balance value of greater than c) an aqueous liquid carrier selected from at least one of: water, isotonic saline, buffered saline and aqueous electrolyte solutions; and

d) a mucolytic and/or biofilm destructing agent

wherein the clofazimine, or the pharmaceutically acceptable derivative or salt thereof, is provided in the form of particles in a suspension, and

wherein the particles of clofazimine, or the pharmaceutically acceptable derivative or salt thereof, have a median size of less than 5 μm and a D90 of less than 6 μm.