	US 12,257,261 B2
	Preparation of preliposomal Annamycin lyophilizate
Donald Picker, Albany, NY (US); and Waldemar Priebe, Houston, TX (US)
Assigned to Board of Regents, The University of Texas System, Austin, TX (US); and Moleculin Biotech, Inc., Houston, TX (US)
Filed by Board of Regents, The University of Texas System, Austin, TX (US); and Moleculin Biotech, Inc., Houston, TX (US)
Filed on Dec. 17, 2021, as Appl. No. 17/554,550.
Application 17/554,550 is a continuation of application No. PCT/US2020/039620, filed on Jun. 25, 2020.
Claims priority of provisional application 62/868,184, filed on Jun. 28, 2019.
Prior Publication US 2022/0105115 A1, Apr. 7, 2022
Int. Cl. A61K 31/704 (2006.01); A61K 9/08 (2006.01); A61K 9/16 (2006.01); A61K 9/19 (2006.01); A61K 47/20 (2006.01); A61K 47/24 (2006.01); A61K 47/26 (2006.01)

CPC A61K 31/704 (2013.01) [A61K 9/08 (2013.01); A61K 9/1694 (2013.01); A61K 9/19 (2013.01); A61K 47/20 (2013.01); A61K 47/24 (2013.01); A61K 47/26 (2013.01)]

17 Claims

1. A method of making lyophilized Annamycin comprising the steps of:

making a solution comprising one or more lipids, one or more non-ionic surfactants, and one or more solvents and having a pH of 4.8-5.9 and wherein said one or more lipids includes DMPG with a pH adjusted to 4.8-5.9;

adding to the lipid solution an Annamycin solution comprising about 8-12 wt. % Annamycin in DMSO to provide a lipid containing solution of Annamycin;

sterile filtering the lipid containing solution of Annamycin; and

lyophilizing the lipid containing solution of Annamycin to provide a preliposomal Annamycin lyophilizate wherein the Annamycin in the lyophilizate produced is at least 95% pure.