US 12,403,092 B2
Liposomal doxorubicin formulation, method for producing a liposomal doxorubicin formulation and use of a liposomal doxorubicin formulation as a medicament
Stéfan Jonathan Halbherr, Bern (CH); Pascal Halbherr, Bern (CH); Christoph Mathieu, Bern (CH); and Patrick Buschor, Bern (CH)
Assigned to InnoMedica Holding AG, Zug (CH)
Appl. No. 17/620,327
Filed by InnoMedica Holding AG, Zug (CH)
PCT Filed Jun. 19, 2020, PCT No. PCT/EP2020/067196
§ 371(c)(1), (2) Date Dec. 17, 2021,
PCT Pub. No. WO2020/254633, PCT Pub. Date Dec. 24, 2020.
Claims priority of application No. 19181524 (EP), filed on Jun. 20, 2019.
Prior Publication US 2022/0265556 A1, Aug. 25, 2022
Int. Cl. A61K 9/1271 (2025.01); A61K 9/00 (2006.01); A61K 31/704 (2006.01); A61P 35/00 (2006.01)
CPC A61K 9/1271 (2013.01) [A61K 9/0019 (2013.01); A61K 31/704 (2013.01); A61P 35/00 (2018.01)] 17 Claims
 
1. A liposomal doxorubicin formulation, wherein the lipid bilayer of the liposomes comprises at least
phosphatidylcholine;
cholesterol;
a polyethyleneglycol-lipid conjugate;
wherein
the liposomes have a mean diameter between 30 and 70 nm, measured by dynamic light scattering and expressed as a Z-average; and/or
the liposomes have a mean diameter between 20 and 50 nm, measured based on cryo-TEM acquired images;
wherein the liposomes have a mean relative circularity of at least 0.99, measured by Cryo-TEM, and where the 10th percentile is at least 0.98;
and wherein the circularity is calculated according to the formula:

OG Complex Work Unit Math
and wherein the liposomal doxorubicin formulation comprises intraliposomal ammonium sulfate.