	US 12,083,138 B2
	Methods to reduce complications of intra-articular steroid
Sheue-Fang Shih, Taipei (TW); Po-Chun Chang, Taipei (TW); and Ming-Ju Wu, Taipei (TW)
Assigned to Taiwan Liposome Co., Ltd., Taipei (TW); and TLC Biopharmaceuticals, Inc., South San Francisco, CA (US)
Appl. No. 17/252,382
Filed by TAIWAN LIPOSOME CO., LTD., Taipei (TW); and TLC BIOPHARMACEUTICALS, INC., South San Francisco, CA (US)
PCT Filed Jul. 8, 2019, PCT No. PCT/US2019/040794 § 371(c)(1), (2) Date Dec. 15, 2020, PCT Pub. No. WO2020/014118, PCT Pub. Date Jan. 16, 2020.
Claims priority of provisional application 62/839,231, filed on Apr. 26, 2019.
Claims priority of provisional application 62/695,763, filed on Jul. 9, 2018.
Prior Publication US 2021/0196733 A1, Jul. 1, 2021
Int. Cl. A61K 31/685 (2006.01); A61K 9/00 (2006.01); A61K 31/573 (2006.01); A61K 31/683 (2006.01); A61P 19/02 (2006.01)

CPC A61K 31/685 (2013.01) [A61K 9/0019 (2013.01); A61K 31/573 (2013.01); A61K 31/683 (2013.01); A61P 19/02 (2018.01)]

14 Claims

1. A method of treating joint pain and reducing side effects induced by an intra-articular (IA) steroid, comprising administering to a subject in need of treatment for joint pain an effective amount of a pharmaceutical composition comprising

(a) a lipid mixture comprising a first phospholipid, a second phospholipid and a cholesterol at a mole percent ratio of 29.5% to 90%:3% to 37.5%:10% to 33%; and

(b) an effective amount of the IA steroid or a pharmaceutically acceptable salt thereof, wherein the IA steroid or pharmaceutically acceptable salt thereof is at a concentration ranging from about 15 mM to about 40 mM; and wherein the pharmaceutical composition is administered via a dosing regimen having at least two intra-articular injections with a dosing interval of at least four weeks.

14. A pharmaceutical composition for treating joint pain or inflammation, wherein the pharmaceutical composition comprises:

(a) a lipid mixture comprising DOPC, DOPG and cholesterol at a mole percent ratio of 29.5% to 90%:3% to 37.5%:10% to 33%; and

(b) an IA steroid or a pharmaceutically acceptable salt thereof,

wherein the IA steroid is dexamethasone sodium phosphate at a dose ranging from 10 mg to 14 mg with a concentration ranging from about 15 mM to about 40 mM; and

wherein the pharmaceutical composition is administered via a dosing regimen having at least two intra-articular injections with a dosing interval of at least four weeks.