US 12,214,077 B2
Liposomal formulation for joint lubrication
Yechezkel Barenholz, Jerusalem (IL); Yaniv Dolev, Raanana (IL); Keren Turjeman, Jerusalem (IL); Gadi Sarfati, Beit Guvrin (IL); and Maty Ayal-Hershkovitz, Herzliya (IL)
Assigned to MOEBIUS MEDICAL LTD., Tel Aviv (IL)
Filed by MOEBIUS MEDICAL LTD., Tel Aviv (IL)
Filed on Aug. 15, 2021, as Appl. No. 17/445,089.
Application 17/445,089 is a continuation of application No. 16/337,188, granted, now 11,123,293, previously published as PCT/IL2018/050923, filed on Aug. 21, 2018.
Claims priority of provisional application 62/548,429, filed on Aug. 22, 2017.
Prior Publication US 2021/0369613 A1, Dec. 2, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/127 (2006.01); A61K 31/685 (2006.01); A61K 47/10 (2017.01); A61K 47/26 (2006.01)
CPC A61K 9/127 (2013.01) [A61K 31/685 (2013.01); A61K 47/10 (2013.01); A61K 47/26 (2013.01)] 27 Claims
 
1. A pharmaceutical composition consisting essentially of:
liposomes consisting essentially of 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC) and 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (DPPC), wherein said liposomes are multilamellar vesicles (MLV) having at least one membrane and a phase transition temperature in the range of about 20° C. to about 39° C.;
a non-ionic tonicity agent, comprising a polyol which is a sugar or sugar alcohol having at least five hydroxyl groups; and
a fluid medium selected from buffer or water in which the liposomes are suspended;
wherein the pharmaceutical composition is essentially free of any additional pharmaceutically active agents;
wherein the pharmaceutical composition is formulated for intra-articular administration; wherein the pharmaceutical composition provides lubrication of a mammalian joint having a temperature which is above the phase transition temperature;
wherein the polyol is present in an amount sufficient to provide osmolality of the composition in the range from about 200 to about 600 mOsm and to improve lubrication efficacy of the composition; and
wherein the polyol is present in a weight percent ranging from about 0.05% (w/w) to about 10% (w/w), of the total weight of the pharmaceutical composition.