JPWO2021038532A5 - - Google Patents

Claims (16)

A pharmaceutically stable liquid formulation, comprising:
a. a pharmacologically active antibody that binds IgE;
b. Phosphate buffer;
c. an aggregation inhibitor selected from arginine or lysine or salts thereof; and
d. including a surfactant ;
pH is 6.0 to 7.0,
A pharmaceutically stable liquid formulation characterized in that the antibody concentration is at least 100 mg/ml. 2. The pharmaceutically stable liquid formulation of claim 1, wherein the pharmacologically active antibody that binds IgE is omalizumab. 3. The pharmaceutically stable liquid formulation of claim 2, wherein the omalizumab is present at at least about 100 mg/ml to about 200 mg/ml. 4. The pharmaceutically stable liquid formulation of claim 3, wherein the omalizumab is present at at least about 150 mg/ml. The pharmaceutically stable liquid formulation of claim 1, wherein the phosphate buffer is present at about 5 mg/ml to about 20 mg/ml. The pharmaceutically stable liquid formulation of claim 1, wherein the arginine or lysine as an aggregation inhibitor is present at about 100 mM to about 200 mM. The pharmaceutically stable liquid formulation of claim 1, wherein the surfactant is selected from polysorbate and poloxamer 188 in an amount of about 0.02% to about 0.04%. a. Omalizumab antibody at about 100 to about 160 mg/ml;
b. about 5mM to about 20mM phosphate buffer;
c. from about 100 mM to about 200 mM of an aggregation inhibitor selected from arginine or arginine HCl and lysine or lysine HCl; and
d. about 0.02% to about 0.04% poloxamer 188;
The pharmaceutically stable liquid formulation according to claim 1, having a pH of 6.0. a. Approximately 150 mg/ml omalizumab antibody;
b. Approximately 20mM phosphate buffer;
c. about 200 mM of an aggregation inhibitor selected from arginine or arginine HCl and lysine or lysine HCl; and
d. Contains about 0.04% poloxamer 188;
The pharmaceutically stable liquid formulation according to claim 8, having a pH of 6.0. A pharmaceutically stable liquid formulation according to claim 1, which does not contain a histidine buffer. a. Omalizumab antibody at about 100 to about 160 mg/ml;
b. about 5mM to about 20mM histidine buffer;
c. from about 100 mM to about 200 mM of an aggregation inhibitor selected from arginine or arginine HCl and lysine or lysine HCl; and
d. about 0.02% to about 0.04% poloxamer 188;
A pharmaceutically stable liquid preparation characterized by having a pH of 6.0 to 7.0. The pharmaceutically stable liquid formulation according to claim 1 or 11, wherein the pH is 6.0. A drug delivery device characterized in that it comprises a pharmaceutically stable liquid formulation according to claim 1 or 11. 12. The pharmaceutically stable liquid formulation of claim 1 or 11, having a kinematic viscosity of about 10 cps to about 15 cps. 15. The pharmaceutically stable liquid formulation of claim 14, having a kinematic viscosity of about 10 cps to about 12 cps. Pharmaceutically stable liquid formulation according to claim 1 or 11, comprising an anti-IgE antibody or omalizumab, for the treatment of diseases selected from asthma, urticaria, allergies, chronic idiopathic urticaria.