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US 2020/0368226 A1Published application
Parenteral Formulations And Uses Thereof
AssigneeEustralis Pharmaceuticals Limited (Trading As Pressura Neuro)
InventorsPierre Vankan, Andreea Sasarman, Grasiela Bourscheit Willmbrink
Life of this patent
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Abstract
This invention relates generally to therapeutic parenteral formulations comprising particular substituted pyridine based compounds, their manufacture, and methods and uses of said formulations in treating elevated intracranial pressure for indications such as, but not limited to, traumatic brain injury and stroke.
Claims20
A reconstitutable, parenteral, pharmaceutical composition comprising:
- (i) a compound of Formula (I) or a pharmaceutically acceptable salt, solvate or prodrug thereof:
- wherein R1 is H or C1-4 alkyl;
- and
- (ii) at least one solubiliser selected from the group comprising of a glycerol, glycerin, dimethylacetamide, N-methyl-2-pyrrolidone, propylene glycol, polyethylene glycol 300, polyethylene glycol 400, ricinoleate based solubiliser, cyclodextrin, Kolliphor HS 15 (Solutol HS 15), Kolliphor EL (Cremophor EL), Kolliphor RH 60 (Cremophor RH 60), polysorbate 80 (Tween 80), castor oil, cottonseed oil, triglyceride, sesame oil, soybean oil, or safflower oil, wherein the at least one solubiliser is present in the composition in an amount of about 10% to about 99.8% wt/wt based on the total weight of the composition.
1 more element
A parenteral, pharmaceutical composition comprising:
- (i) a compound of Formula (I) or a pharmaceutically acceptable salt, solvate or prodrug thereof:
- wherein R1 is H or C1-4 alkyl;
- and
- (ii) at least one solubiliser selected from the group comprising of a glycerol, glycerin, dimethylacetamide, N-methyl-2-pyrrolidone, propylene glycol, polyethylene glycol 300, polyethylene glycol 400, ricinoleate based solubiliser, cyclodextrin, Kolliphor HS 15 (Solutol HS 15), Kolliphor EL (Cremophor EL), Kolliphor RH 60 (Cremophor RH 60), polysorbate 80 (Tween 80), castor oil, cottonseed oil, triglyceride, sesame oil, soybean oil, or safflower oil;
- and
- (iii) an infusion fluid selected from the group comprising of water, saline, potassium solution, glucose (dextrose) solution, glucose saline, balanced crystalloid solution, Hartmann's solution, Ringer's solution, lactated Ringer's solution, acetated Ringer's solution, Normosol-R, Normosol-M, Plasmalyte, plasma, human albumin, hydroxyethyl starch, dextran, whole blood, oxyglobin or a combination thereof.
3 more elements
A method for treating elevated intracranial pressure in a subject in need thereof, the method comprising:
- a) reconstituting a reconstitutable, parenteral, pharmaceutical composition in an infusion fluid selected from the group comprising of water, saline, potassium solution, glucose solution, glucose saline, balanced crystalloid solution, Hartmann's solution, Ringer's solution, lactated Ringer's solution, acetated Ringer's solution, Normosol-R, Normosol-M, Plasmalyte, plasma, human albumin, hydroxyethyl starch, dextran, whole blood, oxyglobin or a combination thereof, the parenteral, pharmaceutical composition comprising:
- (i) a compound of Formula (I) or a pharmaceutically acceptable salt, solvate or prodrug thereof:
- wherein R1 is H or C1-4 alkyl;
- and
- (ii) at least one solubiliser selected from the group comprising of a glycerol, glycerin, dimethylacetamide, N-methyl-2-pyrrolidone, propylene glycol, polyethylene glycol 300, polyethylene glycol 400, ricinoleate based solubiliser, cyclodextrin, Kolliphor HS 15 (Solutol HS 15), Kolliphor EL (Cremophor EL), Kolliphor RH 60 (Cremophor RH 60), polysorbate 80 (Tween 80), castor oil, cottonseed oil, triglyceride, sesame oil, soybean oil, or safflower oil, wherein the at least one solubiliser is present in the composition in an amount of about 10% to about 99.8% wt/wt based on the total weight of the composition;
- and
- b) administering to the subject the reconstituted parenteral, pharmaceutical composition.
4 more elements
A method for treating elevated intracranial pressure in a subject in need thereof, the method comprising administering to the subject a parenteral, pharmaceutical composition comprising:
- (i) a compound of Formula (I) or a pharmaceutically acceptable salt, solvate or prodrug thereof:
- wherein R1 is H or C1-4 alkyl;
- and
- (ii) at least one solubiliser selected from the group comprising of a glycerol, glycerin, dimethylacetamide, N-methyl-2-pyrrolidone, propylene glycol, polyethylene glycol 300, polyethylene glycol 400, ricinoleate based solubiliser, cyclodextrin, Kolliphor HS 15 (Solutol HS 15), Kolliphor EL (Cremophor EL), Kolliphor RH 60 (Cremophor RH 60), polysorbate 80 (Tween 80), castor oil, cottonseed oil, triglyceride, sesame oil, soybean oil, or safflower oil;
- and
- (iii) an infusion fluid selected from the group comprising of water, saline, potassium solution, glucose (dextrose) solution, glucose saline, balanced crystalloid solution, Hartmann's solution, Ringer's solution, lactated Ringer's solution, acetated Ringer's solution, Normosol-R, Normosol-M, Plasmalyte, plasma, human albumin, hydroxyethyl starch, dextran, whole blood, oxyglobin or a combination thereof.
3 more elements
Dependencies are inferred from the claim text.