Concentrated protein formulations and uses thereof
AssigneeCytoDyn Inc.
InventorTracy T. Chen
Life of this patent
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Abstract
Described are low viscosity, hypotonic formulations containing one or more proteins, e.g., antibodies, at high concentration, uses of the formulations, and articles of manufacture. In particular, the formulations are useful and beneficial for the subcutaneous administration or delivery of a high concentration of a protein drug, such as an antibody, to a subject who is afflicted with a disease or condition that is treatable by the protein drug.
Claims21
A formulation comprising concentrated PRO 140 in an amount greater than about 100 mg/mL and less than about 200 mg/mL;
- a tonicifier consisting essentially of a sodium salt and a histidine and glycine buffer present in a combined amount of from about 110 mM to about 120 mM and wherein the buffer is present in an amount of about 10 mM to about 25 mM;
- and a surfactant, wherein the formulation is hypotonic and has a total salt concentration of less than 100 mM.
A formulation comprising:
- concentrated PRO 140 in an amount greater than about 100 mg/mL and less than about 200 mg/mL;
- a sodium salt in an amount greater than about 90 mM and less than 100 mM;
- a histidine and glycine buffer in an amount greater than about 5 mM and less than about 25 mM;
- a surfactant in an amount greater than about 0.001% w/v and less than about 0.2% w/v;
- and, optionally,
- a stabilizing agent or non-salt tonicifier in an amount of about 0.05% w/v to about 1.8% w/v;
- wherein the formulation has an osmolality of about 250 to about 280 mOsm and has a total salt concentration of less than 100 mM.
A low viscosity, hypotonic formulation, comprising:
- (a) concentrated PRO 140 in an amount greater than about 100 mg/mL and less than about 200 mg/mL;
- (b) a sodium salt in an amount selected from about 90 mM or about 95 mM;
- (c) a histidine and glycine buffer in an amount of about 20 mM;
- (d) a surfactant in an amount of 0.005% to 0.2% w/v;
- and optionally
- (e) a stabilizing agent or non-salt tonicifier in an amount sufficient to provide an osmolality of the formulation of about 260-280 mOs/kg;
- wherein the formulation has a total salt concentration of less than 100 mM.
A low viscosity hypotonic formulation, comprising:
- (a) concentrated PRO 140 in an amount greater than about 100 mg/mL and less than about 200 mg/mL;
- (b) a salt in an amount selected from about 90 mM or about 95 mM, wherein the salt is selected from sodium chloride, sodium gluconate, or sodium lactate;
- (c) a histidine and glycine buffer in an amount of about 20 mM;
- (d) a surfactant in an amount of about 0.005% to about 0.2% w/v, wherein the surfactant is a polysorbate, a poloxamer, or a pluronic;
- and
- (e) a stabilizing agent or non-salt tonicifier present in an amount sufficient to provide an osmolality of the formulation of about 230 mOs/kg to about 280 mOs/kg, wherein the stabilizing agent or non-salt tonicifier is selected from a sugar alcohol, a monosaccharide, a disaccharide, or a combination thereof;
- wherein the formulation has a total salt concentration of less than 100 mM.
A composition comprising PRO 140 in an amount greater than about 100 mg/mL and less than about 200 mg/mL, a tonicifier comprising a sodium salt present in a concentration of greater than about 90 mM and a histidine and glycine buffer present in a combined amount of from 110 mM to 120 mM and a surfactant present in an amount of from about 0.001% to about 0.2% w/v, wherein the composition has an osmolality of about 230 to about 290 mOs/kg and a total salt concentration of less than 100 mM.
An article of manufacture comprising a container and a formulation comprising PRO 140 in a concentration of greater than 100 mg/mL and less than 200 mg/mL, a tonicifier of a sodium salt present in a concentration of greater than about 90 mM and a histidine and glycine buffer present in a combined amount of from about 110 mM to about 120 mM and the formulation has a total salt concentration of less than 100 mM, a surfactant in an amount of from about 0.005% to about 0.2%, and instructions for use.
Dependencies are inferred from the claim text.