Reduced-viscosity concentrated protein formulations

Patent metadata

Field	Value
Publication number	US-2016367675-A1
Application number	US-201615253571-A
Country	US
Kind code	A1
Filing date	Aug 31, 2016
Priority date	Oct 12, 2000
Publication date	Dec 22, 2016
Grant date	—

Abstract

The present application concerns concentrated protein formulations with reduced viscosity, which arc particularly suitable for subcutaneous administration. The application further concerns a method for reducing the viscosity of concentrated protein formulations.

First claim

1 .- 55 . (canceled)

56 . A stable liquid formulation comprising a monoclonal antibody in an amount of at least about 80 mg/ml and a salt and/or buffer in an amount of at least 50 mM, wherein the salt and/or buffer is derived from arginine or histidine.

57 . The formulation of claim 56 , comprising said salt and/or buffer in an amount of about 50-200 mM.

58 . The formulation of claim 57 , comprising said salt and/or buffer in an amount of about 100-200 mM.

59 . The formulation of claim 56 , wherein said salt and/or buffer is in an amount of about 50 mM.

60 . The formulation of claim 56 , wherein said salt and/or buffer comprises arginine.

61 . The formulation of claim 56 , wherein said salt and/or buffer is arginine hydrochloride.

62 . The formulation of claim 56 , wherein said salt and/or buffer comprises histidine.

63 . The formulation of claim 56 , further comprising a lyoprotectant.

64 . The formulation of claim 63 , wherein said lyoprotectant is a sugar.

65 . The formulation of claim 64 , wherein said sugar is sucrose or trehalose.

66 . The formulation of claim 65 , comprising said sugar in an amount of about 60-300 mM.

67 . The formulation of claim 56 , further comprising a surfactant.

68 . The formulation of claim 67 , wherein the surfactant is a polysorbate.

69 . The formulation of claim 68 , wherein the polysorbate is polysorbate 20.

70 . The formulation of claim 56 which is a reconstituted formulation.

71 . The formulation of claim 70 , wherein the antibody concentration in the reconstituted formulation is about 2-40 times greater than the antibody concentration in the mixture before lyophilization.

72 . The formulation of claim 56 , wherein the antibody is in an amount of about 80 mg/ml to about 300 mg/ml.

73 . The formulation of claim 56 , wherein the antibody is in an amount of about 90 mg/ml to about 150 mg/ml.

74 . The formulation of claim 56 which is a liquid pharmaceutical formulation.

75 . The formulation of claim 74 which is for subcutaneous administration.

76 . An article of manufacture comprising a container containing the formulation of claim /// 56 .

77 . The article of manufacture of claim 76 further comprising directions for administration of said formulation.

Assignees

• Genentech Inc
• Novartis Ag

Inventors

• Liu Jun
• Shire Steven J

Classifications

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• C07K16/4291

  against IgE · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61P11/06

  Antiasthmatics · CPC title

• A61K39/39591 Primary

  Stabilisation, fragmentation · CPC title