US2018360969A1PendingUtilityA1
Immunoglobulin preparation
Est. expiryFeb 4, 2030(~3.6 yrs left)· nominal 20-yr term from priority
A61P 37/00A61K 47/183A61K 9/0019C07K 16/00A61K 47/22A61K 39/39566A61K 39/395
57
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Claims
Abstract
The present invention relates to the use of proline for reducing the viscosity of a protein preparation.
Claims
exact text as granted — not AI-modified1 .- 20 . (canceled)
21 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises at least 18% immunoglobulin, 100 to 500 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, and wherein the preparation has a viscosity of less than 17 mPa·s as measured by a falling ball viscosimeter at 20.0° C.
22 . The syringe of claim 21 , wherein the immunoglobulin in the preparation consists essentially of IgG obtained from pooled human plasma from at least 1000 donors.
23 . The syringe of claim 21 , wherein the preparation comprises 250 mmol/L proline.
24 . The syringe of claim 21 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push.
25 . The syringe of claim 21 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push.
26 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises at least 18% immunoglobulin consisting essentially of IgG obtained from pooled human plasma from at least 1000 donors, 250 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, wherein the preparation has a viscosity of less than 17 mPA·s as measured by a falling ball viscosimeter at 20.0° C., wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push or rapid push.
27 . The syringe of claim 26 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push.
28 . The syringe of claim 26 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push.
29 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises 20% to 22% immunoglobulin, 100 to 500 mmol/L proline, and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, and wherein the preparation has a viscosity of less than 19 mPa·s as measured by a falling ball viscosimeter at 20.0° C.
30 . The syringe of claim 29 , wherein the immunoglobulin in the preparation consists essentially of IgG obtained from pooled human plasma from at least 1000 donors.
31 . The syringe of claim 29 , wherein the preparation comprises 250 mmol/L proline.
32 . The syringe of claim 29 , wherein the preparation has a viscosity of less than 17 mPa·s as measured by a falling ball viscosimeter at 20.0° C.
33 . The syringe of claim 29 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push.
34 . The syringe of claim 29 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push.
35 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises 20% to 22% immunoglobulin consisting essentially of IgG obtained from pooled human plasma from at least 1000 donors, 250 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, wherein the preparation has a viscosity of less than 19 mPa·s as measured by a falling ball viscosimeter at 20.0° C., wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push or rapid push.
36 . The syringe of claim 35 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push.
37 . The syringe of claim 35 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push.Cited by (0)
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