Facilitated delivery of concentrated antibody formulations using hyaluronidase
AssigneeTakeda Pharmaceutical Company Limited
InventorsJoris HOEFINGHOFF, Peter LEIDENMUEHLER, Bagirath GANGADHARAN, Norbert HAIDER, Andras NAGY, Zhaoyang LI
Life of this patent
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Abstract
Provided is a concentrated pharmaceutical formulation of an immune globulin (IG), and convenient methods for the subcutaneous administration of this pharmaceutical formulation in a warmed state. Such products can be used in methods of treating IG-treatable diseases or conditions. Also provided are combinations, compositions and kits containing an immune globulin (IG) composition and a soluble hyaluronidase composition formulated for subcutaneous administration.
Claims40
A kit comprising:
- (a) a first container comprising a pharmaceutical formulation of recombinant human hyaluronidase in a pharmaceutically acceptable carrier;
- (b) a second container comprising a pharmaceutical formulation of 20% (w/v) IgG in a pharmaceutically acceptable carrier;
- and
- (c) instructions providing guidance for sequentially subcutaneously infusing into a first infusion site, (i), a first aliquot of a pre-determined dosage of the pharmaceutical formulation of recombinant human hyaluronidase and, (ii), following (i), a first aliquot of a pre-determined dosage of the pharmaceutical formulation of 20% (w/v) IgG.
The kit according to any preceding claim, wherein the recombinant human hyaluronidase is rHuPH20.
The kit according to any preceding claim, further comprising an infusion apparatus for sequentially or simultaneously subcutaneously infusing (i), the pharmaceutical formulation of recombinant human hyaluronidase and, (ii), following (i), the pharmaceutical formulation of 20% (w/v) IgG.
The kit according to any preceding claim, further comprising a subcutaneous needle set.
The kit according to any preceding claim, wherein the instructions are a component of a Dosage and Administration section of Complete Prescribing Information.
The kit according to any preceding claim, wherein the instructions provide guidance for subcutaneously infusing the pharmaceutical formulation of rHuPH20 to the first infusion site.
The kit according to any preceding claim, wherein the instructions provide guidance for subcutaneously infusing from about 50 U/g to about 100 U/g IgG of rHuPH20 to the first infusion site.
The kit according to any preceding claim, wherein the instructions provide guidance for subcutaneously infusing at up to at least about 100 mL, at up to at least about 150 mL, up to at least about 200 mL, up to at least about 250 mL, or up to at least about 300 mL of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site.
The kit according to any preceding claim, wherein the instruction provide guidance for subcutaneously infusing the first pre-determined dosage of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site at a rate of at least about 120 mL/hr, at least about 150 mL/hr, at least about 200 mL/hr, at least about 250 mL/hr, or at least about 300 mL/hr.
The kit according to any preceding claim, wherein the instructions provide guidance for subcutaneously infusing at least about 120 mL of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site at a rate of at least about 120 mL/hr, at least about 150 mL/hr, at least about 200 mL/hr, at least about 250 mL/hr, or at least about 300 mL/hr.
The kit according to any preceding claim, wherein the instructions provide, (b) guidance for subcutaneously infusing at least about 300 mL of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site.
The kit according to any preceding claim, wherein the instructions provide (a) guidance for subcutaneously infusing at least about 300 mL of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site at a rate of at least about 300 mL/hr.
The kit according to any preceding claim, wherein the instructions provide guidance for subcutaneously infusing the pharmaceutical formulation of 20% (w/v) IgG warmed to a temperature of from about 30° C. to about 41° C., said pharmaceutical formulation warmed to the temperature prior to the infusing, during the infusing, and a combination thereof.
The kit according to any preceding claim, wherein the instructions further provide guidance on simultaneously or sequentially subcutaneously infusing at a second infusion site, (i), a second aliquot of the pre-determined dosage of the pharmaceutical formulation of recombinant human hyaluronidase and, (ii), following (i), subcutaneously infusing a second aliquot of the pre-determined dosage of the pharmaceutical formulation of 20% (w/v) IgG at the second infusion site.
The kit according to any preceding claim, wherein the instructions provide guidance on subcutaneously infusing the pharmaceutical formulation of rHuPH20 to the first infusion site, followed by infusing the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site using a member selected from:
- (i) a subcutaneous needle set;
- (ii) a pooling bag;
- (iii) a gravity fill set with vented spike;
- (iv) a syringe;
- (v) a pump;
- (vi) a warming device;
- (vii) tubing;
- and a combination thereof.
A method of subcutaneously infusing to a first infusion site a pharmaceutical formulation of 20% (w/v) IgG to a subject in need thereof, the method comprising:
- (a) infusing to the first infusion site, a first aliquot of a pre-determined dosage of hyaluronidase by infusing a pre-determined volume of the pharmaceutical formulation of hyaluronidase to the first infusion site;
- and
- (b) following (a), infusing to the first infusion site, a first aliquot of a pre-determined dosage of IgG by infusing a first pre-determined volume of the pharmaceutical formulation of 20% (w/v) IgG to the first infusion site.
A system for subcutaneously infusing a pharmaceutical formulation of 20% (w/v) IgG, the system configured for subcutaneously infusing the pharmaceutical formulation to a first infusion site of a subject in need thereof, the pharmaceutical formulation comprising:
- at least about 20% (w/v) of IgG and an aqueous pharmaceutically acceptable carrier in which the IgG is dissolved;
- the system comprising:
- a. a first vessel containing the pharmaceutical formulation of 20% (w/v) IgG;
- b. a second vessel containing a pharmaceutical formulation of hyaluronidase:
- c. a first hypodermic needle comprising a first terminus configured to penetrate a first infusion site of the subject, and a terminal opening disposed therein through which the pharmaceutical formulation of 20% (w/v) IgG is delivered to the first infusion site;
- d. an optional first connecting member configured for fluidic connection with the first vessel and the hypodermic needle;
- and
- e. a first warming device configured for thermal contact with a system component selected from the first vessel, the first connecting member, and a combination thereof, the first warming device configured to heat the pharmaceutical formulation of 20% (w/v) IgG to at least about 30° C., maintain the pharmaceutical formulation of 20% (w/v) IgG at a temperature of at least about 30° C., and a combination thereof.
Dependencies are inferred from the claim text.