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US 12,643,950 B1Granted
Autoinjector comprising high concentration formulation of vedolizumab
AssigneeTakeda Pharmaceutical Company Limited
InventorsNobel T. Truong, Willow Diluzio
Life of this patent
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Abstract
Anti-alpha4beta7 integrin antibody liquid formulations are described that have a high concentration of antibody, e.g., 90 mg/ml or more, have a viscosity suitable for injection for subcutaneous delivery, including by self-administration by the patient. In certain embodiments, formulations can be used in combination with an autoinjector having a suitable force of delivery given the viscosity of the formulation.
Claims12
An autoinjector comprising
- a glass syringe comprising a liquid pharmaceutical formulation comprising a humanized anti-alpha4beta7 antibody at a concentration of about 100 mg/mL to 180 mg/mL, a buffer, and an excipient in an amount suitable for achieving a viscosity of the formulation of about 25 cP or less at about 25 degrees Celsius, wherein the formulation has a viscosity of about 35 cP or more at 3 degrees Celsius, wherein the formulation has a pH of about 5 to about 7.5, wherein the antibody is vedolizumab, and wherein the buffer is not citrate,
- a piston covered in a film to increase lubricity of the piston or a piston formed with a lubricity compound therein, wherein the lubricity of the piston reduces breakloose and glide forces associated with the piston, and
- a tubular housing comprising a protrusion configured to receive a recess of an activation means and a resilient member disposed at a proximal end of the tubular housing and in engagement with the activation means, wherein the resilient member is a tension spring or a coil spring configured to apply a force on a plunger rod between about 2-20 N,
- wherein the autoinjector is suitable for subcutaneous self-administration by a human subject.
1 more element
Dependencies are inferred from the claim text.