Thin Wall Cannula
AssigneesBecton Dickinson France, Becton, Dickinson and Company
InventorsSandra Leang, Brigitte Duinat, Benoit Fremon, Alfred W. Prais
Life of this patent
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Abstract
The present invention relates to syringe and needle configurations that facilitate subcutaneous injection of viscous drug formulations, including high-concentration biologics such as omalizumab, while maintaining a relatively small needle outer diameter and providing acceptable injection performance under reasonable forces. The device includes a needle having a length of 12.7 mm, a gauge of 27, a minimum internal diameter of 0.277 mm, and 5 bevels on its distal surface. Methods of treatment using these devices for subcutaneous administration of omalizumab are also provided.
Claims53
A method of treating a patient having one or more of:
- allergic asthma;
- food allergy;
- chronic rhino sinusitis with nasal polyps;
- chronic spontaneous urticaria;
- nasal polyps;
- moderate to severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids, the method comprising administering X mL of a 150 mg/mL omalizumab formulation to the patient, wherein X is 1 or 0.5 and wherein the X mL of the 150 mg/mL omalizumab formulation is administered subcutaneously by a syringe, the syringe comprising:
- a reservoir filled with the X mL of the 150 mg/mL omalizumab formulation, wherein the X mL of the 150 mg/mL omalizumab formulation has 6000 or fewer particles of diameter >10 μm and/or 600 or fewer particles of diameter >25 μm;
- and the syringe further comprising:
- a stopper, and
- a needle having a length of 12.7 mm, a gauge of 27, a minimum internal diameter of 0.277 mm, and 5 bevels on its distal surface;
- and
- the syringe being configured to expel the omalizumab formulation contained in the reservoir through the needle when a force is applied to the stopper, wherein one of the following options is fulfilled when a constant force of 10 N is applied to the stopper:
- a) when X is 1, the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 5 seconds;
- or
- b) when X is 0.5, the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 4 seconds.
A syringe comprising:
- a reservoir filled with X mL of a 150 mg/mL omalizumab formulation, wherein X is 2, 1 or 0.5, wherein the X mL of the 150 mg/mL omalizumab formulation has 6000 or fewer particles of diameter >10 μm and/or 600 or fewer particles of diameter >25 μm;
- and
- the syringe further comprising:
- a stopper, and
- a needle having a length of 12.7 mm, a gauge of 27, a minimum internal diameter of 0.277 mm, and 5 bevels on its distal surface, the syringe being configured to expel the X mL of the omalizumab formulation contained in the reservoir through the needle when a force is applied to the stopper, wherein one of the following options is fulfilled when a constant force of 10 N is applied to the stopper:
- a) when X is 2, the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 16 seconds;
- b) when X is 1, the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 5 seconds;
- or
- c) when X is 0.5, the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 4 seconds.
A method of treating a patient with of one or more of:
- allergic asthma;
- food allergy;
- chronic rhinosinusitis with nasal polyps;
- chronic spontaneous urticaria;
- nasal polyps;
- moderate to severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids, the method comprising administering X mL of 150 mg/ml omalizumab formulation to the patient, wherein X is 2, and wherein the X mL 150 mg/mL omalizumab formulation is administered subcutaneously by a syringe, the syringe comprising:
- a reservoir filled with X mL of 150 mg/mL omalizumab formulation, wherein the X mL 150 mg/mL omalizumab formulation has 6000 or fewer particles of diameter>10 μm and/or 600 or fewer particles of diameter>25 μm;
- and the syringe further comprising:
- a stopper, and
- a needle having a gauge of gauge 25 to gauge 29;
- and
- the syringe being configured to expel the omalizumab formulation contained in the reservoir through the needle when a force is applied to the stopper, wherein when a constant force of 10 N is applied to the stopper,
- the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 16 seconds.
A syringe comprising:
- a reservoir filled with X mL of 150 mg/mL omalizumab formulation, wherein X is 2, wherein the X mL of 150 mg/mL omalizumab formulation has 6000 or fewer particles of diameter>10 μm and/or 600 or fewer particles of diameter>25 μm;
- and the syringe further comprising:
- a stopper, and
- a needle having a gauge of gauge 25 to gauge 29,
- the syringe being configured to expel X mL of the omalizumab formulation contained in the reservoir through the needle when a force is applied to the stopper, wherein when a constant force of 10 N is applied to the stopper:
- the syringe is configured to expel the omalizumab formulation contained in the reservoir through the needle in less than 16 seconds.
A method of treating a patient with one or more of:
- allergic asthma;
- food allergy;
- chronic rhinosinusitis with nasal polyps;
- chronic spontaneous urticaria;
- nasal polyps;
- moderate to severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids, the method comprising administering 300 mg omalizumab formulation to the patient, wherein the method comprises administering 2 mL of 150 mg/mL omalizumab formulation subcutaneously by one syringe filled with 2 mL 150 mg/mL omalizumab formulation.
Dependencies are inferred from the claim text.