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US 2025/0050040 A1Published application
Metered dose inhalers of fluticasone or an ester thereof
AssigneeGlenmark Pharmaceuticals S.A.
InventorsJulianne BERRY, Rajesh ANKAM, Sushrut KULKARNI, Michael CRICK, Hemant PAWAR, Rajesh RAIKAR
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Abstract
The invention relates to metered dose inhaler comprising a stable pharmaceutical composition of fluticasone or its pharmaceutically acceptable ester contained in a canister fitted with a metering valve, an actuator and dose counter. The invention also relates to a process for preparing said pharmaceutical composition and its use in the treatment of respiratory disorders such as asthma in a subject (e.g., a human).
Claims11
A metered dose inhaler comprising:
- a) a canister storing a pharmaceutical composition comprising (i) fluticasone propionate and (ii) a propellant comprising at least one of hydrofluoroalkane 227 or hydrofluoroalkane 134a, wherein:
- the fluticasone propionate is in suspended form in the pharmaceutical composition, and
- an internal surface of the canister is coated with a fluorocarbon polymer;
- b) a metering valve in fluid communication with the canister, the metering valve being configured to acquire a dose of the pharmaceutical composition from the canister, wherein the metering valve comprises one or more sealing gasket(s) made of ethylene propylene diene monomer or cyclic-olefin-copolymer or combination thereof;
- c) an actuator configured to receive the dose from the metering valve and to deliver the dose of the pharmaceutical composition to a user, wherein the actuator has:
- a spray orifice with a diameter of from about 550 μm to about 650 μm,
- a sump volume of from about 12 mm3 to about 20 mm3, and
- a jet length of from about 1.40 mm to about 1.60 mm;
- and
- d) a dose counter connected to the metering valve, the dose counter configured to indicate a number of doses remaining in the canister, wherein the dose counter is inside the actuator and is not connected to the canister.
7 more elements
Dependencies are inferred from the claim text.