WO2026047392 - A PRESSURIZED INHALATION COMPOSITION OF TIOTROPIUM

National phase entry:
Publication Number WO/2026/047392
Publication Date 05.03.2026
International Application No. PCT/IB2024/060352
International Filing Date 22.10.2024
Title **
[English] A PRESSURIZED INHALATION COMPOSITION OF TIOTROPIUM
[French] COMPOSITION D'INHALATION SOUS PRESSION DE TIOTROPIUM
Applicants **
GLENMARK SPECIALTY S.A.
Inventors
DHUPPAD, Ulhas
PAI, Raveendra
CHANAGARE, Ramakant
TRIVEDI, Rakshit
PATIL, Jitendra
Priority Data
202421064341   26.08.2024   IN
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting2522
EPO Filing, Examination, Granting16671
Japan Filing, Examination, Granting2701
South Korea Filing, Examination, Granting3009
USA Filing, Examination, Granting6940
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Abstract[English] A pressurized inhalation composition includes tiotropium or its pharmaceutically acceptable salt thereof, ethanol, a stabilizer, and a propellant. The ethanol can be in an amount of from about 1% (w/w) to about 10% (w/w) based on the total weight of the pressurized inhalation composition. The composition can be pharmacokinetically bioequivalent to non- pressurized aqueous base inhalation formulation of tiotropium. An inhaler can include the composition contained in a canister fitted with metering valve, and an actuator optionally connected with a dose counter. A process of preparing the pressurized inhalation composition and using the pressurized inhalation composition in the treatment of Asthma and Chronic obstructive pulmonary disease (COPD) in a patient in need thereof by inhalation administration are also described.[French] Une composition d'inhalation sous pression comprend du tiotropium ou son sel pharmaceutiquement acceptable, de l'éthanol, un stabilisant et un agent propulseur. L'éthanol peut être en une quantité d'environ 1 % (p/p) à environ 10 % (p/p) sur la base du poids total de la composition d'inhalation sous pression. La composition peut être bioéquivalente de manière pharmacologique à une formulation d'inhalation de base aqueuse non pressurisée de tiotropium. Un inhalateur peut comprendre la composition contenue dans une cartouche équipée d'une valve doseuse, et un actionneur facultativement relié à un compteur de dose. Sont également décrits un procédé de préparation de la composition d'inhalation sous pression et l'utilisation de la composition d'inhalation sous pression dans le traitement de l'asthme et de la bronchopneumopathie chronique obstructive (BPCO) chez un patient en ayant besoin par l'administration par inhalation.

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