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US 2016/0106664 A1Published application
Novel propellant containing preparations for tiotropium
AssigneeBoehringer Ingelheim International GmbH
InventorsBettina Berner, Hubert Hoelz, Mariola Mann
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Abstract
The present invention relates to a novel propellant-gas-containing medicament composition based on tiotropium 1, processes for the preparation thereof and the use of such medicament compositions in the treatment of respiratory complaints.
Claims16
An inhaler containing a pharmaceutical aerosol formulation consisting of:
- (i) a propellant gas HFA 134a;
- (ii) 0.005-0.03% of an active substance tiotropium (1);
- (iii) a mixture of co-solvents ethanol and water, the ethanol content being between 15-40% and the water content being between 0.5-2.5%;
- and
- (iv) an acid,
- wherein a solution consisting of (ii), (iii), and (iv) has a pH between 6 and 8, and wherein a single actuation from the inhaler has the following delivery characteristics:
- (a) a nominal dose between 5.5 μg and 6.5 μg;
- (b) a delivered dose between 4.5-5.6 μg;
- (c) a pulmonary dose (Fine Particle Dose) between 2-3 μg;
- and
- (d) a mean aerodynamic particle size between 2.5-3.5 μm.
8 more elements
An inhaler containing a pharmaceutical aerosol formulation consisting of:
- (i) a propellant gas HFA 134a;
- (ii) 0.005-0.03% of an active substance tiotropium (1);
- (iii) a mixture of co-solvents ethanol and water, the ethanol content being between 15-40% and the water content being between 0.5-2.5%;
- and
- (iv) an acid,
- wherein a solution consisting of (ii), (iii), and (iv) has a pH between 6 and 8, and wherein an inhaled dose is administered to a patient from a spray jet where the dose flows out of the metering chamber by actuation of the inhaler to expel it from a nozzle, an aerosol thus formed having the following delivery characteristics:
- (a) a nominal dose between 5.5 μg and 6.5 μg;
- (b) a delivered dose between 4.5-5.6 μg;
- (c) a pulmonary dose (Fine Particle Dose) between 2-3 μg;
- and
- (d) a mean aerodynamic particle size between 2.5-3.5 μm.
8 more elements
Dependencies are inferred from the claim text.