Aerosol formulations for delivery of dihydroergotamine to the systemic circulation via pulmonary inhalation
First Claim
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1. A surfactant and excipient free pharmaceutical aerosol formulation for delivery by inhalation, said aerosol formulation consisting essentially of:
- (i) a particulate powdered medicament produced by a supercritical fluid process, said particulate powdered medicament having a mass mean aerodynamic diameter of 5 microns or less and being dihydroergotamine; and
(ii) at least one hydrofluoralkane propellant, such that the formulation has a respirable fraction of 40% or greater.
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Abstract
Pharmaceutical aerosol formulations of dihydroergotamine, or pharmaceutically acceptable salts thereof, to administer dry powders and propellant suspensions via pulmonary aerosol or nasal spray inhalation. Such formulations may be used for the treatment of various disease states and conditions, including, but not limited to, migraine headaches. The dihydroergotamine particles are produced using a supercritical fluid process. The aerosol formulations disclosed have superior stability, purity and comprise particle of respirable size particularly suitable for pulmonary delivery.
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Citations
18 Claims
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1. A surfactant and excipient free pharmaceutical aerosol formulation for delivery by inhalation, said aerosol formulation consisting essentially of:
- (i) a particulate powdered medicament produced by a supercritical fluid process, said particulate powdered medicament having a mass mean aerodynamic diameter of 5 microns or less and being dihydroergotamine; and
(ii) at least one hydrofluoralkane propellant, such that the formulation has a respirable fraction of 40% or greater. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18)
- (i) a particulate powdered medicament produced by a supercritical fluid process, said particulate powdered medicament having a mass mean aerodynamic diameter of 5 microns or less and being dihydroergotamine; and
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10. A pharmaceutical aerosol formulation for delivery by inhalation, said aerosol formulation consisting essentially of:
- (i) a particulate powdered medicament produced by a supercritical fluid process, said particulate powdered medicament having a mass mean aerodynamic diameter of 5 microns or less and being dihydroergotamine; and
(iii) a surfactant, said surfactant being oleate, a stearate, a myristate, an alkylether, an alklyarylether, a sorbate or mixtures of any of the foregoing, and said surfactant being present in a mass ratio to the dihydroergotamine of greater than 0.004 to 1, but less than 0.05 to 1 such that the formulation has a respirable fraction of 40% or greater.
- (i) a particulate powdered medicament produced by a supercritical fluid process, said particulate powdered medicament having a mass mean aerodynamic diameter of 5 microns or less and being dihydroergotamine; and
Specification