Method of stabilizing aerosol formulations
First Claim
1. A method of adsorbing a solid particulate drug to a fluoropolymer useful for making a stabilized aerosol drug formulation, comprising:
- combining a solid particulate drug with a fluoropolymer in an organic liquid fluorocarbon aerosol propellant to form a liquid suspension, wherein said fluoropolymer is soluble in said liquid fluorocarbon aerosol propellant, wherein said fluoropolymer is included in said suspension in an amount of from 0.001% to 20% by weight, and wherein said drug is included in said suspension in an amount of from 0.001% to 5% by weight; and
cooling said suspension for a time and to a temperature sufficient to adsorb said fluoropolymer to said solid particulate drug in said liquid fluorocarbon aerosol propellant, wherein said fluoropolymer is adsorbed to said drug so that said formulation is stabilized.
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Abstract
A method of making a stabilized aerosol drug formulation is disclosed, along with the formulations so produced and metered drug inhalers containing the same. The method comprises combining a solid particulate drug composition with a fluoropolymer in a liquid fluorocarbon aerosol propellant to form a stable suspension. Further stabilization can be achieved by cooling the suspension for a time and to a temperature sufficient to adsorb the fluoropolymer to the solid particulate drug composition in the liquid fluorocarbon aerosol propellant. Preferred propellants for carrying out the invention are 1,1,1,2-tetrafluoroethane, heptafluoropropane, and mixtures thereof, and preferred fluoropolymers for carrying out the invention are fluoropolyethers.
215 Citations
21 Claims
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1. A method of adsorbing a solid particulate drug to a fluoropolymer useful for making a stabilized aerosol drug formulation, comprising:
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combining a solid particulate drug with a fluoropolymer in an organic liquid fluorocarbon aerosol propellant to form a liquid suspension, wherein said fluoropolymer is soluble in said liquid fluorocarbon aerosol propellant, wherein said fluoropolymer is included in said suspension in an amount of from 0.001% to 20% by weight, and wherein said drug is included in said suspension in an amount of from 0.001% to 5% by weight; and cooling said suspension for a time and to a temperature sufficient to adsorb said fluoropolymer to said solid particulate drug in said liquid fluorocarbon aerosol propellant, wherein said fluoropolymer is adsorbed to said drug so that said formulation is stabilized. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of adsorbing a solid particulate drug to a fluoropolymer useful for making a metered-dose inhaler containing a stabilized aerosol drug formulation, comprising:
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combining a solid particulate drug with a fluoropolymer in an organic liquid fluorocarbon aerosol propellant to form a suspension, wherein said fluoropolymer is soluble in said liquid fluorocarbon aerosol propellant, wherein said fluoropolymer is included in said suspension in an amount of from 0.001% to 20% by weight, and wherein said drug is included in said suspension in an amount of from 0.001% to 5% by weight; cooling said suspension for a time and to a temperature sufficient to adsorb said fluoropolymer to said solid particulate drug in said liquid fluorocarbon; and packaging said suspension in a metered dose inhaler; wherein said cooling step is carried out before, after, or concurrently with said packaging step, wherein said fluoropolymer is adsorbed to said drug so that said formulation is stabilized. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification