Methods for Manufacturing a drug with a stable aerosol size distribution of Fine Particle and a consistent fraction of Fine Particle

摘要

1.A method for the manufacture of a drug product which comprises: (a) storing a container at a temperature higher than the ambient conditions for at least seven days approximately, wherein Said Container comprises a suspension or solution comprising at least one Active Pharmaceutical Agent, a propellant selected from the group consisting of 1,1,1,2 tetrafluoroethane 1,1,1,2,3,3,3-heptafluoropropane, and combinations thereof, and Optionally, Excipients; and (b) to conduct tests of liberation in the container after the storage. 2. The Method of claim 1, wherein Said Active Pharmaceutical Agent is partially Soluble in ethanol. 3.- a drug product produced by the method of claim 1. The Method of claim 1, wherein the ingredients are selected from the group consisting of co Solvents, Surfactants, vehicles and combinations of two or more of the same. 5.The Method of claim 1, wherein the ingredients are selected from a group consisting of oleic acid, ethanol, and combinations of two or more of the same. The Method according to claim 1, wherein the storage is for a period of time of at least 2 weeks. 7.The Method according to claim 1, wherein the storage for a period of at least 3 weeks. 8. - The Method according to claim 1, wherein the storage is for a period of time of at least 4 weeks. 9.The Method according to claim 1, wherein the storage for a period of at least 5 weeks.