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US 2012/0055469 A1Published application
Stable pharmaceutical drug products
AssigneeSchering Corporation
InventorsJILL K. SHERWOOD, Joel Sequeira, Brent Ashley Donovan
Life of this patent
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AssigneeSchering Corporation
InventorsJILL K. SHERWOOD, Joel Sequeira, Brent Ashley Donovan
Estimating the term…
Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).
A method of manufacturing a pharmaceutical drug product comprising:
A drug product comprising a metered dose inhaler container comprising comprising a propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and a combination thereof, and at least one active pharmaceutical agent having a fine particle size distribution that stays substantially the same over a period of time for about 6 months from the date of manufacture when stored at ambient conditions;
A drug product comprising a metered dose inhaler container comprising at least one active pharmaceutical agent, ethanol, a propellant selected from the group consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, and a combination thereof;
Dependencies are inferred from the claim text.