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US 11,077,058 B2Granted
Dry powder compositions with magnesium stearate
AssigneeOtitopic Inc.
InventorKambiz Yadidi
Life of this patent
Estimating the term…
Abstract
A stable dry powder composition for inhalation includes acetylsalicylic acid in particles having a mass median aerodynamic diameter (MMAD) in a range of about 1 μm to about 5 μm. The dry powder composition may contain a pharmaceutically acceptable excipient, such as a stearate, in an amount ranging from about 0.04% (w/w) to about 0.06% (w/w), or from about 0.4% (w/w) to about 0.6% (w/w), of the composition.
Claims17
A drug delivery system for administering a formulation to a person in need thereof via the respiratory tract, said system comprising:
- (a) a dry powder composition comprising dry particles comprising acetylsalicylic acid (ASA), or a pharmaceutically acceptable salt thereof, co-micronized with magnesium stearate, wherein the magnesium stearate is in an amount of about 0.05% (w/w) to about 0.5% (w/w) of the dry powder composition, and ASA stability maintains about 95% or above after exposure to a condition selected from the group consisting of 15-20° C./35-45% relative humidity (RH), 20° C./40% RH, 30° C./60% RH, 40° C./75% RH, and 50° C./75% RH, for two weeks, four weeks, 30 days, a month, six weeks, eight weeks, or 12 months;
- and
- (b) a dry powder inhaler.
Dependencies are inferred from the claim text.