US2022040206A1PendingUtilityA1

Dry powder formulations for inhalation

74
Assignee: OTITOPIC INCPriority: Jun 3, 2016Filed: Oct 24, 2021Published: Feb 10, 2022
Est. expiryJun 3, 2036(~9.8 yrs left)· nominal 20-yr term from priority
Inventors:Kambiz Yadidi
A61K 31/198A61K 31/616A61P 9/10A61K 9/0075A61K 9/1617A61P 7/02A61K 31/4365A61K 31/216
74
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Claims

Abstract

A respirable dry powder can include acetylsalicylic acid in particles having a mass median aerodynamic diameter (MMAD) within a range of about 0.5 μm to about 10 μm. The respirable dry powder may contain a pharmaceutically acceptable excipient, such as an amino acid (e.g., Leucine), in an amount ranging from about 0.1% (w/w) to about 40% (w/w) of the particles.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A dry powder composition for delivery by inhalation, said dry powder composition comprising dry particles that comprise acetylsalicylic acid or a pharmaceutically acceptable salt thereof, wherein the dry particles have a mass median aerodynamic diameter (MMAD) within a range of about 0.5 μm to about 10 μm, wherein the composition further comprises leucine in an amount ranging from about 5% (w/w) to about 15% (w/w) of the composition. 
     
     
         2 . The dry powder composition of  claim 1 , wherein the leucineis in an amount ranging from about 6% (w/w) to about 15% (w/w) of the composition. 
     
     
         3 . The dry powder composition of  claim 1 , wherein the leucineis in an amount ranging from about 6% (w/w) to about 14% (w/w) of the composition. 
     
     
         4 . The dry powder composition of  claim 1 , wherein the leucineis in an amount ranging from about 7% (w/w) to about 13% (w/w) of the composition. 
     
     
         5 . The dry powder composition of  claim 1 , wherein the leucineis in an amount of about 5% (w/w) of the composition. 
     
     
         6 . The dry powder composition of  claim 1 , wherein the leucineis in an amount of about 15% (w/w) of the composition. 
     
     
         7 . The dry powder composition of  claim 1 , wherein the acetylsalicylic acid or pharmaceutically acceptable salt thereof is in an amount greater than 40% (w/w) of the composition. 
     
     
         8 . The dry powder composition of  claim 1 , wherein acetylsalicylic acid or a pharmaceutically acceptable salt thereof is in an amount greater than 50% (w/w) of the composition. 
     
     
         9 . The dry powder composition of  claim 1 , wherein the MMAD ranges from about 2.0 to about 5.0 μm. 
     
     
         10 . The dry powder composition of  claim 1 , wherein the MMAD ranges from about 3.0 to about 4.0 μm. 
     
     
         11 . The dry powder composition of  claim 1 , wherein the dry powder composition maintains a purity of acetylsalicylic acid or the pharmaceutically acceptable salt thereof of about 98.5% or higher, about 99% or higher, or about 99.5% of higher after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for one or two months. 
     
     
         12 . The dry powder composition of  claim 1 , wherein the dry powder composition maintains a purity of acetylsalicylic acid or the pharmaceutically acceptable salt thereof of about 95.0% or higher, about 96.5% or higher, about 97.0% of higher, about 97.5% or higher, about 98% or higher, about 98.5% or higher, or about 98.8% or higher, after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for six months. 
     
     
         13 . The dry powder composition of  claim 1 , wherein the dry powder composition comprises sialic acid (SA) in an amount of about 5.0% or lower, about 4.0% or lower, about 3.0% or lower, about 2.0% or lower, about 1.0% or lower, about 0.05% or lower, after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for one month, two months, or six months. 
     
     
         14 . The dry powder composition of  claim 1 , wherein the morphology of the dry particles remains consistent after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for one month, two months, or six months. 
     
     
         15 . The dry powder composition of  claim 15 , wherein the particles comprise crystals. 
     
     
         16 . The dry powder composition of  claim 1 , wherein a particle size distribution of the dry particles remains consistent after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for one month, two months, or six months. 
     
     
         17 . The dry powder composition of  claim 16 , wherein one or more parameters selected from the group consisting of MMAD, D (v 0.1), D (v0.5), D(v0.9), D[3,2], D[4,3] and span of the dry particles have a change of about 10% or lower, about 5% or lower, or about 2.5% or lower, after storage at 4° C., 25° C./60% RH, 30° C./65% RH, or 40° C./75% RH for one month, two months, or six months. 
     
     
         18 . A drug delivery system effective to reduce the risk of a thrombotic event or treat thrombosis, wherein the system comprises the dry powder composition of  claim 1 , and wherein acetylsalicylic acid is present at a dose ranging from about 5 mg to about 40 mg. 
     
     
         19 . The drug delivery system of  claim 18 , further comprising clopidogrel. 
     
     
         20 . The drug delivery system of  claim 18 , further comprising another excipient.

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