US2012064126A1PendingUtilityA1

Dry powder formulations and methods for treating pulmonary diseases

48
Individually held — no corporate assignee on recordPriority: Mar 26, 2009Filed: Mar 26, 2010Published: Mar 15, 2012
Est. expiryMar 26, 2029(~2.7 yrs left)· nominal 20-yr term from priority
Inventors:Jean C. SungMichael M. Lipp
A61P 31/04A61P 31/00A61P 31/14A61P 31/12A61P 11/00A61M 15/003A61K 33/06A61K 31/194A61K 31/19A61K 47/36A61K 33/14A61M 2202/064A61K 9/0075A61K 47/10A61M 15/0045A61K 9/14A61K 9/1617A61K 31/14A61K 47/12A61K 9/16
48
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Claims

Abstract

The present invention is directed toward respirable dry particles for delivery of divalent metal cation salts and/or monovalent cation salts to the respiratory tract and methods for treating a subject having a respiratory disease and/or infection.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A respirable dry powder comprising respirable dry particles that comprise a divalent metal cation salt; wherein the divalent metal cation salt provides divalent metal cation in an mount of about 5% or more by weight of the dry particle and wherein the respirable dry particles have a volume median geometric diameter (VMGD) of about 10 microns or less and a dispersibility ratio (1/4 bar) of less than about 2 as measured by laser diffraction (RODOS/HELOS system). 
     
     
         2 . The respirable dry powder of  claim 1 , wherein the respirable dry powder has a volume median geometric diameter (VMGD) of about 5.0 microns or less. 
     
     
         3 . The respirable dry powder of  claim 1 , wherein the respirable dry powder has a dispersibility ratio (1/4 bar) of less than about 1.5 as measured by laser diffraction (RODOS/HELOS system). 
     
     
         4 . The respirable dry powder of  claim 1  wherein the respirable dry powder further comprises a monovalent salt that provides monovalent cation in an amount of about 6% or more by weight of the particles. 
     
     
         5 . The respirable dry powder of  claim 1 , wherein the respirable dry powder has a Fine Particle Fraction (FPF) of less than 5.6 microns of at least 45%. 
     
     
         6 . The respirable dry powder of  claim 1 , wherein the respirable dry powder has a Fine Particle Fraction (FPF) of less than 3.4 microns of at least 30%. 
     
     
         7 . The respirable dry powder of  claim 1 , wherein the respirable dry powder has a Fine Particle Fraction (FPF) of less than 5.0 microns of at least 45%. 
     
     
         8 . The respirable dry powder of  claim 1 , wherein the respirable dry powder have a mass median aerodynamic diameter (MMAD) of about 5 microns or less. 
     
     
         9 . The respirable dry powder of  claim 1 , wherein the divalent metal cation salt has a solubility of ≧0.5 g/L in water. 
     
     
         10 . The respirable dry powder of  claim 1 , wherein the respirable dry particles do not contain calcium phosphate. 
     
     
         11 . The respirable dry powder of  claim 1 , wherein the molecular weight ratio of divalent metal cation to the divalent metal cation salt is greater than about 0.1. 
     
     
         12 . (canceled) 
     
     
         13 . The respirable dry powder of  claim 1 , wherein the respirable dry powder further comprise at least one pharmaceutically acceptable excipient. 
     
     
         14 . (canceled) 
     
     
         15 . The respirable dry powder of  claim 13 , wherein the at least one excipient is present in an amount of about ≦50% by weight and comprises leucine. 
     
     
         16 . (canceled) 
     
     
         17 . The respirable dry powder of  claim 13 , wherein the at least one excipient is present in an amount of about ≦50% by weight and comprises maltodextrin or mannitol. 
     
     
         18 . The respirable dry powder of  claim 1 , wherein said divalent metal salt is selected from the group consisting of a magnesium salt, and a barium salt. 
     
     
         19 . The respirable dry powder of  claim 1 , wherein the divalent metal cation salt is a calcium salt. 
     
     
         20 - 21 . (canceled) 
     
     
         22 . The respirable dry powder of  claim 1  wherein the monovalent salt is a lithium salt or a potassium salt. 
     
     
         23 . The respirable dry powder of  claim 1  wherein the monovalent salt is a sodium salt. 
     
     
         24 - 25 . (canceled) 
     
     
         26 . A respirable dry powder comprising a respirable dry particle comprising a divalent metal cation salt and a monovalent salt, wherein the respirable dry particle comprises an amorphous divalent metal cation phase and a crystalline monovalent salt phase. 
     
     
         27 - 40 . (canceled) 
     
     
         41 . A respirable dry powder comprising respirable dry particles that comprise a divalent metal salt, wherein the divalent metal salt provides a cation in an amount of about 5% or more by weight of the dry particle and wherein the respirable dry powder has a Hausner Ratio of greater than 1.5 and a 1/4 bar or 0.5/4 bar of 2 or less. 
     
     
         42 - 52 . (canceled) 
     
     
         53 . A method for treating a respiratory disease comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of  claim 1 . 
     
     
         54 . A method for treating an acute exacerbation of a respiratory disease comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of  claim 1 . 
     
     
         55 . A method for treating or preventing an infectious disease of the respiratory tract comprising administering to the respiratory tract of a patient in need thereof an effective amount of a respirable dry powder of  claim 1 .

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