Inhalable dry powders

Abstract

The invention related to dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients.

1 - 48 . (canceled) 
     
     
         49 . An article comprising one or more receptacles that are sealed with contents disposed therein, wherein the contents consist of a dry powder that has a total mass of about 5 milligrams or less, said dry powder consists of respirable dry particles that have a volume median geometric diameter (VMGD) of about 10 micrometers or less, a tap density of at least about 0.45 g/cc, and comprise a) one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof, and b) one or more therapeutic agent. 
     
     
         50 - 61 . (canceled) 
     
     
         62 . An article comprising one or more receptacles that are sealed with contents disposed therein, wherein the contents consist of a respirable dry powder that has a total mass of about 5 milligrams to about 15 milligrams, said respirable dry powder consists of respirable dry particles that have a volume median geometric diameter (VMGD) of about 10 micrometers or less, a tap density of at least about 0.45 g/cc, and comprise a) one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof, and b) one or more therapeutic agent; and wherein
 said contents can be disposed into a plurality of said receptacles at a rate of about every 4 seconds or less to produce filled receptacles, wherein the relative standard deviation of the dry powder mass disposed into the receptacles is 3 percent or less, and wherein the plurality of receptacles are filled using a vacuum dosator.   
     
     
         63 - 75 . (canceled) 
     
     
         76 . A process for producing one or more receptacles with a respirable dry powder disposed therein, comprising
 disposing the respirable dry powder into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 4 seconds or less to produce filled receptacles, wherein at least 80% of said filled receptacles contain said respirable dry powder within 85% to 115% of the target fill weight; and   wherein the respirable dry powder consists of respirable dry particles that have a volume median geometric diameter (VMGD) of about 10 micrometers or less, and a tap density of at least about 0.45 g/cubic centimeters, and comprise a) one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof, and b) one or more therapeutic agent.   
     
     
         77 - 128 . (canceled) 
     
     
         129 . The article of  claim 49 , wherein said contents can be disposed into a plurality of said receptacles at a rate of about every 4 seconds or less to produce filled receptacles, wherein the relative standard deviation of the dry powder mass disposed into the receptacles is 3 percent or less. 
     
     
         130 . The article of  claim 49 , wherein the therapeutic agent is present in an amount of 5% or more, by weight. 
     
     
         131 . The article of  claim 49 , wherein the therapeutic agent is present in an amount of about 0.01% to about 20%, by weight; and wherein the one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof is present in an amount of about 20% to about 90%, by weight. 
     
     
         132 . The article of  claim 49 , wherein the therapeutic agent is a long-acting muscarinic anagonists (LAMA). 
     
     
         133 . The article of  claim 132 , wherein the LAMA is tiotropium. 
     
     
         134 . The article of  claim 62 , wherein the therapeutic agent is present in an amount of 5% or more, by weight. 
     
     
         135 . The article of  claim 62 , wherein the therapeutic agent is present in an amount of about 0.01% to about 20%, by weight; and wherein the one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof is present in an amount of about 20% to about 90%, by weight. 
     
     
         136 . The article of  claim 62 , wherein the therapeutic agent is a long-acting muscarinic anagonists (LAMA). 
     
     
         137 . The article of  claim 136 , wherein the LAMA is tiotropium. 
     
     
         138 . The process of  claim 76 , wherein the one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof comprises greater than about 20% to about 60%, by weight, of the respirable dry particles. 
     
     
         139 . The process of  claim 76 , wherein the one or more metal cation salts selected from the group consisting of monovalent metal cation salts, divalent metal cation salts, and combinations thereof comprises greater than about 60% to about 100%, by weight, of the respirable dry particles. 
     
     
         140 . The process of  claim 76 , wherein the one or more metal cation salts is a sodium salt. 
     
     
         141 . The process of  claim 76 , wherein the therapeutic agent is a long-acting muscarinic anagonists (LAMA). 
     
     
         142 . The process of  claim 141 , wherein the LAMA is tiotropium. 
     
     
         143 . The process of  claim 76  wherein the respirable dry powder is filled into a plurality of said receptacles at a target fill weight and at a rate of about one receptacle every 4 second or less to produce filled receptacles, wherein at least 85% of said filled receptacles contain said respirable dry powder within 90% to 110% of the target fill weight. 
     
     
         144 . An article comprising one or more receptacles that are produced by the process of  claim 76 .