Dry powder inhaler

Abstract

A dry powder inhaler including replaceable cartridges containing a dry powder for local or systemic delivery through the pulmonary tract and lungs is disclosed. The inhalers are used with inhalable dry powders, including medicament formulations comprising active agents for local or systemic delivery and for the treatment of diseases such as, pulmonary hypertension, cardiovascular disease, anaphylaxis, diabetes, obesity, cancer, and other diseases, or symptoms associated with these and other diseases, such as nausea, vomiting, pain and inflammation.

We claim: 
     
         1 . A composition comprising microcrystalline particles of fumaryl diketopiperazine and treprostinil, wherein the treprostinil content is up to about 20% (w/w). 
     
     
         2 . The composition of  claim 1 , wherein the treprostinil content is from about 0.5 to about 10% (w/w). 
     
     
         3 . The composition of  claim 1 , further comprising a pharmaceutically acceptable carrier or excipient. 
     
     
         4 . The composition of  claim 3 , wherein the pharmaceutically acceptable carrier or excipient is an amino acid, a sugar, a vitamin, a buffer, a surfactant, or a phospholipid. 
     
     
         5 . The composition of  claim 4 , wherein the amino acid is glycine, L-leucine, isoleucine, trileucine, or methionine. 
     
     
         6 . The composition of  claim 4 , wherein the sugar is lactose, mannose, sucrose, mannitol, or trehalose. The composition of  claim 1  further comprising a cannabinoid. 
     
     
         8 . The composition of  claim 4 , wherein the surfactant is polysorbate 80. 
     
     
         9 . The composition of  claim 4 , wherein the phospholipid is phosphotidylcholine. 
     
     
         10 . The composition of  claim 1 , wherein the composition is a spray-dried powder. 
     
     
         11 . A method for treating pulmonary hypertension, the method comprising:
 administering a dry powder composition comprising microcrystalline particles of fumaryl diketopiperazine and treprostinil, wherein the treprostinil content is up to about 20% (w/w) in the composition, and   treating the pulmonary hypertension.   
     
     
         12 . The method of  claim 11 , wherein the administering is by a dry powder inhaler. 
     
     
         13 . The method of  claim 11 , wherein the treprostinil content is from about 0.5% (w/w) to about 10% (w/w). 
     
     
         14 . The method of  claim 11 , wherein the dry powder composition further comprises a cannabinoid. 
     
     
         15 . The method of  claim 12 , wherein the dry powder inhaler is configured to have flow conduits with a total resistance to flow in a dosing configuration ranging in value from 0.065 to about 0.200 (kPa)/liter per minute. 
     
     
         16 . The method of  claim 11 , wherein the administering provides a dose of about 1 mg to about 15 mg of the dry powder composition. 
     
     
         17 . The method of  claim 11 , wherein the administering is oral. 
     
     
         18 . The method of  claim 11 , wherein the administering is by inhalation. 
     
     
         19 . The method of  claim 12 , wherein the dry powder inhaler includes a housing and a body, wherein the body comprises a mounting area for a cartridge that includes the dry powder composition, and the body and the housing are movable relative to one another linearly and are operably configured to engage one another by insertion to effectuate the cartridge to be reconfigured to attain an airflow pathway for discharging a powder dose upon an inhalation. 
     
     
         20 . A dry powder comprising microcrystalline particles of fumaryl diketopiperazine and treprostinil, wherein the dry powder composition is formed by spray drying a solution including about 0.2 to about 1.0 w/w treprostinil in ethyl alcohol and a suspension of FDKP microcrystallites.