US2007042048A1PendingUtilityA1

Devices, Compositions and Methods for the Pulmonary Delivery of Aerosolized Medicaments

63
Assignee: NEKTAR THERAPEUTICSPriority: Apr 14, 1995Filed: Jun 27, 2006Published: Feb 22, 2007
Est. expiryApr 14, 2015(expired)· nominal 20-yr term from priority
Inventors:Robert M. PlatzJohn S. PattonLinda FosterMohammed Eljamal
A61P 37/02A61P 5/10A61P 5/12A61P 7/02A61P 37/04A61P 3/06A61P 7/04A61P 31/18A61P 9/10A61P 31/10A61P 7/06A61P 35/00A61P 35/02A61P 3/10A61P 31/12A61P 25/02A61P 25/00A61P 19/10A61P 1/16A61P 11/06A61K 9/0075A61P 1/10A61P 19/02A61P 11/00A61P 13/12A61P 19/08A61K 38/57A61K 9/1658A61K 9/1635A61M 2205/0233A61K 38/23A61K 9/1688A61M 2205/073A61M 15/0033A61K 38/28A61K 38/1793A61M 15/0045A61K 9/1652A61K 38/215A61K 31/727C12N 2799/022A61K 9/1617A61M 2202/064A61K 31/7088A61K 9/1623A61K 9/1611A61K 47/544A61K 9/1694B82Y 5/00A61M 15/0051A61K 38/29A61K 48/00A61M 15/0086A61M 15/00
63
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Claims

Abstract

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 μm mass median diameter (MMD), usually 1.0-4.0 μm MMD, and preferably 1.0-3.0 μm MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 μm mass median aerodynamic diameter (MMAD), usually 1.5-4.5 μm MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Claims

exact text as granted — not AI-modified
1 . A unit dosage comprising: 
 a unit dosage receptacle; and    a pharmaceutical composition within the unit dosage receptacle, wherein the pharmaceutical composition comprises a therapeutically effective amount of insulin and a buffer, and wherein the pharmaceutical composition comprises particles having a mass median aerodynamic diameter ranging from about 1 μm to 5 μm.    
     
     
         2 . The unit dosage of  claim 1 , wherein the buffer comprises sodium citrate.  
     
     
         3 . The unit dosage of  claim 1 , wherein the particles have an average particle size less than about 10 μm.  
     
     
         4 . The unit dosage of  claim 1 , wherein about 95% of the mass is in particles having a diameter of about 10 μm or less, and about 80% of the mass is in particles having a diameter of less than 5 μm.  
     
     
         5 . The unit dosage of  claim 1 , wherein more than about 98% of the mass is in particles having a diameter size less than 10 μm, and about 90% of the mass is in particles having a diameter less than 5 μm.  
     
     
         6 . The unit dosage of  claim 1 , wherein the pharmaceutical composition comprises less than about 10 wt % water.  
     
     
         7 . The unit dosage of  claim 1 , wherein the pharmaceutical composition comprises less than about 5 wt % water.  
     
     
         8 . The unit dosage of  claim 1 , wherein the pharmaceutical composition comprises less than about 3 wt % water.  
     
     
         9 . The unit dosage of  claim 1 , wherein an amount of the insulin ranges from about 0.2 wt % to 97.0 wt % of the pharmaceutical composition.  
     
     
         10 . The unit dosage of  claim 1 , wherein the therapeutically effective amount ranges from about 0.5 mg to 15 mg.  
     
     
         11 . The unit dosage of  claim 1 , wherein the unit dosage receptacle comprises a capsule.  
     
     
         12 . The unit dosage of  claim 1 , wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         13 . The unit dosage of  claim 1 , wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         14 . The unit dosage of  claim 1 , wherein the particles have an average particle size less than about 10 μm, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         15 . The unit dosage of  claim 1 , wherein the buffer comprises sodium citrate, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         16 . The unit dosage of  claim 1 , wherein the buffer comprises sodium citrate, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         17 . The unit dosage of  claim 1 , wherein the particles have an average particle size less than about 10 μm, wherein the buffer comprises sodium citrate, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         18 . An inhalation device, wherein the unit dosage receptacle of  claim 1  is within the inhalation device.  
     
     
         19 . A unit dosage comprising: 
 a unit dosage receptacle; and    a pharmaceutical composition within the unit dosage receptacle, wherein the pharmaceutical composition comprises a therapeutically effective amount of insulin and a penetration enhancer, and wherein the pharmaceutical composition comprises particles having a mass median aerodynamic diameter ranging from about 1 μm to 5 μm.    
     
     
         20 . The unit dosage of  claim 19 , wherein the particles have an average particle size less than about 10 μm.  
     
     
         21 . The unit dosage of  claim 19 , wherein about 95% of the mass is in particles having a diameter of about 10 μm or less, and about 80% of the mass is in particles having a diameter of less than 5 μm.  
     
     
         22 . The unit dosage of  claim 19 , wherein more than about 98% of the mass is in particles having a diameter size less than 10 μm, and about 90% of the mass is in particles having a diameter less than 5 μm.  
     
     
         23 . The unit dosage of  claim 19 , wherein the pharmaceutical composition comprises less than about 10 wt % water.  
     
     
         24 . The unit dosage of  claim 19 , wherein the pharmaceutical composition comprises less than about 5 wt % water.  
     
     
         25 . The unit dosage of  claim 19 , wherein the pharmaceutical composition comprises less than about 3 wt % water.  
     
     
         26 . The unit dosage of  claim 19 , wherein an amount of the insulin ranges from about 0.2 wt % to 97.0 wt % of the pharmaceutical composition.  
     
     
         27 . The unit dosage of  claim 19 , wherein the therapeutically effective amount ranges from about 0.5 mg to 15 mg.  
     
     
         28 . The unit dosage of  claim 19 , wherein the unit dosage receptacle comprises a capsule.  
     
     
         29 . The unit dosage of  claim 19 , wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         30 . The unit dosage of  claim 19 , wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         31 . The unit dosage of  claim 19 , wherein the particles have an average particle size less than about 10 μm, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         32 . The unit dosage of  claim 19 , wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         33 . The unit dosage of  claim 19 , wherein the particles have an average particle size less than about 10 μm, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         34 . An inhalation device, wherein the unit dosage receptacle of  claim 19  is within the inhalation device.  
     
     
         35 . A unit dosage comprising: 
 a unit dosage receptacle; and    a pharmaceutical composition within the unit dosage receptacle, wherein the pharmaceutical composition comprises a therapeutically effective amount of insulin, wherein the pharmaceutical composition comprises less than about 10 wt % water, and wherein the pharmaceutical composition comprises particles having a mass median aerodynamic diameter ranging from about 1 μm to 5 μm.    
     
     
         36 . The unit dosage of  claim 35 , wherein the particles have an average particle size less than about 10 μm.  
     
     
         37 . The unit dosage of  claim 35 , wherein about 95% of the mass is in particles having a diameter of about 10 μm or less, and about 80% of the mass is in particles having a diameter of less than 5 μm.  
     
     
         38 . The unit dosage of  claim 35 , wherein more than about 98% of the mass is in particles having a diameter size less than 10 μm, and about 90% of the mass is in particles having a diameter less than 5 μm.  
     
     
         39 . The unit dosage of  claim 35 , wherein the pharmaceutical composition comprises less than about 5 wt % water.  
     
     
         40 . The unit dosage of  claim 35 , wherein the pharmaceutical composition comprises less than about 3 wt % water.  
     
     
         41 . The unit dosage of  claim 35 , wherein an amount of the insulin ranges from about 0.2 wt % to 97.0 wt % of the pharmaceutical composition.  
     
     
         42 . The unit dosage of  claim 35 , wherein the therapeutically effective amount ranges from about 0.5 mg to 15 mg.  
     
     
         43 . The unit dosage of  claim 35 , wherein the unit dosage receptacle comprises a capsule.  
     
     
         44 . The unit dosage of  claim 35 , wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         45 . The unit dosage of  claim 35 , wherein the pharmaceutical composition comprises less than about 5 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         46 . The unit dosage of  claim 35 , wherein the particles have an average particle size less than about 10 μm, wherein the pharmaceutical composition comprises less than about 5 wt % water, and wherein the unit dosage receptacle comprises a capsule.  
     
     
         47 . The unit dosage of  claim 35 , wherein the pharmaceutical composition comprises less than about 5 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         48 . The unit dosage of  claim 35 , wherein the particles have an average particle size less than about 10 μm, wherein the pharmaceutical composition comprises less than about 5 wt % water, and wherein the unit dosage receptacle comprises a foil plastic laminate.  
     
     
         49 . An inhalation device, wherein the unit dosage receptacle of  claim 35  is within the inhalation device.  
     
     
         50 - 76 . (canceled)

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