Pharmaceutical suspensions containing drug particles, devices for their administration, and methods of their use

Abstract

The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

1 . (canceled) 
     
     
         2 . A method of administering a pharmaceutical composition comprising a drug to a patient, the method comprising:
 (i) inserting a drug delivery device comprising the pharmaceutical composition into a mouth of the patient;   (ii) continuously or semi-continuously administering the pharmaceutical composition into the mouth of the patient at a rate between 0.015 mL/hour and 1.25 mL/hour; and   (iii) removing said drug delivery device from the mouth of said patient,   wherein the drug delivery device comprises a propellant-driven pump comprising a first chamber comprising the pharmaceutical composition, a second chamber comprising the propellant, and a deformable wall separating said first chamber from said second chamber, wherein the deformable wall transmits pressure from the second chamber comprising the propellant to the first chamber comprising the pharmaceutical composition, thereby pushing the pharmaceutical composition out of said first chamber through a tube, and wherein said propellant-driven pump is configured to be worn in a buccal vestibule and to administer said pharmaceutical composition on a lingual side of said patient’s teeth via the tube.   
     
     
         3 . The method of  claim 2 , wherein the rate varies by less than ±20% over a period of at least 4 hours. 
     
     
         4 . The method of  claim 2 , wherein the propellant has a vapor pressure at about 37° C. of greater than 1 bar and less than 50 bar. 
     
     
         5 . The method of  claim 2 , wherein said administering is for a period of at least 4 hours. 
     
     
         6 . The method of  claim 2 , wherein the drug delivery device further comprises a fastener to removably secure the drug delivery device to a surface of the patient’s mouth. 
     
     
         7 . The method of  claim 2 , wherein the drug comprises baclofen or a pharmaceutically acceptable salt thereof. 
     
     
         8 . The method of  claim 7 , wherein said patient has spasticity. 
     
     
         9 . The method of  claim 2 , wherein said drug comprises pilocarpine. 
     
     
         10 . The method of  claim 9 , wherein said patient has xerostomia. 
     
     
         11 . The method of  claim 2 , wherein the drug comprises pyridostigmine or a pharmaceutically acceptable salt thereof. 
     
     
         12 . The method of  claim 11 , wherein said patient has myasthenia gravis. 
     
     
         13 . The method of  claim 2 , wherein the drug comprises levodopa or a pharmaceutically acceptable salt thereof. 
     
     
         14 . The method of  claim 13 , wherein said patient has Parkinson’s disease. 
     
     
         15 . The method of  claim 2 , wherein the pharmaceutical composition comprises a paste, solution, or suspension having a dynamic viscosity greater than 10,000 cP at 37° C. 
     
     
         16 . The method of  claim 2 , wherein the tube has a length of less than 4 cm. 
     
     
         17 . The method of  claim 16 , wherein the tube has a length of greater than 10 mm.