Treatment of asthma and chronic obstructive pulmonary disease with anti-proliferate and anti-inflammatory drugs

Abstract

Embodiments of the present invention provide a method for treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease, and chronic sinusitis, including cystic fibrosis, interstitial fibrosis, chronic bronchitis, emphysema, bronchopulmonary dysplasia and neoplasia. The method involves administration, preferably oral, nasal or pulmonary administration, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogues).

1 - 91 . (canceled) 
     
     
         92 . A device sized and configured for insertion into a passage of a respiratory system, the device comprising a layer overlying an exterior surface of the device, the layer comprising a water insoluble drug for the treatment of the respiratory system and an additive that enhances absorption of the drug into tissue of the respiratory system, wherein:
 the device is a balloon catheter;   the water insoluble drug is chosen from paclitaxel and rapamycin; and   the additive is chosen from PEG laurate, PEG oleate, PEG stearate, PEG glyceryl laurate, PEG glyceryl oleate, PEG glyceryl stearate, polyglyceryl laurate, plyglyceryl oleate, polyglyceryl myristate, polyglyceryl palmitate, PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate, PEG sorbitan stearate, or combinations thereof.   
     
     
         93 . (canceled) 
     
     
         94 . The device according to  claim 92 , wherein the drug is not enclosed in micelles or encapsulated in polymer particles. 
     
     
         95 . The device according to  claim 92 , wherein the layer does not include oil, a lipid, or a polymer. 
     
     
         96 - 100 . (canceled) 
     
     
         101 . A method for treating a respiratory system comprising:
 inserting a balloon catheter comprising a coating layer into an airway, wherein the coating layer comprises a drug and an additive, wherein:
 the drug is chosen from paclitaxel and rapamycin; and 
 the additive is chosen from PEG laurate, PEG oleate, PEG stearate, PEG glyceryl laurate, PEG glyceryl oleate, PEG glyceryl stearate, polyglyceryl laurate, plyglyceryl oleate, polyglyceryl myristate, polyglyceryl palmitate, PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate, PEG sorbitan stearate, or combinations thereof; 
   inflating the balloon catheter and releasing the drug to a wall of the airway;   deflating the balloon; and   withdrawing the balloon catheter from the airway.   
     
     
         102 . The method according to  claim 101 , wherein the additive enhances absorption of the drug into tissue of the respiratory or sinus system. 
     
     
         103 - 110 . (canceled) 
     
     
         111 . The device of  claim 92 , wherein the additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate. 
     
     
         112 . The device of  claim 92 , wherein the additive is chosen from PEG-20 sorbitan monolaurate and PEG-20 sorbitan monooleate. 
     
     
         113 . The device of  claim 92 , wherein the water-insoluble drug is paclitaxel and the additive is chosen from PEG-20 sorbitan monolaurate and PEG-20 sorbitan monooleate. 
     
     
         114 . The device of  claim 92 , wherein the layer further comprises an additional drug selected from the group consisting of budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, terbutaline, albuterol, ipratropium, pirbuterol, epinephrine, salmeterol, levalbuterol, or formoterol. 
     
     
         115 . The method according to  claim 101 , wherein the additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monopalmitate, PEG-20 sorbitan monostearate, and PEG-20 sorbitan monooleate. 
     
     
         116 . The method according to  claim 101 , wherein the additive is chosen from PEG-20 sorbitan monolaurate and PEG-20 sorbitan monooleate. 
     
     
         117 . The method according to  claim 101 , wherein the water-insoluble drug is paclitaxel and the additive is chosen from PEG-20 sorbitan monolaurate and PEG-20 sorbitan monooleate. 
     
     
         118 . The method according to  claim 101 , wherein the layer further comprises an additional drug selected from the group consisting of budesonide, flunisolide, triamcinolone, beclomethasone, fluticasone, mometasone, dexamethasone, hydrocortisone, methylprednisolone, prednisone, cortisone, betamethasone, terbutaline, albuterol, ipratropium, pirbuterol, epinephrine, salmeterol, levalbuterol, or formoterol.