Transdermal delivery of dronabinol

Abstract

Provided is a transdermal drug delivery system comprising dronabinol. The dronabinol transdermal delivery system provides a drug plasma concentration at predetermined rate for a predetermined period of time, offering a simplified therapeutic regimen by decreasing dosing frequency for the treatment and/or prevention of nausea and/or vomiting associated with, for example, chemotherapy.

It is claimed: 
     
         1 . A pharmaceutical composition, comprising: dronabinol in a dosage form for transdermal delivery. 
     
     
         2 . The pharmaceutical composition of  claim 1 , comprising no additional antiemetic drug. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein dronabinol is in a form selected from the group consisting of co-crystals, amorphous, coated, crystalline, a salt, an isomer, a solid solution, a prodrug, an analog, a derivative, a metabolite, a solution, synthetic, an ethanol solution, and a naturally derived delta-9-tetrahydrocannabinol. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein dronabinol is in the composition at between about 0.01%-95% w/w or between about 0.01%-95% w/v. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein dronabinol is selected from a group consisting of amorphous dronabinol, crystalline dronabinol, co-crystals of dronabinol, coated dronabinol, and ethanolic solution of dronabinol in the range of 0.01%-95% w/w or w/v. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein dronabinol is in a salt form. 
     
     
         7 . The pharmaceutical composition of  claim 1 , formulated as transdermal liquid formulation, transdermal semisolid formulation and/or transdermal polymer matrix formulation. 
     
     
         8 . The pharmaceutical composition of  claim 1 , comprising a carrier or an ingredient in effective amount either alone or in combinations thereof selected from the group consisting of solvents, gelling agents, polymers, penetration enhancers, emollients, skin irritation reducing agents, buffering agents, pH stabilizers, solubilizers, suspending agents, dispersing agents, stabilizers, plasticizers, surfactants, antioxidants, and oxidants. 
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein the carrier or ingredient is in the composition in a range of between about 0.01%-95% w/w or w/v. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is formulated as a transdermal patch. 
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the transdermal patch is selected from the group consisting of a reservoir patch, a micro-reservoir patch, a matrix patch, a pressure sensitive adhesive patch, and an extended release transdermal film. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is formulated as microneedles. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein the microneedles are formulated as a transdermal patch. 
     
     
         14 . A method for the treatment and/or prevention and/or control of nausea and/or vomiting associated with cancer chemotherapy, comprising:
 selecting a patient in need of treatment and/or prevention and/or control of nausea and/or vomiting associated with cancer chemotherapy; and   topically applying or instructing to topically apply the pharmaceutical composition of  claim 1 ,   wherein the topically applying is performed at least once in a day.   
     
     
         15 . The method of  claim 14 , wherein the composition is a liquid formulation and/or a semisolid formulation, wherein the topically applying is done two to six times in a day, once in a day, once in two days, once in three days, once in four days, once in five days, once in six days, once in a week. 
     
     
         16 . The method of  claim 14 , wherein the composition is topically applied once in two days, once in three days, once in four days, once in five days, once in six days, once in a week, or once in ten days. 
     
     
         17 . The method of  claim 14 , wherein said topically applying provides a constant rate of delivery of the active components of the transdermal patch over a time period. 
     
     
         18 . The method of  claim 14 , wherein said topically applying provides a steady absorption rate of dronabinol over a time period. 
     
     
         19 . The method of  claim 14 , wherein said topically applying achieves a constant blood serum level of dronabinol over a time period. 
     
     
         20 . The method of  claim 14 , wherein said topically applying achieves a reduced variability in blood serum level of dronabinol over a time period relative to oral administration of a dronabinol over the time period. 
     
     
         21 . The method of  claim 14 , wherein said topically applying achieves a plasma concentration of dronabinol in a therapeutic range over a period of time. 
     
     
         22 . A method for the treatment and/or prevention and/or control of nausea and/or vomiting associated with cancer chemotherapy and/or anorexia associated with weight loss in patients with AIDS, comprising:
 selecting a patient in need of the treatment and/or prevention and/or control of nausea and/or vomiting associated with cancer chemotherapy and/or anorexia associated with weight loss in patients with AIDS;   topically applying or instructing to topically apply the pharmaceutical composition of  claim 1 ,   wherein said applying achieves topical delivery of dronabinol for the treatment and/or prevention and/or control of nausea and/or vomiting associated with cancer chemotherapy and/or anorexia associated with weight loss in patients with AIDS.   
     
     
         23 . The method of  claim 22 , wherein the pharmaceutical composition is topically applied once in a day, once in two days, once in three days, once in four days, once in five days, once in six days, once in a week, or once in ten days. 
     
     
         24 . The method of  claim 22 , wherein the pharmaceutical composition is topically applied two to six times in a day, once in a day, once in two days, once in three days, once in four days, once in five days, once in six days, once in a week. 
     
     
         25 . The method of  claim 22 , wherein the pharmaceutical composition is a liquid formulation or a semisolid formulation. 
     
     
         26 . The method of  claim 22 , wherein the pharmaceutical composition is a transdermal delivery system.