Systems and methods for increasing stability of dronabinol compositions

Abstract

Disclosed in certain embodiments is a system and method of providing a dronabinol oral solid dosage form with increased stability.

1 - 13 . (canceled) 
     
     
         14 . A method of treating chemotherapy-induced nausea and vomiting comprising administering to a patient in need thereof a dronabinol oral solid dosage form received from a packaging system comprising a container housing:
 the dronabinol oral solid dosage form, wherein the solid oral dosage form is a soft gelatin capsule comprising dronabinol; and   an oxygen scavenger.   
     
     
         15 . The method of  claim 14 , wherein the dronabinol oral solid dosage form does not comprise the oxygen scavenger. 
     
     
         16 . The method of  claim 14 , wherein the oxygen scavenger is contained in a canister or packet. 
     
     
         17 . The method of  claim 14 , wherein the oxygen scavenger is incorporated into integral components of the container. 
     
     
         18 . The method of  claim 14 , wherein the oxygen scavenger is selected from the group consisting of organic-based scavengers, non-organic-based scavengers, polymer-based scavengers, enzyme-based scavengers and mixtures thereof. 
     
     
         19 . The method of  claim 14 , wherein the packaged dronabinol oral solid dosage form provides not more than 0.3% by weight of degradant×(Relative Retention Time 0.85) of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity. 
     
     
         20 . The method of  claim 14 , wherein the packaging system provides stability of the soft gelatin capsule at room temperature for a time period of at least three months. 
     
     
         21 . The method of  claim 14 , wherein the system provides less than 0.5% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity. 
     
     
         22 . The packaging system of  claim 14 , wherein the system provides less than 0.35% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 25° C. and 60% relative humidity. 
     
     
         23 . The method of  claim 14 , wherein the system provides less than 0.2% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 25° C. and 60% relative humidity. 
     
     
         24 . The method of  claim 14 , wherein the soft gelatin capsule comprises trans-(−)-Δ 9 -tetrahydrocannabinol. 
     
     
         25 . The method of  claim 14 , wherein the soft gelatin capsule comprises at least 98% by weight trans-(−)-Δ 9 -tetrahydrocannabinol. 
     
     
         26 . The method of  claim 14 , wherein the system provides less than 1.0% by weight of impurities of dronabinol when measured at 3 months after storage under conditions of 40° C. and 75% relative humidity. 
     
     
         27 . The method of  claim 14 , wherein the oxygen scavenger in the at least one soft gelatin capsule comprises sesame oil. 
     
     
         28 . The method of  claim 14 , wherein the container is glass. 
     
     
         29 . The method of  claim 14 , wherein the container is plastic.