Formulation and method for increasing oral bioavailability of drugs

Abstract

The application discloses a formulation and method for increasing bioavailability of an orally administered drug.

1 - 48 . (canceled) 
     
     
         49 . A composition for oral administration of at least one drug, said composition comprising:
 a) a dispersible concentrate, wherein it is capable of forming, upon contact with an aqueous solution, particles of a size of less than about 500 nm, said dispersible concentrate comprising:
 (i) at least one surfactant; 
 (ii) at least one solid component at room temperature; and 
 (iii) an amphiphilic solvent; 
   b) an amount of at least one piperine, piperine analog or isomer thereof, sufficient to increase the bioavailability of said composition.   
     
     
         50 . The composition according to  claim 49 , further comprising at least one drug. 
     
     
         51 . The composition according to  claim 49 , wherein the surfactant is a combination of at least one high HLB (hydrophilic/lipophilic balance) surfactant, having an HLB of at least about 8, with at least one surfactant being a low HLB surfactant having an HLB of less than about 5. 
     
     
         52 . The composition according to  claim 49 , further comprising a phospholipid. 
     
     
         53 . The composition according to  claim 49 , further comprising a fatty acid ester. 
     
     
         54 . The composition according to  claim 49 , wherein said amphiphilic solvent is selected from the group consisting of lower alkyl esters of lactic acid, lower alkyl lactone esters and N-methylpyrrolidone. 
     
     
         55 . The composition according to  claim 49 , wherein said piperine is obtained from  Piper longum  or  Piper nigrum.    
     
     
         56 . The composition according to  claim 50 , wherein said drug is a lipophilic compound or a mixture of at least two lipophilic compounds. 
     
     
         57 . The composition according to  claim 56 , wherein the lipophilic compound is a cannabinoid, a derivative or a synthetic analog thereof, or a mixture of cannabinoids. 
     
     
         58 . The composition according to  claim 50 , wherein the composition and at least one drug are formulated for administration in the same pharmaceutical formulation. 
     
     
         59 . The composition according to  claim 50 , wherein the composition and drug are formulated for administration in different pharmaceutical formulations. 
     
     
         60 . The composition according to  claim 50 , wherein said at least one drug is a cannabinoid, a derivative or a synthetic analog thereof, or a mixture of cannabinoids. 
     
     
         61 . The composition according to  claim 60 , wherein said cannabinoid being selected from the group consisting of tetrahydrocannabinol, cannabidiol (CBD), cannabinol, cannabigerol, tetrahydrocannabivarin, cannabidivarin and cannabichromene. 
     
     
         62 . A method for increasing the bioavailability of a drug in a mammal in need of said drug, the method comprising orally administering:
 (1) said drug, and   (2) a composition according  claim 49 , wherein said at least one piperine, piperine analog or isomer thereof being present in said composition in an amount sufficient to provide a greater bioavailability of said drug than bioavailability of said drug in the absence of said at least one piperine, piperine analog or isomer thereof.   
     
     
         63 . The method according to  claim 62 , wherein said composition being administered substantially simultaneously with the drug. 
     
     
         64 . The method according to  claim 62 , wherein said composition and drug are sequentially administered. 
     
     
         65 . The method according to  claim 62 , wherein the drug is administered in at least one dose within 24 hrs after administration of the dose of said composition. 
     
     
         66 . The method according to  claim 62 , for treatment of at least one disease or disorder. 
     
     
         67 . The method according to  claim 62 , wherein said at least one drug is a cannabinoid, a derivative or a synthetic analog thereof, or a mixture of cannabinoids. 
     
     
         68 . The method according to  claim 62 , wherein said drug is a cannabinoid being selected from the group consisting of tetrahydrocannabinol, cannabidiol (CBD), cannabinol, cannabigerol, tetrahydrocannabivarin, cannabidivarin and cannabichromene.