Solid pharmaceutical dosage formulation of hydrophobic drugs

Abstract

A novel solid pharmaceutical dosage formulation of hydrophobic drugs is disclosed, which provides enhanced dissolution and improved bioavailability. The formulation comprises: a base substrate comprising a first polymer; a deposit, comprising a therapeutic amount of a hydrophobic drug, deposited on the base substrate; a cover substrate comprising a second polymer, the cover substrate covering the deposit and joined to the base substrate by a bond that encircles the deposit; and a dissolution-enhancing amount of a surfactant, disposed within a carrier that is segregated from, but in contact with, the deposit. In another embodiment, the dosage form may include any pharmaceutically acceptable additive, disposed within a carrier that is segregated from, but in contact with, the deposit. In a preferred embodiment, the hydrophobic drug is deposited electrostatically on the base substrate.

We claim:  
     
         1 . An improved solid pharmaceutical dosage formulation of a hydrophobic drug, comprising: 
 a base substrate comprising a first polymer;    a deposit, comprising a therapeutic amount of a hydrophobic drug, deposited on the base substrate;    a cover substrate comprising a second polymer, the cover substrate covering the deposit and joined to the base substrate by a bond that surrounds the deposit; and    a dissolution-enhancing amount of a surfactant, disposed within a carrier that is segregated from, but in contact with, the deposit.    
     
     
         2 . The dosage formulation of  claim 1 , wherein the base substrate comprises a planar film.  
     
     
         3 . The dosage formulation of  claim 1 , wherein the cover substrate comprises a planar film.  
     
     
         4 . The dosage formulation of  claim 3 , wherein the cover substrate film has a shape comprising a semi-spherical bubble, wherein the deposit is disposed within the perimeter of the semi-spherical bubble.  
     
     
         5 . The dosage formulation of  claim 2 , wherein the base substrate film has a shape comprising a semi-spherical bubble, wherein the deposit is disposed within the perimeter of the semi-spherical bubble.  
     
     
         6 . The dosage formulation according to  claim 1 , wherein the deposit has a shape that is substantially circular, and the deposit has a diameter in the range of about 3 millimeters to about 7 millimeters.  
     
     
         7 . The dosage formulation according to  claim 1 , wherein the first polymer or second polymer comprises a thermoplastic material.  
     
     
         8 . The dosage formulation according to  claim 1 , wherein the first polymer or second polymer is selected from the group consisting of polymers and copolymers of polyvinyl alcohol, polyvinyl pyrrolidinone, polysaccharide polymers, acrylate polymers, methacrylate polymers, phthalate polymers, polyvinyl acetate, methyl cellulose, carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, ethyl cellulose, polyethylene oxide, polypropylene, polyester and polyamide films, Eudragits, starch-based polymers and gelatin.  
     
     
         9 . The dosage formulation according to  claim 1 , wherein the first polymer and the second polymer are the same.  
     
     
         10 . The dosage formulation according to  claim 1 , wherein the base substrate and the cover substrate are ingestible.  
     
     
         11 . The dosage formulation according to  claim 1 , wherein the carrier is the cover substrate.  
     
     
         12 . The dosage formulation according to  claim 1 , wherein the carrier is an ingestible adhesive that is applied to the cover substrate.  
     
     
         13 . The dosage formulation according to  claim 1 , wherein the carrier is a pouch, disposed between the deposit and the cover substrate, the pouch comprising an ingestible material.  
     
     
         14 . The dosage formulation according to  claim 1 , wherein the hydrophobic drug is deposited electrostatically.  
     
     
         15 . An improved solid pharmaceutical dosage formulation, comprising: 
 a base substrate comprising a first polymer;    a deposit, comprising a therapeutic amount of a drug, deposited on the base substrate;    a cover substrate comprising a second polymer, the cover substrate covering the deposit and joined to the base substrate by a bond that surrounds the deposit; and    a pharmaceutically acceptable additive, disposed within a carrier that is segregated from, but in contact with, the deposit.    
     
     
         16 . The dosage formulation according to  claim 15 , wherein the drug is deposited electrostatically.