Dosage form comprising therapeutic formulation

Abstract

A dosage form is disclosed comprising a semipermeable walled container that houses a capsule, which capsule comprises a drug formulation, a piston, and an osmotic composition. The dosage form delivers the drug formulation through a passageway at a controlled rate over a sustained-release period of time up to 24 hours.

1 . A dosage form for oral administration of a drug comprising:
 a capsule;   a dry drug formulation that becomes liquid when said dosage form imbibes liquid in a liquid environment disposed in the capsule, comprising a dosage of drug and a pharmaceutically acceptable carrier comprising   a poly(alkyleneoxide) of 50 kD-300 kD average molecular weight,   an alkali carboxy alkyl cellulose of 7.5 kD-25 kD average molecular weight,   a copoly(ethyleneoxide-propyleneoxide) polymer of 4 kD-25 kD average molecular weight,   a polysaccharide comprising hydroxyl and carboxyl groups having a 250 kD-400 kD average molecular weight,   a poly(carboxylated vinyl)polymer, or   a cyclodextrin   or combinations thereof;   an expandable composition disposed in the capsule, the expandable composition comprising an osmopolymer, an osmagent, and a member selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, and hydroxypropylbutylcellulose, wherein the expandable composition increases in volume in the presence of an aqueous fluid;   a wall surrounding the capsule that is permeable to passage of fluid and substantially impermeable to passage of the drug;   an exit in the wall for releasing the drug formulation from the capsule at a sustained release rate over an extended period of time; and   a movable piston positioned between the drug formulation and the expandable composition, the movable piston being directly in contact with the drug formulation and with the expandable composition.   
     
     
         2 . The dosage form of  claim 1 , wherein the drug is microfluidized. 
     
     
         3 . The dosage form of  claim 1 , wherein the expandable composition comprises polyethylene oxide, sodium chloride, and hydroxypropylmethylcellulose. 
     
     
         4 . The dosage form of  claim 3 , wherein the polyethylene oxide possesses a molecular weight of 2,000,000, and the hydroxypropylmethylcellulose possesses a molecular weight of 9,200. 
     
     
         5 . The dosage form of  claim 1 , wherein the wall surrounding the capsule comprises cellulose acetate and polyethylene glycol. 
     
     
         6 . The dosage form of  claim 1 , wherein the wall surrounding the capsule is made of an injection-moldable composition comprising a thermoplastic polymer. 
     
     
         7 . A method for administering a drug to a recipient which comprises orally administering the dosage form of  claim 1 .