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 drug formulation disposed in the capsule, the drug formulation comprising a dosage of the drug and a pharmaceutically acceptable carrier, the pharmaceutically acceptable carrier comprising a member selected from the group consisting of a poly(alkylene oxide) of 50,000 to 300,000 weight average molecular weight, an alkali of carboxyalkylcellulose of 7,500 to 25,000 weight average molecular weight, a copoly(ethylene oxide-propylene oxide) of 4,000 to 25,000 weight average molecular weight, a poly(carboxylated vinyl) polymer, a polysaccharide comprising hydroxyl and carboxyl groups of 250,000 to 400,000 weight average molecular weight, a cyclodextrine, a solid polymerized ethylene glycol, a thixotropic gel, a solid poly(ethylene glycol) of 500 to 10,000 weight average molecular weight;   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, the wall comprising a composition 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 in contacting relation with the drug formulation and the expandable composition.   
     
     
         2 . The dosage form of  claim 1 , wherein the expandable composition comprises sodium carboxymethylcellulose, sodium chloride, and hydroxypropylmethycellulose. 
     
     
         3 . The dosage form of  claim 2 , wherein the drug formulation comprises progesterone, polyoxyl 35 castor oil, and acetylated monoglyceride. 
     
     
         4 . The dosage form of  claim 1 , wherein the expandable composition comprises polyethylene oxide, sodium chloride, and hydroxypropylmethylcellulose. 
     
     
         5 . The dosage form of  claim 4 , wherein the polyethylene oxide possesses a molecular weight of 2,000,000, and the hydroxypropylmethylcellulose possesses a molecular weight of 9,200. 
     
     
         6 . The dosage form of  claim 4 , wherein the drug formulation comprises acyclovir, polyoxyethylene 20 stearate, polyoxyl 35 castor oil, and polyoxyl 40 stearate. 
     
     
         7 . The dosage form of  claim 6 , wherein the wall surrounding the capsule comprises cellulose acetate and polyethylene glycol. 
     
     
         8 . The dosage form of  claim 1 , wherein the wall surrounding the capsule is made of an injection-moldable composition comprising a thermoplastic polymer. 
     
     
         9 . The dosage form of  claim 1 , wherein the drug comprises a member selected from the group consisting of progestins and estrogens. 
     
     
         10 . The dosage form of  claim 1 , wherein the drug formulation further comprises a surfactant selected from the group consisting of polyoxyethylenated castor oil comprising 9 moles to 52 moles of ethylene oxide, polyoxyethylenated sorbitan monopalmitate comprising 20 moles of ethylene oxide, polyoxyethylenated sorbitan monostearate comprising 4 moles of ethylene oxide, polyoxyethylenated sorbitan tristearate comprising 20 moles of ethylene oxide, polyoxyethylenated lauryl ether, polyoxyethylenated stearic acid comprising 30 moles to 40 moles of ethylene oxide, polyoxyethylenated stearyl alcohol comprising 2 moles of ethylene oxide, and polyoxyethylenated oleyl alcohol comprising 2 moles of ethylene oxide. 
     
     
         11 . The dosage form of  claim 1 , wherein the drug comprises a member selected from the group consisting of peptide, protein, protein anabolic hormone, growth promoting hormone, endocrine system hormone, porcine growth promoting hormone, bovine growth promoting hormone, equine growth promoting hormone, human growth hormone, hormones derived from the pituitary gland, hormones derived from the hypothalamus gland, recombinant DNA, somatropin, gonadotropic releasing hormone, follicle stimulating hormone, luteinizing hormone, LH-RH, insulin, cochicine, chorionic gonadotropin hormone, oxytocin, vasopressing adrenocorticothropic hormone, prolactin, cosyntropin, bypressin, thyroid stimulating hormone, secretin, pancroezymin, enkephalin, and glucagon. 
     
     
         12 . The dosage form of  claim 1 , wherein the extended period of time is up to twenty-four hours. 
     
     
         13 . A method for administering a drug to a recipient, comprising the steps of:
 administering to the recipient a dosage form comprising:
 a capsule; 
 a drug formulation disposed in the capsule, the drug formulation comprising a dosage of the drug and a pharmaceutically acceptable carrier, the dry pharmaceutically acceptable carrier comprising a member selected from the group consisting of a poly(alkylene oxide) of 50,000 to 300,000 weight average molecular weight, an alkali of carboxyalkylcellulose of 7,500 to 25,000 weight average molecular weight, a copoly(ethylene oxide-propylene oxide) of 4,000 to 25,000 weight average molecular weight, a poly(carboxylated vinyl) polymer, a polysaccharide comprising hydroxyl and carboxyl groups of 250,000 to 400,000 weight average molecular weight, a cyclodextrine, a solid polymerized ethylene glycol, a thixotropic gel, a solid poly(ethylene glycol) of 500 to 10,000 weight average molecular weight; 
 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, the wall comprising a composition 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 in contacting relation with the drug formulation and the expandable composition; 
   
     
     
         14 . The method of  claim 13 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the expandable composition comprises sodium carboxymethylcellulose, sodium chloride, and hydroxypropylmethycellulose. 
     
     
         15 . The method of  claim 14 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the drug formulation comprising progesterone, polyoxyl 35 castor oil, and acetylated monoglyceride. 
     
     
         16 . The method of  claim 13 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the expandable composition comprises polyethylene oxide, sodium chloride, and hydroxypropylmethylcellulose. 
     
     
         17 . The method of  claim 16 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the drug formulation comprises acyclovir, polyoxyethylene 20 stearate, polyoxyl 35 castor oil, and polyoxyl 40 stearate. 
     
     
         18 . The method of  claim 17 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the drug formulation comprises acyclovir, polyoxyethylene 20 stearate, polyoxyl 35 castor oil, and polyoxyl 40 stearate. 
     
     
         19 . The method of  claim 18 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the wall surrounding the capsule comprises cellulose acetate and polyethylene glycol. 
     
     
         20 . The method of  claim 13 , wherein administering to the recipient a dosage form comprises administering to the recipient the dosage form wherein the drug comprises a member selected from the group consisting of progestins and estrogens.