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US 2003/0157163 A1Published application
Dosage form comprising therapeutic formulation
OwnerLiang-Chang Dong, Patrick S.L. Wong +2inventors
InventorsLiang-Chang Dong, Patrick S.L. Wong, Vincent Joseph Ferrari, Steven Espinal
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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.
Claims18
A process for providing a dosage form, said process comprising the following steps:
- (a) blending an osmopolymer, an osmagent and a hydroxypropylalkylcellulose to provide an osmotic composition;
- (b) blending a hydroxyalkylcellulose with a fluid to provide a granulating fluid;
- (c) spraying the granulating fluid onto the osmotic composition;
- (d) blending a drug and surfactant to form a drug formulation:
- (e) adding the drug formulation into a capsule;
- (f) adding the osmotic composition into the capsule;
- (g) closing the capsule;
- (h) inserting the capsule into an injection-molded wall housing comprising a closed bottom and an open mouth;
- and
- (i) crimping the wall to close the mouth while maintaining an orifice in the dosage form.
7 more elements
A dosage form comprising:
- (a) a capsule comprising an internal space;
- (b) a therapeutic formulation in the capsule comprising 100 ng to 1500 mg of a drug and a pharmaceutically acceptable carrier selected from the group consisting of a poly(alkylene oxide), copoly(ethylene oxidepropylene oxide), carboxyalkylcellulose, poly(saccharide), poly(carboxyvinyl) polymer, cyclodextrine, thixotropic gel, and poly(ethylene glycol);
- (c) a composition in the capsule that occupies space in the presence of fluid that enters the capsule;
- (d) a wall that surrounds the capsule, said wall comprising a thermoplastic polymer;
- and,
- (e) an exit in the wall that communicates with the therapeutic formulation for delivering the therapeutic formulation at a sustained-release rate over an extended time up to thirty-hours.
3 more elements
A dosage form comprising:
- (a) a capsule comprising a member selected from one and two section capsules;
- (b) a drug formulation in the capsules, said drug formulation comprising a drug, a surfactant, and an oil that provides an emulsion;
- (c) a composition in the capsules, which composition in the presence of an aqueous fluid occupies space in the capsule;
- (d) a wall that surrounds the capsule, said wall comprising a thermoplastic polymer;
- and,
- (e) an exit in the wall that connects with the drug formulation for releasing the drug formulation when the dosage form when the dosage form is in operated at a sustained-release rate over an extended time.
3 more elements
A sustained-release dosage form designed and adapted for administerally a drug orally and as an in vivo implant, the dosage form comprising:
- (a) a capsule;
- (b) a drug formulation in the capsule comprising a dosage of drug and a pharmaceutically acceptable carrier comprising an oil-in-water emulsion, a water-in-oil emulsion, an emulsion of castor oil in an aqueous solution of pigskin gelatin, an emulsion of gum arabic, an oil with an emulsifier comprising mono-and di-glycerides of a fatty acid, lecithin, and a fatty acid ester;
- (c) a hydrophilic composition in the capsule, which hydrophilic composition in the presence of an aqueous fluid that enters the capsule, absorbs the fluid, increases in volume, and thereby displaces the drug formulation from the dosage form;
- (d) a wall that surrounds the capsule, said wall comprising a thermoplastic polymer possessing a softening point of 40° C. to 180° C.;
- and
- (e) an exit in the wall that communicates with the drug formulation for releasing the drug formulation at a sustained-release rate over time.
3 more elements
A dosage form adapted for administering a dose of drug over an extended period of time, said dosage form comprising:
- (a) a capsule comprising an internal space;
- (b) a therapeutic formulation in the capsule comprising 0.5 wt % to 65 wt % of a drug and 0.5 wt % to 60 wt % of a pharmaceutically acceptable carrier comprising a member selected from the group consisting of a vegetable, mineral, animal, and marine oil, and 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, polyoxyethylented sorbitan monostearate comprising 4 moles of ethylene oxide, polyoxyethylenated sorbitan tristearate comprising 20 moles of ethylene oxide, polyoxyethylene 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;
- (c) a wall that surrounds the capsule, said wall comprising a thermoplastic composition possessing an injection-moldable temperature of 40° C. to 180° C.;
- and,
- (e) an exit in the wall that communicates with the drug formulation for releasing the drug formulation at a sustained-release rate over an extended time.
2 more elements
A process for providing a dosage form, wherein the process comprises the following steps:
- (a) formulating a therapeutic composition comprising a drug and a pharmaceutically acceptable carrier;
- (b) formulating an expandable composition comprising a homopolymer and an osmotically effective solute;
- (c) adding the therapeutic composition to a capsule;
- (d) adding the expandable composition to the capsule;
- (e) coating the capsule with a thermoplastic composition;
- and,
- (f) providing exit means in the wall in communication with the therapeutic composition for releasing the therapeutic composition at a sustained-release rate over an extended time, when the dosage form is in operation on an animal environment of use.
4 more elements
A method for administering a drug to a recipient, wherein the method comprises:
- (a) admitting into the recipient a dosage form comprising
- (1) a capsule comprising a drug formulation, a surfactant, pharmaceutically acceptable carrier, and an expandable composition;
- (2) a wall comprising a thermoplastic composition that surrounds the capsule;
- (3) an exit in the wall for releasing the drug from the dosage form;
- and,
- (b) delivering the drug at a sustained and controlled rate over an extended time up to twenty-four hours.
3 more elements
Dependencies are inferred from the claim text.