Dosage form for delivering soluble or insoluble drugs

• US 5,035,897 A
• Filed: 09/05/1989
• Issued: 07/30/1991
• Est. Priority Date: 09/05/1989
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Ayer, Atul D., Kuczynski, Anthony L., Wong, Patrick S.
• Primary Examiner(s): Cashion, Jr., Merrell C.
• Assistant Examiner(s): HORNE, LEON
• Application Number:
  US07/403,523
• Time in Patent Office: 693 Days
• Field of Search: 424/473, 424/469, 424/470
• US Class Current: 424/473
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form is disclosed comprising granule means for delivering soluble to insoluble drug to a warm-blooded animal.

Claims

1. A dosage form for administering a drug to a warm-blooded animal, wherein the dosage form comprises:

(a) a wall that surrounds;

(b) a compartment;

(c) a layer in the compartment comprising granules, the granules comprising a film comprising a polyvinylpyrrolidone polymer comprising a 10,000 to 500,000 molecular weight, that surrounds a drug possessing a solubility of 1 part of drug in less than 1 part of aqueous solvent to 1 part of drug in more than 10,000 parts of aqueous solvent, and a hydroxyalkylcellulose comprising a 10,000 to 1,000,000 molecular weight;

(d) a layer in the compartment comprising a composition that imbibes fluid, consumes space and displaces the drug from the dosage form; and

(e) at least one exit passageway in the wall that connects the exterior with the interior of the dosage form for delivering the drug to the warm-blooded animal over a prolonged period of time.

2. The dosage form for administering the drug to a warm-blooded animal according to claim 1, wherein the hydroxyalkylcellulose is a member selected from the group consisting of hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose, hydroxypentylcellulose, hydroxytertpentylcellulose, hydroxyhexylcellulose and hydroxyisohexylcellulose.

3. A dosage form for administering a drug to a warm-blooded animal, wherein the dosage form comprises:

(a) a wall that surrounds;

(b) a compartment;

(c) a layer in the compartment comprising granules, the granules comprising a polyvinylpyrrolidone copolymer film that surrounds a hydroxyalkylcellulose comprising a 10,000 to 1,000,000 molecular weight, and a drug solute possessing a solubility of 1 part of drug solute in less than 1 part of aqueous solvent to 1 part of solute in more than 10,000 parts of aqueous solvent;

(d) a layer in the compartment comprising a formulation that imbibes fluid, consumes space and thereby displaces the drug from the dosage form; and

(e) at least one passageway in the wall that connects the exterior with the interior of the dosage form for delivering the drug to the warm-blooded animal over a prolonged period of time.

4. A Method for administering a drug to a patient, wherein the method comprises:

(a) admitting into the patient a dosage form comprising;

(1) a wall comprising at least on part a composition permeable to the passage of fluid, which wall surrounds;

(2) a compartment;

(3) a layer in the compartment comprising granules, the granules comprising a film comprising a member selected from the group consisting of polyvinylpyrrolidone and a polyvinylpyrrolidone copolymer, which film surrounds from 0.01 weight percent to 80 weight percent of a drug possessing a solubility of 1 pat of drug in less than 1 part of aqueous solvent to 1 part of drug in more than 10,000 parts of aqueous solvent, said drug a member selected from the group consisting of Drugs that act on peripheral nerves, adrenergic receptors, cholinergic receptors, nervous system, skeletal muscles, cardiovascular system, smooth muscles, blood circulatory system, synaptic sites, neuroeffector junctional sites, endocrine system, hormone systems, immunological system, organ systems, reproductive systems, autocoid systems, alimentary and excretory systems, and a hydroxyalkylcellulose comprising a 10,000 to 1,000,000 weight;

(4) a layer in the compartment comprising a composition that imbibes fluid, consumes space and displaces the drug from the dosage form; and

(5) at least one passageway in the wall that connects the exterior with the interior of the dosage form for delivering the drug from the dosage form;

(b) imbibing fluid into the dosage form for contacting the layer that displaces the drug;

thereby,

(c) administering the drug to the patient in a therapeutically effective amount over time.

5. A method for administering a drug to a warm-blooded animal according to claim 4, wherein the polyvinylpyrrolidone copolymer is a member selected from the group consisting of polyvinylpyrrolidone vinyl acetate copolymer, polyvinylpyrrolidone vinyl alcohol copolymer, polyvinylpyrrolidone vinyl chloride copolymer, polyvinylpyrrolidone vinyl fluoride copolymer, polyvinylpyrrolidone vinyl butyrate copolymer, polyvinylpyrrolidone vinyl laurate copolymer, and polyvinylpyrrolidone vinyl stearate copolymer.

6. A method for administering a drug to a warm-blooded animal according to claim 4, wherein the hydroxyalkylcellulose comprises a member selected from the group consisting of hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxybutylcellulose, hydroxypentylcellulose, hydroxytertpentylcellulose, hydroxyhexylcellulose and hydroxyisohexylcellulose.