Osmotically triggered device with gas generating means

• US 4,203,441 A
• Filed: 12/18/1978
• Issued: 05/20/1980
• Est. Priority Date: 12/18/1978
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Theeuwes, Felix
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Rosenbaum, C. F.
• Application Number:
  US05/970,537
• Time in Patent Office: 519 Days
• Field of Search: 128/260, 128/261, 128/268, 128/172, 128/203, 128/204, 128/219, 128/225, 222/386.5, 222/389, 222/399, 428/159, 428/206, 428/221, 428/327, 428/480, 428/481
• US Class Current: 604/892.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: Y10S 428/913 Material designed to be responsive to temperature, light, moisture
• CPC Class Codes: Y10T 428/254 Polymeric or resinous material

Abstract

A device is disclosed for supplying and delivering an useful agent. The device comprises (1) a housing defining an internal space, (2) a flexible container in the housing and having a passageway for connecting the container with the exterior of the device, (3) a useful agent in the container, and (4) a gas generating means located between the housing and the container. In operation, when the device is in a fluid environment, fluid is admitted into the device and contacts the means, causing it to produce a gas that exerts pressure against the container. The pressure urges the container to decrease its dimensions and correspondingly deliver agent through the passageway from the device. Also, article of manufactures are enclosed, which articles consists of a gas generating means between two different polymeric films, and a gas generating means housed in a polymeric matrix.

Claims

1. A device for delivering a useful agent to an environment of use, comprising:

(a) a useful agent;

(b) a housing comprising a shape-retaining wall formed of a semipermeable polymer that defines an internal space and has an opening that connects the space with the exterior of the device;

(c) a container in the housing, said container comprising a flexible wall surrounding a reservoir for storing the agent, and a passageway that passes through the opening for delivering the agent from the container to the exterior of the device; and

,

(d) means for generating a gas in the device interposed between the housing and the container, said means generating gas in response to fluid admitted into the device, which gas exerts pressure on the container causing it to decrease in volume and correspondingly delivers agent through the passageway from the device in a unit time.

2. The device for delivering a useful agent to an environment of use according to claim 1, wherein the container is formed of a member selected from the group consisting essentially of natural rubber, gutta percha rubber, cyclised rubber, isoprene rubber, butadiene rubber, styrene-butadiene copolymer rubber, nitrile rubber, chloroprene rubber, ethylene-propylene rubber, butyl rubber, poly(piperylene) rubber, poly(2,3-dimethyl-1,3-butadiene) rubber, butadiene-acrylonitrile rubber, poly(2-chloro-1,3-butadiene) rubber, poly(isobutylene) rubber, vinyl-chloride-acrylonitrile copolymer rubber, and the condensation product of sodium tetrasulfide and dichlorodiethyl ether rubber.

3. The device for delivering a useful agent to an environment of use according to claim 1, wherein the agent is a drug.

4. The device for delivering a useful agent according to claim 1 wherein the environment is a biological environment, and the agent is a drug selected from the group consisting of locally and systemically acting gastrointestional, nervous system, hypnotic, sedative, psychic energizer, tranquilizer, anticonvulsant, antiparkinson, muscle relaxant, analgesic, antipyretic, antiinflammatory, anesthetic, antispasmodic, antimicrobial, antiviral, antiucler, hormonal, sympathomimetic, diuretic, hypoglycemic, and contraceptive drugs.

11. The device for delivering a useful agent to an environment of use according to claim 1, wherein the means for generating gas is calcium carbide.

5. An article of manufacture useful for fabricating a gas-powered device for delivering a beneficial agent to an agent receptive environment, the article comprising a first layer of a polymer selected from the group consisting of cellulose ester, cellulose ether, cellulose acylate, cellulose diacylate and cellulose triacylate, the first layer positioned adjacent to a second layer which second layer comprises a means for generating a gas, and which second layer is in contacted arrangement with a third layer of a flexible, elastomeric polymer.

6. The article of manufacture useful for fabricating a gas-powered device for delivering a beneficial agent according to claim 5 wherein the means for generating a gas comprises an acidic component and a basic component which when brought into fluid reactive environment generate gas.

7. A gas-powered dispensing device comprising:

(a) a container for storing a beneficial agent, said container changeble from a storing to a substantially emptied state;

(b) a passageway for connecting the container with the exterior of the device for dispensing agent from the device;

(c) means for generating gas on the exterior surface of the container, said means comprising an acidic component and a basic component that react in the presence of aqueous fluid admitted into the device and generate a gas;

(d) a wall for maintaining the physical shape and dimensions of the device, and for admitting fluid into the device, the wall surrounding and enclosing the container and the gas generating means; and

(e) wherein, when the device is in operation, in a fluid environment, fluid is admitted into the device causing the means to generate gas that is applied against the container, urging the container to undergo change to an empty state, thereby dispensing agent through the passageway from the device in unit time.

8. The gas-powered dispensing device for dispensing a beneficial agent according to claim 7 wherein the acidic component is a member selected from the group consisting essentially of malic, fumaric, tartaric, itaconic, malric, citric, adipic, succinic, mesaconic and glycine, and the basic component is a member selected from the group consisting essentially of sodium carbonate, potassium carbonate, magnesium carbonate, sodium bicarbonate, potassium bicarbonate, magnesium bicarbonate, and mixtures thereof.

9. The gas-powered dispensing device for dispensing a beneficial agent according to claim 7 wherein the device is sized, shaped and adapted for use in a fluid environment which environment is the gastrointestinal tract.

10. The gas-powered dispensing device for dispensing a beneficial agent according to claim 7 wherein the acidic component is a member selected from the group consisting of inorganic acids, organic acids, salts of acids and mixtures thereof, and the basic component is a carbonate containing component, selected from the group consisting of alkali metal carbonates, alkali metal bicarbonates, alkaline earth carbonates, alkaline earth bicarbonates, and mixtures thereof.

12. An article of manufacture useful for generating a gas in a fluid environment comprising a gas generating couple consisting of an acidic component and a basic component dispersed in a polymer that is permeable to the passage of fluid, said polmer a member selected from the group consisting of polyolefins and vinyl polymers, poly(hydroxyalkyl methacrylate), poly(acrylamide), gelatin, poly(methacrylamide), poly(N-vinyl-2-pyrrolidone), dextran, carbohydrate, anionic and cationic hydrogels, poly(electrolyte) complexes, lightly cross-linked poly(vinyl alcohol), poly(vinyl alcohol), poly(glyceryl methacrylate), poly(hydroxypropyl methacrylate), poly(sulphide), poly(sulphoxide), poly(sulphone), poly(styrene), copolymeric(divinylbenzene and styrene), poly(dialkylaminoethyl styrene), cation and anion exchange resins, collodin, sulfonated copolymers of styrene and divinylbenzene, copolymers of methacrylic and divinylbenzene, poly(urethane), cellulose esters, and cellulose ethers, and wherein the article when in a fluid environment admits fluid into the polymer causing the couple to react and generate gas that is released from the polymer over time.

13. An article of manufacture useful for generating gas according to claim 12 wherein the polymer exhibits a decrease in the glass transition temperature in the presence of fluid.

14. An article of manufacture useful for generating gas according to claim 12 wherein the article consists essentially of from 1 to 30% of of gas generating couple up to 100% by weight of combined polymer and couple.

15. An article of manufacture useful for generating gas according to claim 12 wherein the article consists essentially of from 30 to 95% of gas generating couple up to 100% by weight of combined polymer and couple.