Method of delivering drug with aid of effervescent activity generated in environment of use
First Claim
1. An osmotic device for delivering a drug to an environment of use, said device comprising:
- (a) a shaped laminated wall comprising a lamina formed of a semi-permeable material and a lamina formed of a microporous material, said wall permeable to the passage of an external fluid present in the environment of use and substantially impermeable to the passage of drug, the wall surrounding and forming;
(b) a compartment containing the drug indomethacin which exhibits a limited solubility in the fluid, and a pharmaceutically acceptable compound selected from the group consisting of carbonates, bicarbonates and mixtures thereof, which compounds are capable of reactively effervescing with fluid present in the environment of use; and
,(c) a passageway in the wall connecting the compartment and the exterior of the device for delivering (1) the drug in a therapeutically effective amount to the envirionment, and (2) the compound which reacts with fluid in the environment and effervesces, and thereby aids in delivering the drug to the environment over a prolonged period of time.
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Abstract
A method is disclosed for delivering a drug substantially free of rapid precipitation from an osmotic device. The osmotic device comprises a semipermeable wall surrounding a compartment, housing (1) a drug that exhibits limited solubility under neutral and acid conditions; and (2) a compound capable of evolving carbon dioxide in the presence of an acid in the environment of use. The method comprises, (a) imbibing fluid through the wall into the compartment at a rate determined by the permeability of the wall and the osmotic pressure gradient across the wall, (b) forming in the compartment a basic solution containing drug and compound, which solution is delivered from the compartment through the passageway, (c) reacting the compound with the acid in the environment at the device-environment interface for evolving carbon dioxide, thereby, (d) providing an effervescent suspension in the environment that delivers the drug in a finely dispersed form to the environment of use over time. Also, a composition is disclosed comprising the drug and the compound.
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Citations
29 Claims
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1. An osmotic device for delivering a drug to an environment of use, said device comprising:
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(a) a shaped laminated wall comprising a lamina formed of a semi-permeable material and a lamina formed of a microporous material, said wall permeable to the passage of an external fluid present in the environment of use and substantially impermeable to the passage of drug, the wall surrounding and forming; (b) a compartment containing the drug indomethacin which exhibits a limited solubility in the fluid, and a pharmaceutically acceptable compound selected from the group consisting of carbonates, bicarbonates and mixtures thereof, which compounds are capable of reactively effervescing with fluid present in the environment of use; and
,(c) a passageway in the wall connecting the compartment and the exterior of the device for delivering (1) the drug in a therapeutically effective amount to the envirionment, and (2) the compound which reacts with fluid in the environment and effervesces, and thereby aids in delivering the drug to the environment over a prolonged period of time. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An osmotic device for orally delivering a drug to a human, which device comprises:
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(a) a shaped laminated wall comprising a semipermeable lamina and a microporous lamina, said wall permeable to the passage of an external fluid and substantially impermeable to the passage of drug, the wall surrounding and forming; (b) a compartment containing from 0.5 milligrams to 3 grams of the drug indomethacin, and from 0.5 milligrams to 3 grams of a pharmaceutically acceptable compound selected from the group consisting of carbonates, bicarbonates and mixtures thereof that are capable of effervescing in the presence of the fluid; and
,(c) a passageway in the wall for delivering from the device at a controlled and continuous rate, a therapeutically effective amount of the drug, and an amount of the compound for reactively effervescing with the fluid over a prolonged period of time. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. An osmotic device for orally delivering a drug to a human, which device comprises:
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(a) a shaped semipermeable, wall said wall permeable to the passage of an external fluid and substantially impermeable to the passage of drug, the semipermeable wall surrounding and forming; (b) a compartment containing from 0.5 milligrams to 3 grams of the drug indomethacin, and from 0.5 milligrams to 3 grams of a pharmaceutically acceptable compound selected from the group consisting of carbonates, bicarbonates and mixtures thereof that are capable of reactively effervescing in the presence of the fluid; and
,(c) a passageway in the wall for delivering from the device to the human at a controlled and continuous rate, a therapeutically effective amount of the drug, and an amount of the compound for reactively effervescing with the fluid over a prolonged period of time. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29)
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Specification