Oros push-stick for controlled delivery of active agents
First Claim
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1. A sustained release dosage form for delivering a pharmaceutically active agent to a patient in need thereof, comprising:
- 1) a sustained release component and 2) an immediate release component, wherein the immediate release component is not an immediate release drug coating.
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Abstract
A sustained release dosage form is provided comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the dosage form provides burst release of the pharmaceutically active agent without the use of an immediate release drug coating. The dosage form is able to deliver high doses of poorly soluble or slowly dissolving active agents at a controlled rate. Methods of using the dosage forms to treat disease or conditions in human patients are also disclosed.
142 Citations
73 Claims
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1. A sustained release dosage form for delivering a pharmaceutically active agent to a patient in need thereof, comprising:
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1) a sustained release component and 2) an immediate release component, wherein the immediate release component is not an immediate release drug coating. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 67)
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14. A sustained release dosage form for delivering a nonsteroidal anti-inflammatory agent to a patient in need thereof, comprising:
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1) a sustained release component and 2) an immediate release component, wherein the immediate release component is not an immediate release drug coating. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 38, 39, 68)
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- 37. A sustained release dosage form comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the dosage form provides a burst release of the pharmaceutically active agent without the presence of a drug coating.
- 48. A sustained release dosage form comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over prolonged period of time, wherein the rate of release of the pharmaceutically active agent is modulated by the presence of an osmagent in the erodible solid.
- 49. A sustained release dosage form comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the rate of release of the pharmaceutically active agent in the first hour is controlled by the amount of osmagent, binding agent and disintegrant present in the erodible solid.
- 50. A sustained release dosage form comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the rate of release of the pharmaceutically active agent in the first hour is controlled by the relative rates of hydration of the osmagent, binding agent and disintegrant present in the erodible solid.
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63. A method for providing an effective dose of a nonsteroidal anti-inflammatory agent to a patient in need thereof for an extended period of time, comprising orally administering a sustained release dosage form comprising:
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(1) a semipermeable wall defining a cavity and including an exit orifice formed or formable therein;
(2) a drug layer comprising a therapeutically effective amount of a nonsteroidal anti-inflammatory agent contained within the cavity and located adjacent to the exit orifice;
(3) a push displacement layer contained within the cavity and located distal from the exit orifice;
(4) a flow-promoting layer between the inner surface of the semipermeable wall and at least the external surface of the drug layer that is opposite the wall;
wherein the dosage form provides an in vitro rate of release of the nonsteroidal anti-inflammatory agent for up to about 16 hours after being contacted with water in the environment of use. - View Dependent Claims (64, 65, 66, 73)
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Specification