CONTROL OF DRUG RELEASE BY TRANSIENT MODIFICATION OF LOCAL MICROENVIRONMENTS
First Claim
1. A method for inhibiting the gelation, aggregation, or precipitation of a drug released from a reservoir in an implanted drug delivery device comprising:
- providing a drug which has limited solubility or tends to undergo gelation, aggregation, or precipitation at a physiological pH at a site at which said drug delivery device is to be implanted; and
formulating the drug in a dry solid form with a release-modifying agent within said reservoir;
opening said reservoir to permit the physiological fluid to solubilize the drug, wherein the release modifying agent is present in an amount effective to changes the pH of a microenvironment in or about the reservoir in an amount effective to inhibit gelation, aggregation, or precipitation of the drug, whereby the solubilized drug can be released from the implanted drug delivery device.
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Accused Products
Abstract
Methods, formulations, and devices are provided for enhancing drug delivery from a medical device. The method is provided for increasing the rate or quantity of a drug formulation released from an implantable drug delivery device, which method comprises the step of providing a release-modifying agent within or proximate to the implantable drug delivery device, in a manner effective to inhibit gelation, aggregation, or precipitation of the drug formulation being released from the device. The drug formulation and the release-modifying agent may be stored together in at least one reservoir in the implantable drug deliver device. Alternatively, the release-modifying agent may be stored in one or more reservoirs separate from the drug formulation.
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Citations
16 Claims
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1. A method for inhibiting the gelation, aggregation, or precipitation of a drug released from a reservoir in an implanted drug delivery device comprising:
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providing a drug which has limited solubility or tends to undergo gelation, aggregation, or precipitation at a physiological pH at a site at which said drug delivery device is to be implanted; and formulating the drug in a dry solid form with a release-modifying agent within said reservoir; opening said reservoir to permit the physiological fluid to solubilize the drug, wherein the release modifying agent is present in an amount effective to changes the pH of a microenvironment in or about the reservoir in an amount effective to inhibit gelation, aggregation, or precipitation of the drug, whereby the solubilized drug can be released from the implanted drug delivery device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An implantable medical device for the storage and controlled release of a drug formulation comprising:
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a body portion having at least one reservoir which has one or more release openings; a drug formulation, which comprises a drug and a release-modifying agent, disposed in a dry solid form within the at least one reservoir; one or more reservoir caps closing off the one or more release openings; and electrical circuitry, a power source, and a controller for disintegrating said reservoir caps to release the drug formulation, wherein the release modifying agent comprises a non-volatile, monoprotic or polyprotic organic acid or a non-volatile, mono- or poly-functional base. - View Dependent Claims (13, 14, 15, 16)
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Specification