Implantable device for long-term delivery of drugs
Inventors
Martin, Francis J. • Kang, Ling-Ling
Assignees
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Publication Number
US-10974036-B2
Publication Date
2021-04-13
Expiration Date
Abstract
A device for sustained delivery of a poorly water soluble drug is described. A drug reservoir within the device, when in operation, contains an aqueous suspension of the drug mixed with a suspension of an excipient that, in one embodiment, generates acidic groups for a sustained period of time to maintain a desired pH in the aqueous suspension that in turn provides a constant concentration of a soluble form of the drug.
Core Innovation
The invention provides an implantable drug delivery device having a non-erodible, non-porous housing member defining a reservoir, the housing member having a water impermeable outer surface and opposing ends, with a microporous partition positioned in a first end of the housing member. The device contains a drug formulation in the reservoir that comprises a sparingly water soluble drug having a soluble form and an insoluble form.
The insoluble form of the sparingly water soluble drug is retained in the reservoir, while the soluble form freely diffuses out of the device across the microporous partition. The formulation further includes a solubility-modifying excipient capable of generating acid groups when the drug formulation is hydrated, and the generated acid groups provide a concentration of the drug sufficient to provide release of a therapeutic dose from the device.
The device is configured so that therapeutic dose release is provided for a period between about 2-12 months. The release is achieved as the soluble form diffuses out across the microporous partition while the concentration is maintained by the solubility-modifying excipient generating acid groups during hydration.
Claims Coverage
The document provides two independent claims, one device claim and one method claim, centered on a microporous partitioned reservoir system using a solubility-modifying excipient that generates acid groups to enable sustained release of a sparingly water soluble drug with soluble and insoluble forms over about 2-12 months.
Non-erodible non-porous housing reservoir with water-impermeable outer surface
A drug delivery device comprising a non-erodible, non-porous housing member defining a reservoir, the housing member having a water impermeable outer surface and first and second opposing ends.
Microporous partition positioned in the housing
A microporous partition positioned in the first end of the housing member.
Sparingly water soluble drug formulation with soluble and insoluble forms plus solubility-modifying excipient generating acid groups
Contained within the reservoir, a drug formulation comprised of a sparingly water soluble drug having a soluble form and an insoluble form, wherein the insoluble form is retained in the reservoir, and a solubility-modifying excipient capable of generating acid groups to provide a concentration of the drug when the drug formulation is hydrated.
Diffusion of soluble form across microporous partition with therapeutic dose release for about 2-12 months
The device provides release of a therapeutic dose of the drug from the device for a period between about 2-12 months, as the soluble form freely diffuses out of the device across the microporous partition.
Treating a patient by implanting a microporous-partitioned reservoir device with solubility-modifying excipient generating acid groups
A method for treating a patient with a sparingly water soluble drug, comprising implanting a device comprising a microporous partition with pores having a pore size and with a porosity, a reservoir and a formulation contained in the reservoir, the formulation comprising a sparingly water soluble drug having a soluble form and an insoluble form and a solubility-modifying excipient that generates acidic groups for a period of between about 2-12 months.
Patient treatment by providing diffusive release of soluble form and retention of insoluble form across microporous partition
Providing, when the formulation is hydrated, a concentration of drug in the soluble form that freely diffuses out of the device across the microporous partition and a concentration of drug in the insoluble form that is retained in the device by the microporous partition, and delivering a therapeutic dose of the drug for the period.
Across the independent claims, the inventive concept is the combination of a non-erodible, non-porous, water-impermeable housing reservoir with a microporous partition, a sparingly water soluble drug present as soluble and insoluble forms where insoluble drug is retained, and a solubility-modifying excipient generating acid groups upon hydration to provide a sustained concentration that enables release by diffusion of the soluble form over about 2-12 months.
Stated Advantages
Provides release of a therapeutic dose of a sparingly water soluble drug from the device for a period between about 2-12 months.
Documented Applications
Method for treating a patient with a sparingly water soluble drug by implanting the microporous-partitioned device and delivering a therapeutic dose for the period.
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