Device and method for sustained release of antipsychotic medications
Inventors
Assignees
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Publication Number
US-10137081-B2
Publication Date
2018-11-27
Expiration Date
Abstract
A drug delivery device comprising a non-erodible, non-porous housing member defining a reservoir is provided. The reservoir is loaded with a dry formulation of a selected salt of a neuroleptic agent. The housing member has one or more porous partitions, where the pores of the partitions are sufficiently small to retain the insoluble powder particles within the reservoir yet large enough to allow diffusion of the active agent once the device is hydrated. A therapeutic dose of the drug is released from the device at a constant rate over a period of approximately 2-6 months.
Core Innovation
A drug delivery device is provided that includes a non-erodible, non-porous housing member defining a reservoir, with a porous partition positioned in the housing member. A drug formulation is contained within the reservoir and comprises a salt form of risperidone selected from risperidone octanoate, risperidone hexanoate, and risperidone pentanoate. When hydrated, the drug formulation releases risperidone at a rate that provides a therapeutic dose over a period of at least about 2 months.
The device is configured to maintain therapeutic dosing over an extended period, including release at a substantially constant, near zero-order rate. Hydration of the contained dry neuroleptic salt particles supports diffusion-driven release of the soluble drug, while insoluble dry neuroleptic salt particles are retained by the porous partition. The mechanistic basis described involves concentration gradient and Fickian diffusion, including pH gradient considerations.
Documented results include comparative and supportive in vitro release data showing therapeutic window coverage and sustained release behavior. Rat in vivo pharmacokinetics are described as showing sustained plasma levels for months, with in vitro/in vivo correlation. Overall, the invention focuses on an implantable, non-erodible, non-porous, porous-partition-retaining drug delivery system that enables sustained diffusion-based risperidone release from specific salt forms.
Claims Coverage
The document provides one independent claim defining an implantable drug delivery device with two main inventive features: a non-erodible, non-porous housing with reservoir and porous partition, and a hydrated-releasing risperidone salt formulation selected from specified octanoate, hexanoate, and pentanoate forms to provide a therapeutic dose for at least about 2 months.
Non-erodible non-porous housing with reservoir and porous partition
A drug delivery device includes a non-erodible, non-porous housing member defining a reservoir, with a porous partition positioned in the housing member.
Risperidone salt formulation with hydration-driven release for therapeutic dosing
The reservoir contains a drug formulation comprised of a salt form of risperidone selected from risperidone octanoate, risperidone hexanoate, and risperidone pentanoate, wherein the drug formulation when hydrated releases risperidone at a rate that provides a therapeutic dose over a period of at least about 2 months.
Across the independent claim coverage, the inventive combination is an implantable device architecture coupled with a hydrated-release risperidone salt formulation limited to octanoate, hexanoate, and pentanoate forms, delivering a therapeutic dose for at least about 2 months.
Stated Advantages
Provides a therapeutic dose over a period of at least about 2 months.
Enables substantially constant, near zero-order release rate over the extended period.
Documented Applications
Implantable, subcutaneous extended delivery for a subject needing treatment with risperidone.
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