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Publication Number

US-11419824-B2

Patent

Publication Date

2022-08-23

Expiration Date


Abstract

The present invention relates to a drug delivery system, in particular for a controlled administration of one or more active pharmaceutical ingredients to a body, and further in particular for oral administration of one or more active pharmaceutical ingredients to a body. The system thereby comprises a base component soluble in body fluids and a separate first component soluble in body fluids. The first component thereby comprises a therapeutically effective amount of a first active pharmaceutical ingredient.

Core Innovation

The invention relates to a drug delivery system for controlled administration of an active pharmaceutical ingredient, API, to a body. The system comprises a base component soluble in body fluids, and separate first and second components, each also soluble in body fluids, with a therapeutically effective amount of a first API and a second API, respectively. The base component is provided as a three-dimensional body.

The first component and the second component are inhomogeneously arranged in the base component and are inhomogeneously arranged throughout the base component along the three dimensions. The concentration of the first API and the second API varies throughout the system, defining API-specific concentration variation within the same soluble base component.

Upon application of the system to the body, release of the first API starts before release of the second API. The system is arranged to provide different release timing between the first and second APIs, and concentration profiles are used to produce a predetermined release profile and different concentration profiles for the first and second APIs.

Further refinements include configurations where the first API concentration varies spatially, including concentration profiles with a highest concentration at a center region and smooth transitions, timing windows for when the first API release starts before the second API release, and optional optically different markings forming a two-dimensional pattern on the system’s surface.

Claims Coverage

The independent claim provides a three-dimensional, body-fluid-soluble, inhomogeneously arranged dual-API drug-delivery system configured for sequential release timing. The independent claim contains 5 core inventive features, and dependent claims further specify concentration-profile and timing refinements plus optional surface marking and spatial arrangement limitations.

Soluble base component three-dimensional body

A base component soluble in body fluids, wherein the base component is provided as a three-dimensional body.

Separate first and second body-fluid-soluble components with therapeutically effective amounts

A separate first component soluble in body fluids comprising a therapeutically effective amount of a first API, and a separate second component soluble in body fluids comprising a therapeutically effective amount of a second API.

Inhomogeneous arrangement along three dimensions throughout the base

The first component and the second component are inhomogeneously arranged in the base component, and are inhomogeneously arranged throughout the base component along the three dimensions.

Variable API concentrations throughout the system

The concentration of the first API and the second API varies throughout the system.

Sequential release timing: first API starts before second API

The first component and the second component are arranged in the system such that upon application of the system, release of the first API starts before release of the second API.

Overall, the independent claim centers on a three-dimensional, body-fluid-soluble base with two separate, inhomogeneously arranged, body-fluid-soluble API components, where varying API concentrations across the three dimensions are configured so that the first API release begins before the second API release; dependent claims further narrow spatial concentration profile forms, predetermined release profiles, explicit release-start timing windows, and optional optically different two-dimensional surface markings.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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