Drug delivery system
Inventors
Schneeberger, Achim • Kühne, Klaus • KERSCHBAUMER, Helmut • VASIC, Srdan
Assignees
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Publication Number
US-11986558-B2
Publication Date
2024-05-21
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, including oral and dissolvable/bioerodible forms. The system comprises a base component soluble in body fluids, and separate first and second components that are also soluble in body fluids. Each component comprises a therapeutically effective amount of its respective API, with the first component and second component being inhomogeneously arranged in the base component rather than homogeneously mixed.
By arranging the first component within the soluble base in an inhomogeneous or discontinuous arrangement, the system controls a time-dependent API release profile. The concentration profile in the system, including concentration variation across the base and spatially defined patterns such as center/edge/gradient arrangements, smooth transitions, and discontinuous or onion-skin layers, shapes dissolution and release, including constant-rate sections and time ranges associated with predetermined constant API amounts at an outer surface.
The system optionally includes a separately soluble second component with a second API that can have an independent and different release profile and a defined temporal ordering relative to the first API. In addition, the first component or a separate marking component is optically different from the base component and arranged to form a two-dimensional pattern on the surface of the system, providing optical marking for authentication/security. The document also describes structured surfaces and multiple dosage forms, with example embodiments and figure-referenced design options showing inhomogeneous placement and resulting release profiles compared with homogeneous prior art.
Claims Coverage
The independent claim defines a controlled drug delivery system with three soluble material components arranged with inhomogeneity, carrying first and second APIs, and with an optically different surface feature forming a two-dimensional pattern. Dependent claims add quantitative concentration-variation thresholds, defined spatial concentration maxima, quantified multi-dosage timing offsets and release lead times between APIs, and authentication-related functionality of the two-dimensional pattern.
Inhomogeneously arranged soluble components carrying APIs
A base component soluble in body fluids, a separate first component soluble in body fluids, and a separate second component soluble in body fluids, wherein the first component comprises a therapeutically effective amount of a first API, the second component comprises a therapeutically effective amount of a second API, and the first component and the second component are inhomogeneously arranged in the base component.
Optically different two-dimensional surface pattern
The first component or a separate marking component is optically different from the base component and arranged such that it forms a two-dimensional pattern on the surface of the system.
Multi-dosage release for a first API with a timing offset
A concentration profile for a first API that releases the API at two or more dosages, with one dosage starting 1 second to 10 days before another dosage.
First API lead time over second API
A system wherein the first API is released 1 second to 10 days before a second API upon application of the system.
Minimum concentration variation threshold for the first API
A system configured such that the concentration of the first API varies by at least 5% across the system.
Spatial concentration maximum at the center
A system configured such that the concentration of the first API is highest at the center of the system.
Two-dimensional pattern enabling authentication of origin
A system including a two-dimensional pattern that enables authentication of the origin of a drug delivery system.
The claim set centers on a soluble base with inhomogeneously arranged, soluble first and second components carrying therapeutically effective first and second APIs, together with an optically different surface feature forming a two-dimensional pattern. Dependent features further refine the first API’s concentration distribution and quantify multi-dosage timing and inter-API release lead relationships, while tying the two-dimensional pattern to authentication of origin.
Stated Advantages
Provides controlled administration of an API to a body via controlled time-dependent dissolution and release based on inhomogeneous arrangement.
Provides optical marking on the surface via a two-dimensional pattern that is optically different from the base component.
Enables authentication of the origin of a drug delivery system via the two-dimensional pattern.
Documented Applications
Controlled administration of an active pharmaceutical ingredient, API, to a body, including oral administration and dissolvable/bioerodible forms.
Authentication and security marking of the origin of a drug delivery system using an optically different two-dimensional pattern on the surface.
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