Retentive devices and systems for in-situ release of pharmaceutical active agents
Inventors
Betser, Nir • Artmanov, Valery
Assignees
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Publication Number
US-11129793-B2
Publication Date
2021-09-28
Expiration Date
Abstract
Gastric retentive devices and systems including a gastric retentive element including at least one expandable compartment and a dosage form element including at least one active agent are provided. The devices and systems, as well as kits thereof are used in a method for in-situ release and delivery of the at least one active agent.
Core Innovation
The invention relates to gastric retentive delivery systems for in-situ release of active agents, using a folded expandable gastro-retentive system that is swallowed and then unfolds in the stomach. The system includes a gastric retentive element comprising at least one expandable compartment, where the compartment walls are formed by at least one external enterically biodegradable film having an inner surface and an outer surface. Peripheral areas where the walls are joint together enclose a space defined by the inner surface of the walls.
Within the enclosed space, at least one gel-forming compound is contained and is enveloped by the walls as a distinct element from the external enterically biodegradable film. The external enterically biodegradable film and the gel-forming compound do not together form a multi-layer film. The gel-forming compound is capable of increasing the volume of each expandable compartment from an initial collapsed form to an expanded form.
When the folded expandable gastro-retentive system is swallowed, the folded gastric retentive element is unfolded. The gel-forming compound absorbs water, increases in volume as it absorbs water, and expands the compartment to define the expanded form. The gastric retentive element adopts a structure of a ring, a rod or a polygonal shape, and the system includes a dosage form element comprising at least one active agent connected to the gastric retentive element.
Claims Coverage
The provided material includes three independent claims: a system claim, a method claim, and an additional system claim. Collectively, the inventive features are the folded expandable gastro-retentive element with external enterically biodegradable-film-walled expandable compartments containing enveloped gel-forming compounds that expand after water absorption, producing a ring/rod/polygonal structure, with a dosage form element containing an active agent connected to the gastric retentive element.
Folded expandable gastro-retentive system with external enterically biodegradable film walls enclosing distinct gel-forming compound
A folded gastric retentive element comprising at least one expandable compartment, where the compartment walls are formed by at least one external enterically biodegradable film and joint together at peripheral areas to enclose a space by the inner surface; at least one gel-forming compound is contained within the enclosed space and enclosed by the walls as a distinct element from the external enterically biodegradable film, with the external enterically biodegradable film and the gel-forming compound not together forming a multi-layer film.
Water-absorbing gel expansion to form ring, rod or polygonal structure
The at least one gel-forming compound is capable of increasing the volume of each expandable compartment from an initial collapsed form to an expanded form, such that when the folded expandable gastro-retentive system is swallowed: the folded gastric retentive element is unfolded, the at least one gel-forming compound absorbs water, the volume increases to define the expanded form, and the gastric retentive element adopts a structure of a ring, a rod or a polygonal shape.
Connected dosage form element comprising an active agent
The system further comprises a dosage form element comprising at least one active agent, wherein the gastric retentive element and dosage form element are connected to each other.
Method of gastrically delivering an active agent using the unfolded expandable gel-compartment system
A method of gastrically delivering an active agent to a patient comprising administering to the patient a system including: a folded gastric retentive element with at least one expandable compartment having walls formed by at least one external enterically biodegradable film joint together to enclose a space by the inner surface; at least one gel-forming compound contained within the space and enclosed by the walls as a distinct element from the external enterically biodegradable film, with the external enterically biodegradable film and the at least one gel-forming compound not together forming a multi-layer film and all gel-forming compound being within the enclosed space; and a dosage form element comprising at least one active agent connected to the gastric retentive element, such that when swallowed the element is unfolded, the gel-forming compound absorbs water, increases in volume to expand the compartment, and adopts a ring, rod or polygonal shape.
External enterically biodegradable film and gel-forming compound not multi-layered in folded and expanded forms
A folded expandable gastro-retentive system as above, further specifying that the external enterically biodegradable film and the at least one gel-forming compound do not together form a multi-layer film in the folded form and in the expanded form.
Across the independent claims, the core coverage centers on a folded expandable gastro-retentive system whose external enterically biodegradable-film walls enclose a distinct gel-forming compound element that absorbs water and expands compartments to produce a ring/rod/polygonal structure when swallowed, together with a connected dosage form element containing an active agent (for the system claims), and corresponding administration steps (for the method claim).
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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