Method and apparatus for forming delivery devices for oral intake of an agent
Inventors
Tsabari, Moshe • Balshey, Avner • Yofe, Erez • Friedman, Michael
Assignees
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Publication Number
US-8609136-B2
Publication Date
2013-12-17
Expiration Date
Abstract
Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. The method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an intergraded device; folding the intergrated delivery device to form a folded integrated delivery device; and at least partially enclosing the folded delivery device to a form suitable for oral delivery.
Core Innovation
The invention relates to a gastro-retentive agent delivery device for oral intake that is configured for unfolding from a folded configuration to an unfolded configuration for gastric retention. The device comprises two external layers sandwiching a functional layer therebetween, and the functional layer comprises at least one layer comprising an agent or agent-releasing formulation.
The functional layer is configured for imparting mechanical strength to the device sufficient to enable, upon unfolding, the preservation of the unfolded configuration to provide gastric retention. In the folded configuration, the device has a plurality of folds and a device axis, where the folds have increasingly smaller amplitudes upon extending away from the device axis so as to form a partially rounded cross section.
At least one of the external layers comprises perforations. The arrangement supports gastro-retention by combining perforated external layers, a functional agent-containing layer that provides mechanical strength during unfolding, and a fold geometry in which fold amplitudes decrease away from the device axis to yield a partially rounded cross section.
Claims Coverage
Independent claim clm-00001 covers a gastro-retentive oral agent delivery device with five inventive features.
Unfolding gastro-retentive folded-to-unfolded configuration
The device is configured for unfolding from a folded configuration for oral intake to an unfolded configuration for gastric retention.
Sandwiched layered construction with an agent functional layer
The device comprises two external layers sandwiching a functional layer therebetween, wherein the functional layer comprises at least one layer comprising an agent or agent-releasing formulation.
Mechanical-strength functional layer preserving unfolded configuration for gastric retention
The functional layer is configured for imparting mechanical strength to the device sufficient to enable, upon unfolding of the device, the preservation of said unfolded configuration to provide gastric retention.
Perforations on at least one external layer
At least one said external layer comprises perforations.
Decreasing-amplitude fold geometry forming a partially rounded cross section
In the folded configuration the device has a plurality of folds and a device axis, the folds being of increasingly smaller amplitudes upon extending away from the device axis so as to form a partially rounded cross section.
The claims focus on a gastro-retentive oral device that unfolds into a retained unfolded configuration, using a layered sandwich structure with an agent-containing functional layer that provides mechanical strength, perforated external layers, and a fold geometry defined by decreasing fold amplitudes away from a device axis to produce a partially rounded cross section.
Stated Advantages
Preservation of the unfolded configuration to provide gastric retention upon unfolding.
Documented Applications
Oral intake of a gastro-retentive agent delivery device that unfolds from a folded configuration to an unfolded configuration for gastric retention.
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