# US 2014/0360132 A1 · Method and apparatus for forming delivery devices for oral intake of an agent > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0360132 A1 - Document ID: US20140360132A1 - Status: Published application - Kind: A1 - Application number: 14/305,600 - Filed: 2014-06-16 - Published: 2014-12-11 - Earliest claimed: 2006-01-18 - Assignees: Intec Pharma Ltd. - Applicants: Intec Pharma Ltd. - Inventors: Moshe TSABARI; Avner BALSHEY; Erez YOFE; Michael FRIEDMAN - Web page: https://patentgrep.com/patent/US20140360132A1 ## CPC - A61J 3/074: {Filling capsules; Related operations} - A61J 3/00: Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms - A61J 3/071: {into the form of telescopically engaged two-piece capsules} - A61J 3/078: {into the form of wafers or cachets} - A61K 9/0065: {Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus} - A61K 9/2086: {Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat (active cores with a complete drug-free outer coat A61K9/28)} - A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)} - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - B29C 53/02: Bending or folding (B29C53/22, B29C53/34, B29C53/36, B29C53/56 take precedence) - B29C 53/04: of plates or sheets {(B29C63/04 takes precedence; bending or folding paper B31F1/0003; folding films B65H45/00)} - B29C 53/24: of plates or sheets - B32B 7/12: using interposed adhesives or interposed materials with bonding properties - B32B 27/08: of synthetic resin - B32B 37/12: characterised by using adhesives - B32B 37/185: {Laminating sheets, panels or inserts between two discrete plastic layers} - B32B 37/26: with at least one layer which influences the bonding during the lamination process, e.g. release layers or pressure equalising layers - B32B 39/00: Layout of apparatus or plants, e.g. modular laminating systems - B65B 7/28: by applying separate preformed closures, e.g. lids, covers - B65B 63/04: for folding or winding articles, e.g. gloves or stockings - B29K 2105/0035: {Medical or pharmaceutical agents} - B29K 2105/256: {Sheets, plates, blanks or films} - B29K 2995/0056: Biocompatible, e.g. biopolymers or bioelastomers - B29K 2995/006: Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible - B29K 2995/0078: Shear strength - B32B 2037/268: {Release layers} - B32B 2307/542: Shear strength - B32B 2307/70: Other properties - B32B 2307/748: Releasability - Y10T 156/1025: to form undulated to corrugated sheet and securing to base with parts of shaped areas out of contact - Y10T 156/1051: by folding - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. In the broadest aspect, 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 integrated, for example a laminated, device; folding the integrated delivery device to form a folded integrated delivery device; and at least partially enclosing the fold delivery device to a form suitable for oral delivery. The integrated device can include a first external layer of a first material; a frame of a second material mounted on the first external layer; an agent-releasing formulation housed within the frame; and a second external layer of the first material mounted on the frame. ## Claims ### Claim at position 1 1-58. (canceled) ### Claim 59 A system for producing an agent delivery device for oral intake, comprising: (i) an assembly apparatus configured to assemble one or more layers comprising one or more materials and an agent or an agent-releasing formulation into a generally planar assembly to form an integrated device; (ii) a folding apparatus configured to fold the integrated device into a folded integrated device defining a first axis, such that the folded device has folds of increasingly smaller amplitudes upon extending away from the first axis so as to form a partially rounded cross section; and (iii) an enclosing apparatus adapted to at least partially enclose the folded integrated device within an enclosure to form a device in a form suitable for oral delivery. ### Claim 60 (depends on 59) The system according to claim 59, wherein said assembling apparatus is configured to assemble an integrated device, the integrated device comprising: (i) a first external layer comprising a first material; (ii) one or more functional layers mounted on said first external layer, said one or more functional layers comprising a second material and said agent or agent releasing formulation; and (iii) a second external layer comprising said first material and mounted on said functional layer. ### Claim 61 (depends on 59) The system according to claim 59, wherein said assembling apparatus comprises a dicing apparatus configured to cut at least one shaped piece from a sheet from a first material and at least one shaped piece from a sheet of a second material. ### Claim 62 (depends on 59) The system according to claim 59, comprising an application apparatus configured to apply an integration agent onto at least one of the devices layers prior to the assembly. ### Claim 63 (depends on 59) The system according to claim 59, wherein said assembly apparatus is configured to provide a laminated device by adhering, welding, curing, or fusing of the device's layers. ### Claim 64 (depends on 59) The system according to claim 59, comprising at least one of: a perforation apparatus configured to provide at least one of said external layers with a plurality of perforations; and a coating apparatus configured to provide a coat onto at least one side of the integrated device. ### Claim 65 (depends on 59) The system according to claim 59, wherein said folding apparatus comprises a press having two opposite faces, each face having a corrugated surface with ridges of one corrugated surface being essentially opposite to troughs of the other corrugated surface and essentially fitting one into the other; whereby upon placing the integrated device in the press and pressing the two opposite faces one versus the other an undulated, three dimensional device is formed with undulations that correspond in shape to that of said corrugated surfaces. ### Claim 66 (depends on 59) The system according to claim 59, wherein said folding apparatus comprises a press with two opposite faces, each face having a corrugated surface with ridges of one corrugated surface being essentially opposite to troughs of the other corrugated surface and essentially fitting one into the other; whereby upon placing the integrated device in the press and pressing the two opposite faces one versus the other an undulated, three dimensional device is formed with undulations that correspond in shape to that of said corrugated surfaces, wherein said folding apparatus is configured to press the undulated device in a direction perpendicular to the undulations so as to form a folded device having folds formed along ridges and troughs of the undulation. ### Claim 67 A folding apparatus for folding a generally planar single or multi-layered sheet comprising a primary press with two opposite faces, each face having a corrugated surface with ridges of one corrugated surface being essentially opposite to troughs of the other corrugated surface and essentially fitting one into the other; whereby upon placing at least a portion of the single or multi-layered sheet in the primary press and pressing the two opposite faces one versus the other a three dimensional device is formed with undulations that correspond in shape to that of said corrugated surfaces, the folding apparatus being configured for providing the three dimensional device with folds of increasingly smaller amplitudes upon extending away from an axis of the device so as to form a partially rounded cross section. ### Claim 68 (depends on 67) The folding apparatus according to claim 67, wherein said corrugated surface is formed by a series of fingers comprising a movable central finger having a first length, and at least one pair of secondary movable fingers siding said central finger and having a second length being shorter than the first length, the folding apparatus further comprising a control utility for controlling upwardly and downwardly movement of said central finger and at least one pair of secondary fingers towards the said other corrugated surface. ### Claim 69 (depends on 68) The folding apparatus of claim 68, comprising a movable central finger having a first length, at least one pair of secondary movable fingers siding said central finger and having a second length being shorter than the first length, and a pair or outer movable fingers having a third length being shorter than the second length, each outer finger siding one of the secondary fingers. ### Claim 70 (depends on 67) The folding apparatus according to claim 67, comprising a secondary press having opposite faces perpendicular to the undulations formed in the device following operation of the primary press, such that activation of said secondary press provides a folded device having a dimension which is at least five times smaller than that of the sheet prior to pressing. ### Claim 71 (depends on 59) A method for folding a single or multi-layered sheet, comprising: (i) placing said sheet in a folding apparatus as defined in claim 59; and (ii) pressing the two opposite faces of the first press one towards the other to form an undulated, three dimensional device with undulations that correspond in shape to that of said corrugated surfaces. ### Claim 72 (depends on 71) The method according to claim 71, further comprising activating a secondary press so as to press the undulated device in a direction perpendicular to the direction of pressing by said first press so as to obtain a folded device having a dimension which is at least five times smaller than that of the sheet prior to pressing. ### Claim 73 An apparatus for folding a discrete single or multi-layered sheet, comprising: (i) a primary press for folding said discrete sheet to provide a folded discrete sheet comprising a plurality of adjacent folded segments having respective fold lines extending along a first dimension of said discrete sheet; and (ii) a secondary press for pressing said folded segments of said folded discrete sheet towards one another along directions generally orthogonal to said first dimension to provide a compact configuration for the folded sheet.