WO2024013649A2 - Article gonflable relatif à la nutrition - Google Patents
Article gonflable relatif à la nutrition Download PDFInfo
- Publication number
- WO2024013649A2 WO2024013649A2 PCT/IB2023/057084 IB2023057084W WO2024013649A2 WO 2024013649 A2 WO2024013649 A2 WO 2024013649A2 IB 2023057084 W IB2023057084 W IB 2023057084W WO 2024013649 A2 WO2024013649 A2 WO 2024013649A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- item according
- swellable item
- swellable
- poroelastic
- cellulose
- Prior art date
Links
- 235000016709 nutrition Nutrition 0.000 title description 3
- 230000035764 nutrition Effects 0.000 title description 3
- 239000002245 particle Substances 0.000 claims abstract description 29
- 239000012530 fluid Substances 0.000 claims abstract description 26
- 210000000813 small intestine Anatomy 0.000 claims abstract description 23
- 230000006835 compression Effects 0.000 claims abstract description 16
- 238000007906 compression Methods 0.000 claims abstract description 16
- 230000002496 gastric effect Effects 0.000 claims abstract description 15
- 235000015097 nutrients Nutrition 0.000 claims abstract description 13
- 210000004913 chyme Anatomy 0.000 claims abstract description 12
- 229920002678 cellulose Polymers 0.000 claims description 38
- 239000001913 cellulose Substances 0.000 claims description 38
- 238000000034 method Methods 0.000 claims description 38
- 239000000835 fiber Substances 0.000 claims description 34
- 239000011148 porous material Substances 0.000 claims description 26
- 238000004519 manufacturing process Methods 0.000 claims description 22
- 210000002784 stomach Anatomy 0.000 claims description 21
- 238000000576 coating method Methods 0.000 claims description 19
- 239000000463 material Substances 0.000 claims description 17
- 239000011248 coating agent Substances 0.000 claims description 16
- 210000001072 colon Anatomy 0.000 claims description 16
- 239000002775 capsule Substances 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 11
- 235000021472 generally recognized as safe Nutrition 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 238000006116 polymerization reaction Methods 0.000 claims description 9
- 238000010521 absorption reaction Methods 0.000 claims description 8
- 230000009747 swallowing Effects 0.000 claims description 8
- 239000013585 weight reducing agent Substances 0.000 claims description 8
- 210000001198 duodenum Anatomy 0.000 claims description 7
- 235000013305 food Nutrition 0.000 claims description 5
- 241001465754 Metazoa Species 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 4
- 239000004014 plasticizer Substances 0.000 claims description 4
- 239000004627 regenerated cellulose Substances 0.000 claims description 4
- 230000000996 additive effect Effects 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 3
- 239000000796 flavoring agent Substances 0.000 claims description 2
- 235000019634 flavors Nutrition 0.000 claims description 2
- 239000000576 food coloring agent Substances 0.000 claims description 2
- 239000003205 fragrance Substances 0.000 claims description 2
- 235000010980 cellulose Nutrition 0.000 claims 14
- 150000004676 glycans Chemical class 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 229920001282 polysaccharide Polymers 0.000 claims 2
- 239000005017 polysaccharide Substances 0.000 claims 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 239000000243 solution Substances 0.000 description 14
- 238000009987 spinning Methods 0.000 description 13
- 238000002386 leaching Methods 0.000 description 11
- 229920000642 polymer Polymers 0.000 description 11
- 238000001125 extrusion Methods 0.000 description 10
- 238000005187 foaming Methods 0.000 description 9
- 208000008589 Obesity Diseases 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 230000008901 benefit Effects 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- 210000001187 pylorus Anatomy 0.000 description 6
- 229920001169 thermoplastic Polymers 0.000 description 6
- 229920000297 Rayon Polymers 0.000 description 5
- 235000020824 obesity Nutrition 0.000 description 5
- 230000008929 regeneration Effects 0.000 description 5
- 238000011069 regeneration method Methods 0.000 description 5
- 239000004416 thermosoftening plastic Substances 0.000 description 5
- 230000004580 weight loss Effects 0.000 description 5
- 230000001580 bacterial effect Effects 0.000 description 4
- 238000005520 cutting process Methods 0.000 description 4
- 239000004744 fabric Substances 0.000 description 4
- 238000000855 fermentation Methods 0.000 description 4
- 230000004151 fermentation Effects 0.000 description 4
- 210000001035 gastrointestinal tract Anatomy 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000000291 postprandial effect Effects 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 229920002301 cellulose acetate Polymers 0.000 description 3
- 235000014113 dietary fatty acids Nutrition 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000000194 fatty acid Substances 0.000 description 3
- 229930195729 fatty acid Natural products 0.000 description 3
- 239000006260 foam Substances 0.000 description 3
- 210000003767 ileocecal valve Anatomy 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 230000008520 organization Effects 0.000 description 3
- 239000003361 porogen Substances 0.000 description 3
- 238000007127 saponification reaction Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 235000000346 sugar Nutrition 0.000 description 3
- 238000002166 wet spinning Methods 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 2
- 239000004604 Blowing Agent Substances 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- VQTUBCCKSQIDNK-UHFFFAOYSA-N Isobutene Chemical compound CC(C)=C VQTUBCCKSQIDNK-UHFFFAOYSA-N 0.000 description 2
- WQDUMFSSJAZKTM-UHFFFAOYSA-N Sodium methoxide Chemical compound [Na+].[O-]C WQDUMFSSJAZKTM-UHFFFAOYSA-N 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 239000006227 byproduct Substances 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 230000006196 deacetylation Effects 0.000 description 2
- 238000003381 deacetylation reaction Methods 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 230000003111 delayed effect Effects 0.000 description 2
- 235000015872 dietary supplement Nutrition 0.000 description 2
- 210000004921 distal colon Anatomy 0.000 description 2
- 238000001523 electrospinning Methods 0.000 description 2
- 239000000839 emulsion Substances 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 150000004665 fatty acids Chemical class 0.000 description 2
- 238000004108 freeze drying Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000004899 motility Effects 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 239000004745 nonwoven fabric Substances 0.000 description 2
- 238000004091 panning Methods 0.000 description 2
- 239000006187 pill Substances 0.000 description 2
- 239000002964 rayon Substances 0.000 description 2
- 230000036186 satiety Effects 0.000 description 2
- 235000019627 satiety Nutrition 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- -1 sugar alcohols) Chemical class 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- 239000006188 syrup Substances 0.000 description 2
- 235000020357 syrup Nutrition 0.000 description 2
- 239000004753 textile Substances 0.000 description 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- 229920001747 Cellulose diacetate Polymers 0.000 description 1
- DQEFEBPAPFSJLV-UHFFFAOYSA-N Cellulose propionate Chemical compound CCC(=O)OCC1OC(OC(=O)CC)C(OC(=O)CC)C(OC(=O)CC)C1OC1C(OC(=O)CC)C(OC(=O)CC)C(OC(=O)CC)C(COC(=O)CC)O1 DQEFEBPAPFSJLV-UHFFFAOYSA-N 0.000 description 1
- 208000017667 Chronic Disease Diseases 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 206010017943 Gastrointestinal conditions Diseases 0.000 description 1
- 208000013016 Hypoglycemia Diseases 0.000 description 1
- 229920000433 Lyocell Polymers 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- IOVCWXUNBOPUCH-UHFFFAOYSA-M Nitrite anion Chemical compound [O-]N=O IOVCWXUNBOPUCH-UHFFFAOYSA-M 0.000 description 1
- 206010033307 Overweight Diseases 0.000 description 1
- 206010033645 Pancreatitis Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 238000006640 acetylation reaction Methods 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000004964 aerogel Substances 0.000 description 1
- 239000000883 anti-obesity agent Substances 0.000 description 1
- 238000007681 bariatric surgery Methods 0.000 description 1
- 230000006399 behavior Effects 0.000 description 1
- 239000004566 building material Substances 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 235000019577 caloric intake Nutrition 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 229920006218 cellulose propionate Polymers 0.000 description 1
- 239000002666 chemical blowing agent Substances 0.000 description 1
- 238000001311 chemical methods and process Methods 0.000 description 1
- 238000002485 combustion reaction Methods 0.000 description 1
- 208000012696 congenital leptin deficiency Diseases 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 229920006037 cross link polymer Polymers 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 235000001916 dieting Nutrition 0.000 description 1
- 230000037228 dieting effect Effects 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000007515 enzymatic degradation Effects 0.000 description 1
- 230000002255 enzymatic effect Effects 0.000 description 1
- 210000003238 esophagus Anatomy 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- ZOOODBUHSVUZEM-UHFFFAOYSA-N ethoxymethanedithioic acid Chemical compound CCOC(S)=S ZOOODBUHSVUZEM-UHFFFAOYSA-N 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 235000012041 food component Nutrition 0.000 description 1
- 230000030135 gastric motility Effects 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 210000001630 jejunum Anatomy 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 239000000693 micelle Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 208000001022 morbid obesity Diseases 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 239000002667 nucleating agent Substances 0.000 description 1
- 230000008855 peristalsis Effects 0.000 description 1
- 238000005191 phase separation Methods 0.000 description 1
- 230000037081 physical activity Effects 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920005597 polymer membrane Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 238000012913 prioritisation Methods 0.000 description 1
- 235000021067 refined food Nutrition 0.000 description 1
- 238000007378 ring spinning Methods 0.000 description 1
- 230000000276 sedentary effect Effects 0.000 description 1
- 235000002639 sodium chloride Nutrition 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000002195 soluble material Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 150000003445 sucroses Chemical class 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000002123 temporal effect Effects 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000012991 xanthate Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
Definitions
- Obesity is a global epidemic.
- the World Health Organization (WHO) estimates that in 2016, more than 1.9 billion adults (or 1 in 3 worldwide!) were overweight, and of those, over 650 million were obese.
- the prevalence of obesity has increased dramatically in recent decades, from about 10% in 1975, to over 30% of adults worldwide (2016).
- Obesity is associated with a number of chronic diseases, including heart disease, stroke, type 2 diabetes, and cancer. It is also a major risk factor for premature death.
- the solutions are broadly segmented by product type and intervention.
- product type there are weight loss supplements, drugs, surgical solutions, and weight loss programs.
- the weight loss supplements segment stands out as being one of the most natural and safe of all weight loss solutions.
- Weight loss drugs are very expensive, require prescription, and have significant side effects and compliance challenges. Side effects include indigestion, pancreatitis and hypoglycemia; Weight loss surgery is exercised almost only with morbid obesity patients due to its risk profile (including risk of death during surgery), invasiveness, long term side effects and detrimental effects on quality of life.
- FIG. 1 illustrates an example of a sponge like open cell porous thick filament fiber
- FIG. 2 illustrates an example of a sponge like open cell porous thick filament fiber after cutting and in an expanded state
- FIG. 3 illustrates an example of a sponge like open cell structure manufactured by extrusion foaming and particulate or polymer leaching
- FIG. 4 illustrates an example of a sponge like open cell structure manufactured by spinning (electro spinning, dry jet wet spinning or other methods of spinning) of non- porous thin filament fibers spun helically through a spinneret perpendicular to the drawing axis to create a "yam like" tangle non-woven fabric;
- FIG. 5 illustrates an example of a porous filament fibers spun (twisted) to a compressed yam.
- Any reference in the specification to an swellable item should be applied mutatis mutandis to a method for manufacturing the swellable item and/or should be applied mutatis mutandis for a method for administering the swellable item and/or should be applied mutatis mutandis to a method for consuming the swellable item.
- an orally swellable item that includes a dissolvable surrounding element that is dissolvable in gastro-intestinal fluids and a poroelastic structure (which is highly porous and elastic), held compressed by the dissolvable surrounding and exhibits a compression ratio that exceeds ten.
- compression ration expansion ratio
- compression and expansion ratio refer to a relationship between a volume of a structure when expanded to the volume of the structure when compressed. The expanded volume exceeds the compressed volume.
- the swellable item is configured to the following: a. Transfer from the mouth, through the esophagus to the stomach while the structure is in compressed state. b. The structure expands to its original size, in the stomach or in the duodenum, after the surrounding dissolves, exposed to gastro-intestinal fluids. c. The structure absorbs gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding. d. The expanded structure maintains the majority of the gastro-intestinal fluids with dissolved nutrients and chyme particles while transferring through the small intestine, until exiting the ileocecal valve. e. The structure releases most of the gastro-intestinal fluids while being mechanically compressed and/or disintegrated (by bacterial fermentation) in the colon.
- the dissolvable surrounding element is configured to surround the structure and maintain the structure in a compressed form before being dissolved.
- the swellable item is safe for human consumption.
- the swellable item may be formed solely from Generally Recognized as Safe (GRAS) materials - as defined Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act.
- GRAS Generally Recognized as Safe
- the poroelastic structure is made of cellulose.
- the poroelastic structure is made of regenerated cellulose.
- the poroelastic structure includes cellulose and a plasticizer.
- the poroelastic structure includes cellulose and an additive that has a higher bacterial fermentability than the cellulose.
- the cellulose can include a blend of high average degree of polymerization (e.g. 100-1500) and/or higher crystallinity index (e.g. a>30%) cellulose for good mechanical charasteristics and low average degree of polymerization (e.g. ⁇ 100) and/or low crystallinity (e.g. a ⁇ 30%) cellulose for good bacterial fermentation and dismantling.
- the poroelastic structure is configured to absorb specific materials through its building materials or coating, as an example, it can be oleophylic in order to enhance fatty acid absorption.
- the swellable item is further integrated or impregnated or combined or co-administered with edible food coloring and or food flavors and/or edible fragrances to improve taste, smell or appearance.
- the porosity of the poroelastic structure exceeds ninety eight percent.
- the swellable item is a powder particle (multiparticulate).
- the swellable item is a powder particle having a length that ranges between 100 and 700 microns.
- the swellable item is a capsule, encapsulating multiple such poroelastic structures in compressed state.
- a volume of the daily orally delivered amount of swellable items will not exceed few tens of cubic centimeters, and According to an embodiment, the volume of the daily swelled amount of poroelastic structures when uncompressed will be few hundreds cubic centimeters.
- a diameter of the expanded poroelastic structure does not exceed three millimeters and a length of the expanded poroelastic structure does not exceed ten millimeters.
- the poroelastic structure is configured to withstand one cycle of full compression to the swellable item and full expansion after the surrounding dissolves, and also thousands of partial compression and expansion cycles within the small intestine.
- the poroelastic structure is configured to be dismantled in a colon.
- the structure includes multiple groups of pores, According to an embodiment, pores of each group of pores are in fluid communication with each other.
- the poroelastic structure is a spongelike structure element of an interconnected pores network type ("open cell”: fluid flow is possible to penetrate among the pores and to and from the outside).
- the structure includes multiple non-porous fibers that are spun to provide a poroelastic yarn.
- the poroelastic structure is manufactured by a manufacturing process that includes generating a structure that includes fully enclosed pores ("closed cell”); and forming holes that link the pores among themselves and to the outside (“open cell”).
- swellable item may include a swellable "sponge like” structure ("open cell” porous structure), which is swallowed while in compressed state within an outer case or coating and reaches its target expansion location (the stomach or the upper small intestine - duodenum or Jejunum), captures (absorbs) gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding (before most of the nutrients absorption in the small intestine takes place), move along the gastro-intestinal tract transferring most of these materials while in expanded state throughout the small intestine to the colon and either transfers it outside the body or releases most of the trapped liquid and materials within the colon (with or without poroelastic structure full or partial dismantling in the colon).
- open cell the target expansion location
- gastro-intestinal fluids with dissolved nutrients and chyme particles while expanding (before most of the nutrients absorption in the small intestine takes place)
- move along the gastro-intestinal tract transferring most of these materials while in expanded state throughout the small intestine to the colon and
- the mixture of gastro-intestinal fluids and chyme can be partially in the form of a solution (dissolved materials, e.g. nutrients such as carbohydrates), a mixture of the fluids with small (up to 1mm diameter) non-soluble particles or emulsion (e.g. fatty acid micelles).
- a solution dissolved materials, e.g. nutrients such as carbohydrates
- a mixture of the fluids with small (up to 1mm diameter) non-soluble particles or emulsion e.g. fatty acid micelles.
- the total volume of absorbed chyme should be in the order of at least several 100's of CC, while a reasonable volume for swallowing such swellable items is few CC to very few 10's of CC.
- the poroelastic structure should have very high porosity (e.g. >98%) and very high compression ratio (e.g. >95%).
- Gastric motility is characterized by relatively weak pressure waves in the upper stomach ( ⁇ 20 mmHg) and relatively strong and short (several seconds) pressure waves (40 - >100 mmHg) in the distal antrum and pylorus.
- Small bowel motility is characterized by medium pressure waves (both peristalsis and segmental, ⁇ 25mmHg), short (several seconds) with maximal frequency of 8-12 cycles per minute.
- Colon motility is characterized by stronger pressure waves (50-100 mmHg) which are short (several seconds) in the proximal colon but much longer (up to almost static) in the distal colon.
- the poroelastic structure should be elastic enough (not brittle) to withstand at least one cycle of compressing to its compressed packed state and decompressing to its expanded state in the gastro-intestinal tract.
- the poroelastic structure can be dismantled within the colon (e.g. through degradation by bacteria fermentation), and/or compressed by the pressures in the colon to release most of the trapped fluids and particles, since there is no significant nutrients absorption at this stage.
- poroelastic structure It is preferred that all the materials of which the poroelastic structure are built from should be generally recognized as safe and permitted to be used as food, food supplements or dietary supplements, no new dietary ingredients (e.g. regenerated cellulose).
- Different swellable items can be used for different populations (e.g. adults vs. children), for example: different delivering options (multiparticulates Vs. capsules), different poroelastic structure dimensions (e.g. 1mm Vs. 3 mm diameter in expanded state) etc.
- Expanding in the small intestine has several advantages: (i) gastric fluids low acidity (after neutralizing in the duodenum), so release of some of the fluids further in the small intestine or the colon due to external pressure will not cause any acid bums, (ii) not accumulating in the stomach, which could have negative impacts such as stomach pain, nausea and vomiting, and (iii) lower viscosity fluids (easier absorption in the poroelastic structure).
- expanding within the stomach can also improve the satiety, especially if the expanded poroelastic structures are too big to exit the pyloric sphincter during standard digestion so it accumulates and released to the small intestine mostly during the interdigestive migrating motor complex, which means that the mass of expanded poroelastic structures remains in the stomach for a longer period of time.
- the dimension requirements can be on the swellable items (before surrounding dissolving and poroelastic structures expanding) as well as on the expanded poroelastic structures.
- the requirements are for the following: (i) delivering (swallowing), (ii) Passing from the stomach to the small intestine (through the pyloric sphincter), and (iii) Passing along the small intestine and through the ileocecal valve to the colon.
- Pills capsules
- the diameter of each ingested capsule should be ⁇ 8mm, and the length ⁇ 20mm, the volume is in the range of 0.5-1 CC.
- the main drawback is the large number of such capsules required to deliver large volumes and the fact that many people (especially young) cannot or dislike swallowing large pills,
- Multiparticulates A large number of small particles, having dimensions in the 100's of microns range (e.g. 200- 500pm), delivered as a "powder” and drunk mixed with water. This delivery option is much easier for large volumes (e.g. 10's of CC), replacing 10's of capsules.
- the main drawback is the grittiness "sandy" feeling.
- particles In order to pass from the stomach through the pyloric sphincter to the small intestine in parallel to the chyme during the postprandial period, particles should be up to 2mm in diameter and 5-10 mm length (depending on its stiffness, elastic structures can be somewhat larger).
- Poroelastic structure that should expand in the stomach can be up to 2-3 mm diameter in expanded state, in which case it would transfer to the small intestine during the postprandial period, or larger than this and accumulate in the stomach until the mmc cycle, causing longer satiety period but with the risk of over accumulation in the stomach.
- Poroelastic structure that should expand in the small intestine should be up to 2-3mm diameter in compressed state, in order to pass to the small intestine during the postprandial period and capture nutrients dissolved in the gastric fluids.
- each particle will easily pass through the pyloric sphincter during digestive period in compressed (and probably also expanded) state.
- the manufacturing process for these "sponge like" open cell porous structure can be based on a wide variety of known methods, either for textile fibers and non-woven fabrics manufacturing (e.g. cellulose regeneration for fibers such as rayon fibers), filtration polymer membrane manufacturing (e.g. casting plus particulate leaching), tissue engineering / polymer scaffold manufacturing (e.g. extrusion foaming followed by porogen leaching) or even aerogel manufacturing (e.g. polymer dissolving, solvent exchange and freeze drying).
- textile fibers and non-woven fabrics e.g. cellulose regeneration for fibers such as rayon fibers
- filtration polymer membrane manufacturing e.g. casting plus particulate leaching
- tissue engineering / polymer scaffold manufacturing e.g. extrusion foaming followed by porogen leaching
- aerogel manufacturing e.g. polymer dissolving, solvent exchange and freeze drying.
- the manufacturing process can start with a solution (polymer dissolved in a solvent), a molten or softened thermoplastic polymer or a liquid containing monomers or non crosslinked polymer that will later on precipitate or coagulate into a polymeric structure.
- a solution polymer dissolved in a solvent
- a molten or softened thermoplastic polymer or a liquid containing monomers or non crosslinked polymer that will later on precipitate or coagulate into a polymeric structure.
- These methods include for example: (i) thermoplastic foaming (either extrusion or injection molding), creating mostly closed cell foam, followed by opening holes in the closed cells to make an open cell foam structure, e.g.
- phase separation e.g. mixing a polymer-solvent solution with nonsolvent.
- Emulsion templating e.g. PolyHIPE.
- Porogen/particulate leaching e.g. table salt or calcium carbonate
- Polymer leaching e.g. water soluble polymer such as PEO.
- Freeze drying e.g.
- a manufacturing process produces an "endless”, “sponge” like, poroelastic thick yarn (few millimeters diameter in non-compressed state) which has all the required mechanical and physical properties. This yam is then twisted (spinned) in order to be compressed, coated in order to hold it in compressed state and to withstand gastro-intestinal conditions until required expansion and cut to appropriate length.
- the "endless" yarns can be drawn through all production stages (from fiber creation until cutting), it could be beneficial to roll "endless” filament fibers after process steps and un-roll in proceeding process stages.
- One benefit can be load balancing of manufacturing processes, using several such fibers in parallel for slow processes (e.g. saponification).
- Another benefit could be performing different manufacturing stages at different locations (e.g. by sub-contractors).
- the manufacturing process starts with extrusion foaming of a cellulose thermoplastic derivative (e.g. ester derivative such as cellulose acetate or cellulose acetate butyrate, viscose: cellulose xanthate, cellulose propionate, ether derivative such as ethylcellulose, cellulose nitrite etc.).
- a cellulose thermoplastic derivative e.g. ester derivative such as cellulose acetate or cellulose acetate butyrate, viscose: cellulose xanthate, cellulose propionate, ether derivative such as ethylcellulose, cellulose nitrite etc.
- the extrusion is from a 200-300pm diameter die into an "endless" closed cell porous single filament fiber yarn with a diameter of 2-3mm.
- the foaming can be done with the help of chemical or physical blowing agents, e.g. water, SC-CO2, N2, isobutene etc. Better volume expansion ratio is achieved with larger blowing agent molecules (lower diffusion) and lower process temperatures
- nucleating agents can be added to improve the foaming uniformity, pores size and the volume expansion ratio.
- a plasticizer e.g. glycerol, glycerol tri-acetate etc.
- the yarns will be drawn and dipped in baths for further reticulation and/or leaching (opening the pores into "open cell” form and enlarging the porosity).
- the cellulose can be regenerated (e.g. by saponification of ester derivatives such as cellulose acetate, for example by dipping in a solution of NaOH/H2O, NaOH/Ethanol or NaOMe/MeOH, similar to saponification of acetate rayon fibers to rayon as done in the case of Fortisan fibers, described in US patent 2,053,766).
- ester derivatives such as cellulose acetate
- Cellulose regeneration e.g. deacetylation of cellulose acetate
- the compressed yarn goes through a bath (or air spray coating) in order to be coated with a coating that will hold the yam compressed until dissolving.
- Such hard crystalline coating that can hold the twisted fibers is similar to hard panning of sugar, polyol (e.g. sugar alcohols), sucrose esters etc., performed by coating with multi thin layers of a syrup which crystallizes.
- Another option is similar to soft panning, a syrup that would not crystallize but be utilized as an adhesive to a powder (e.g. confectionary sugar, sugar mixed with starch etc.) "dusted" afterwards.
- Another coating can be applied for delayed expansion, either in acidic environment (stomach) or neutral environment (small intestine).
- An example for such coating that can be used as enteric (dissolving only in the neutral acidity small intestine) is stearic or palmitic fatty acid (also generally recognized as safe food).
- the coatings for mechanically holding the compressed poroelastic structure and delayed expansion can be one or two different coatings.
- the second coating can also be provided after cutting the yam, since coating before cutting the fibers means that the fibers are not coated at the cut sides, but only around the cylindrical surface.
- the last stage is cut the coated, compressed twisted yam to required length (in the case of multiparticulates: 200-500pm).
- the manufacturing process starts with extrusion (without foaming) of an endless solid (non-porous) thick (2-3mm) yarn comprised of cellulose thermoplastic derivative combined with large amount of soluble particles.
- the materials can be the same as in embodiment one, the main difference from embodiment one is that the extrusion is of a solid polymer thick fiber (through a 2-3 mm diameter die) and not a foamed thick fiber (that expands after extrusion through 200-300pm diameter die).
- the open cell porous structure is formed by porogen/particulate leaching within a bath filled with an appropriate solvent (e.g. water for water soluble particles).
- an appropriate solvent e.g. water for water soluble particles.
- the manufacturing process starts with filament fibers spinning (e.g. solution blow spinning through spinnerets) of "endless" thin non-porous filament fibers which build a non-woven, tangled, "thick yarn like” poroelastic fabric.
- filament fibers spinning e.g. solution blow spinning through spinnerets
- An example for such a fabric creation is by spinning helical shapes downwards while the fabric is drawn to the side.
- the spinning can be using single or multiple nozzles.
- the helices are built in several layers and the outcome is an "endless" few hundred microns to few millimeters wide (about the helix diameter in one axis and the number of layers multiplied by the fiber diameter on the other axis, both perpendicular to the "endless” drawing axis).
- the spinning can be of molten thermoplastic cellulose derivative, as well as dissolved cellulose derivative (e.g. viscose: cellulose xantate or dissolved cellulose diacetate in acetone) or dissolved pure cellulose (e.g. lyocell process).
- dissolved cellulose derivative e.g. viscose: cellulose xantate or dissolved cellulose diacetate in acetone
- pure cellulose e.g. lyocell process
- Each fiber can be l-100pm diameter; the fabric should be 2-3 mm diameter (can also be of rectangular shape, compressed to 200-300pm diameter after twisting).
- the materials can be the same as in embodiment one, the main difference from embodiment one is that the extrusion is of solid polymer thin fibers and not a foamed thick fiber.
- This structure is inherently "open cell" (the gaps between the thin fibers), so there is no need for particulate leaching or reticulation.
- a method for weight reduction of a human comprises swallowing a swellable item illustrated in the specification and/or drawings and/or claims.
- the human may be a human that suffers from excess weight and/or a patient that was diagnosed as suffering for excess weight.
- a method for weight reduction of a human comprises administering to a person a swellable item illustrated in the specification and/or drawings and/or claims.
- the human may be a human that suffers from excess weight and/or a patient that was diagnosed as suffering for excess weight.
- a method for weight reduction of a animal comprises swallowing a swellable item illustrated in the specification and/or drawings and/or claims.
- a method for weight reduction of a animal comprises administering to a person a swellable item illustrated in the specification and/or drawings and/or claims.
- any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved.
- any two components herein combined to achieve a particular functionality may be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermedial components.
- any two components so associated can also be viewed as being “operably connected,” or “operably coupled,” to each other to achieve the desired functionality.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Article gonflable comprenant (i) un élément environnant dissoluble dans les fluides gastro-intestinaux et (ii) une structure poroélastique, présentant un rapport de compression et de dilatation supérieur à dix et conçue pour absorber les nutriments dissous et les particules de chyme lorsqu'elle se dilate en présence de fluides gastro-intestinaux et pour conserver une majorité des nutriments dissous et des particules de chyme jusqu'à ce qu'ils sortent de l'intestin grêle. L'élément environnant dissoluble est conçu pour entourer la structure et la maintenir sous une forme comprimée avant d'être dissoute. L'article gonflable est sans danger pour la consommation humaine.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US202263359893P | 2022-07-11 | 2022-07-11 | |
US63/359,893 | 2022-07-11 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2024013649A2 true WO2024013649A2 (fr) | 2024-01-18 |
WO2024013649A3 WO2024013649A3 (fr) | 2024-03-28 |
Family
ID=89536095
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2023/057084 WO2024013649A2 (fr) | 2022-07-11 | 2023-07-11 | Article gonflable relatif à la nutrition |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2024013649A2 (fr) |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2669699B2 (ja) * | 1989-11-28 | 1997-10-29 | 日本碍子株式会社 | 空燃比センサ |
WO1994028881A1 (fr) * | 1993-06-11 | 1994-12-22 | Merix Corporation | Formulation de retention a liberation retardee pour adsorbant d'acides biliaires |
CA2591662C (fr) * | 2004-12-17 | 2014-01-28 | Dow Global Technologies Inc. | Compositions de polyethylene aux proprietes rheologiques modifiees possedant une resistance a la fusion relativement elevee et procedes de fabrication de tuyaux, de pellicules, de feuilles et d'articles moules par soufflage |
US9757346B2 (en) * | 2008-09-03 | 2017-09-12 | Volant Holdings Gmbh | Compositions and methods for treating insulin resistance and non-insulin dependent diabetes mellitus (type II diabetes) |
EP2542181A1 (fr) * | 2010-03-03 | 2013-01-09 | Allurion Technologies, Inc. | Produit de synthèse remplissant le volume gastrique |
RU2637167C2 (ru) * | 2012-03-28 | 2017-11-30 | Этикон Эндо-Серджери, Инк. | Компенсатор толщины ткани, содержащий контролируемое высвобождение и расширение |
WO2015137170A1 (fr) * | 2014-03-12 | 2015-09-17 | 富士フイルム株式会社 | Procédé de production de particules cellulosiques poreuses, et particules ainsi obtenues |
MX2017009805A (es) * | 2015-01-29 | 2018-05-07 | Gelesis Llc | Método para la producción de hidrogeles que juntan alto módulo elástico y absorbancia. |
CA2989511A1 (fr) * | 2015-07-07 | 2017-01-12 | Perora Gmbh | Composition comestible comprenant un polysaccharide et un lipide |
KR101896476B1 (ko) * | 2017-06-19 | 2018-10-18 | 재단법인대구경북과학기술원 | 공용매를 이용한 고결정성 재생 셀룰로오스 섬유의 제조 방법 |
IL301911B1 (en) * | 2020-10-06 | 2024-04-01 | Tensive S R L | A three-dimensional matrix for implantation and with a reduced reaction to foreign objects |
-
2023
- 2023-07-11 WO PCT/IB2023/057084 patent/WO2024013649A2/fr unknown
Also Published As
Publication number | Publication date |
---|---|
WO2024013649A3 (fr) | 2024-03-28 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
He et al. | Cellulose and cellulose derivatives: Different colloidal states and food-related applications | |
US8722066B2 (en) | Devices and methods for weight control and weight loss | |
US20140276330A1 (en) | High porosity cellulosic sponge | |
CN104334123B (zh) | 膨胀装置 | |
WO2003043609A1 (fr) | Compositions de film pour capsules non gelatineuses et capsules utilisant celles-ci | |
RU2662566C1 (ru) | Целлюлозная губка высокой пористости | |
AU2019316654B2 (en) | Superabsorbent materials and methods of making the same | |
EP3655464A1 (fr) | Compositions de polymère | |
WO2024013649A2 (fr) | Article gonflable relatif à la nutrition | |
US20220031624A1 (en) | Shape-guided controlled release and retention with structures including crosslinked poly(glycerol sebacate) | |
US20020001610A1 (en) | Active ingredient delivery systems and devices based on porous matrices | |
EP3646827B1 (fr) | Dérivation gastrique et cathéter de tube digestif antibactérien associé | |
CN108245493A (zh) | 一种基于可降解支架材料的减肥胶囊 | |
JP5250285B2 (ja) | 経口物用被覆材、可食性容器およびそれらを用いた経口物 | |
CN117223862A (zh) | 一种高膨胀率藻类膳食纤维缓释胶囊及其制备方法和应用 | |
US20050008677A1 (en) | Delivery system of homogeneous, thermoreversible gel film containing kappa-2 carrageenan | |
CN111494332A (zh) | 高孔隙度纤维素海绵 | |
CN102641496A (zh) | 高分子聚合物的新用途及其组成物 | |
CA3067189A1 (fr) | Composition auto-moussante en milieu acide et procede de preparation | |
CN101433525B (zh) | 一种结肠定位压制包芯片的制备方法 | |
CN112544964A (zh) | 一种可食用胶囊及其制备方法与应用 | |
Sreya et al. | Science and Technology of Alginates: A Review | |
RU2341250C2 (ru) | Гомогенная термообратимая гелевая пленка, содержащая каппа-2-каррагинан, и полученные из нее мягкие капсулы | |
KR101355897B1 (ko) | 올리고당을 함유한 연질 캡슐의 피막 조성물 | |
KR101870683B1 (ko) | 꿀을 포함하는 식용 캡슐 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 23839143 Country of ref document: EP Kind code of ref document: A2 |