US2022241188A1PendingUtilityA1

Method and system for making personalized nutritional and pharmaceutical formulations using additive manufacturing

Assignee: ONEFUL HEALTH INCPriority: Apr 10, 2018Filed: Apr 22, 2022Published: Aug 4, 2022
Est. expiryApr 10, 2038(~11.7 yrs left)· nominal 20-yr term from priority
A23P 10/28B33Y 10/00A61K 31/197B33Y 80/00A61K 31/455A23P 20/15A23G 3/203A23G 3/2007A61K 31/44A61K 31/519A61K 31/714A61K 9/2095A61K 31/525A23G 3/0072A61K 31/375A61K 9/0056A23P 20/18A61K 31/4188A61K 31/4415A61K 31/07
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Claims

Abstract

The presently disclosed subject matter is directed to a system and method of preparing personalized nutritional and/or pharmaceutical formulations using additive manufacturing technology. Active pharmaceutical or dietary supplement ingredients are suspended in thixotropic stable carrier medias. The thixotropic suspensions are deposited onto a surface of a solid substrate, which can be a snack bar or small wafer used as a mechanical carrier. The disclosed system enables each additive active ingredient to be variably dosed based on a formula that is determined for each specific individual and manufactured on demand. Once the active ingredients are deposited on substrate, the entire assembly can be enrobed with one or more edible solid coatings to seal the active ingredients and provide taste-masking agent characteristics to the assembly.

Claims

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . A method of treating a medical condition, the method comprising:
 administering one or more active pharmaceutical ingredients to a subject, whereby the medical condition is treated;   wherein the one or more active pharmaceutical ingredients is configured in a solid assembly for oral consumption comprising:
 a solid substrate defining one or more depressions; 
 one or more thixotropic suspensions deposited within the depressions of the solid substrate, wherein each thixotropic suspension comprises a homogenous dispersion of one or more active pharmaceutical ingredients and a carrier; 
 one or more coatings applied over one or more surfaces of the solid substrate; 
   wherein each active pharmaceutical ingredient is dosed based on a formula that is determined for a specific subject consuming the solid assembly, wherein the formula is responsive to a preference or characteristic of an individual that will consume the solid assembly.   
     
     
         22 . The method of  claim 21 , the substrate is comprised of protein fiber, carbohydrates, and lipid, and one or more of: fillers, pH adjusting agents, preservatives, anti-adhesives, plasticizers, opacifiers, coloring agents, pigments, surfactants, diluents, anti-foaming agents, lubricants, binders, granulating aids, taste modifying agents, and glidants. 
     
     
         23 . The method of  claim 21 , wherein the depressions are configured as a plurality of longitudinal channels. 
     
     
         24 . The method of  claim 21 , wherein the one or more active pharmaceuticals ingredients are selected from compounds used for prevention, diagnosis, treatment, or cure of a chronic condition. 
     
     
         25 . The method of  claim 21 , wherein the one or more active ingredients are encapsulated into microspheres. 
     
     
         26 . The method of  claim 25 , wherein the microspheres are selected from reservoir-type microspheres, matrix-type microspheres, or combinations of reservoir-type and matrix-type microspheres. 
     
     
         27 . The method of  claim 25 , wherein the microspheres have a size of about 1200 μm or less. 
     
     
         28 . The method of  claim 25 , wherein the microspheres are homogeneously distributed within the thixotropic carrier. 
     
     
         29 . The method of  claim 21 , wherein the carrier is selected from gelatin, polymeric glycosaminoglycan, agar, carrageenan, alginate, natural gum, carboxymethyl cellulose, xylitol, sorbitol, mannitol, glycerin, pectin, dextran, dextran derivative, pullulan, xanthan, xyloglucan, starch, hyaluronic acid, guar gum, locust bean gum, gellan, carboxy-methyl-cellulose, acacia gum, propylene glycol, polyethylene glycol, polypropylene glycol, poly(tetramethylene ether) glycol, or combinations thereof. 
     
     
         30 . The method of  claim 21 , wherein the carrier is liquid or semi-solid. 
     
     
         31 . The method of  claim 21 , wherein the one or more active pharmaceutical ingredients are uniformly dispersed but undissolved within the carrier. 
     
     
         32 . The method of  claim 21 , wherein the carrier has a water activity (Aw) of about 0.95 or less. 
     
     
         33 . The method of  claim 21 , wherein the carrier is aseptic. 
     
     
         34 . The method of  claim 21 , wherein the one or more coatings are solid or semi-solid. 
     
     
         35 . The method of  claim 21 , wherein the one or more thixotropic suspensions have a shelf life of at least 14 days under refrigerated conditions of about 40° F. 
     
     
         36 . The method of  claim 21 , wherein the one or more thixotropic suspensions have a shelf life of at least 300 days under refrigerated conditions of about 40° F. 
     
     
         37 . The method of  claim 23 , wherein the thixotropic suspensions are stacked to achieve a higher total number of active pharmaceutical ingredients, where stacking includes depositing a first layer of the one or more suspensions and depositing a second layer of the one or more suspensions on top of the first layer. 
     
     
         38 . The method of  claim 21 , further comprising verifying the dose of each active pharmaceutical ingredient in the solid assembly satisfies the formula determined for the subject by a machine vision 3D volume scanner or structured light plane. 
     
     
         39 . The method of  claim 21 , further comprising verifying the dose of each active pharmaceutical ingredient in the solid assembly satisfies the formula determined for the subject by a gravimetric weighing system.

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