US2022233476A1PendingUtilityA1

Iron supplement

Assignee: BALCHEM CORPPriority: Jun 6, 2013Filed: Apr 12, 2022Published: Jul 28, 2022
Est. expiryJun 6, 2033(~6.9 yrs left)· nominal 20-yr term from priority
A61K 9/2013A61K 33/30A61K 31/16A61K 45/06A61K 33/26A61P 39/04A61P 3/02
67
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Claims

Abstract

An orally deliverable dosage system comprises (a) iron in a form of one or more physiologically acceptable iron grades, compounds and/or complexes; and (b) an agent to mitigate one or more gastrointestinal adverse effects of unabsorbed iron, said agent comprising one or both of a zinc component and a chelator component, said zinc component if present comprising one or more physiologically acceptable zinc compounds and/or complexes, and said chelator component if present comprising an ion-chelating compound formulated for release distal to the primary site of iron absorption in the duodenum.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for mitigating one or more gastrointestinal adverse effects of unabsorbed iron in a human subject receiving supplemental iron in a total elemental iron amount of about 0.6 to about 3 mmol, the method comprising orally administering one or both of a zinc component and a chelator component, said zinc component if present comprising one or more physiologically acceptable zinc compounds and/or complexes, in a total elemental zinc amount of about 0.1 to about 1.2:1 mmol per mmol iron, and said chelator component if present comprising one or more ion-chelating compounds formulated for release distal to the primary site of iron absorption in the duodenum. 
     
     
         2 . The method of  claim 1 , wherein no chelator component is administered. 
     
     
         3 . The method of  claim 1 , wherein the chelator component is administered, and the chelator component comprises DFO (deferoxamine), ethylene diamine tetraacetic acid (EDTA), deferiprone, or deferasirox. 
     
     
         4 . The method of  claim 3 , wherein the chelator component is DFO. 
     
     
         5 . The method of  claim 1 , wherein the zinc component is administered, and the zinc component comprises zinc arginate, zinc aspartate, zinc bisglycinate, citrated zinc bisglycinate, or zinc histidinate. 
     
     
         6 . The method of  claim 1 , wherein the iron comprises ferrous asparto glycinate, ferrous bisglycinate, ferric glycinate, ferrous aspartate, and ferrous histidinate. 
     
     
         7 . The method of  claim 1 , wherein the one or more physiologically acceptable zinc compounds and/or complexes comprises zinc arginate, zinc aspartate, zinc bisglycinate, citrated zinc bisglycinate, or zinc histidinate. 
     
     
         8 . The method of  claim 1 , wherein the zinc component and/or the chelator component are administered together with the supplemental iron. 
     
     
         9 . The method of  claim 1 , wherein the zinc component and/or the chelator component are administered up to about 4 hours before administration of the supplemental iron. 
     
     
         10 . The method of  claim 1 , wherein the zinc component and/or the chelator component are administered up to about 4 hours after administration of the supplemental iron. 
     
     
         11 . A method for mitigating one or more gastrointestinal adverse effects of unabsorbed iron in a human subject, the method comprising orally administering one or more ion-chelating compounds formulated for release distal to the primary site of iron absorption in the duodenum. 
     
     
         12 . The method of  claim 11 , wherein the one or more ion-chelating compounds comprises DFO (deferoxamine), ethylene diamine tetraacetic acid (EDTA), deferiprone, or deferasirox. 
     
     
         13 . The method of  claim 11 , wherein the one or more ion-chelating compounds is in the form of an apochelator. 
     
     
         14 . The method of  claim 11 , wherein the ion-chelating compound is provided in a total amount of about 30 mg to about 1000 mg. 
     
     
         15 . A method for mitigating one or more gastrointestinal adverse effects of unabsorbed iron in a human subject, the method comprising orally administering one or more zinc compounds and/or complexes in a total elemental zinc amount effective (i) to inhibit cytosolic and/or mitochondrial aconitase activity and (ii) to increase metallothionein expression in enterocytes of the subject at one or more sites of iron absorption.

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