IP Library Granted Patent US 11,331,287
Granted Patent B2
US 11,331,287 · App. 14/288,802 · Granted May 17, 2022

Iron supplement

Inventor: Jonathan David Bortz (St. Louis, MO)
Assignee: Balchem Corporation
A61K31/16A61K9/2013A61K33/26A61K33/30A61K45/06
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Quick Facts
Patent No.
US 11,331,287
App. No.
14/288,802
Granted
May 17, 2022
Kind
B2
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 (16)

1. An orally deliverable dosage system for supplementing iron nutrition comprising

(a) iron in a form of one or more physiologically acceptable iron grades, compounds and/or complexes, in a total elemental iron amount of about 0.6 to about 3 mmol, wherein the iron is not in a controlled release form; and

(b) an agent to mitigate one or more gastrointestinal adverse effects of unabsorbed iron, said agent comprising an ion-chelating compound formulated for release distal to the primary site of iron absorption in the duodenum, wherein the ion-chelating compound is not complexed with iron;

wherein the dosage system is an iron supplement in a form of a single composition containing said iron and said mitigating agent, or in a form of an iron-containing composition and a companion composition containing the mitigating agent.

2. The dosage system of claim 1 , wherein the ion-chelating compound is chosen from DFO (deferoxamine), ethylene diamine tetraacetic acid (EDTA), deferiprone, or deferasiro.

3. The dosage system of claim 1 , wherein said dosage system comprises a form of iron selected from ferrous asparto glycinate, ferrous bisglycinate, ferric glycinate, ferrous aspartate, and ferrous histidinate.

4. The dosage system of claim 1 , wherein said dosage system is a nonfood dosage system.

5. The dosage system of claim 1 , wherein the mitigating agent further comprises one or more physiologically acceptable zinc compounds and/or complexes, in a total elemental zinc amount of about 0.1 to about 1.2 mmol per mmol iron, optionally formulated for release of the one or more zinc compounds and/or complexes distal to the primary site of iron absorption in the duodenum.

6. A method for supplementing iron nutrition in a human subject in need thereof, comprising orally administering the dosage system of claim 1 .

7. The dosage system of claim 1 , wherein the zinc is provided as zinc arginate, zinc aspartate, zinc bisglycinate, citrated zinc bisglycinate, or zinc histidinate.

8. The dosage system of claim 1 , wherein the dosage system is an iron supplement in a form of a single composition containing said iron and said mitigating agent.

9. An oral supplement in a single discrete dosage form, wherein the dosage form comprises:

(a) an iron-containing composition comprising iron in a form of one or more compounds and/or complexes, physiologically acceptable grades of iron, in an amount of total elemental iron from about 0.06 to about 3 mmol, wherein the iron-containing composition is not in a controlled release form; and

(b) a companion composition comprising an ion-chelating compound in a time or pH-triggered, controlled release form for release of the ion-chelating compound distal to the primary site of iron absorption in the duodenum, wherein the ion-chelating compound is not complexed with iron.

10. The oral supplement in a single discrete dosage form of claim 9 , wherein the ion-chelating compound is in the form of an apochelator.

11. The dosage system of claim 1 , wherein the ion-chelating compound is in the form of an apochelator.

Assignments (6)
SECURITY INTEREST Recorded Jul 28, 2022
From: ALBION LABORATORIES, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 060656/0226 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENTS Recorded Jun 29, 2018
From: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
To: ALBION LABORATORIES, INC. (FORMERLY AMIP, LLC)
Reel/Frame 046464/0731 →
SECURITY INTEREST Recorded Jun 27, 2018
From: ALBION LABORATORIES, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 046221/0237 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 16, 2017
From: AMIP, LLC
To: BALCHEM CORPORATION
Reel/Frame 041592/0870 →
NOTICE OF GRANT OF SECURITY INTEREST IN PATENTS Recorded May 4, 2016
From: AMIP, LLC
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 038606/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2014
From: BORTZ, JONATHAN DAVID
To: AMIP, LLC,
Reel/Frame 032994/0415 →
Continuity (2)
Provisional Application 61831879 · Jun 6, 2013
Related Publication 20140364491A1 · Dec 11, 2014