Granted Patent
B2
US 12,246,036 · App. 16/635,516 · Granted Mar 11, 2025
Composition for use in the prevention and in the treatment of iron deficiency
Assignee:
PHARMANUTRA S.P.A.
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Abstract
The present invention relates to a composition for use in a method for the preventive or curative treatment of an iron deficiency and pathologies and disorders connected thereto in a subject. The disclosed methods include administering the composition to a subject in need thereof.
Claims (28)
1. A method for the treatment of a pathology or disorder connected to iron deficiency, the method comprising
administering to a subject in need thereof, an effective amount of a composition comprising
(a) 4000 IU of a group D vitamin, esters, acetates, or amides thereof, or mixtures thereof,
(b) a sucrosomial iron in which an iron (III) coordination complex, an iron (III) oxide or an iron (III) salt, formulated in association with a sucrose fatty acid ester in an amount from 10% to 20% by weight and a lecithin in an amount from 0.1% to 1.5% by weight based on the total weight of the composition; and
optionally, pharmaceutical or food grade excipients, additives or co-formulants, or combinations thereof;
wherein in said iron (III) coordination complex, one or more atoms, ions or molecules surround the iron (III) at least partially without forming either an ionic or covalent bond; and
wherein said pathology or disorder connected to iron deficiency is an anaemia of inflammation.
2. The method of claim 1 , wherein the composition is formulated for oral administration.
3. The method of claim 1 , wherein the sucrosomial iron, is further formulated with a gelatinized or pregelatinized vegetable starch.
4. The method of claim 1 , wherein said group D vitamin is vitamin D3 or cholecalciferol.
5. The method of claim 1 , wherein said iron (III) salt is iron (III) pyrophosphate.
6. The method of claim 5 , wherein the iron (III) pyrophosphate is formulated in association with sucrose fatty acid esters E473, lecithin E322 and, optionally, pregelatinized starch.
7. The method of claim 1 , wherein said sucrosomial iron is in an amount from 12.5 to 18.5% by weight based on the total weight of the composition.
8. The method of claim 1 , wherein said sucrosomial iron is in an amount from 16 to 18.0% % by weight based on the total weight of the composition.
9. The method of claim 1 , wherein the lecithin is in an amount from 0.4 to 1.0% by weight based on the total weight of the composition.
10. The method of claim 1 , wherein the lecithin is in an amount from 0.50 to 0.8% by weight % based on the total weight of the composition.
11. The method of claim 3 , wherein said gelatinized or pregelatinized vegetable starch is in an amount from 15 to 40%, relative to the weight of the sucrosomial iron.
12. The method of claim 3 , wherein said gelatinized or pregelatinized vegetable starch is in an amount from 20 to 35%, relative to the weight of the sucrosomial iron.
13. The method of claim 3 , wherein said gelatinized or pregelatinized vegetable starch is in an amount from 25 to 30%, relative to the weight of the sucrosomial iron.
14. A method for the treatment of a pathology or disorder connected to iron deficiency, the method comprising
administering to a subject in need thereof, an effective amount of a composition comprising:
(a) 4000 IU of a group D vitamin, esters, acetates, or amides thereof, or mixtures thereof,
(b) a sucrosomial iron in which iron (III) pyrophosphate is formulated in association with a sucrose fatty acid ester in an amount from 10% to 20% by weight and a lecithin in an amount from 0.1% to 1.5% by weight based on the total weight of the composition; and
optionally, pharmaceutical or food grade excipients, additives or co-formulants, or combinations thereof;
wherein said pathology or disorder connected to iron deficiency is an anaemia of inflammation.
15. The method of claim 14 , wherein the iron (III) pyrophosphate is formulated in association with sucrose fatty acid esters E473, lecithin E322 and, optionally, pregelatinized starch.
16. The method of claim 14 , wherein said group D vitamin is vitamin D3 or cholecalciferol.
17. The method of claim 14 , wherein the sucrosomial iron is further formulated with a gelatinized or pregelatinized vegetable starch.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 8, 2020
From: LACORTE, ANDREA; TARANTINO, GERMANO
To: PHARMANUTRA S.P.A.
Reel/Frame 052349/0350 →
Priority Claims (1)
IT 102017000089258
· Aug 2, 2017
· national
Continuity (1)
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