# US 10,765,752 B2 · Solid composition comprising iron for use in iron deficient conditions

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- Number: US 10,765,752 B2
- Document ID: US10765752B2
- Status: Granted
- Kind: B2
- Application number: 16/216,432
- Filed: 2018-12-11
- Published: 2019-04-11
- Granted: 2020-09-08
- Earliest claimed: 2012-07-31
- Assignees: Alesco S.R.L.
- Applicants: Alesco S.R.L.
- Inventors: Andrea Lacorte; Germano Tarantino
- Web page: https://patentgrep.com/patent/US10765752B2

## CPC

- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/1617: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 33/26: Iron; Compounds thereof
- A61K 33/42: Phosphorus; Compounds thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 7/06: Antianaemics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

An iron-based composition is described. The composition can be used in conditions of total or relative iron deficiency. In particular, a solid composition is described, preferably in the form of powder or granules, for use in the treatment of disorders or diseases related to or derived from an iron deficiency. The composition is suitable for pediatric subjects, adolescents, athletes, men, women, pregnant women and elderly. Finally, a process for preparing the solid composition is also described.

## Claims

### Claim 1

A solid composition comprising an iron (Ill) salt, said iron (Ill) salt being ferric pyrophosphate in an amount from 30% to 70% by weight, sucrose esters or sucresters E473, wherein said sucrose esters or sucresters E473 are in an amount from 10% to 30% by weight, and a non-hydrolyzed lecithin wherein said lecithin is in an amount from 0.1% to 1.5% by weight.

### Claim 2 (depends on 1)

The composition according to claim 1, wherein said composition further comprises a gelatinized or pregelatinized starch.

### Claim 3 (depends on 1)

The composition according to claim 1, wherein said non-hydrolyzed lecithin is a lecithin E322 and is selected from the group consisting of the maize, sunflower and soya lecithin.

### Claim 4 (depends on 1)

The composition according to claim 1, wherein said sucrose ester or sucrester and said non-hydrolyzed lecithin are in the composition in a weight ratio from 25:1 to 20:1.

### Claim 5 (depends on 2)

The composition according to claim 2, wherein said gelatinized or pregelatinized starch is selected from the group consisting of rice starch and maize starch; said starch is in an amount from 15 to 40% by weight.

### Claim 6 (depends on 1)

The composition according to claim 1, comprising a ferric pyrophosphate in an amount from 50 to 55% by weight; a sunflower lecithin in an amount from 0.5 to 0.8% by weight; sucrester E473 in an amount from 16 to 20% by weight; and gelatinized or pregelatinized rice starch in an amount from 25 to 30% by weight.

### Claim 7 (depends on 1)

A supplement product or a medical device or a pharmaceutical composition for oral use comprising the solid composition according to claim 1 for use in the treatment of iron deficiency in pediatric subjects, adolescents, athletes, men, women, pregnant women and elderly.

### Claim 8 (depends on 1)

A method for preparing the solid composition of claim 1, comprising:
coating or encapsulating the iron (Ill) salt with said sucrose esters or sucresters E473 and the non-hydrolyzed lecithin.

### Claim 9 (depends on 8)

The method of claim 8, wherein the coating or encapsulating comprises:
contacting the iron (Ill) salt in solid state with said lecithin to produce a coated iron (Ill) salt with lecithin uniformly arranged over the iron (Ill) salt; and
contacting the coated iron (Ill) salt with said sucrose ester or sucrester E473 and optionally a vegetable starch.

### Claim 10 (depends on 8)

The method of claim 8, wherein the solid composition has an iron (Ill) salt content from 60 mg/g to 140 mg/g.

### Claim 11 (depends on 8)

The method of claim 8, wherein said sucrose ester or sucrester and said non-hydrolyzed lecithin are in a weight ratio from 20:1 to 15:1 and wherein the solid composition optionally comprises: a starch in an amount from 15 to 40%, said starch being rice starch or maize starch.

### Claim 12 (depends on 8)

The method according to claim 8, wherein the non-hydrolyzed lecithin is selected from the group consisting of sunflower, maize and soya lecithin.

### Claim 13 (depends on 8)

The method according to claim 8, wherein the lecithin is sunflower lecithin E322 in powder form.

### Claim 14 (depends on 1)

The composition according to claim 1, wherein the ferric pyrophosphate is in an amount from 40 to 60% by weight.

### Claim 15 (depends on 1)

The composition according to claim 1, wherein said sucrose esters or sucresters E473 are in an amount from 15% to 25% by weight.

### Claim 16 (depends on 1)

The composition according to claim 1, wherein said lecithin is in an amount from 0.4 to 1% by weight.

### Claim 17 (depends on 1)

The composition according to claim 1, wherein said sucrose ester or sucrester and said non-hydrolyzed lecithin are in the composition in a weight ratio from 20:1 to 15:1.

### Claim 18 (depends on 5)

The composition according to claim 5, wherein said gelatinized or pregelatinized starch is in an amount from 20 to 35% by weight.
