# US 11,110,118 B2 · Formulations for treating acid reflux comprising sodium alginate

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- Number: US 11,110,118 B2
- Document ID: US11110118B2
- Status: Granted
- Kind: B2
- Application number: 16/289,242
- Filed: 2019-02-28
- Published: 2019-09-05
- Granted: 2021-09-07
- Earliest claimed: 2018-03-02
- Assignees: Pharagen LLC
- Applicants: Pharagen LLC
- Inventors: Joseph Ryan Smolarz
- Web page: https://patentgrep.com/patent/US11110118B2

## CPC

- A61K 31/734: Alginic acid
- 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 9/485: {Inorganic compounds}
- A61K 9/4858: {Organic compounds}
- A61K 9/4875: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/4858)}
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/10: Carbonates; Bicarbonates
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- 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

The disclosure provides for pharmaceutical compositions comprising an alginate salt, such as sodium alginate. The disclosure further provides for processes and methods for making pharmaceutical compositions. In yet a further aspect, the disclosure provides for methods of utilizing a pharmaceutical composition for treatment of acid reflux diseases. In another aspect, the disclosure provides for formulations suitable for oral use in dosage forms of capsules and dry powders.

## Claims

### Claim 1

A method of treating acid reflux disease in an individual in need thereof, comprising administering to an individual in need thereof a pharmaceutical composition formulated as a powder consisting of:
(i) one or more alginate salts, present in an amount from about 30% to 78% wt of the pharmaceutical composition,
(ii) sodium bicarbonate, present in an amount from about 1% to 10% wt of the pharmaceutical composition,
(iii) calcium carbonate, present in an amount from about 1% to 10% wt of the pharmaceutical composition,
(iv) citric acid, present in an amount from about 21% to 30% wt of the pharmaceutical composition,
(v) optionally one or more natural or artificial sweetener or flavorants; and
dissolving the powder form in liquid prior to administration to individual and wherein the composition forms alginate raft prior to administering to an individual.

### Claim 2 (depends on 1)

The method of claim 1, wherein the alginate salt comprises sodium alginate.

### Claim 3 (depends on 1)

The method of claim 1, wherein the citric acid is present in an amount from about 22% to 29% wt, about 23% to 28% wt, or about 24% to 27% wt.

### Claim 4 (depends on 1)

The method of claim 1, wherein the (v) one or more natural or artificial sweetener or flavorants are present in an amount from about 1% to 40% wt of the pharmaceutical composition.

### Claim 5 (depends on 4)

The method of claim 4, wherein the (v) one or more natural or artificial sweetener or flavorants comprises stevia extract.

### Claim 6 (depends on 4)

The method of claim 4, wherein said pharmaceutical composition consists of:
(i) one or more alginate salts, present in an amount from about 30% to 50% wt of the pharmaceutical composition,
(ii) sodium bicarbonate, present in an amount from about 1% to 5% wt of the pharmaceutical composition,
(iii) calcium carbonate, present in an amount from about 1% to 5% wt of the pharmaceutical composition,
(iv) citric acid, present in an amount from about 21% to 30% wt of the pharmaceutical composition,
(v) optionally one or more natural or artificial sweetener or flavorants, and dissolving the powder form in liquid prior to administration to individual, and wherein the composition forms alginate raft prior to administering to an individual.

### Claim 7 (depends on 4)

The method of claim 4, wherein said pharmaceutical composition consists of:
(i) one or more alginate salts, present in an amount from about 51% to 75% wt of the pharmaceutical composition,
(ii) sodium bicarbonate, present in an amount from about 1% to 5% wt of the pharmaceutical composition,
(iii) calcium carbonate, present in an amount from about 1% to 5% wt of the pharmaceutical composition,
(iv) citric acid, present in an amount from about 21% to 30% wt of the pharmaceutical composition,
(v) optionally one or more natural or artificial sweetener or flavorants, and dissolving the powder form in liquid prior to administration to individual, and wherein the composition forms alginate raft prior to administering to an individual.

### Claim 8 (depends on 1)

The method of claim 1, wherein the alginate salt comprises sodium alginate present in an amount 35% to 75% wt, 40% to 70% wt, 45% to 65% wt, or 50% to 60% wt.

### Claim 9 (depends on 1)

The method of claim 1, wherein the sodium bicarbonate is present in an amount from about 1% to 10% wt, 2% to 9% wt, 3% to 8% wt, or 4% to 7% wt.

### Claim 10 (depends on 1)

The method of claim 1, wherein the calcium carbonate is present in an amount 1% to 10% wt, 2% to 9% wt, 3% to 8% wt, or 4% to 7% wt.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the pharmaceutical composition is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day to a patient in need thereof.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the powder form is dissolved in one-quarter or half cup of water prior to administration to individual.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is selected from the group consisting of gastroesophageal reflux disease, laryngopharyngeal reflux, and erosive esophagitis.

### Claim 14 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is gastroesophageal reflux disease.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is laryngopharyngeal reflux.

### Claim 16 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is erosive esophagitis.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is not gastroesophageal reflux disease.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the acid reflux disease is not gastroesophageal reflux disease and only patients diagnosed with laryngopharyngeal reflux are treated.

### Claim 19 (depends on 1)

The method according to claim 1, further comprising treating at least one symptom of acid reflux disease in an individual in need thereof, wherein the at least one symptom of acid reflux disease is selected from a group consisting of vagally mediated throat clearing and coughing responses caused by irritation of the distal esophagus, and laryngeal injury caused by direct contact with erosive gastric refluxate.

### Claim 20 (depends on 1)

The method of claim 1, wherein the composition gels and foams prior to administering to an individual.

### Claim 21 (depends on 1)

The method of claim 1, wherein the composition does not include polyols.