# US 10,307,441 B2 · Pharmaceutical formulations of nitrite and uses thereof

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- Number: US 10,307,441 B2
- Document ID: US10307441B2
- Status: Granted
- Kind: B2
- Application number: 14/847,966
- Filed: 2015-09-08
- Published: 2016-03-10
- Granted: 2019-06-04
- Earliest claimed: 2009-10-14
- Assignees: Board of Supervisors of Louisiana State University and Agricultural and Mechanical College
- Applicants: Board of Supervisors of Louisiana State University and Agricultural and Mechanical College
- Inventors: Christopher Kevil; Anthony Giordano; Douglas R Flanagan; Panayiotis P Constantinides
- Web page: https://patentgrep.com/patent/US10307441B2

## CPC

- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/2068: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/2013)}
- A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/5042: {Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 7/06: Antianaemics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 25/02: for peripheral neuropathies
- 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 present invention relates to pharmaceutical compositions of nitrites such as inorganic nitrites, or any pharmaceutically acceptable salts, solvates, or prodrugs thereof, and the medical use of these compositions. The pharmaceutical compositions, which can be formulated for oral administration, can provide immediate release or extended release of the nitrite ion (NO2−). The pharmaceutical compositions of the invention are useful, for example, for the treatment of chronic tissue ischemia.

## Claims

### Claim 1

A method for treating peripheral neuropathy in a human, the method comprising orally administering two times per day for at least three days a solid, sustained release pharmaceutical composition comprising about 40 mg of sodium nitrite, or a pharmaceutically acceptable salt thereof, and a binding agent, wherein the pharmaceutical composition is coated with an enteric coating.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sodium nitrite is not substantially released in the stomach of the human.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sustained release pharmaceutical composition is administered for at least seven days.

### Claim 4 (depends on 1)

The method of claim 1, wherein the sustained release pharmaceutical composition is administered for at least ten days.

### Claim 5 (depends on 1)

The method of claim 1, wherein the binding agent is sucrose, glucose, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone, or polyethlene glycol.

### Claim 6 (depends on 5)

The method of claim 5, wherein the binding agent is hydroxypropyl methylcellulose, microcrystalline cellulose, or polyvinyl pyrrolidone.

### Claim 7 (depends on 1)

The method of claim 1, wherein the enteric coating comprises a polymer selected from cellulose acetate phthalate, hydroxypropylmethylcellulose acetate succinate, methacrylate acid copolymers, cellulose acetate trimellitate, polyvinyl acetate phthalate, hydroxyethylcellulose phthalate, and hydroxypropyl methylcellulose phthalate.