# US 2014/0194520 A1 · Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same

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- Number: US 2014/0194520 A1
- Document ID: US20140194520A1
- Status: Published application
- Kind: A1
- Application number: 14/158,091
- Filed: 2014-01-17
- Published: 2014-07-10
- Earliest claimed: 2007-09-07
- Assignees: United Therapeutics Corporation
- Applicants: United Therapeutics Corporation
- Inventors: Roger Andrew Jeffs; David Zaccardelli
- Web page: https://patentgrep.com/patent/US20140194520A1

## CPC

- A61K 47/18: Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/10: Antimycotics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 47/02: Inorganic compounds
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Buffer solutions for pharmaceutical preparations that have bactericidal activity preferentially against gram negative bacteria are provided. The buffers have a pH of greater than about 10 or less than about 4.5 with low buffer capacity. Methods of their use in reducing the occurrence of blood stream infections in a mammal is also provided.

## Claims

### Claim at position 1

-23. (canceled)

### Claim 24

A method of reducing occurrence of a bacterial infection in a human in need of an active pharmaceutical ingredient (API) other than epoprostenol, comprising diluting a starting solution of the API with a buffer comprising glycine and having a pH of greater than 10 to provide a final solution of the API with a pH of greater than 10 and administering the final solution to the human in need thereof.

### Claim 25 (depends on 24)

The method of claim 24, wherein the administering is by injection.

### Claim 26 (depends on 25)

The method of claim 25, wherein the injection is intravenous injection.

### Claim 27 (depends on 24)

The method of claim 24, wherein the buffer further comprises sodium hydroxide.

### Claim 28 (depends on 24)

The method of claim 24, wherein the buffer has a pH between 10 and 12.

### Claim 29 (depends on 28)

The method of claim 28, wherein the buffer has a pH between 10.2 and 10.8.

### Claim 30 (depends on 29)

The method of claim 29, wherein the final solution is administered intravenously.

### Claim 31 (depends on 24)

The method of claim 24, wherein the final solution is administered at a concentration between about 0.001 mg/mL to about 1 mg/mL.

### Claim 32 (depends on 31)

The method of claim 31, wherein the final solution is administered at a concentration between about 0.004 mg/mL to about 0.13 mg/mL.

### Claim 33 (depends on 24)

The method according to claim 24, wherein the administration reduces the growth of gram negative bacteria.

### Claim 34 (depends on 24)

The method of claim 24, wherein the buffer is a 50 mL solution of 94 mg of glycine, 73.3 mg of sodium chloride, and sodium hydroxide.

### Claim 35 (depends on 34)

The method of claim 34, wherein the administering is by injection.

### Claim 36 (depends on 35)

The method of claim 35, wherein the injection is intravenous injection.