# US 10,441,536 B2 · Micronized colistimethane sodium pharmaceutical compositions

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,441,536 B2
- Document ID: US10441536B2
- Status: Granted
- Kind: B2
- Application number: 14/772,748
- Filed: 2014-03-07
- Published: 2016-01-28
- Granted: 2019-10-15
- Earliest claimed: 2013-03-13
- Assignees: Actavis Group Ptc Ehf
- Applicants: Forest Laboratories Holdings Limited
- Inventors: Richard Anthony Flynn; Rahul Surana; Anil Chhettry; David Farrington; Ritesh Sanghvi
- Web page: https://patentgrep.com/patent/US10441536B2

## CPC

- A61K 9/0075: {for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles}
- A61J 1/035: {Blister-type containers (blisters in general B65D75/36)}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/145: {with organic compounds}
- A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)}
- A61K 9/4858: {Organic compounds}
- A61K 38/12: Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 31/04: Antibacterial agents
- B65D 75/367: {and forming several compartments}
- 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)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Described herein are micronized powder particles of colistimethate sodium wherein at least 50% by volume of the micronized particles have a diameter of less than 7 micrometers but not less than 3 micrometers and the powder has a total moisture content of from 5 to 10% by weight, for use in the treatment of a pulmonary infection by powder inhalation, wherein the colistimethate sodium is not separated into component form. The micronized powder particles of colistimethate sodium are useful in the treatment of infections caused by gram-negative bacteria, particularly in patients suffering from cystic fibrosis.

## Claims

### Claim 1

A powder composition consisting of: micronized powder particles of colistimethate sodium wherein at least 50% by volume of the micronized particles have a diameter of less than 7micrometers but not less than 3 micrometers, and wherein the powder composition has a total moisture content of from 5 to 10% by weight, for use in the treatment of a pulmonary infection by powder inhalation, wherein the colistimethate sodium is not separated into component form.

### Claim 2 (depends on 1)

The powder composition according to claim 1 wherein 10% by volume of the micronized powder particles of colistmethate sodium have a particle size of less than 3 micrometers but not less than 1.5 micrometers.

### Claim 3 (depends on 1)

The powder composition according to claim 1, wherein the micronized powder particles of colistimethate sodium are present with a minimum critical moisture content of about 6 wt % and a maximum critical moisture content of about 10 wt %.

### Claim 4 (depends on 1)

The powder composition according to claim 1, wherein the micronized powder particles of colistimethate sodium are present with a minimum critical moisture content of about 5.5 wt % and a maximum critical moisture content of about 8 wt %.