# US 8,772,317 B2 · Aqueous pharmaceutical suspensions containing rebamipide and manufacturing process thereof

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- Number: US 8,772,317 B2
- Document ID: US8772317B2
- Status: Granted
- Kind: B2
- Application number: 12/447,065
- Filed: 2007-10-24
- Published: 2010-02-04
- Granted: 2014-07-08
- Earliest claimed: 2006-10-26
- Assignees: Otsuka Pharmaceutical Co., Ltd.
- Applicants: Yoshito Masuda
- Inventors: Yoshito Masuda
- Web page: https://patentgrep.com/patent/US8772317B2

## CPC

- A61K 31/4704: 2-Quinolinones, e.g. carbostyril
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/0078: {for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions}
- A61K 9/10: Dispersions; Emulsions
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 27/02: Ophthalmic agents
- A61P 27/04: Artificial tears; Irrigation solutions
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- 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 invention provides a rebamipide-containing aqueous pharmaceutical suspension which can be prepared by a simple process and keep the dispersed fine-particle state of rebamipide stable without having the fine particle agglutinated. The rebamipide-containing aqueous pharmaceutical suspension of the invention is prepared by mixing polyvinyl alcohol and additionally a sodium salt compound with rebamipide.

## Claims

### Claim 1

An aqueous suspension comprising fine particles of rebamipide having a mean particle size ranging from 0.2 μm to 5 μm and polyvinyl alcohol.

### Claim 2 (depends on 1)

The aqueous suspension of claim 1 further comprising a sodium salt compound.

### Claim 3 (depends on 1, 2)

The aqueous suspension of claim 1 or 2 wherein rebamipide is in 0.1-30 w/v % and polyvinyl alcohol is in 0.1-4 w/v %.

### Claim 4 (depends on 1, 2, 3)

The aqueous suspension of any one of claims 1-3, which is an ophthalmic formulation.

### Claim 5

A process for the preparation of an aqueous suspension comprising rebamipide, which comprises
(1) mixing water and polyvinyl alcohol to prepare an aqueous solution containing polyvinyl alcohol, and
(2) adding fine particles of rebamipide having a mean particle size ranging from 0.2 μm to 5 μm to the aqueous solution containing polyvinyl alcohol and mixing to give the aqueous suspension comprising rebamipide.