# US 6,284,804 B1 · Topical suspension formulations containing ciprofloxacin and dexamethasone

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- Number: US 6,284,804 B1
- Document ID: US6284804B1
- Status: Granted
- Kind: B1
- Application number: 09/636,563
- Filed: 2000-08-10
- Granted: 2001-09-04
- Earliest claimed: 1999-09-24
- Assignees: Alcon Universal Ltd.
- Inventors: Onkar N. Singh; Haresh G. Bhagat
- Web page: https://patentgrep.com/patent/US6284804B1

## CPC

- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 9/0043: {Nose}
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 11/02: Nasal agents, e.g. decongestants
- A61P 27/00: Drugs for disorders of the senses
- A61P 27/02: Ophthalmic agents
- A61P 27/16: Otologicals
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

Suspension formulations containing dexamethasone and ciprofloxacin are disclosed. The formulations contain a nonionic polymer, a nonionic surfactant and an ionic tonicity agent, but are physically stable and easily re-suspended. The formulations are intended for topical application to the eye, ear or nose.

## Claims

### Claim 1

A topically administrable suspension composition intended for application to the eye, ear or nose consisting essentially of
a) 0.1% (wt.) dexamethasone alcohol;
b) 0.35% (wt.) ciprofloxacin hydrochloride, monohydrate;
c) NaCI in an amount sufficient to cause the composition to have an osmolality of about 250-350 mOsm;
d) 0.2% (wt.) hydroxyethyl cellulose;
e) 0.05% (wt.) tyloxapol;
f) a buffer comprising sodium acetate and acetic acid;
g) 0.01% (wt.) benzalkonium chloride;
h) 0.01% (wt.) edetate disodium;
i) 0.6% (wt.) boric acid; and
wherein the composition has a pH of 4.5±0.2.