Generated: April 23, 2017
|Title:||Method of treating middle ear infections|
|Abstract:||Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.|
|Inventor(s):||Wall; G. Michael (Fort Worth, TX), Conroy; Peter J. (Fort Worth, TX)|
|Assignee:||ALCON PHARMACEUTICALS LTD (CH)|
1. A method of treating a middle ear infection in a human patient comprising the steps of: (a) diagnosing the patient as having otitis media and an open tympanic membrane in
at least one ear; and (b) topically applying into the ear canal of the patient's ear an aqueous suspension composition containing a combination of ciprofloxacin and dexamethasone, wherein the composition comprises a) 0.01-0.5% (wt.) dexamethasone,
wherein the dexamethasone has an average particle size on a mean volume basis of less than 10 .mu.M; b) 0.1-0.4% (wt.) ciprofloxacin; c) 0.1-0.9% (wt.) tonicity agent; d) 0.01-0.2% (wt.) of a nonionic surfactant; e) a buffer; and wherein the
composition has a pH from about 3-5.
2. The method of claim 1 wherein the dexamethasone is dexamethasone alcohol and the ciprofloxacin is ciprofloxacin hydrochloride, monohydrate.
3. The method of claim 1 wherein the aqueous suspension composition contains 0.1% (wt.) dexamethasone and 0.3% (wt.) ciprofloxacin.
4. The method of claim 3 wherein three or four drops of the aqueous suspension composition are administered to the patient's ear twice a day, wherein each drop is 30-35 .mu.L.
5. The method of claim 1 wherein the aqueous suspension composition consists essentially of a) 0.1% (wt.) dexamethasone alcohol; b) 0.35% (wt.) ciprofloxacin hydrochloride, monohydrate; c) NaCl 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 about 4.5.
6. The method of claim 1 wherein the method further comprises the step of pumping the tragus to force the aqueous suspension composition through the open tympanic membrane and into the middle ear.
7. The method of claim 1 wherein the dexamethasone has an average particle size on a mean volume basis of less than 3 .mu.m.
8. The method of claim 1 wherein the otitis media is acute otitis media.
9. The method of claim 1 wherein the otitis media is chronic suppurative otitis media.
10. The method of claim 1 wherein the aqueous suspension composition containing a combination of ciprofloxacin and dexamethasone is packaged with directions for use that indicate the composition may be used to treat otitis media in patients with an open tympanic membrane.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.