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Claims for Patent: 9,114,168

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Claims for Patent: 9,114,168

Title:Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Abstract: Pharmaceutical compositions containing a fluoroquinolone antibiotic drug are disclosed. The compositions exhibit improved homogeneity, improved bioavailability, lower turbidity or a combination thereof. The composition can be use as otic or nasal compositions, but are particularly useful as ophthalmic compositions.
Inventor(s): Campins; Inmaculada (Mataro, ES), Jimenez; Nuria (Barcelona, ES), Vidal; Roman (Vallromanes, ES), Carreras; Nuria (Caldes de Montbui, ES), Martinez; Carmen (Llicade Vall, ES), Galan; Francisco Javier (Teia, ES)
Assignee: Alcon Pharmacueticals Ltd. (Fribourg, CH)
Application Number:13/745,062
Patent Claims: 1. An aqueous ophthalmic composition, comprising: 0.4 w/v %--less than 1.0 w/v % moxifloxacin; sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to moxifloxacin that is between 1.0 and 1.7; 0.02 w/v %--less than 0.1 w/v % surfactant, wherein the surfactant comprises a polyether alcohol; 0.2 w/v %--less than 1 w/v % total of a borate and a polyol; 0.3 w/v %--less than 1.2 w/v % xanthan gum; and water; wherein the composition has a turbidity less than 13 NTU.

2. The composition of claim 1 wherein the total concentration of the borate and the polyol is at least 0.5 w/v % but less than 0.7 w/v %.

3. The composition of claim 1 wherein the concentration of the surfactant is at least 0.04 w/v % but less than 0.1 w/v %.

4. The composition of claim 1 wherein the composition is packaged in an eye drop container.

5. The composition of claim 1 wherein the polyol includes sorbitol and the borate includes boric acid.

6. The composition of claim 1 wherein the composition has a turbidity less than 10 NTU.

7. The composition of claim 1 wherein the composition has a pH of 6.4 to 7.5.

8. An aqueous pharmaceutical composition, comprising: 0.4 w/v %--less than 1.0 w/v % moxifloxacin; sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to moxifloxacin that is between 1.1 and 1.4; 0.04 w/v %--less than 0.07 w/v % surfactant, wherein the surfactant comprises an alkyl aryl polyether alcohol; 0.5 w/v %--less than 1 w/v % total of a borate and a polyol; 0.6 w/v %--less than 0.75 w/v % xanthan gum; and water; wherein the composition has a turbidity less than 10 NTU and a pH of 6.7-7.5.

9. The composition of claim 8 wherein the composition is packaged in an eye drop container.

10. The composition of claim 8 wherein the polyol includes sorbitol and the borate includes boric acid.

11. An aqueous pharmaceutical composition, consisting essentially of: 0.4 w/v %--less than 1.0 w/v % moxifloxacin; sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to moxifloxacin that is between 1.1 and 1.4; 0.04 w/v %--less than 0.07 w/v % surfactant, wherein the surfactant comprises an alkyl aryl polyether alcohol; 0.5 w/v %--less than 1 w/v % total of a borate and a polyol; 0.6 w/v %--less than 0.75 w/v % xanthan gum; and water; wherein the composition has a turbidity less than 10 NTU, a pH of 6.7-7.5 and an osmolality of 200 to 400 mOsm/kg.
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