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Claims for Patent: 8,450,311

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Claims for Patent: 8,450,311

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 (Llica de Vall, ES), Galan; Francisco Javier (Teia, ES)
Assignee: Novartis AG (Basel, CH)
Application Number:12/474,307
Patent Claims: 1. An aqueous pharmaceutical composition, comprising: a fluoroquinolone drug consisting of moxifloxacin in the composition at a concentration that is at least 0.4 w/v % but less than 1.0 w/v %; and a pharmaceutical vehicle for the fluoroquinolone drug, the pharmaceutical vehicle consisting essentially of: i. sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to the fluoroquinolone drug in the composition that is between 1.0 and 1.7; ii. a surfactant that assists in evenly distributing the fluoroquinolone drug throughout the pharmaceutical vehicle wherein the surfactant is a polyether alcohol; iii. a borate and a polyol; iv. a polysaccharide viscosity enhancing agent comprised of xanthan gum in an amount such that the concentration of the xanthan gum in the composition is at least 0.3 w/v % but less than 1.2 w/v % wherein the xanthan gum is at least 90% by weight of the viscosity enhancing agent; v. a pH adjusting agent; and vi. water; wherein the composition is an aqueous ophthalmic solution and wherein the composition exhibits turbidity that is less than 13 NTU.

2. A composition as in claim 1 wherein the composition is located within a container that dispenses the composition as drops.

3. A composition as in claim 1 wherein the sodium chloride is in the composition at a concentration such that the weight/volume ratio of sodium chloride to the fluoroquinolone drug that is between 1.1 and 1.4.

4. A composition as in claim 1 wherein the polyol comprises sorbitol.

5. A composition as in claim 1 wherein the viscosity enhancing agent consists of xanthan gum.

6. A composition as in claim 1 wherein the pharmaceutical vehicle consists essentially of sodium chloride, a surfactant, a borate, a polyol, xanthan gum, sodium hydroxide and water.

7. A composition as in claim 1 wherein the composition has a pH of 6.8 to 7.4 and the turbidity is less than 10 NTU.

8. An aqueous pharmaceutical composition, comprising: a fluoroquinolone drug wherein the fluoroquinolone drug is moxifloxacin at a concentration that is at least 0.4 w/v % but less than 1.0 w/v %; and a pharmaceutical vehicle for the fluoroquinolone drug, the pharmaceutical vehicle consisting essentially of: i. sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to the fluoroquinolone drug in the composition that is between 1.1 and 1.4; ii. a surfactant that assists in evenly distributing the fluoroquinolone drug throughout the pharmaceutical vehicle; iii. a borate and a polyol; and iv. a polysaccharide viscosity enhancing agent comprised of xanthan gum in an amount such that the concentration of the xanthan gum in the composition is at least 0.3 w/v % but is less than 1.2 w/v % wherein the xanthan gum is at least 90% by weight of the viscosity enhancing agent; v, a pH adjusting agent; and vi, water; wherein the composition is an aqueous ophthalmic solution and wherein the composition is located within a container that dispenses the composition as drops and wherein the composition exhibits turbidity that is less than 10 NTU.

9. A composition as in claim 8 wherein the composition has a pH of 6.8 to 7.4.

10. A composition as in claim 8 wherein the polysaccharide viscosity enhancing agent consists of xanthan gum.

11. A composition as in claim 8 wherein the surfactant is a polyether alcohol.

12. A composition as in claim 8 wherein the surfactant is an alkyl aryl polyether alcohol.

13. A composition as in claim 12 wherein the polysaccharide viscosity enhancing agent consists of xanthan gum.

14. A composition as in claim 12 wherein the composition has a pH of 6.8 to 7.4.

15. A composition as in claim 1 wherein the surfactant is an alkyl aryl polyether alcohol.

16. An aqueous pharmaceutical composition, comprising: a fluoroquinolone drug comprised of moxifloxacin in the composition at a concentration that is at least 0.4 w/v % but less than 0.7 w/v %; and a pharmaceutical vehicle for the fluoroquinolone drug, the pharmaceutical vehicle including the following: i. sodium chloride in an amount that provides a weight/volume ratio of sodium chloride to the fluoroquinolone drug in the composition that is between 1.1 and 1.4; ii. a surfactant that assists in evenly distributing the fluoroquinolone drug throughout the pharmaceutical vehicle wherein the surfactant is a polyether alcohol; iii. a borate and a polyol; iv. a polysaccharide viscosity enhancing agent comprised of xanthan gum in an amount such that the concentration of the xanthan gum in the composition is at least 0.6 w/v % but is less than 0.75 w/v % wherein the xanthan gum is at least 90% by weight of the viscosity enhancing agent; v. a pH adjusting agent; and vi. water; wherein the composition is an aqueous ophthalmic solution and wherein the composition exhibits turbidity that is less than 13 NTU.

17. A composition as in claim 16 wherein the composition has a pH of 6.8 to 7.4 and the turbidity is less than 10 NTU.
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