Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
View Patent ↗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.
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.