Otic formulations, methods and devices

1. An otic formulation comprising:

a) therapeutic agents consisting of:

i) about 1.5% to 1.9% w/w of marbofloxacin;

ii) about 1.6% to 2.0% w/w of terbinafine or salts thereof; and

iii) about 0.1% to 0.25% w/w of dexamethasone; wherein the formulation further comprises

b) about 78% to 80% w/w mineral oil; and

c) about 17% to 18% w/w paraffin.

2. The formulation of claim 1 , wherein the formulation is in a flowable fluid form that can be delivered to an ear canal of a mammal.

3. The formulation of claim 2 , wherein upon introduction into the ear canal the formulation remains in the ear canal for at least 3 days releasing the therapeutic agents.

4. The formulation of claim 1 , wherein the formulation has a viscosity of about 10-80,000 cPs at 37° C.

5. An otic formulation, comprising:

a) therapeutic agents consisting of:

i) about 1.5% to 1.9% w/w of marbofloxacin;

ii) about 1.6% to 3.3% w/w of terbinafine or salts thereof; and

iii) about 0.1% to 0.3% w/w of dexamethasone; wherein the formulation further comprises

b) about 17% to 26% w/w of wax; and

c) about 70% to 80% w/w of mineral oil.

6. The formulation of claim 5 , wherein after applying to an ear canal of a mammal having an ear infection, the formulation remains in the ear canal and has a viscosity of about 10-80,000 cPs at 37° C.

7. The formulation of claim 6 , wherein upon introduction into the ear canal the formulation remains in the ear canal releasing the active ingredients for 2-7 days, and thereafter is not found in the ear canal.

8. The formulation of claim 7 , wherein the formulation comprises about 1.50% to 1.9% w/w of marbofloxacin, about 2.7% to 3.3% w/w of terbinafine, about 0.1% to 0.3% w/w of dexamethasone, about 22% to 26% w/w of wax, and about 70% to 74% w/w of mineral oil.

9. The formulation of claim 8 , wherein the formulation is for single treatment and has a clinical cure rate of at least 90% within a duration of less than 27 days.

10. An otic formulation, comprising therapeutic agents consisting of about 1.5% to 1.9% w/w of marbofloxacin, about 1.6% to 3.3% w/w of terbinafine or salts thereof and about 0.1% to 0.3% w/w dexamethasone in an aurally acceptable carrier, the carrier having about 10-80,000 cPs at 37° C., wherein the carrier retains the marbofloxacin, the terbinafine, and the dexamethasone wherein the formulation further comprises an ear for 7-14 days and then egresses or is absorbed, and wherein the formulation is for single treatment and has a clinical cure rate of at least 90% within a duration of less than 27 days.

11. An otic formulation comprising:

a) therapeutic agents consisting of:

i) about 1.5% to 1.9% w/w of marbofloxacin;

ii) about 2.7% to 3.3% w/w of terbinafine or salts thereof; and

iii) about 0.1% to 0.3% w/w of dexamethasone; wherein the formulation further comprises

b) about 70% to 74% w/w mineral oil; and

c) about 22% to 26% w/w paraffin.

12. An otic formulation comprising:

a) therapeutic agents consisting of:

i) about 1.5% to 1.9% w/w of marbofloxacin;

ii) about 2.7% to 3.3% w/w of terbinafine or salts thereof; and wherein the formulation further comprises

iii) about 0.1% to 0.3% w/w of dexamethasone;

b) about 71% to 72% w/w mineral oil; and

c) about 23% to 24% w/w paraffin.

13. A therapeutic kit comprising an injection unit comprising a storage compartment fluidly coupled to a delivery component, and a formulation of claim 1 stored within the storage compartment.

14. A method for treating an infection in an ear canal of a mammal, comprising applying a single dose of the formulation of claim 1 into the ear canal of a mammal with an ear infection.

15. The method of claim 14 , wherein the ear infection is clinically resolved within a duration of less than about 27 days.

16. The method of claim 14 , wherein the mammal is a human, canine or feline.