Use of glucocorticoids for the treatment of epithelial microbial infections of a fluid containing organ with a natural exterior orifice in mammals
Inventors
Havrileck, Bertrand • JASMIN, Pierre • MCGAHIE, David
Assignees
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Publication Number
US-11819506-B2
Publication Date
2023-11-21
Expiration Date
Abstract
The disclosure is directed to glucocorticoids for the treatment of epithelial microbial infections in fluid-containing organ having a natural exterior orifice in mammals; this new therapeutic use finds particular interest in the treatment of epithelial microbial infections of ear (such as otitis externa), udder (such as mastitis), and uterus (such as endometritis).
Core Innovation
The invention relates to a method for the treatment and/or the prevention of an epithelial microbial infection of the ear in a non-human mammal by administering hydrocortisone or a salt thereof. The epithelial microbial infection is otitis externa, and the hydrocortisone is topically administered to the ear to be treated. The method is framed as a non-antibiotic approach to manage epithelial microbial infection.
A key aspect is that the pharmaceutical composition used for topical administration comprises a pharmaceutically acceptable carrier while not containing any antibiotic agent, antifungal agent, antiviral agent or antimicrobial agent. In this way, the therapy relies on hydrocortisone or its salt as the active component rather than combining it with antimicrobial, antifungal, or antiviral agents. The described approach is also positioned as restoring and maintaining the epithelial microbial flora.
The document further specifies dosing and administration schedules for otitis externa, including an effective amount range and different regimens for treatment versus prevention. Prevention is administered at least once a week, while treatment is administered once a day up to 20 consecutive days.
Claims Coverage
The provided material contains two independent claims, each covering treatment and/or prevention of otitis externa as an epithelial microbial infection of the ear in a non-human mammal. The claims introduce two main inventive features: topical hydrocortisone with specified dosing for prevention and treatment, and formulation as a pharmaceutical composition with a pharmaceutically acceptable carrier that does not contain antibiotic, antifungal, antiviral, or antimicrobial agents.
Topical hydrocortisone for otitis externa prevention and treatment in non-human mammals
A method for the treatment and/or the prevention of an epithelial microbial infection of the ear in a non-human mammal in need thereof, comprising topically administering in the ear to be treated an effective amount of hydrocortisone or a salt thereof, wherein the epithelial microbial infection is otitis externa; wherein the effective amount is between 0.1 and 0.5 mg and is administered at least once a week when the method is for prevention, and/or is administered once a day up to 20 consecutive days when the method is for treatment.
Hydrocortisone formulation without antibiotic, antifungal, antiviral, or antimicrobial agents
A method for the treatment and/or the prevention of an epithelial microbial infection of the ear in a non-human mammal in need thereof, comprising topically administering in the ear to be treated an effective amount of hydrocortisone or a salt thereof, wherein the epithelial microbial infection is otitis externa; wherein the hydrocortisone or a salt thereof is formulated in a pharmaceutical composition also comprising a pharmaceutically acceptable carrier and wherein the composition does not contain any antibiotic agent, antifungal agent, antiviral agent or antimicrobial agent.
Across the independent claims, the coverage centers on topical administration of hydrocortisone or a salt thereof for otitis externa in non-human mammals, with specified effective amounts and prevention versus treatment regimens, and with a pharmaceutical composition that excludes antibiotic, antifungal, antiviral, and antimicrobial agents.
Stated Advantages
Non-antibiotic therapy for epithelial microbial infection of the ear (otitis externa).
Restores epithelial microbial flora without antimicrobial, antibiotic, antifungal, or antiviral agents.
At least as effective as Surolan in acute erythemato-ceruminous otitis externa in dogs.
Good tolerability for curing mild mastitis in lactating cows/heifers.
Documented Applications
Treatment and/or prevention of epithelial microbial infection of the ear (otitis externa) in a non-human mammal, including a dog or a cat.
Clinical use as illustrated by comparison with Surolan in acute erythemato-ceruminous otitis externa in dogs.
Mild mastitis in lactating cows/heifers treated with hydrocortisone aceponate (HCA) with curing and good tolerability.
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