Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
2000-05-19
2003-01-21
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
C514S311000, C514S912000
Reexamination Certificate
active
06509327
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to the provision of topical pharmaceutical compositions for treating otic infections, particularly acute otitis externa infections caused by two newly discovered bacterial species,
Microbacterium
sp. nov.
otitidis
and
Microbacterium
sp. nov.
alconae.
The present inventors have isolated these species, and have determined that these species are pathogens in acute otitis externa infections. The present invention is directed to the provision of topical pharmaceutical compositions and methods for treating otic infections that are partially or wholly attributable to these newly discovered bacterial species, as well as ophthalmic and nasal infections wherein these species are acting as pathogens. The compositions and methods of the present invention are based on the use of quinolone antibiotics to treat such infections, particularly second and third generation quinolones, such as gatifloxacin and moxifloxacin, respectively.
Quinolone antibiotics have been previously utilized to treat ophthalmic and otic infections. For example, a topical ophthalmic composition containing the quinolone ciprofloxacin is marketed by Alcon Laboratories, Inc. under the name CILOXAN™ (Ciprofloxacin 0.3%) Ophthalmic Solution, and a topical otic composition containing a combination of ciprofloxacin and hydrocortisone is marketed by Alcon Laboratories, Inc. under the name CIPRO™ HC. The following quinolones have also been utilized in ophthalmic antibiotic compositions:
Quinolone
Product
Manufacturer
Ofloxacin
OCUFLOX ™
Allergan
Norfloxacin
CHIBROXIN ™
Merck
Lomefloxacin
LOMEFLOX ™
Senju
Ofloxacin has also been utilized to treat otic infections.
The foregoing quinolone antibiotic compositions are generally effective in treating ophthalmic infections, and have distinct advantages over prior ophthalmic antibiotic compositions, particularly those having relatively limited spectrums of antimicrobial activity, such as: neomycin, polymyxin B, gentamicin and tobramycin, which are primarily useful against gram negative pathogens; and bacitracin, gramicidin, and erythromycin, which are primarily active against gram positive pathogens. However, despite the general efficacy of the ophthalmic quinolone therapies currently available, there is a need for improved compositions and methods of treatment based on the use of antibiotics that are more effective than existing antibiotics against key ophthalmic pathogens, and less prone to the development of resistance by those pathogens.
There is an even greater need for effective topical compositions and methods for treating otic and nasal infections, particularly bacterial infections. The use of oral antibiotics to treat otic infections in children has limited efficacy, and creates a serious risk of pathogen resistance to the orally administered antibiotics. Although ciprofloxacin has proven to be an effective agent in treating otic infections, there is a need for a better understanding of the etiology of these infections and a corresponding need for therapies that address the causes of these infections more directly and effectively.
Ophthalmic, otic and nasal infections are frequently accompanied by inflammation of the infected ophthalmic, otic and nasal tissues and perhaps even surrounding tissues. Similarly, ophthalmic, otic and nasal surgical procedures that create a risk of microbial infections frequently also cause inflammation of the affected tissues. Thus, there is also a need for ophthalmic, otic and nasal pharmaceutical compositions that combine the anti-infective activity of one or more antibiotics with the anti-inflammatory activity of one or more steroid or non-steroid agents in a single composition.
SUMMARY OF THE INVENTION
The invention is based on the use of a potent new class of antibiotics to treat ophthalmic, otic and nasal infections, as well as the use of these antibiotics prior to surgery to sterilize the surgical field and prophylactically following surgery or other trauma to otic, ophthalmic or nasal tissues to minimize the risk of infection. The compositions of the present invention may also be administered to the affected tissues during otic, ophthalmic or nasal surgical procedures to prevent or alleviate post-surgical infection. As utilized herein, the terms “treat”, “treating” and derivations thereof are intended to include both treatments of existing infections and treatments to prevent or reduce the risk of infections.
The compositions preferably also contain one or more anti-inflammatory agents to treat inflammation associated with infections of otic, ophthalmic, or nasal tissues. The anti-inflammatory component of the compositions is also useful in treating inflammation associated with physical trauma to otic, ophthalmic, or nasal tissues, including inflammation resulting from surgical procedures. The compositions of the present invention are therefore particularly useful in treating inflammation associated with trauma to otic, ophthalmic, or nasal tissues wherein there is either an infection or a risk of an infection resulting from the trauma.
Examples of ophthalmic conditions that may be treated with the compositions of the present invention include conjunctivitis, keratitis, blepharitis, dacyrocystitis, hordeolum and corneal ulcers. The compositions of the invention may also be used prophylactically in connection with various ophthalmic surgical procedures that create a risk of infection.
Examples of otic conditions that may be treated with the compositions of the present invention include otitis externa and otitis media. With respect to the treatment of otitis media, the compositions of the present invention are primarily useful in cases where the tympanic membrane has ruptured or tympanostomy tubes have been implanted. The compositions may also be used to treat infections associated with otic surgical procedures, such as tympanostomy, or to prevent such infections.
The compositions and methods of the present invention are particularly useful in the treatment of acute infections of the external ear canal, which are commonly referred to as “acute otitis externa” or “AOE”. The present invention is based in part on the isolation of two bacterial species that have not previously been identified as pathogens relative to acute otitis externa infections. These bacterial species are described in greater detail below. The present invention is also based in part on a finding that the quinolone antibiotics utilized in the present invention, particularly third generation quinolones, such as Moxifloxacin, have a very high level of antimicrobial activity against these newly discovered pathogens, and therefore are particularly useful in the treatment of acute otitis externa infections involving these pathogens.
The compositions of the present invention are specially formulated for topical application to otic, ophthalmic, and nasal tissues. The compositions are preferably sterile, and have physical properties (e.g., osmolality and pH) that are specially suited for application to otic, ophthalmic, and nasal tissues, including tissues that have been compromised as the result of preexisting disease, trauma, surgery or other physical conditions.
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Abshire Robert L.
Cagle Gerald
Clark Linda L.
McLean Celeste H.
Stroman David W.
Alcon Manufacturing Ltd.
Brown Gregg C.
Fay Zohreh
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