Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-07-24
2003-04-22
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S250000, C514S912000
Reexamination Certificate
active
06552020
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to compositions including antibiotics and to methods for using such compositions. More particularly, the invention relates to compositions including antibiotics which have added protection against fungal contamination, which reduce inflammation or pain and/or which are useful in the treatment of corneal ulcers.
Various antibiotic components have been used in ocular applications, for example, to control or manage or prevent ocular infections and the like. Moreover, antibiotic components, such as tobramycin have been suggested for use in combination with other materials, such as ophthalmically acceptable non-steroidal anti-inflammatory drugs or NSAIDs. See, for example, Fu et al. U.S. Pat. No. 5,414,011, the disclosure of which is incorporated in its entirety herein by reference. Quinolones, such as ofloxacin, have been used in compositions for treating ocular infections. These antibiotic compositions include one or more additional components which act as preservatives, for example, benzalkonium chloride (BAK) or organomercurials.
Antibiotic compositions, even with preservatives, have been susceptible to microbial, for example, fungal, contamination. In addition, preservatives tend to cause irritation, allergic reactions, and/or other detrimental side effects when the preserved composition is administered to a patient.
Thus, it would be advantageous to provide antibiotic compositions, and methods for using such compositions, which have added protection against microbial contamination and/or which include relatively reduced concentrations of preservatives.
Corneal injuries, such as corneal ulcers and other corneal conditions which are infected or if left untreated are likely to become infected, are quite painful and sometimes require lengthy periods of time to heal. It would be advantageous to provide compositions and methods effective to reduce the pain of these corneal injuries, for example, while such injuries are healing.
SUMMARY OF THE INVENTION
New antibiotic compositions, for example, for use in mammalian eyes, preferably human eyes, and methods for using such compositions have been discovered. By administering present compositions to humans or animals, for example, to the eyes of humans or animals, desired therapeutic effects are provided, such as the prevention, control or management or substantial elimination of ocular microbial infections, reductions in inflammation and/or pain, reductions in pain caused by corneal injuries and the like.
The present compositions preferably have added protection against microbial, for example, fungal contamination. This feature provides added assurance to the user that the present compositions are free of detrimental microbial contamination. This feature may allow reduced concentrations of preservatives to be included in the present compositions, thereby advantageously reducing detrimental side effects caused by such preservatives when the compositions are administered to patients. The present compositions can be easily produced, for example, using conventional techniques and can be conveniently used, for example, employing conventional methods of administration.
In accordance with one aspect of the invention, the compositions comprise a quinolone component, a NSAID component and a carrier component. The quinolone component is present in an amount effective as a antibiotic when the composition is placed in a mammalian eye. In one useful embodiment, the quinolone component in the composition has fungistatic activity. That is, the quinolone components in the present compositions have sufficient anti-fungal properties or activity to substantially prevent increases in populations of fungi in such compositions. In effect, the present quinolone components act as effective preservatives against fungal growth or contamination in the present compositions. The fungistatic activity of the presently useful quinolone components in the present compositions provide benefits, for example, as described elsewhere herein, which are surprising and substantial. The NSAID component is present in an amount effective to reduce at least one of inflammation and pain when the composition is placed in a mammalian eye. The carrier component is present in an amount effective to act as a carrier for the quinolone component and the NSAID component in the composition, and preferably is ophthalmically acceptable.
The present compositions preferably include a quinolone component which is halogenated, more preferably fluorinated. Very useful compositions and results are obtained when the quinolone component is an ofloxacin component.
Although any NSAID component may be used, the NSAID components included in the present compositions preferably are carboxylic (—COOH) group-containing NSAID components. More preferably, the NSAID component is a pyrrolo pyrrole component, still more preferably a ketorolac component.
The present carrier components may contain one or more pharmaceutically or ophthalmically acceptable ingredients, for example, tonicity adjuster components, buffer components, viscosity components, lubricating components, surfactant components, preservative components and the like, conventionally used, for example, in ophthalmic formulations. Preferably, the compositions have pH's in the physiological range of human beings, for example, in the range of about 4 to about 8.5.
The present compositions may be in any form suitable for effective administration to the human or animal to be treated. Preferably, the compositions are present in a form selected from solutions, suspensions, gels, ointments solids and the like which are very effective for ocular administration. The carrier component may conveniently be selected and/or compounded to provide the composition in the form desired.
Methods of using these compositions are included in the scope of the present invention. Such methods comprise administering to a human or animal, preferably to a mammalian eye, a therapeutically effective amounts of the compositions as described herein. Such methods provide one or more benefits to the human or animal treated in accordance with the present methods. For example, such benefits include prevention, control or management of microbial infections, and reduction in inflammation and/or pain.
In another aspect of the present invention, methods for treating corneal injuries are provided. As used herein, the term “corneal injury” refers to an injury of the cornea which is infected by harmful and/or unwanted microorganism or which, if left untreated is likely to become so infected, for example, before this injury heals. A corneal ulcer is an example of a corneal injury. Such methods comprise administering to a mammalian eye having a corneal injury a therapeutically effective amount of a composition comprising a quinolone component in an amount effective as an antibiotic in the mammalian eye and a NSAID component in an amount effective, in combination with the quinolone component, to provide a reduction in pain caused by the corneal injury. Such reduction in pain, together with the antibiotic effectiveness of the presently useful compositions, reduces the discomfort to the patient resulting from the corneal injury and facilitates or promotes the healing of the injury. The present useful compositions preferably include a carrier component in an amount effective to act as a carrier for the quinolone component and the NSAID component in the presently useful composition.
In another aspect of the present invention, methods for treating ocular infections, such as corneal infections and the like, are provided. Such methods comprise administering to a mammalian eye having an infection caused by one or more microbes or pathogens a therapeutically effective amount of a composition comprising a quinolone component in an amount effective as an antibiotic in the mammalian eye and an effective amount of a NSAID component. In one embodiment, the NSAID component is present in an amount effective to reduce the time needed to eliminate the in
Bancroft Elizabeth A.
Cheetham Janet K.
Jensen Harold G.
Kuan Teresa H.
Muller Christopher A.
Allergan Inc.
Fay Zohreh
Stout, Uxa Buyan & Mullins, LLP
Uxa Frank J.
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