Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2000-10-05
2002-12-10
Fay, Zohreh (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S250000, C514S254080, C514S912000
Reexamination Certificate
active
06492361
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to antibiotic compositions and to methods for using such compositions. More particularly, the invention relates to antibiotic compositions which are effective in use and reduce the risks of harmful side effects, such as, irritation, on the body part, for example, the eye, being treated.
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.
However, the use of BAK, organomercurials or other preservative components may be problematic. For example, BAK may be incompatible with certain active components and organomercurials pose difficulties due to potential mercury toxicity, as well as poor chemical stability. Although these problems may be significant, a more pervasive and common concern caused by preservatives components is the tendency of such components to cause irritation, allergic reactions, and/or other detrimental side effects when the preserved composition is administered to a patient.
It would be advantageous to provide stable, effective antibiotic compositions, and methods for using such compositions, that provide reduced risks of irritation and/or other harmful side effects caused by preservatives typically present in such compositions.
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 of ocular microbial infections, reductions in inflammation and/or pain and the like. Importantly, the present compositions are substantially is free of added or separate preservatives. This feature provides substantial benefits, for example, substantial elimination of irritation and/or other detrimental effects which may be caused by the presence of such added preservative components. 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 and a carrier component. The compositions are substantially free of other components effective as preservatives. 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 may have sufficient anti-fungal properties or activity to substantially prevent increases in populations of fungi in such compositions. In effect, the present quinolone components may act as effective preservatives against fungal growth in the present compositions. The carrier component is present in an amount effective to act as a carrier for the quinolone component, and other active component or components, if present, in the composition, and preferably is ophthalmically acceptable.
In one very useful embodiment, the present compositions comprise a quinolone component, a non-steroidal anti-inflammatory drug (NSAID) component, and a carrier component effective to act as a carrier for the quinolone and NSAID components. The quinolone component is effective as an antibiotic, as described elsewhere herein. The NSAID component is present in an amount effective to reduce at least one of inflammation and pain when the is composition is placed in a mammalian eye.
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, lubricity components, surfactant 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. Because the present compositions include no additional preservatives, the human or animal being treated is subjected to reduced risks of irritation and/or other detrimental or unpleasant side effects caused by the presence of such preservatives.
Any and all features described herein and combinations of such features are included within the scope of the present invention provided that the features of any such combination are not mutually inconsistent.
These and other aspects and advantages of the present invention are in the following detailed description and Examples and claims.
DETAILED DESCRIPTION
The present compositions comprise quinolone components and carrier components. Importantly, the present compositions are substantially free of other components effective as preservatives. Such substantially preservative-free compositions remain effective to provide the desired antibiotic effectiveness of the present compositions, while at the same time reducing the risk of irritation and/or other uncomfortable side effects caused by the presence of one or more added preservatives. Even though the present compositions are substantially preservative-free, it has been found that the present compositions have sufficient preservative efficacy to meet or exceed the standards of the United States Preservative Efficacy Test (USPET).
The present compositions include quinolone components. A number of such quinolone components are known and have been used for many years in antibiotic applications. For example, nalidixic acid has been available for the treatment of urinary tract infections. The useful quinolone components preferably are four-quinolones that contain a carboxylic moiety in the three position of the basic structure shown below:
Preferably, the present quinolone components exhibit fungistatic properties in the present compositions. That is, the quinolone components in the present compositions preferably are e
Bancroft Elizabeth A.
Cheetham Janet K.
Jensen Harold G.
Kuan Teresa H.
Muller Christopher A.
Allergan Sales, Inc
Fay Zohreh
Uxa Frank J.
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