Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-03-17
2001-02-20
Cook, Rebecca (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S772000
Reexamination Certificate
active
06191143
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of topically administering antimicrobial agents for the treatment of systemic bacterial diseases in mammals.
BACKGROUND OF THE INVENTION
It has been generally accepted that intravenous infusion, intramuscular injection, subcutaneous, buccal, oral, and rectal routes are the methods for administration of a wide variety of antimicrobial agents for the treatment of systemic bacterial diseases. Due to lack of systemic level effects with antimicrobial agents administered topically, the topical administration of antimicrobial agents has been limited to the treatment of localized infections of the skin or eyes.
However, it is known that the aforementioned non-topical methods of administration for the treatment of systemic bacterial diseases have certain disadvantages. For example, buccal and rectal administration often produce discomfort and aggravation to the mammals that are treated. The intravenous, subcutaneous and intramuscular routes are not only painful, but also must be performed by trained individuals. In addition, there is a risk of needle injury, infection, and other trauma including the emotional trauma inevitably associated with injections. Oral administration, although generally acceptable, may have the disadvantages of poor absorption of the therapeutic agent from the gastrointestinal tract and/or degradation which may be caused by the acidic medium of the stomach, or causes digestive disfunction in ruminants. Furthermore, in the case of treating animals, the aforementioned methods of administration are labor and time consuming. Topical administration of antimicrobial agents would circumvent these problems by allowing a more convenient, non-invasive method for the treatment of systemic bacterial diseases.
Thus, it is desirable to have antimicrobial agents that produce systemic effects when they are topically administrated for the treatment of systemic diseases.
It has been unexpectedly discovered, during the investigation of activities of antimicrobial agents by topical administration, that certain antimicrobial quinolones, such as premafloxacin, premafloxacin-like compound, ciprofloxacin, and enrofloxacin, and certain cephalosporin derivatives, such as cefquinome and cefpodoxime, as well as gentamicin and erythromycin, when administrated topically using dimethyl sulfoxide and water as a carrier, are effective for the treatment of systemic bacterial infections. It has also been discovered that premafloxacin, premafloxacin-like compound and its esters, when administrated topically using propylene glycol and oleyl alcohol or propylene glycol and Azone as a carrier, are effective for the treatment of systemic bacterial infections
INFORMATION DISCLOSURE
Premafloxacin, ciprofloxacin, enrofloxacin, danofloxacin, and their quinolone families are series of new and potent antimicrobial agents with a broad spectrum of antimicrobial activity. These quinolone families are active against a variety of human and veterinary pathogens, including both gram-positive and gram-negative bacteria. Premafloxacin and its esters are disclosed in U.S. Pat. Nos. 4,665,079 and 5,563,155, issued May 12, 1987 and Oct. 8, 1996 to Warner-Lambert Company. Ciprofloxacin and enrofloxacin are disclosed in U.S. Pat. No. 4,670,444, issued Jun. 2, 1987 to Bayer Aktiengesellschaft. Danofloxacin is disclosed in European Patent 215650, issued to Pfizer Inc.
Ceftiofur, cefquinome, and cefpodoxime are derivatives of the family of cephalosporins, which have been recognized as highly active antimicrobial agents. Ceftiofur is disclosed in U.S. Pat. No. 4,464,367, issued Aug. 7, 1984 to Sanofi. Cefpodoxime is disclosed in U.S. Pat. No. 4,486,425, issued Dec. 4, 1984 to Sankyo Company Limited. Cefquinome is a known compound which is disclosed in, among the others, U.S. Pat. No. 4,754,031, European Patent 64,740, and European Patent 74,645.
Gentamicin is a known aminoglycoside antibiotic complex derived from
Micromonospora purpurea
, or
M. Echinospora
. Gentamicin is effective against a wide range of aerobic gram-negative bacilli, especially the Enterobacteriaceae and Pseudomonas, and some gram-positive bacteria. Gentamicin is disclosed in, inter alia, U.S. Pat. Nos. 3,091,572 and 3,136,704.
Erythromycin is an intermediate spectrum macrolide antibiotic, produced by
Streptomyces erythreus
, effective against most gram-positive and certain gram-negetive bacteria. Erythromycin is disclosed in, among the others, U.S. Pat. Nos. 2,653,899 and 2,823,203.
SUMMARY OF THE INVENTION
In one aspect, the present invention provides a method of treating or preventing systemic bacterial diseases in mammals which comprises topically administering to such mammal an effective amount of an antimicrobial agent selected from the group consisting of premafloxacin, premafloxacin-like compound, ciprofloxacin, enrofloxacin, cefquinome, cefpodoxime, gentamicin or erythromycin in a DMSO/H
2
O carrier.
In another aspect, the present invention provides a method of treating or preventing systemic bacterial diseases in mammals which comprises topically administering to such mammal an effective amount of premafloxacin, premafloxacin-like compound, or its ester in a PG/OA or a PG/Azone carrier.
REFERENCES:
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patent: 4464367 (1984-08-01), Labeeuw et al.
patent: 4486425 (1984-12-01), Nakao et al.
patent: 4665079 (1987-05-01), Culbertson et al.
patent: 4670444 (1987-06-01), Grohe et al.
patent: 4754031 (1988-06-01), Angerbauer et al.
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Chemical Abstract, vol. 87, No. 6, Aug. 8, 1977, B. Bazhdokov, et al., Dimethyl Sulfoxide As a Carrier of Broad-Spectrum Antibiotics, XP002040745.
Dermatol, Venerol, vol. 16, No. 1, 1977, SOFIA, pp. 33-36.
B. Idson: Percutaneous Absorption Enhancers, Drug & Cosmetic, vol. 137, No. 1, 1985, pp. 30-32, XP002040744.
Chemical Abstract38855, vol. 122, No. 4, Jan. 23, 1995, Abstract CN 1081103A, Jan. 26, 1994 (Faming Zhuanli Shenqing Gongkai Shuomingshu)..
Stehle Randall G.
Watts Jeffrey L.
Cook Rebecca
Pharmacia & Upjohn Company
Solomon Andrew M.
Yang Lucy X.
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