Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
1994-04-04
2001-10-02
Travers, Russell (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S645000, C514S644000
Reexamination Certificate
active
06297278
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a novel method and novel articles for inhibiting the activity of enveloped viruses. The invention also relates to treatment of viral infections. More particularly, the invention relates to a method for inhibiting the development of diseases and infections caused by enveloped viruses. In one aspect the invention particularly relates to a method of inhibiting the activity of viruses whose major mode of transmission is sexual. In other aspects the invention also relates to methods of inhibiting the activity of enveloped viruses whose mode of transmission is nonsexual. The compositions of use in the invention are also effective in the inhibition of bacteria and fungi which coexist with viruses or viral infections. Additionally, the invention relates to a treatment for virus related diseases, particularly sexually transmitted diseases related to AIDS, and to diseases related to this and other opportunistic infections of the immune-compromised host.
The method of the invention relates to using mixtures of betaines and amine oxides in the inhibition of viruses and treatment of viral infections. The betaine is selected from the group consisting of (a) an alkyl-N-betaine, an alkyl-N-sulfobetaine, an acyl-N-betaine, an alkyl N-substituted aminopropionic acid and an alkylimidazolinium betaine and the amine oxide is selected from the group consisting of (b) an alkyl-N, N-dimethylamine oxide, an alkyl-N, N-dihydroxyethylamine oxide and an acylamide t-amide oxide. The term “betaine” when used herein means an N-dimethyl glycine and their lower alkyl homologs. The term includes N-dimethyl amino propionic acids and sulfo betaines which are the sulfonic acid analogs of such compounds. Unless otherwise specified a N-dimethyl compound is intended. More particularly, the invention relates to a method for employing mixtures of alkyl N-di (lower alkyl) betaines and alkyl N-di (lower alkyl) amine oxides in the inhibition of enveloped viruses and use of these mixtures in the treatment of infections caused by these viruses.
The mixtures may also be used as spermicides, either alone or in combination with conventional spermicides. These mixtures may be used in combination with contraceptive devices or may be incorporated into the contraceptive device.
2. Description of the Prior Art
It is known that certain mixtures of amines are effective antimicrobial agents against gram negative and gram positive bacteria. For instance, it is known that certain mixtures of a) alkyl-N-betaine, alkyl-N-sulfobetaine, acyl-N-betaine, alkyl N-substituted aminopropionic acid or an alkylimidazolinium betaine and (b) alkyl-N, N-dimethylamine oxide, alkyl-N, N-dihydroxyethylamine oxide or acylamide t-amide oxide can be used for skin degerming, cleansing and deodorizing (see for example U.S. Pat. No. 4,183,952, issued to E. B. Michaels; U.S. Pat. No. 4,075,350 issued to E. B. Michaels, and U.S. Pat. No. 4,107,328; issued to E. B. Michaels). These compositions are also useful for long term inhibition of body odor. Mixtures of the same active ingredients are also known to enhance oral hygiene by reducing oral microflora and inhibiting formation of dental plaque. (U.S. Pat. No. 4,839,158 issued to E. B. Michaels). Compositions of this type are also known to be effective fungicides. Corner, A. M., et al.
Antimicrobial Agents and Chemotherapy,
32(3):350-353 (March 1988); Corner, A. M.
The Journal of Clinical Dentistry,
Vol. 2(2): 34-38. (1990)). (See also U.S. Pat. Nos. 4,075,350, 4,107,328, 4,183,952 and 4,839,158 issued to E. B. Michaels.)
It is also known that nonionic surface-active agents possessing ether or amide linkages between the hydrophilic and hydrophobic portions of the molecule rapidly inactivate the infectivity of herpes simplex virus I and II. (Asculai, S. S., et al.
Antimicrobial Agents Chemotherapy.
Vol. 13:686-690 (1978)). Asculai et al. also states that cytocidal activity has been used as an index of antiviral activity. The compositions utilized in this invention have an advantage over the compositions described in Asculai et al. in that these compositions inactivate viruses and bacteria while exhibiting low cytocidal activity.
The spermicide Nonoxynol-9 (N-9), has been found to have bactericidal and viricidal effects. For example, N-9 has been found to inactivate viruses related to AIDS (e.g. HIV, human immunodeficiency virus) and herpes simplex viruses (HSV I and II). In vitro, N-9 has been shown to be effective against the organisms that cause gonorrhea, chlamydia, syphilis, trichomoniasis, and other sexually transmitted diseases. (U.S. Pharmacopeial Convention USPDI Update 1990 pps. 755-756).
SUMMARY OF THE INVENTION
It has now unexpectedly been found that certain hereinbelow defined mixtures of betaines such as (a) alkyl-N-betaines, alkyl-N-sulfobetaines, acyl-N-betaines, alkyl-N-substituted aminopropionic acids and alkylimidazolinium betaines, and amine oxides such as (b) alkyl-N, N-dimethylamine oxides, alkyl-N, N-dihydroxyethylamine oxides or acylamide t-amide oxides in acceptable diluents, carriers and excipients are effective in inhibiting the activity of enveloped viruses. The invention provides a method of inhibiting the activity of enveloped viruses for which a major mode of transmission is sexual. The invention relates to a method for treating diseases and infections caused by enveloped viruses. These compositions are also effective in the inhibition of bacteria and fungi that co-exist with viruses or viral infections and for treatment of bacterial and fungal infections which co-exist with viruses or viral infections.
The invention also provides a method for disinfecting air and surfaces contaminated with enveloped viruses.
The invention also provides a method for preventing the transmission of enveloped viruses.
The compositions used in the method of the present invention can also be used as spermicides. These compositions can be used alone, with other known spermicides and with or incorporated into contraceptive devices such as condoms, sponges, vaginal inserts, contraceptive films, diaphragms, suppositories, contraceptive patches or sustained release devices. These compositions can also be incorporated into douches. The compositions can be incorporated into wipes. For use as viricides, these compositions can be applied alone; with other spermicides; and with or incorporated into the contraceptive devices described above.
The compositions can also be applied in the form of a foam, gel, cream, salve, jelly or lotion. The compositions can also be applied in the form of a liquid, aerosol, mist or spray.
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Fields Virology, 3rd Ed, Field et al Ed, Lippineott-Raven Philadephia PA, 1992.*
Miko et al. 102CA:209078a 1985.*
A.M. Corner, et. al. Journal of Clinical Dentistry, vol. 2, No. 2, pp. 34-38 (1990).
A.M. Corner, et.al. Antimicrobial Agents and Chemotherapy vol. 32 (3) pp
Malamud Daniel
Michaels Edwin B.
Akin Gump Strauss Hauer & Feld L.L.P.
Biosyn Inc. (a Pennsylvania Corporation)
Travers Russell
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