Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2000-06-19
2002-10-08
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
Reexamination Certificate
active
06462030
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention concerns a method for treating or preventing bacterial vaginosis using cellulose acetate phthalate and/or hydroxypropyl methylcellulose phthalate.
2. Background Information
Recent findings suggest that bacterial vaginosis (“BV”) may increase susceptibility to HIV-1 infection (Sewankambo, EN., Gray R. H., Wawer et al., M. J., “HIV-1 Infection Associated with Abnormal Vaginal Flora Morphology and Bacterial Vaginosis”,
Lancet
, 350, 546-550, (1997); Taha, T. E., Hoover, D. R., Dallabeta et al., G. A., “Bacterial Vaginosis and Disturbances of Vaginal Flora: Association with Increased Acquisition of HIV”,
AIDS
, 12, 1699-1706, (1998); Cohen, C. R., Duerr, A., Pruithithada et al., N., “Bacterial Vaginosis and HIV Seroprevalence Among Female Commercial Sex Workers in Chiang Mai, Thailand”, AIDS, 9, 1093-1097, (1995)). Depending on the population studied, up to nearly 40% of selected groups may have BV (Sobel, J. D., “Vaginitis”,
New England J. Med
., 337, 1896-1903, (1997)). Although unequivocal evidence that BV is a sexually transmitted disease is lacking (Carr, P. L., Felsenstein, D., Friedman, R. H., “Evaluation and Management of Vaginitis”,
J. Gen. Intern. Med.
, 13, 335-346, (1998)), BV behaves in many ways as if it were a sexually transmitted disease (“STD”) (Schwebke, J. R., “Bacterial Vaginosis—More Questions Than Answers” [editorial],
Genitourin Med.
, 73, 333-334, (1997)). Therefore, treatment of BV is expected to contribute to controlling the spread of STDs, including HIV-1 (Schwebke, J. R., “Bacterial Vaginosis—More Questions Than Answers” [editorial],
Genitourin Med.
, 73, 333-334, (1997)).
It has recently been reported that cellulose acetate phthalate (“CAP”) (Eastman Kingston, Tenn., USA) which has heretofore been used as an excipient for the enteric coating of tablets and capsules (Lee, J. C., (1994), Cellulose acetate phthalate,
Handbook of Pharmaceutical Excipients
, 2nd Ed., Wade, A. and Weller, P. J., pp. 91-93, American Pharmaceutical Association Publishers, Washington, D.C.), has antiviral activity in vitro against HIV-1 and herpesviruses (“HSV”) and, when appropriately formulated, inactivated HIV-1, herpesviruses and several bacterial STD pathogens without affecting Lactobacilli (Neurath, A. R., Strick, N., Li, Y-Y, Jiang, S., “Design of a ‘Microbicide’ for Prevention of Sexually Transmitted Diseases Using ‘Inactive’ Pharmaceutical Excipients”,
Biologicals
, 27, 11-21, (1999)), essential for maintaining a normal vaginal flora (Martin, Jr., H. L., Richardson, B. A., Nyange, P., Lavreys, L., Hiller, S. L., Chohan, B. et al. (1999), “Vaginal Lactobacilli, Microbial Flora, and Risk of Human Immunodeficiency Virus Type 1 and Sexually Transmitted Disease Acquisition”,
Journal of Infectious Diseases
, 180, 1863-1868), (
Handbook of Pharmaceutical Excipients
), Wade, A. and Weller, P. J., eds., 2nd Ed., American Pharmaceutical Association, (1994); Klebanoff, S. J., Coombs, R. W., “Viricidal Effect of Lactobacillus Acidophilus on Human Immunodeficiency Virus Type 1: Possible Role in Heterosexual Transmission”,
J. Exp. Med
., 174, 289-292, (1991)). These findings have been further strengthened by the favorable outcome of experiments in the HSV-2/mouse (Gyotoku, T., Aurelian, L. and Neurath, A. R., “Cellulose Acetate Phthalate (CAP): An ‘Inactive’ Pharmaceutical Excipient with Antiviral Activity in the Mouse Model of Genital Herpesvirus Infection”,
Antiviral Chemistry
&
Chemotherapy
, 10, 327-332, (1999)) and simian immunodeficiency virus/monkey models for vaginal infection.
Considering the role of BV in susceptibility to infection by HIV-1 and other STD pathogens, it seemed important to the present inventor to also evaluate the effect of CAP on microorganisms associated with BV, namely,
Gardnerella Vaginalis
, Mycoplasmas,
Mobiluncus curtisii
and
Prevotella corporis
(Sobel, J. D., “Vaginitis”,
New England J. Med.
, 337, 1896-1903, (1997); Schwebke, J. R., “Bacterial Vaginosis—More Questions Than Answers” [editorial],
Genitourin Med.
, 73, 333-334, (1997); Hill, G. B., “The Microbiology of Bacterial Vaginosis”,
Am. J. Obstet. Gynecol.
, 169, 450-454, (1993)).
Heretofore uses of CAP are described in U.S. Pat. No. 5,985,313 and U.S. application Ser. No. 09/175,909.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a method for treating and preventing bacterial vaginosis.
The present invention concerns a method for treating or preventing bacterial vaginosis comprising administering to a human female an effective anti-bacterial vaginosis amount of a composition comprising at least one active compound selected from the group consisting of cellulose acetate phthalate and hydroxypropyl methylcellulose phthalate, either alone or in combination with a pharmaceutically acceptable carrier.
REFERENCES:
patent: 5314904 (1994-05-01), Edigio et al.
patent: 5741525 (1998-04-01), Larsen
patent: 5985313 (1999-11-01), Neurath et al.
patent: 6165493 (2000-12-01), Neurath
Sewankambo, N., Gray R.H., Wawer et al., M.J., “HIV-1 Infection Associated with Abnormal Vaginal Flora Morphology and Bacterial Vaginosis”,Lancet, 350, 546-550, (1997).
Taha, T.E., Hoover, D.R., Dallabeta et al., G.A., “Bacterial Vaginosis and Disturbances of Vaginal Flora: Association with Increased Acquisition of HIV”,AIDS, 12, 1699-1706, (1998).
Cohen, C.R., Duerr, A., Pruithithada et al., N., “Bacterial Vaginosis and HIV Seroprevalence Among Female Commercial Sex Workers in Chiang Mai, Thailand”,AIDS, 9, 1093-1097, (1995).
Sobel, J.D., “Vaginitis”,New England J. Med., 337, 1896-1903, (1997).
Carr, P.L., Felsenstein, D., Friedman, R.H., “Evaluation and Management of Vaginitis”,J. Gen. Intern. Med., 13, 335-346, (1998).
Schwebke, J.R., “Bacterial Vaginosis—More Questions Than Answers” [editorial],Genitourin Med., 73, 333-334, (1997).
Lee, J.C., (1994), “Cellulose acetate phthalate”,Handbook of Pharmaceutical Excipients, 2nd Ed., Wade, A. and Weller, P.J., pp. 91-93, American Pharmaceutical Association Publishers, Washington, D.C.
Neurath, A.R., Strick, N., Li, Y-Y, Jiang, S., “Design of a ‘Microbicide’ for Prevention of Sexually Transmitted Diseases Using ‘Inactive’ Pharmaceutical Excipients”,Biologicals, 27, 11-21, (1999).
Martin, Jr., H.L., Richardson, B.A., Nyange, P., Lavreys, L., Hiller, S.L., Chohan, B. et al. (1999), “Vaginal Lactobacilli, Microbial Flora, and Risk of Human Immunodeficiency Virus Type 1 and Sexually Transmitted Disease Acquisition”,Journal of Infectious Diseases, 180, 1863-1868.
Klebanoff, S.J., Coombs, R.W., “Viricidal Effect of Lactobacillus Acidophilus on Human Immunodeficiency Virus Type 1: Possible Role in Heterosexual Transmission”,J. Exp. Med., 174, 289-292, (1991).
Gyotoku, T., Aurelian, L. and Neurath, A.R., “Cellulose Acetate Phthalate (CAP) : An ‘Inactive’ Pharmaceutical Excipient with Antiviral Activity in the Mouse Model of Genital Herpesvirus Infection”,Antiviral Chemistry&Chemotherapy, 10, 327-332, (1999).
Hill, G.B., “The Microbiology of Bacterial Vaginosis”,Am. J. Obstet. Gynecol., 169, 450-454, (1993).
Frishauf Holtz Goodman & Chick P.C.
Maier Leigh C.
New York Blood Center Inc.
Wilson James O.
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