Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2000-07-11
2002-07-09
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S431000, C424S432000, C424S434000, C424S443000, C424S433000
Reexamination Certificate
active
06416779
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention concerns devices, methods and compositions for intravaginal or transvaginal treatment of vaginal fungal, bacterial, viral or parasitic infections by administration of therapeutic and/or palliative antifungal, antibacterial, antiviral or parasiticidal drugs intravaginally to the vaginal mucosa or transvaginally to the uterus and general blood circulation. In particular, the invention concerns a targeted site delivery of drugs to the vagina for treatment of fungal, viral, bacterial or parasitic infection using a medicated intravaginal device. The medicated intravaginal device allows delivery of the drug into the vagina and provides a continuous contact with the vaginal mucosa and epithelium thereby asserting its therapeutic effect topically on the vaginal mucosa and/or transvaginally into the uterus or to the systemic circulation. The medicated intravaginal device of the invention permits administration of lower concentrations of the drug than those needed for systemic treatment, prevents leaking of the drug out of the vagina, provides better and longer bioavailability of the drug by maintaining the continuous contact with the vaginal mucosa and improves sanitary conditions of vaginal treatments.
2. Background and Related Disclosures
Vaginitis, vaginosis and other conditions caused by yeast, bacteria, viruses or parasites are common medical problems in women that are associated with substantial discomfort, particularly due to a copious pathologic discharge which is often accompanied by irritation, pruritus, odor or urinary symptoms. Several commonly known infections, such as yeast infection, bacterial vaginosis, trichomonas, chlamydia or gonococcal infections are common causes of the vaginal discharge.
Currently available treatments of vaginitis or other vaginal conditions include a systemic oral administration therapy or topically intravaginally introduced intravaginal creams, intravaginal suppositories, ointments or tablets which, in order to release the drug from these formulations, melt or dissolve in the vagina. The drug and other formulation components which are released during this process leak from the vagina creating unsanitary conditions and discomfort and also, more importantly, resulting in delivery of unpredictable amount of the drug.
One of the most recent studies, described in
J. Reprod. Med
., 44:543 (1999), reports that at this time, oral therapy is still preferred over intravaginal therapy. This is no doubt due to problems associated with vaginally delivered pharmaceutical agents. These problems include a discharge and leaking from the vagina which occurs during the treatment period, loss of drug due to such leaking, uncertainty of the amount of the drug delivered and general feeling of non-sanitary conditions which occur during such treatment.
Systemic treatment of vaginitis, which seems to be currently preferred, however, leads to the use of much higher doses of drugs which are potentially dangerous and typically cause severe secondary symptoms and complications. For example, local treatment of vaginal candiditis, a yeast infection, requires the use of antifungal drugs, such as nystatin, clotrimazole, miconazole and such similar drugs, administered as a cream via applicator, as suppository, or as a tablet, at bedtime. Due to a leakage encountered with such local treatment, once-a-day at bedtime treatment is recommended.
Once-a-day local administration of the drug does not provide continuous level of drug to treat the vaginal conditions, to deliver the drug to the uterus or to the general blood circulation and may lead to development of drug-resistance.
Thus it would be advantageous to have available treatment which would provide a continuous and predictable delivery of the drug to the vaginal mucosa and/or which would deliver the drug transvaginally into uterus or to the general blood circulation to avoid a necessity to administer the drug in high doses and to avoid a deactivation of the drug by the gastrointestinal tract.
Transvaginal delivery of a drug via a vaginal device has been disclosed by inventors and is described in the U.S. Pat. No. 6,197,327 and in U.S. Pat. No. 6,086,909, both incorporated herein by reference.
It is therefore a primary object of this invention to provide a device, composition and a method for topical and local treatment of vaginal infections by providing an intravaginal device comprising an antifungal, antibacterial, antiviral, trichomonicidal or parasiticidal agents incorporated within the device. The method of the invention provides a treatment of vaginal candidiasis, bacterial vaginosis, genital herpes, chlamydiosis, trichomoniasis, gonorrhea and human papilloma virus which eliminates the need for systemic treatment, which permits continuous delivery of the drug to the vaginal mucosa locally and topically and, where appropriate, which permits transvaginal delivery of the drug to the uterus and/or to the general circulation.
All references, patents and patent applications cited herein are hereby incorporated by reference in their entirety.
SUMMARY OF THE INVENTION
One aspect of the present invention is a device, method and a composition for intravaginal or transvaginal delivery of effective doses of a pharmaceutical agent to the vagina, uterus or to the general blood circulation.
Another aspect of this invention is a medicated device containing a pharmaceutical agent suitable for treatment of vulvovaginal candidiasis, bacterial vaginosis, chlamydiosis, genital herpes, gonorrhea, human papilloma virus or trichomoniasis.
Yet another aspect of this invention is an intravaginal device for intravaginal delivery of a pharmaceutical agent selected from the group consisting of an intravaginal tampon, tampon-like device, intravaginal ring, intravaginal pessary, intravaginal sponge, intravaginal tablet or intravaginal suppository comprising a pharmaceutical agent formulated as a cream, lotion, foam, ointment, solution or gel incorporated within said device.
Still yet another aspect of this invention is an intravaginal device for delivering an effective amount of a pharmaceutical agent to the vaginal mucosa for treating a human female suffering from vaginitis, vaginosis or other infection or disease, wherein the device is an absorbent intravaginal tampon or tampon-like device comprising a proximal and a distal end wherein a means for delivery of the pharmaceutical agent to the vaginal epithelium and/or to the uterus through the vaginal mucosa is situated at the distal end of the tampon and wherein a means for conveying fluid discharged from the vagina is situated near the proximal end of the tampon thereby preventing contact and dilution of the agent with the fluid.
Still another aspect of this invention is a method for treating a human female patient suffering from vaginal or uterine infections, conditions or diseases, said method comprising contacting the vaginal epithelium of the female with a pharmaceutical agent selected from the group consisting of an antifungal agent, antibacterial agent, parasiticidal agent, antiviral agent and/or trichomonicidal agent.
Still another aspect of this invention is a composition comprising an antifungal, antibacterial, antiviral, parasiticidal or trichomonicidal agent alone or in combination with other therapeutical agents in admixture with a biocompatible, pharmaceutically acceptable excipient for application of said agent(s) to the vaginal epithelium or for the transvaginal delivery through the vaginal mucosa, said agent(s) present in an amount sufficient to attain a therapeutically effective amount of the agent(s) in the vagina or in the uterus upon insertion of intravaginal device comprising said composition incorporated thereto.
Still yet another aspect of this invention is a pharmaceutically acceptable composition, in dosage unit form, for intravaginal or transvaginal delivery to a human female via a device of the invention, said composition comprising a combination of an effective amount of a pharmaceutical agent with
D'Augustine Merida A.
Harrison Donald C.
Liu James H.
Bennett Rachel M.
Page Thurman K.
UMD, Inc.
Verny Hana
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