Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-11-30
2001-12-11
Azpuru, Carlos A. (Department: 2165)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424SDIG001, C514S841000, C514S843000, C514S960000, C514S975000, C128S830000, C128S832000, C128S833000, C604S058000
Reexamination Certificate
active
06328991
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a composition of active pharmaceutical agent for administration into the vaginal canal to prevent the spread and transmission of Sexually Transmitted Diseases. The present invention also relates to a composition for administration into the vaginal canal to prevent the transmission of HIV, and the spread of AIDS.
The invention also relates to a method of administration of an active pharmaceutical agent via the vaginal cavity and to a sponge capable of delivering such agent into the vaginal canal during insertion of the sponge, while the sponge is resident in the vagina and during removal from the vagina.
The present invention also relates to vaginal sponges for the topical or systemic, sustained release of a wide range of active pharmaceutical compounds. And the invention relates to sterile, packaged vaginal sponges containing predetermined dosages of active pharmaceuticals which sponges can be conveniently inserted and removed by the user without compromising the predetermined dosage and without waste or mess.
THE PRIOR ART
Sexually Transmitted Diseases
The term “Sexually Transmitted Disease” (STD) is a relatively new one that has gradually replaced the term “Venereal Disease.” This terminology has expanded not only the awareness of infectious diseases transmitted through sexual contact, but now describes an expanded array of diseases.
Venereal diseases originally encompassed five traditional infections: Gonorrhea, Syphilis, Chancroid, Lymphogranuloma Venereum, and Granuloma Inguinale. The term STD today includes more than twenty specific organisms and syndromes, including HIV, Chlamydia Trachomatis, Genital Herpes, Genital Warts and Cervical Neoplasia. Thus, the use of the term STD has grown in its scope, and now encompasses a large number of sexually transmitted infections. These include Acquired Immunodeficiency Syndrome (AIDS), Acute Urethral Syndrome or Cystitis, Bacterial Vaginosis Vulvovaginitis, Candidiasis, Cervical Intraepithelial Neoplasia, Chancroid, Chlamydia, Cytomegalovirus infections, Enteric infections, Genital Warts, Gonorrhea, Granuloma Inguinale, Hepatitis B, Herpes Genitalis, Human Papillomavirus (HPV), Lymphogranuloma venereum (LGV), Molluscum Contagiosum, Mucopurulent Cervicitis, Nongonococcal Urethritis, Pediculosis Pubis, Pelvic Inflammatory Disease (PID), Scabies, Syphilis, Trichomoniasis and Vulvovaginitis.
STDs are getting worse both in magnitude and severity. A large and growing number of pathogens have been implicated as causative agents. To name a few of the causative agents currently known, Acquired Immunodeficiency Syndrome is caused by Human Immunodeficiency Virus (HIV). Acute Urethral Syndrome is caused by
E. coli
, C. trachomatis, N. gonorrhea and other gram-negative bacteria. Cervical Intraepithelial Neoplasia (CIN) has been associated with human papilloma virus (HPV), and the Herpes Simplex Virus. Chancroid is caused by Hemophilus Ducreyi. Chlamydia, one of the most common bacterial STD infections in the United States, is caused by Chlamydia trachomatis. Cytomegalovirus infections are caused by a DNA virus of the Herpes virus group. Enteric infections, which are outside, but are related to STDs, are caused by many sexually transmissible bacteria, viruses and protozoa, and by other organisms that produce disease, and are carried in the gastrointestinal tract. Genital Warts are caused by the human papillomavirus (HPV), a small DNA virus belong to the papillomavirus group. Gonorrhea is caused by Neisseria Gonorrhea, a gram-negative diplococcus. Granuloma Inguinale is caused by the gram-negative bacteria calymmato-bacterium granulomatis. Hepatitis B is caused by Hepatatis B virus (HBV), a DNA virus with multiple antigenic components. Herpes Genitalis is caused by the Herpes Simplex II virus (HSV). Lymphogranuloma venereum (LGV) is caused by immuno-types L I, L II, or L III of Chlamydia Trachomatis. Molluscum Contagiosum is caused by the Molluscum Contagiosum virus, the largest DNA virus of the poxvirus group. Mucopurulent Cervicitis is caused by Chlamydia and Gonorrhea. Nongonococcal Urethritis (NGU) is caused by Chlamydia of the D to K immunotypes. Pediculosis Pubis, which, strictly speaking is not a true sexually transmitted disease, is caused by a pubic or crab louse, an ectoparasite. Pelvic Inflammatory Disease (PID) is caused by Gonorrhea, Chlamydia, and other anaerobic bacteria and gram-negative rods, such as
E. coli
and mycoplasma homines. Scabies is caused by Sarcoptes scabies, a female mite approximately 0.4 mm long. (Although not a true STD disease it is commonly found among those with other STD infections). Syphilis is caused by Treponema Pallidum, a spirochete. Vulvovaginitis is caused by Trichomonas Vaginalis.
As can be seen from the foregoing, a broad variety of microorganisms can potentially enter the vaginal tract through sexual intercourse, and result in a sexually transmitted disease. These microorganisms include bacteria, viruses, fungi, protozoa, and yeasts among others. The health consequences which can result from the contraction of a sexually transmitted disease can be severe, and extremely debilitating. The risk of contracting AIDS through sexual intercourse, for example, is a major concern for many individuals.
From a health care perspective, numerous other sexually transmitted diseases, as provided, for example, in the listing above, are likewise a potential concern. Accordingly, there is a need in the prior art for a chemical composition or medication for administration into the vaginal canal to prevent the tranmission and spread of sexually transmitted diseases, including AIDS.
Thus, there is need for suitable and effective microbiocides which would kill microorganisms in the vaginal canal before they can cause infection. In addition, there is also a need for effective contraceptive agents and preparations for use before or during sexual intercourse, as well.
The Vaginal Sponge
One of the primary concerns encountered when medication is to be administered to an individual is that the medication reach the targeted area of treatment and be maintained in that targeted area. For example, when treating vaginal disorders it is often desirable that medication be applied for extended period of time to remote regions of the vaginal canal or cervix. These regions are not readily accessible by conventional vaginal suppositories due to their size and shape. Moreover, because of the structure and nature of the vaginal canal, inserted suppositories often do not stay in place or, upon melting, may drain out of the vagina substantially reducing the effectiveness of the medication. Vaginal foams formed by delivering foam-forming materials into the vagina are short lived and hence are unsuitable for sustained release of active agents. Moreover, both vaginal suppositories and vaginal foams are very messy to use. Use of tampons and other similar devices have not proved successful because of their configuration and the nature of their compositions.
Physical swabbing and douching can cleanse the vaginal canal, but neither can provide sustained release of active agents.
Contraceptive vaginal foam sponges have been previously proposed but even those currently in commercial use do not provide for a predetermined level of sustained release of spermicide and medicaments over a given period of time.
Clinical studies have indicated that young women using oral contraceptives may increase their risk of developing breast and cervical cancers in midlife. Whether this type of contraception is dangerous is debateable but it is recognized that the “pill” interferes with the hormonal balance of the user. Multiple and considerable side effects from the use of oral contraceptives have been observed in many women.
Many attempts to find safer and more effective contraceptive methods which reduce or eliminate side effects have been made. A 24-hour vaginal contraceptive sponge has been commercially marketed. The device comprises a polyurethane sponge disc having a central recess and containing 1,000 milligra
Azpuru Carlos A.
Levisohn, Lerner, Berger & Langsam
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