Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Solid synthetic organic polymer
Reexamination Certificate
2000-01-20
2001-05-01
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Solid synthetic organic polymer
C514S941000, C514S944000, C514S969000, C514S789000, C514S887000, C424S400000, C424S433000
Reexamination Certificate
active
06225356
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates most generally to the field of therapeutic topical ointments containing cromolyn sodium and to therapeutic treatments for the pain and discomfort of such conditions as vulvar vestibulitis, interstitial cystitis, vulvar vaginitis or vaginitis dynea.
Vulvar vestibulitis, interstitial cystitis, vulvar vaginitis and vaginitis dynea are relatively common conditions of the female vaginal, vulvar, and urinary areas, causing discomfort or pain during sexual intercourse or urination, or an increase in the frequency of urination. The conditions are believed to result from inflammation of specific areas. Typical anti-inflammatory treatments have proven ineffective against these conditions. Ineffective treatments for vulvar vestibulitis, which is localized in the vestibule area comprising the meeting point of the vulva and the vagina and which contains the Bartholin's glands, the urethra and minor vestibular glands, include steroid, zinc oxide and ketoconazole creams, as well as oatmeal sitz baths, calendula and hypercal creams, bland aqueous creams and the application of tea bags. Interstitial cystitis is a chronic inflammatory condition of the bladder wall and is not related to common cystitis, which is a urinary tract infection caused by bacteria. Interstitial cystitis is not caused by bacteria and does not respond to antibiotic therapy. Ineffective treatments include oral medications such as pentosan polysulfate sodium, tricyclic antidepressants, antispasmodics, antihistamines and muscle relaxants, as well as bladder distention and injection of dimethyl sulfoxide, heparin, silver nitrate, oxychlorosene sodium, bacillus Calmette-Guerin or hyaluronic acid.
Cromolyn sodium is a known therapeutic composition which inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. The cromolyn inhibits the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast cell. Some studies have shown that cromolyn further inhibits the degranulation of non-sensitized mast cells by phospholipase A and the subsequent release of chemical mediators, although contrary studies exist. Cromolyn has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity. Cromolyn sodium is well known in the treatment of certain conditions of the eye, such as vernal keratoconjunctivitis, vernal conjunctivitis and vernal keratitis, as well as in the treatment of certain allergic reactions and contact blepharitis. Cromolyn sodium is also used in the treatment of certain heart conditions, asthma, gastrointestinal conditions and skin conditions such as eczema or psoriasis. Cromolyn sodium has not been used in the treatment of vulvar vestibulitis, interstitial cystitis, vulvar vaginitis or vaginitis dynea.
It is an object of this invention to provide a novel method and composition for topical application which effectively treats the conditions of vulvar vestibulitis, interstitial cystitis, vulvar vaginitis and vaginitis dynea, where the active ingredient cromolyn sodium is provided in a therapeutically effective amount via a carrier composition or ointment.
SUMMARY OF THE INVENTION
The invention comprises a composition and method for the treatment of the conditions vulvar vestibulitis, interstitial cystitis, vulvar vaginitis or vaginitis dynea wherein a composition containing cromolyn sodium in effective amount is applied to the vaginal vestibule area, with the application repeated as necessary to effectively address the symptoms and conditions. Preferably, the cromolyn sodium is present in an amount of about 2 to 10 percent in a carrier ointment or cream, with the carrier composition preferably comprising a mixture of pluronic gel and lecithin organogel.
REFERENCES:
patent: 5817699 (1998-10-01), Flores et al.
patent: 6083933 (2000-07-01), Hahn
patent: WO 99/00130 (1999-01-01), None
Di Nola-Baron Liliana
Page Thurman K.
Saitta Thomas C.
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