Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Selenium or compound thereof
Reexamination Certificate
1999-07-21
2001-06-05
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Selenium or compound thereof
C424S094100, C424S400000, C424S729000, C424SDIG001, C514S882000, C514S562000, C514S937000, C514S944000, C514S966000, C514S969000
Reexamination Certificate
active
06242010
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention deals with compositions for ano-rectal inflammatory processes, hemorrhoidal syndromes, pruritus ani and ano-rectal wounds comprising a complex of synergistic antioxidants, including enzymatic co-factors, thiol and selenium compounds, zinc salts and cellular growth factors to decrease the local inflammatory response, abolish symptoms, and to promote wound healing and surgical repairs, such as post-hemorrhoidectomies, fistulectomies, and fissurectomies. These active ingredients will be administered using topical ano-genital and intra-rectal preparations, most particularly, ointments, salves, lotions, creams, patches, aerosols, sprays and others and as suppositories and foams for internal hemorrhoids and rectal inflammatory conditions so that the antioxidants neutralize and scavenge the free radicals generated in ano-rectal diseases and local wounds thereby reducing the pain, inflammation, swelling, itching, and tenderness in these anatomical parts, and together with other optional ingredients promote repair and healing.
BACKGROUND OF THE INVENTION
Hemorrhoids are one of man's main afflictions.
Homo sapiens
pays this price, hemorrhoids, for its primate ancestor,
Pithecanthropus erectus
, stood up in contrast to his other non-human primates and other mammalian species wherein hemorrhoids do not occur. Hemorrhoidal syndromes are a condition with great morbidity but fortunately minimal mortality, albeit frequent bothersome symptoms and complications.
“Hemorrhoids”, often referred to as “piles” or “almorranas” by Hispanics, are truly enlarged veins in the area around the anus, anatomically known as the hemorrhoidal plexi. These veins constitute the external and the internal hemorrhoids. The hemorrhoidal plexus is formed by the anastomosis of two distinct venous systems; the systemic via the inferior vena cava and the hepatic via the portal vein. Whichever venous system has an increase in its pressure, permanent or intermittent, will cause varicose dilation of the hemorrhoidal veins. The most common etiology for the former venous system is right sided congestive heart failure while for the latter, is caused by cirrhosis of the liver with portal hypertension. Unfortunately, both types of clinical syndromes are commonly associated with hemorrhoidal complications often affecting these chronically, very ill patients. However, hemorrhoidal syndromes are very common even in the absence of the aforementioned venous hypertension entities.
Signs and symptoms of the hemorrhoidal syndrome are variable and result from the “swollen” (enlarged) hemorrhoidal veins in and around the anus and rectum, respectively labeled external and internal hemorrhoidal syndromes. Although the presence of these dilated veins may be asymptomatic, many patients complain of passing bright red blood covering the stool, or noticing blood on the toilet paper or toilet bowl. Internal hemorrhoids may protrude through the anus becoming irritated and painful and pathologically having a severe cellular inflammatory response in the contiguous tissues. External hemorrhoids may likewise include an inflammatory response in the anal mucosa and may include a painful selling or hard lump, particularly with a thrombus (clot), around the anus. Excessive straining, rubbing or cleaning around the anus may cause further irritation and inflammation with generation of free radical species to further the painful symptoms, with consequent bleeding, itching, and draining mucus, a true curse of the inflammation and distention of these veins.
Although hemorrhoidal symptoms may subside within a few days, many cases are associated with local and rectal complications, including fissures, fistulae, abscesses or irritation and itching (so called pruritus ani). The inflammatory reactions are chronic, indolent and infected. Not infrequently these patients succumb to one or another of the available surgical treatments. Surgical therapies include electrical or coagulation laser or infrared photocoagulation to “burn” the hemorrhoids; rubber band ligation to cut off circulation; sclerotherapy to shrink these veins by injecting agents that “scar” these veins or by surgical removal, hemorrhoidectomy. All these primitive and advanced methods may be averted by proper preventive measures and therapeutic applications such as reparative sitz baths and the use of local ointments, creams, lotions, patches and suppositories with both therapeutic anti-inflammatory agents, vaso-constrictors, and synergistic anti-oxidants as in this patent application to reduce inflammation, swelling and free radical species damage to the putative ano-rectal tissues and hemorrhoidal veins.
In addition to the hemorrhoidal syndromes, there are other important anal inflammatory conditions. Inflammations of the anal conduit (canal) are variously called anusitis, cryptitis and papillitis, usually caused by alterations in the rhythm of defecation, that is, alternating periods of constipation and diarrhea, the latter with its variations in stool pH and fecal chemical constituents, such as the presence of active digestive enzymes. Alterations in fecal micro-flora, gastrointestinal infections and parasitic infestations, particularly pinworm, are responsible for anal inflammation, whereby the antioxidant complex of the present invention in appropriate delivery vehicles may be an adjunct to therapy of ano-rectal diseases.
Another common and very painful condition is anal fissure, which is a linear ulcerating lesion in the anal canal. This is purportedly tabulated as the most painful anal inflammatory condition. Pruritus ani is another common syndrome accompanied by intractable itching and local inflammation resulting from hemorrhoids, local infections, dermatologic diseases and pinworm disease among the most common. The intense itching leads to excoriations, ulcerations and complicating inflammation with secondary infections.
Other causes of ano-rectal inflammation are sexually transmitted diseases and perianal infections and abscesses. The later often originate from a suppurative cryptitis, or from a fissure. Fistula-in-ano may result from a perianal abscess and is a chronic, indolent and painful condition. Inflammation is most prominent and requires antibiotics and drainage with local care including topical analgesics. The present antioxidant preparations would be an important adjunct in the symptomatic and reparative management of these ano-rectal inflammations.
There are a number of patents which have been issued for compositions and methods of treating hemorrhoids and related ano-rectal wounds. Topical formulations not only treat hemorrhoidal pain but also sphincter spasm and related symptoms. Gallina in U.S. Pat. No. 5,234,914 dated Aug. 10, 1993, taught a method of applying to ano-rectal tissues and to hemorrhoids a composition which included hyaluronic acid or its salts in amounts ranging from 0.1 to 10% by weight, in acceptable carriers. The uses of hyaluronic acid included its anti-inflammatory and wound healing properties for ano-rectal conditions and diseases,
Packman and Oskman described the use of hemorrhoidal compositions containing disaccharide polysulfate-aluminum compounds, like sucralfate in U.S. Pat. No. 5,196,405, Mar. 23, 1993. This method of alleviating hemorrhoidal symptoms included sucralfate alone or in combination with antibiotics, anti-fungal agents or local anesthetics in an attempt to ameliorate ano-rectal symptoms and heal the putative wounds. Compositions could also include anti-inflammatory agents, steroids, and/or vaso-constrictors, causing a complex matrix to be formed between the wound and the sucralfate in order to promote a prolonged adhesion of the preparation to the affected tissue.
U.S. Pat. No. 4,761,285, dated Aug. 2, 1988, taught various compositions for the relief of hemorrhoidal symptoms and the treatment of hemorrhoids. It taught a preparation comprising leptandra's culver root, chick peas, and grape seeds. The latter are now known to contain proanthocynidins, antioxidants which are
Tate Christopher R.
Thione INternational, Inc.
Wittenberg Malcolm B.
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