Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-02-22
2004-12-07
Barts, Samuel (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S123100, C536S119000, C424S486000, C424S078360, C424S070150
Reexamination Certificate
active
06828308
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to certain compositions useful for the management of painful ulcerative and inflammatory conditions of moist surfaces including the mouth, oropharynx, oesophagus, vagina and rectum (including, but not limited to, mucositis, stomatitis, aphthous ulcerations, and Behcet's syndrome).
BACKGROUND OF THE INVENTION
Aggressive cancer treatment may have toxic effects on normal cells as well as cancer cells. The gastrointestinal tract, including the mouth, is especially affected because these cells are replaced by the body continuously.
Mucositis, an inflammation of the mucous membranes in the mouth, is one of the most common oral problems occurring after chemotherapy and radiation therapy. Mucositis can contribute to oral infections, inability to taste normally and pain arising from the resulting open sores that can develop. Mucositis can become so painful that the patient will not eat or drink, contributing to dehydration and malnutrition.
Radiation therapy to the head and neck for cancers in those areas commonly injure saliva glands and the inside of the mouth which can cause dry mouth, leading to dental disease.
The mucositis problem is not restricted to cancer patients, as mucositis frequently also occurs in HIV patients, particularly when associated with Kaposi's sarcoma, in patients affected with non-Hodgkin's lymphoma, in debilitated elderly patients and in patients receiving BRM treatments like interleukin-2, TNF, interferons, lymphokine-activated lymphocytes and the like.
Such oral problems may make it difficult for the cancer or AIDS patient to receive a complete dose of chemotherapy or radiation therapy. Sometimes treatment must be stopped completely. Such problems are not infrequent: about half of the patients have severe oral lesions that require medical intervention, mostly involving the changes in cancer medication or treatment mentioned above.
Current therapies for mucositis are limited. Cleaning the mouth is recommended to retard the progression of the condition.
Oral cleaning care includes gently cleaning the mouth, moisturizing the lips and mouth, and relieving pain and swelling. A soft toothbrush or toothette cleans teeth well and gently. Cleansing agents can include “salt and soda” (½ tsp. salt and 2 Tbs. of sodium bicarbonate in 32 oz. of warm water), normal saline, sterile water, or sodium bicarbonate (1 tsp. in 8 oz of water). Hydrogen peroxide diluted in equal amounts of water or weak salt water can be used when crusting is present. (This should be used for 1 or 2 days only because it will keep mucositis from healing.) Gentle wiping with a wet gauze dipped in salt water helps remove particles. Toothettes may be too rough for some areas. Particles should be removed before ointments or other medications are put onto the gums or tissues. Rinsing often cleans and moistens the tissues, prevents crusting, and soothes sore gums and tissues. Frequent rinsing prevents particles and bacteria from collecting in the mouth. A salt and baking soda solution neutralizes acids and dissolves thick saliva.
Capsaicin, the active ingredient in hot peppers, reportedly has used to increase a person's ability to tolerate pain. When capsaicin is put on inflamed tissues in the mouth, mucositis pain may decrease as the burning feeling from the capsaicin decreases. Capsaicin is only being used experimentally; however, all side effects are not known.
Mostly, physicians have resorted ice chips or to rather makeshift mixtures of benzocaine with kaopectate and the like. These approaches provide rather limited, temporary relief.
Carrington Laboratories of Irving, Tex. has sold a mucositis product called “Radiacare” for a number of years. However, this product has made limited inroads into the marketplace, and thus has provided few patients relief from the symptoms of mucositis.
Many women get oral aphthous ulceration at specific times of the menstrual cycle and simultaneously get the same kind of ulcers in the genital tract, in particular the vulva and vagina. This is sometimes very severe and can cause retention of urine and require strong painkillers and sedatives. The most severe form is called Behcet's syndrome.
The terms mucositis and stomatitis are often used interchangeably but may include some general distinctions. Mucositis describes a toxic inflammatory reaction affecting the gastrointestinal tract, which may result from exposure to chemotherapeutic agents or ionising radiation. Mucositis typically manifests as an erythematous, burn-like lesion or as random, focal-to-diffuse, ulcerative lesions. Stomatitis refers to an inflammatory reaction affecting the oral mucosa, with or without ulceration, that may be caused or intensified by pharmacological, particularly chemotherapeutic treatments, or by radiotherapy. Stomatitis can range from mild to severe; the patient with severe stomatitis is unable to take anything by mouth.
Thus, there is a clear need for compositions and methods useful for treating or preventing inflammation, including but not limited to, mucositis, stomatitis, aphthous ulcerations, Behcet's syndrome, etc.
Citation of a reference in this or any section of the specification shall not be construed as an admission that such reference is prior art to the present invention.
SUMMARY OF THE INVENTION
The present invention is directed to a composition comprising from about 0.01 to about 5 percent by weight of hyaluronic acid, or a pharmaceutically acceptable salt thereof, having a molecular weight from about 1.6 and 2.2 million daltons; from about 0.04 to about 15% by weight of a K60 to K100 polyvinylpyrrolidone; and from about 86 to about 98% water. In one embodiment, the viscosity of the composition is from about 50 to about 500 centipoise. In an embodiment the polyvinylpyrrolidone is from about K85 to about K95 and is from about 3 to about 10% by weight of the composition. In another embodiment, the polyvinylpyrrolidone is from about 7 to about 10% by weight of the composition. In yet another embodiment, the hyaluronic acid, or the pharmaceutically acceptable salt thereof, is from about 1.8 to about 2.0 million daltons, and from about 0.01 to about 2% by weight of the composition, and wherein the viscosity of the composition is from about 90 to about 1000 centipoise. In yet another embodiment, the hyaluronic acid, or the pharmaceutically acceptable salt thereof, is from about 1.8 to about 2.0 million daltons and from about 0.01% to about 2% by weight of the composition. In an embodiment, the viscosity of the composition is from about 90 to about 1000 centipoise. In a preferred embodiment, the composition is in the form of a gel.
The present invention is also directed to a composition comprising from about 0.04 to about 5 percent by weight of hyaluronic acid, or a pharmaceutically acceptable salt thereof, with a molecular weight from about 1.6 to about 2.2 million daltons; from about 0.08 to about 15% by weight of a K60 to K100 polyvinylpyrrolidone; and from about 86 to about 98% water. In one embodiment, the viscosity of the composition is from about 50 to about 500 centipoise. In an embodiment, the polyvinylpyrrolidone, is from about K85 to about K95, and is from about 6 to about 12% by weight of the composition. In another embodiment, the polyvinylpyrrolidone is from about 8 to about 10% by weight of the composition. In yet another embodiment, the hyaluronic acid, or the pharmaceutically acceptable salt thereof, is from about 1.8 to about 2.0 million daltons and from about 0.04 to about 2% by weight of the composition. In yet another embodiment, the hyaluronic acid, or the pharmaceutically acceptable salt thereof is from about 1.8 to about 2.0 million daltons and from about 0.04 to about 2% by weight of the composition. In a preferred embodiment, the composition is in the form of a gel.
The present invention is also directed to a flexible packet comprising a composition comprising from about 0.04 to about 5 percent by weight of hyaluronic acid, or a pharmaceutically acceptable salt thereof,
Braguti Gianluca
Mastradonato Marco
Barts Samuel
Henry Michael C.
Jones Day
Sinclair Pharmaceuticals, Ltd.
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