Treatment of mucositis using N-acetylcysteine

Abstract

This present invention provides a therapeutic composition for use in the treatment of mucositis and a method for using such a therapeutic composition. The therapeutic composition includes a pharmaceutical substance effective for treating mucositis formulated with a biocompatible polymer, such as a biocompatible reverse-thermal gelation polymer.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is divisional of U.S. patent application Ser. No. 10 / 728,277 filed Dec. 4, 2003, which is a continuation of U.S. patent application Ser. No. 09 / 993,383 filed Nov. 21, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09 / 721,516 filed Nov. 22, 2000, the entire contents, and each portion thereof, of each and every one of these referenced applications are incorporated herein by reference as if set forth herein in full.FIELD OF THE INVENTION [0002] This invention relates to a therapeutic composition useful for treatment of mucositis and methods for using the therapeutic composition. BACKGROUND OF THE INVENTION [0003] Mucositis is a serious and often very painful disorder involving inflammation of the mucous membrane, with the inflammation often accompanied by infection and / or ulceration. Mucositis can occur at any of the different mucosal sites in the body. A nonlimiting list of examples of locations...

AI Technical Summary

Benefits of technology

"The present invention provides a therapeutic composition for the treatment of mucositis, which is a disease that affects the mucosal surfaces of the body, including the mouth, esophagus, stomach, nasal cavity, and rectal or vaginal mucosal surfaces. The composition is made up of a pharmaceutical substance and a biocompatible polymer that helps deliver the pharmaceutical substance to the targeted mucosal site. The composition can be in the form of a gel, which is preferred for treating oral mucositis and esophagitis. The therapeutic composition has reverse-thermal viscosity behavior, meaning it is fluid at low temperatures but becomes more viscous as it warms up in the body. This allows for easy administration as a flowable medium or as a gel, depending on the specific application. The composition can be administered as a nasal spray, eye-drops, or in the form of a viscous gel for rectal or vaginal mucosal surfaces."

Problems solved by technology

Mucositis is a serious and often very painful disorder involving inflammation of the mucous membrane, with the inflammation often accompanied by infection and / or ulceration.

While cancerous cells are the primary targets of cancer therapies, other cell types can be damaged as well.

Exposure to radiation and / or chemotherapeutics often results in significant disruption of cellular integrity in mucosal epithelium, leading to inflammation, infection and / or ulceration at mucosal sites.

As one example, oral mucositis (OM) is a painful and costly complication of some cancer therapies.

The oral cavity is lined with mucosal epithelium, and exposure to radiation and / or chemotherapeutics results in the disruption of cellular integrity leading to the development of ulcerative lesions commonly referred to as oral mucositis.

The risk of developing mucositis is markedly exacerbated when chemotherapeutic agents that typically produce mucosal toxicity are given in high doses, in frequent repetitive schedules, or in combination with ionizing irradiation (e.g., conditioning regimens prior to bone marrow transplant).

These painful lesions often limit a patient's ability to eat and drink and in some cases require hospitalization.

The presence of these lesions can also interrupt scheduled chemotherapy and / or radiation treatments.

Although topical antifungal prophylaxis and treatment may clear superficial oropharyngeal infections, topical agents tend not to be well absorbed and have not been demonstrated to be effective against more deeply invasive fungal infections, which typically involve the esophagus and lower gastrointestinal tract.

Analgesics such as lidocaine mouthwashes are effective for short periods of time but within hours the pain and discomfort usually returns.

Also, studies utilizing nonsteroidal agents and coating agents, such as sucralfate (Carafate), have had conflicting results.

Finally, claims that chlorhexidine (Peridex) reduces mucositis in both irradiated patients and leukemia patients receiving bone marrow transplants have not been verified.

To date, none of these approaches has shown a significant impact.

Esophagitis in this patient population can impede the progress of cancer treatment.

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