Mineral salt-sulfonic acid compositions and methods of use

Abstract

The present disclosure generally relates to the medical use of compositions comprising a mineral salt and a sulfonic acid for prevention and / or treatment of one or more mucosal diseases, disorders, or conditions or one or more dermal diseases, disorders, or conditions.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 169,540 filed on Apr. 15, 2009, which is incorporated herein by reference in its entirety.STATEMENT REGARDING SEQUENCE LISTING[0002]The Sequence Listing associated with this application is provided in text format in lieu of a paper copy, and is hereby incorporated by reference into the specification. The name of the text file containing the Sequence Listing is 170169—401PC_SEQUENCE_LISTING.txt. The text file is 81 KB, was created on Apr. 15, 2010 and is being submitted electronically via EFS-Web.BACKGROUND[0003]1. Field[0004]The present disclosure generally relates to the medical use of compositions comprising a mineral salt and a sulfonic acid for prevention and / or treatment of one or more mucosal or dermal diseases, disorders, or conditions.[0005]2. Description of the Related Art[0006]Prolonged and recurrent inflammation associated with dermal or mucosal disorders...

AI Technical Summary

Benefits of technology

[0015]Provided herein are methods for treating mucosal and dermal disorders. In one embodiment, a method is provided for treating a mucosal disorder or a dermal disorder in a subject, which method comprises administering to the subject a physiologically acceptable composition that comprises a mineral salt and a sulfonic acid. In one embodiment, the mucosal disorder comprises mucositis. In specific embodiments, mucositis comprises inflammation of mucosa of the gastrointestinal tract, bladder, esophagus, vagina, rectum, lung, a nasal cavity, an ear, or ocular mucosa. In another embodiment, the mucosal disorder comprises oral stomatitis, oral mucositis, an oral ulceration, inflammatory bowel disease (including Crohn's disease and ulcerative colitis), periodontitis, interstitial cystitis, or a wound. In yet other embodiments, the mucosal disorder comprises vaginal dryness, vaginal burning, vaginal ulceration, dyspareunia, leu

Problems solved by technology

Prolonged and recurrent inflammation associated with dermal or mucosal disorders can result in extensive damage to the mucosal epithelium, leading to severe ulceration, pain, and infection and may ultimately require surgery.

In addition, damaged mucosal epithelium may be associated with severe malabsorption of nutrients, diarrhea, weight loss, and the frequent need for oral and parenteral nutrient supplementation.

However, definitive efficacy data are lacking for almost all OTC preparations used for treating atrophic vaginitis.

Moreover, some women may experience sensitivity or allergy to components of moisturizers or lubricants.

Thus, an unfulfilled need remains for a first-line product that can treat or relieve symptoms of atrophic vaginitis.

Oral mucositis is a significant side effect of cancer therapy and bone marrow transplantation, but it is not adequately managed by current approaches (Sonis, “Oral Complications,” In Cancer Medicine, pp.

A variety of approaches for treating oral mucositis, including mitigation of the potential for subsequent oral infections, have been tested with limited success.

However, subsequent randomized and controlled studies have failed to demonstrate any benefit (Loprinzi et al., Sem. Oncol. 22 (S3):95-97, 1995; Epstein et al., Int. J. Radiat. Oncol. Biol. Phys. 28:693-698, 1994; Verdi et al., Oral Surg.

However, the efficacy of chlorhexidine has been observed to be significantly decreased in saliva, and this compound is relatively ineffective against the Gram negative bacteria that tend to colonize the oral cavity in patients undergoing radiation therapy (Spijkervet et al., Oral Surg.

In addition, at least one study has shown that the use of chlorhexidine may be detrimental and result in a higher incidence of mucositis (Foote et al., J. Clin. Oncol. 12:2630-2633, 1994).

However, despite the clear need for therapeutic compositions to simply and reliably treat oral mucositis, no drugs are currently approved for this indication.

As a result no standard treatment is available for this mucosal disorder, and an unmet need remains.

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