Mineral salt-sulfonic acid compositions and methods of use

a technology of mineral salt and composition, applied in the field of mineral salt-sulfonic acid compositions and methods of use, can solve the problems of severe malabsorption of nutrients, pain, infection, and ulceration, and achieve the effects of reducing the number of syringes, and improving the permeability of the syringes

Inactive Publication Date: 2012-09-27
BMG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 potenti

Method used

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  • Mineral salt-sulfonic acid compositions and methods of use
  • Mineral salt-sulfonic acid compositions and methods of use
  • Mineral salt-sulfonic acid compositions and methods of use

Examples

Experimental program
Comparison scheme
Effect test

example 1

Bactericidal Activity of Compositions Comprising Zinc Gluconate and Taurine

[0177]This example illustrates the microbicidal activity of a composition comprising zinc gluconate and taurine.

[0178]GelX™ ORAL GEL was formulated as a viscous gel comprised of purified water, polyvinyl pyrrolidone (PVP), taurine, zinc gluconate, PEG-40 hydrogenated castor oil, sodium saccharin, sodium hydroxide, and flavoring. GelX™ ORAL GEL has a mechanical action which provides pain relief by adhering to the mucosal surface of the mouth and throat soothing lesions.

[0179]Antimicrobial activity of a composition comprising zinc gluconate and taurine was determined by a method typically used to demonstrate whether one or more agents may be included as a preservative in a composition formulated under conditions such that the composition will be considered a non-sterile composition according to regulatory authorities.

[0180]The minimum inhibitory concentration of solutions containing differing amounts of zinc gl...

example 2

Treatment of Oral Aphthous Stomatitis

[0188]This example describes the effectiveness of using a composition comprising zinc gluconate and taurine and polyvinyl pyrrolidone (PVP) for treatment of oral aphthous stomatitis.

[0189]A painful ulcer inside the oral cavity caused by a rupture of the membrane is defined by the term aphthous. An aphthous ulcer is also called a canker sore. When multiple aphthous ulcers occur and / or when the condition is chronic (or recurrent), the condition is called aphthous stomatitis (see, e.g., Natah et al., Int. J. Oral. Maxillofac. Surg. 33:221-34 (2004)).

[0190]Over a period of eleven months, in a dentist's surgery in Italy, 150 patients who were affected by minor aphthous were recruited to participate in a clinical study. The patients (87 female and 63 male) were between the ages of 18 and 71 and provided informed consent to participate. The patients were randomly divided into five groups, thirty people each.[0191]Group A: Patients were treated with 100%...

example 3

Inhibition of IL-6 and IL-8 Production in Cells by Zinc AND Taurine

[0198]This example describes the capability of zinc (e.g., zinc gluconate) in combination with taurine to inhibit production of cytokines, IL-6 and IL-8, in cells stimulated by either lipopolysaccharide (LPS) or doxorubicin, a chemotherapeutic agent.

[0199]CaCo2 cells (human intestinal (colonic) epithelial cells) were grown in culture in 24-well tissue culture dishes according to methods routinely practiced in the cell culture art. Zinc gluconate and taurine were combined at varying concentrations and added to the cells in the absence and presence of proinflammatory agents (lipopolysaccharide, doxorubicin, dextran-sulfate sodium (DSS)). In one series, zinc gluconate and taurine were combined with lipopolysaccharide (LPS) (1 μg / ml) for six hours. In a second series, zinc gluconate and taurine were combined with doxorubicin (3 μM) for 24 hours. In a third series, zinc gluconate and taurine were combined with DSS (5% w / w...

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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...

Claims

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Application Information

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IPC IPC(8): A61K31/315A61P29/00A61P1/04A61P1/00A61P1/02A61P17/02A61P15/02A61P5/00A61P37/06A61P31/12A61P31/10A61P31/04A61P17/00A61P17/06A61P17/10A61P17/18C12N5/071A61K38/40
CPCA01N25/24A61K38/40A01N55/02A61K9/006A61K31/28A01N37/36A61K31/185A61K9/08A61K9/0034A61K9/0014A61K33/30A01N41/08A01N2300/00A61K2300/00A61K31/145A61K31/191A61K38/482A61P1/00A61P1/02A61P1/04A61P15/02A61P17/00A61P17/02A61P17/06A61P17/10A61P17/18A61P29/00A61P31/04A61P31/10A61P31/12A61P37/06A61P5/00A61K9/0053A61K31/79
Inventor GOOLSBEE, WILLIAM A.LILLARD, JEFFREY L.
Owner BMG PHARMA
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