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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: 2013-12-19
BMG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes methods for treating mucosal and dermal disorders by administering a physiologically acceptable composition that includes a mineral salt and a sulfonic acid. The mineral salt can be zinc, calcium, iron, copper, magnesium, manganese, cobalt, chromium, selenium, or vanadium, and the sulfonic acid can be taurine. The composition can also include other ingredients such as flavoring agents, mucoadhesive agents, pH adjusting agents, solubilizing agents, viscosity modulating agents, and stabilizing agents. The methods can be used to treat mucosal and dermal disorders such as mucositis, oral stomatitis, esophagitis, pneumonia, urinary tract infections, skin dryness, dermatitis, eczema, psoriasis, and more.

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. Biot. 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.

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
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Effect test

example 1

Bactericidal Activity of Compositions Comprising Zinc Gluconate and Taurine

[0179]This example illustrates the microbicidal activity of a composition comprising zinc gluconate and taurine.

[0180]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.

[0181]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.

[0182]The minimum inhibitory concentration of solutions containing differing amounts of zinc gl...

example 2

Treatment of Oral Aphthous Stomatitis

[0193]This example describes the effectiveness of using a composition comprising zinc gluconate and taurine and polyvinyl pyrrolidone (PVP) for treatment of oral aphthous stomatitis.

[0194]A painful ulcer inside the oral cavity caused by a rupture of the membrane is defined by the term aphthous. Anaphthous 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)).

[0195]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.[0196]Group A: Patients were treated with 100% ...

example 3

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

[0203]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.

[0204]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 APPLICATIONS[0001]This application is a Continuation of U.S. patent application Ser. No. 13 / 264,690, filed on May 31, 2012, which is U.S. national stage application filed under 35 U.S.C. §371 of International Patent Application No. PCT / US2010 / 031319, accorded an international filing date of Apr. 15, 2010, which claims the benefit of U.S. Provisional Application No. 61 / 169,540 filed on Apr. 15, 2009, which applications are incorporated herein by reference in their 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—401C1_SEQUENCE_LISTING.txt. The text file is 84 KB, was created on Mar. 12, 2013 and is being submitted electronically via EFS-Web.BACKGROUND[0003]1. Field[0004]The present disclosure generally relates to the medi...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K33/30A61K31/185A61K38/40
CPCA61K33/30A61K38/40A61K31/185A01N25/24A01N37/36A01N55/02A61K9/006A61K31/28A61K9/0014A61K9/0034A61K9/08A61K31/145A61K31/191A61K38/482A61P1/00A61P1/02A61P1/04A61P15/02A61P17/00A61P17/02A61P17/06A61P17/10A61P17/18A61P29/00A61P31/04A61P31/10A61P31/12A61P37/06A61P5/00A01N41/08A01N2300/00A61K2300/00A61K9/0053A61K31/79
Inventor GOOLSBEE, WILLIAM A.LILLARD, JEFFREY L.
Owner BMG PHARMA
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