Zinc gluconate gel compositions

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heavy metal containing doai

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Details

514635, 424642, A61K 31315

Patent

active

057080232

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The use of physical barriers such as gloves or condoms has been recommended to minimize the risk of contact with body fluids containing infectious microbial pathogens such as HIV (Human Immunodeficiency Virus) and hepatitis. However, it has been reported that a significant number of these physical barriers allow fluids to seep through existing or newly created pinholes. Furthermore, chemical or mechanical insults during use can damage glove surfaces, increasing permeability to viruses. Other than serving as a physical barrier, gloves do not provide any anti-microbial protection unless specifically coated with an anti-microbial agent. The development and manufacture of such coated gloves may be complicated and costly.
The common practice of washing hands with antiseptics prior to glove donning cannot provide adequate protection, because the necessary antiseptic concentration needed for rapid kill of subsequently intruding pathogens is not available from the residual amount of antiseptic left on a washed skin surface. Use of relatively large amounts of antiseptics such as HIBISTAT (0.5% chlorhexidine gluconate in 70% isopropanol) or HIBICLENS (4% chlorhexidine gluconate skin cleanser), while initially providing some protection, fails to fully inactivate intruding pathogens because of absorption of the anti-microbial agent to the skin. Existing barrier creams such as UNI SALVE (Smith and Nephew, Largo, Fla.) are also not effective for rapid inactivation.
U.S. Pat. No. 4,853,978 (Stockum) describes a glove having an inner coating containing an anti-microbial agent and cross-linked starch. However, such gloves release the anti-microbial agent slowly, and therefore cannot provide rapid disinfection. U.S. Pat. No. 5,089,205 (Huang et al.) describes processes for producing a glove having an internal anti-microbial surface. However, the glove resulting from such processes also fails to provide rapid disinfection.
U.S. Pat. No. 5,133,090 (Modak et al.) describes a glove having an inner coating comprising chlorhexidine which is capable of inactivating microbial pathogens such as HIV and HBV (Hepatitis B Virus). The glove described in U.S. Pat. No. 5,133,090 must be pretreated so as to prevent absorption of the chlorhexidine into the glove matrix. The glove described in U.S. Pat. No. 5,133,090 does not provide rapid microbial inactivation.
Glove use for protection from microbial pathogens is also known to give rise to allergic reactions in the skin of the glove wearer. Gloves, particularly latex gloves and gloves coated on the inside with starch powder, release allergens to which a wearer may be allergic.
Our invention provides, in part, a composition which can be used for rapidly inactivating microbial pathogens by application to a surface, such as skin. The anti-microbial agent in the composition does not bind to the surface due to the inclusion of an anti-binding substance in the composition, allowing the anti-microbial agent to be released in cidal doses when a fluid contacts the composition. In some embodiments, the anti-binding substance in the composition enhances the anti-microbial activity of the composition due to synergistic interaction with the anti-microbial agent.
Our composition overcomes some of the above-described problems associated with inactivation of microbial pathogens by providing the following advantages: minimally bind to the skin, permitting release of the anti-microbial agent and rapid microbial inactivation when the composition is contacted with a fluid; regardless of the type of glove used, thereby giving a glove-wearer more choice as to which type of glove to wear; and rapid inactivation of allergens released from gloves, thereby permitting a glove-wearer to wear a glove to which he might otherwise be allergic.


SUMMARY OF THE INVENTION

This invention provides a composition of matter for applying to a surface which comprises from binding to the surface, amount effective to inactivate irritants in fluids which contact the composition.
This invention also prov

REFERENCES:
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patent: 4587266 (1986-05-01), Verdicchio
patent: 4853978 (1989-08-01), Stockum
patent: 5031245 (1991-07-01), Milner et al.
patent: 5089205 (1992-02-01), Huang et al.
patent: 5133090 (1992-07-01), Modak et al.
patent: 5164107 (1992-11-01), Khan et al.
patent: 5208031 (1993-05-01), Kelly
patent: 5357636 (1994-10-01), Dresdner, Jr. et al.
Lawrence, J.C. et al., "Evaluation of Phenoxeotol--Chlorhexidine Cream as a Prophylactic Antibacterial Agent in Burns," The Lancet, pp. 1037-1040, May 8, 1992.
Fitzgerald, K.A., Davies, A., and Russel, A.D., "Mechanism of Action of Chlorhexidine Diacitate and Phenoxyethanol Singly and in Combination Against Gram-negative Bacteria," 215 Mibrobio 70:215-229 (1992).
Modak S. et al., "Rapid Inactivation of Infections Pathogess by Chlorhexidine Coated Gloves," Infection Control and Hospital Epidemiology, 13:463-471, (1992).
"Drug Information for the Health Care Professional," vol. 1A, USP-D1, 1989, Ninth Edition, pp. 792-793, Banta Company, VIR.
PDR--39th Edition, 1985, pp. 2037-2038, chlorhexidine.
PDR--39th Edition, 1985, p. 1858 Lotrisone.
Schmolka, I.R., "The Synergistic Effects of Nonionic Surfactants Upon Cationic Germicidal Agents," J. Soc. Cosmet. Chem., 24:577-592, 1973.
Goodman, Gillman's "The Pharmacological Basis of Therapeutics," A Textbook of Pharmacology, Toxicology, and Therapeutics for Physicians and Medical Students, Fourth Edition, p. 989 and Table of Contents, The Macmillan Co., 1970.
Heard, D.D., and Ashworth, R.W., "The Colloidal Properties of Chlorhexidine and its Interaction with Some Macromolecules," J. Pharm. Pharmac. 20:505-12, 1968.
Rubbo and Gardiner, "A Review of Sterilization and Disinfection, Year Book Medical Publishers," Chicago, 161-162 (1965).

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