Composition for treating abnormal conditions of the epithelium of bodily orifices

• US 6,017,554 A
• Filed: 09/21/1998
• Issued: 01/25/2000
• Est. Priority Date: 07/06/1993
• Status: Expired due to Term

• Current Assignee: Micropure Incorporated (Arcadia Consumer Healthcare, Inc.)
• Original Assignee: Micropure Incorporated (Arcadia Consumer Healthcare, Inc.)
• Inventors: Ratcliff, Perry A.
• Primary Examiner(s): Bawa, Raj
• Application Number:
  US09/189,782
• Time in Patent Office: 491 Days
• Field of Search: 424/45, 424/49, 424/52, 424/53, 424/57, 424/78.02, 424/427, 424/434, 424/437, 424/430, 424/661, 424/673, 424/676, 424/DIG. 15, 514/944, 514/945, 514/966, 514/967, 514/968
• US Class Current: 424/422
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/20 Elemental chlorine; Inorganic compounds releasing chlorine
• CPC Class Codes: A61K 33/40 Peroxides
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 8/20 Halogens; Compounds thereof
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/24 Phosphorous; Compounds thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: A61Q 15/00 Anti-perspirants or body deodorants deodorisation of air A61L9/00
• CPC Class Codes: Y10S 424/15 Suppositories

Abstract

A stable solution cream, salve, or spray composition containing activated stabilized chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices include bacterial infections, such as Actinobacillus actinomycetemcomitans and Porphyromonoas gingivalis, and fungal infections, such as Candida, and leukoplakia. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.4, at which pH stabilized chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Claims

1. A topical composition for treating conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices, brought about by the occurrence of any of fungal and bacterial infections, leukoplakia, penetration of bacterial toxins, living unicellular microorganisms, vaginitis, endometriosis, Porphyromonoas gingivalis, Actinobacillus actinomycetemcomitans, Pseudomonades, Candid species and leukoplakia vulvae, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound comprising trisodium phosphate, wherein the concentration of the phosphate compound is in a range of about 0.02% to about 3.0% to retard escape of the chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

3. The composition as set forth in claim 1, wherein the phosphate compound is sodium monofluorophosphate.

4. The composition as set forth in claim 1, wherein the concentration of the chlorine dioxide is about 0.2% and the concentration of the phosphate compound is about 1.0%.

2. A topical composition treating conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices, brought about by the occurrence of any of fungal and bacterial infections, leukoplakia, penetration of bacterial toxins, living unicellular microorganisms, vaginitis, endometriosis, Porphyromonoas gingivalis, Actinobacillus actinomycetemcomitans, Pseudomonades, Candida species and leukoplakia vulvae, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate or sodium monofluorophosphate, wherein the concentration of the phosphate compound is in a range of about 0.02% to about 3.0% to retard escape of chlorine dioxide from said topical preparation said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

5. A topical composition for treating conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices, brought about by the occurrence of any of fungal and bacterial infections, leukoplakia, penetration of bacterial toxins, living unicellular microorganisms, vaginitis, endometriosis, Porphyromonoas gingivalis, Actinobacillus actinomycetemcomitans, Pseudomonades, Candida species and leukoplakia vulvae, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains a concentration of at least 0.1% chlorine dioxide and a concentration of at least 0.05% of a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate to retard escape of the chlorine dioxide from said topical preparation- said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

6. The composition as set forth in claim 5, wherein the phosphate compound is sodium monofluorophosphate.

7. A topical composition treating conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices, brought about by the occurrence of any of fungal and bacterial infections, leukoplakia, penetration of bacterial toxins, living unicellular microorganisms, vaginitis, endometriosis, Porphyromonoas gingivalis, Actinobacillus actinomycetemcomitans, Pseudomonades, Candida species and leukoplakia vulvae, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains a concentration of at least 0.005% chlorine dioxide and a concentration of at least 0.02% of a phosphate compound comprising trisodium phosphate to retard escape of the chlorine dioxide from said topical preparation said total preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

8. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the number of bacteria, including Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis, in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate in a concentration in the range of about 0.02% to about 3.0% to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

9. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the number of bacteria, including Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis, in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains a concentration of at least 0.1% chlorine dioxide and a concentration of at least 0.05% of a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

10. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the occurrence of leukoplakia in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate in a concentration in the range of about 0.02% to about 3.0% to retard escape of chlorine dioxide from said topical preparation, said tropical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

11. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the occurrence of leukoplakia in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains a concentration of at least 0.1% chlorine dioxide and a concentration of at least 0.05% of a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

12. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the number of yeasts including Candida albicans in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate in a concentration in the range of about 0.02% to about 3.0% to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

13. A topical composition for treating the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices by reducing the number of yeasts including Candida albicans in the orifices, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein said topical preparation contains a concentration of at least 0.1% chlorine dioxide and a concentration of at least 0.05% of a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

14. A composition for treating vaginitis and endometriosis by reducing any of Candida, Actinobacillus actinomycetemcomitans, Pseudomonades, and Porphyromonas gingivalis bacteria present in the vagina or the uterus, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories to be applied to the vagina or the uterus, wherein said topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate in a concentration in the range of about 0.02% to about 3.0% to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.

15. A topical composition for treating vaginitis and endometriosis by reducing any of Candida, Actinobacillus actinomycetemcomitans, Pseudomonades, and Porphyromonas gingivalis bacteria present in the vagina or the uterus, said composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories to be applied to the vagina or the uterus, wherein said topical preparation contains chlorine dioxide in a concentration of at least 0.1% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, or sodium monofluorophosphate in a concentration of at least 0.05% to retard escape of chlorine dioxide from said topical preparation, said topical preparation being at a pH in the range of about 6.0 to about 7.4, thereby increasing the shelf life and efficacy of said topical preparation.