Oral care compositions comprising stabilized chlorine dioxide

Details Oral care compositions comprising stabilized chlorine dioxide Oral care compositions comprising stabilized chlorine dioxide

2002-08-29

2003-06-24

Rose, Shep K. (Department: 1614)

Drug, bio-affecting and body treating compositions

Dentifrices

Oxygen or chlorine releasing compound containing

C424S049000, C424S661000, C424S613000, C424S489000, C424S052000, C426S533000, C426S534000, C516S053000, C264S004100

Reexamination Certificate

active

06582682

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to oral care compositions, and methods for making the oral care compositions, comprising chlorine dioxide, and excipients, including flavoring agents and ethoxylated hydrogenated castor oils having ethoxylation numbers from about 35 to about 60. The flavoring agents become bound to the hydrophobic side of the ethoxylated hydrogenated castor oil in a microemulsion, and become microencapsulated as the hydrophilic side of the ethoxylated hydrogenated castor oil wraps around the flavoring agent thus stabilizing the flavoring agent against oxidation from residual chlorine in the solution. Therefore, oral care compositions of the invention do not have yellowing discoloration or exhibit chlorine odor and can be packaged, stored, sold and used in a single package.
2. The Prior Art
Oral malodor, plaque, gingivitis, periodontal disease, and discoloration of the teeth, are all undesirable conditions that affect many people. Malodor of the oral cavity is also known as halitosis or bad breath and it is generally believed that the cause of this condition is due to the presence of anaerobic bacteria, especially gram-negative anaerobic bacteria, in the mouth. These bacteria will generate volatile sulfur compounds (VSC) which are known to cause breath malodor.
Some breath malodor is caused by three chemical compounds. Specifically, hydrogen sulfide (H—S—H), methyl mercaptan (CH
3
—S—H) and dimethyl sulfide CH
3
—S—CH
3
. These compounds result from the degradation of epithelial cells and bacteria in the oral cavity. The polypeptide chains of the epithelial cell walls are composed of a series of amino acids including cysteine and methionine which contain sulfur side chains. The death of microorganisms or epithelial cells results in degradation of the polypeptide chains into their amino acid components, especially cysteine and methionine. Cysteine and methionine are precursors to the formation of VSC.
Oral malodor not only comes from the posterior dorsal surface of the tongue but also from periodontal pockets. A person with gingivitis or periodontal disease may have increased oral malodor from disintegrated epithelial cells. Epithelial cells turn over faster if inflammation is present. Therefore, a larger number of these dead epithelial cells remain in the oral cavity and will degrade into the malodorous compounds. In addition VSC will also alter the epithelial barrier, permitting penetration of the barrier by antigenic substances.
Oral care compositions, such as mouthwashes and rinses, toothpaste, gels, powders, gums, mouth sprays and lozenges, are directed, completely or in part, towards alleviating the conditions in the mouth which cause malodor, generally by physical means, such as brushing teeth with a dentifrice, or chemical means involving the application of mouthwashes or mouth rinses. Oral care compositions and methods for treating breath malodor using stabilized chlorine dioxide are described in the art. Stabilized chlorine dioxide is, generally, an aqueous solution comprising sodium chlorite and stabilizers to prevent the degradation of the sodium chlorite to molecular chlorine dioxide. Examples of mouthwashes and oral care products comprising stabilized chlorine dioxide are provided by the disclosures of U.S. Pat. Nos. 4,689,215, 4,837,009, 4,696,811, 4,808,389, 4,786,492, 4,788,053, 4,792,442, 4,818,519, 4,851,213, 4,855,135, 4,793,989, 4,855,135, 4,793,989, 4,889,714, 4,925,656, 4,975,285, 4,978,535, 5,200,171, 5,348,734, 5,618,550, and 5,489,435.
Dual phase mouthwash compositions comprising separate chlorite and activator phases are described in U.S. Pat. No. 5,281,412. European Patent Specification 0 565 134 B1 and U.S. Pat. No. 4,986,990 describe two solution mouthwash with a separate chlorite containing solution and activator solution which are mixed prior to use. Other examples of oral care products comprising activators for the delivery of chlorine dioxide or chlorine containing compounds are described in the disclosures of U.S. Pat. Nos. 5,019,402, 4,891,216 and 4,330,531; DE 2,329,753 and WO 95/27472. Additional references relating to chlorine dioxide compositions include U.S. Pat. No. 6,017,515, GB 2,289,841, WO 89/03179 and Japanese references JP 60054311 and JP 60105610.
U.S. Pat. No. 6,077,502 concerns, oral care products having chlorite ion. Examples in U.S. Pat. No. 6,077,502 include: (1) a dual phase mouthwash comprising the chlorite ion in one of the two phases, (2) single phase mouthwash product containing only water, sodium chlorite, sodium carbonate and sodium bicarbonate, and (3) a dry powdered mouth rinse comprising sodium chlorite that requires reconstitution with water prior to use.
Sodium chlorite in an acidic environment, such as the human mouth, releases molecular chlorine dioxide (ClO
2
). Molecular chlorine dioxide is associated with antibacterial properties and, thus, molecular chlorine dioxide will kill and/or inhibit growth of the bacteria in the mouth which causes breath malodor or halitosis.
Commercially preferred mouthwash and mouth rinse compositions generally comprise excipients, in addition to the active ingredients such as stabilized chlorine dioxide or chlorite ion. Use of stabilized chlorine dioxide in mouthwash, rinses and other oral care compositions comprising excipients is limited, however, by oxidation reactions and the tendency of the chlorine dioxide to cause chlorine odor and yellowing discoloration. This aspect of oral care compositions, including mouthwash and mouth rinse, comprising chlorine dioxide and excipients is a drawback to use as a consumer product and eliminates or limits the ability to package and sell such oral care products in a convenient, consumer friendly package.
To overcome the drawbacks associated with oral care compositions comprising stabilized chlorine dioxide, molecular chlorine and/or chlorite ion and excipients, such oral care compositions and products are generally packaged and sold in either liquid form as a dual phase or two solution system, with one phase/solution comprising the stabilized chlorine dioxide, chlorite ion, molecular chlorine dioxide or precursor and another phase/solution comprising excipients and/or an activator compound, or in a dry form requiring reconstitution prior to use. U.S. Pat. No. 6,077,502 provides an example (Example 4) of a dual phase mouthwash and examples (Examples 7 and 8) of dry powder mouth rinse.
Dual phase/two solution oral care products, such as mouthwashes and rinses, present increased packaging costs and affect consumer acceptance because of the need for the consumer to combine the dual phases/two solutions. For example, the disclosure of WO 95/27472 discusses a kit comprising water, a chlorine-releasing oxidant, a chlorite metal salt and a buffering agent which must be combined prior to use. Also, dry form oral care products require reconstitution with water prior to use which also affects consumer acceptance. A preferred consumer product would enable a mouthwash, mouth rinse or other oral care composition comprising chlorine dioxide and excipients, particularly flavoring agents, to be packaged and sold as a single composition which can be used by the consumer from the packaging without the need to combine the phases or solutions as described in the prior art. There is a need for flavored oral care compositions comprising chlorine dioxide and excipients, and indeed a demand for such products.
It was an object of the invention to develop oral care compositions, including mouthwash and mouth rinse, comprising chlorine dioxide, including the stabilized form, which upon activation, converts to molecular chlorine dioxide, and excipients, including flavoring and coloring agents, which are stable and are not affected by oxidation reactions or exhibit chlorine odor and yellowing discoloration. This can be achieved by use of certain ethoxylated hydrogenated castor oils in the composition which have a hydrophilic side and a hydrophobic side that microencapsulates the flavoring agents in the oral car

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