Process for making personal care compositions comprising...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice

Reexamination Certificate

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C424S617000

Reexamination Certificate

active

06569439

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention concerns a process for making personal care compositions and personal care compositions made by the process, such as oral hygiene compositions, pharmaceutical compositions and the like. The invention also concerns a process for making an opacifying agent that can be used with finished bases to make cloudy and milky consumer care products and/or comestible goods. The components are processed in a specific sequence of steps to obtain a composition having a cloudy and milky, e.g. opaque, appearance as a result of the suspension of titanium dioxide in the composition. The cloudy and milky appearance is attained by first combining water, humectant and, optionally, other ingredients then adding one or more thickening agents and then adding titanium dioxide. The finished products, which also include other components such as fillers, additives, colorants, cooling agents, warming agents, numbing agents, additional flavorings, active compounds and the like, maintain a stable cloudy and milky appearance in long term use and storage.
2. The Prior Art
One drawback encountered in the art with personal care compositions having a cloudy and milky appearance is the ability to form a stable suspension or emulsion such that the clouding and/or whitening agent remains in suspension in the product without the consumer agitating the product, such as by shaking the container. Products that maintain a cloudy and milky appearance during storage in a retail environment and during the useful product life are preferred over products requiring agitation to achieve a cloudy and milky appearance. From a marketability viewpoint, products that cannot maintain a cloudy and milky appearance may have impaired consumer acceptance compared to those products that remain cloudy and milky during storage on a retail shelf.
U.S. Pat. No. 5,328,682 describes abrasive oral hygiene compositions that do not experience sedimentation of the solid abrasive particles over long term storage. These compositions have suspending agents comprising synthetic and natural clays.
There is growing consumer demand for products containing calcium, as calcium is an essential element in the diet of all segments of society, particularly women and children. Calcium lactate and salts of calcium lactate are a source for dietary calcium and the ability to include calcium lactate in a personal care composition having a stable cloudy and milky appearance is attractive from a marketability viewpoint because of the natural association between milk and calcium.
In an embodiment of the invention, the personal care composition is in the form of oral hygiene compositions, such as mouthwashes and rinses, toothpaste, gels, powders, gums, mouth sprays and lozenges, which 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 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.
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 hygiene compositions have traditionally been in the form of clear solutions, examples of which are commercially available products like those from Proctor & Gamble, Cincinnati, Ohio, U.S.A., under the trademark SCOPE® and from the Warner Lambert Consumer Group of Pfizer, Morris Plains, N.J., U.S.A. under the trademarks LISTERINE® and PLAX®. Increasingly, however, there has been consumer demand for new and interesting oral hygiene compositions, such as those having a cloudy and milky appearance.
In U.S. Pat. No. 5,531,983, it was recently disclosed that calcium lactate and calcium lactate salts are effective in combating tartar formation on teeth. The inclusion of calcium lactate in oral hygiene compositions having a cloudy and milky appearance is particularly attractive because such compositions would serve to provide both oral care and a source of calcium in the diet, and have the beneficial consumer association between calcium and milk.
In another preferred embodiment of the invention, the personal care composition is used for treating upper gastrointestinal tract distress, such as heartburn, indigestion, stomach ache and the like. Inclusion of calcium in such compositions has the added benefit of providing enhanced acid relief to the user.
In yet another ebodiment of the invention, the process can be modified to result in an opacifying agent which can be used, optionally in concentrated form, with finished bases to form an end product. This opacifying agent may be used in a wide variety of consumer care products and comestible goods, and may also provide whitening properties.
It was an object of the invention to develop personal care compositions, such as oral care compositions and pharmaceutical compositions for treating upper gastrointestinal tract distress, having a cloudy and milky, e.g opaque, appearance.
It was a further object of the invention to develop a process for making personal care compositions having a stable cloudy and milky appearance such that the clouding and/or whitening agents would not settle during the expected useful life of the product.
It was yet another object of the invention to develop a process for making personal care compositions having a stable cloudy and milky appearance that include calcium lactate.
It was still a further object of the invention to provide for making an opacifying agent that can be used, either full strength or as a concentrate, as a component of consumer care products or comestible goods to opacify and/or whiten, and an object of the invention was to develop such opacifying agents.
These and other objects of the invention are achieved by a process wherein personal care compositions are made by making a water phase by first dissolving sweetener in water and humectant, then adding thickening agent and then adding titanium dioxide, and then combining the water phase with an oil phase. Calcium lactate can be included in the composition by incorporation in the water phase after the addition of the titanium dioxide. Additives and fillers may also be included in the composition. The personal care composition will retain a cloudy and milky appearance without any, or significant, agitation during long term use and storage, such as during the expected useful life of the composition.
Also, objects of the invention were achieved by modifying the process for making the water phase to obtain the opacifying agent. The opacifying agent can be included in a wide variety of consumer care products and comestible goods as an opacifying agent and/or whitening agent and provides the product with a stable cloudy and milky appearance without any, or significant, agitation during long term use and storage.
In the present Specification, all parts and percentages are on a weight by weight basis unless otherwise noted.
SUMMARY OF THE INVENTION
The personal care compositions are made by combining a water phase and an oil phase. The water phase is made by first mixing water and humectant and at least one sweetener, then adding at least one th

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