Systems comprising organosiloxane resins for delivering oral...

Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing

Reexamination Certificate

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C424S049000, C433S215000, C433S216000

Reexamination Certificate

active

06692727

ABSTRACT:

FIELD
The present invention relates to systems for delivering oral care substances to the surfaces of the teeth and for prolonging such delivery. More specifically, the present invention relates to a system comprising a delivery composition comprising organosiloxane resins and at least one oral care substance for delivering the oral care substance, and a protective composition comprised of organosiloxane resins for prolonging the presence of the delivery composition in the oral cavity. The delivery composition forms a film on the surface to which it has been applied and provides sustained release of the oral care substance from the film for prolonged therapeutic, prophylactic, and/or cosmetic benefits. In addition, it is believed that the systems herein may further provide sustained release benefits to other oral surfaces, such as the gingival and mucosal tissues, as well as to the surfaces of the teeth.
BACKGROUND
Oral care products by which various oral care substances or actives can be delivered to the soft and hard tissues of the oral cavity have previously been known. Examples of such oral care products include, for example, brushing aids such as dentifrice products for delivery of anti-caries actives such as fluoride or other actives for the reduction of the bacteria that lead to the formation of plaque, and mouthwashes containing breath freshening actives and/or anti-bacterial actives. In addition, bleaching agents such as peroxide that can be applied directly to the surfaces of the teeth, i.e., to the tooth enamel, have been developed.
However, it has been found that such conventional product forms typically do not provide substantivity sufficient to maintain actives on the hard and soft oral tissues for a period of time sufficient to enhance or prolong the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. Neither have such conventional product forms been able to provide sustained delivery of oral care actives, without periodic reapplication at relatively short time intervals, or without a special delivery device or containment means such as a mouthpiece.
Attempts have previously been made to enhance the substantivity of whitening bleaches, bactericides, and other active components of oral care products. See, e.g., U.S. Pat. No. 5,425,953 to Sintov et al. on Jun. 20, 1995, in which a film forming, water-soluble cellulosic polymer is used to deliver a bleaching agent to the teeth; U.S. Pat. No. 5,438,076 to Friedman et al., in which liquid methacrylate acid copolymer compositions are used to deliver a bacteriocidal pharmacological agent; and International Patent Appln. No. PCT/CN97/00 to Huang, published on Jul. 24, 1997, disclosing a film-coating composition comprising cellulose and polyvinyl acetal, coumarone-indene resin, or shellac as a film former to deliver bleaches to the tooth enamel.
However, the above systems are water-soluble, i.e., they are readily dissolved by saliva, generally within about 1-3 hours after application. Therefore, their degree of durability is low, and they cannot provide long-term delivery of the active ingredient that is present in the composition. In addition, their water-soluble nature precludes them from being used with oral care actives that would be unstable in water-based films. Sodium percarbonate is one example of such an active; it would be unstable in the high pH environment of an aqueous-based film.
In order to provide an applied composition with a relatively higher degree of durability, the use of protective coatings that are applied to the teeth has been described. See, U.S. Pat. No. 5,401,528, to Schmidt on Mar. 18, 1995, in which organically modified silicic acid polycondensates are deposited on the teeth, then polymerized in-situ by curing, to coat the teeth in order to protect them from plaque deposits. This system is not a true delivery system by which an active ingredient is released over time; instead, it provides a barrier by which the deleterious effect of plaque-causing bacteria may be diminished.
Although such a barrier coating may offer a benefit in terms of enhanced durability, it requires the use of special equipment and complex application; thus, it cannot be performed at home and cannot be used for self-treatment.
Therefore, it can be seen that none of these previous developments can offer the combination of both long-term delivery of an oral care substance or active ingredient and the convenience of discrete self-treatment and home use. Based on the foregoing, there is a need for a convenient delivery system for various oral care substances in which the substantivity of the active ingredients is enhanced, and in which the presence of the oral care substance in the oral cavity is prolonged to further enhance the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. None of the existing art provides all of the advantages and benefits of the present invention.
SUMMARY
The present invention is directed to systems for delivering an oral care substance to the oral cavity comprising: (a) a delivery composition comprised of: (i) an organosiloxane resin; (ii) a volatile carrier capable of solubilizing the organosiloxane resin; (iii) a rheology modifier; and (iv) at least one oral care substance; and (b) a protective composition comprised of: (i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin. The protective composition may further comprise a fluid diorganopolysiloxane-based polymer and/or a rheology modifier.
The present invention is further directed to systems for delivering an oral care substance to the oral cavity comprising: (a) a delivery composition comprised of: (i) an organosiloxane resin; (ii) a fluid diorganopolysiloxane-based polymer; (iii) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer; (iv) a rheology modifier; and (v) at least one oral care substance; and (b) a protective composition comprised of: (i) an organosiloxane resin; and (ii) a volatile carrier capable of solubilizing the organosiloxane resin. The protective composition may further comprise a fluid diorganopolysiloxane-based polymer and/or a rheology modifier.
The present invention further is directed to a method of using these systems.
These and other features, aspects, and advantages of the invention will become evident to those skilled in the art from a reading of the present disclosure.
DETAILED DESCRIPTION
While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description.
All percentages and ratios used hereinafter are by weight of total composition, unless otherwise indicated.
All measurements referred to herein are made at 25° C. unless otherwise specified.
All percentages, ratios, and levels of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, fillers, or other materials with which the ingredient may be combined as a commercially available product, unless otherwise indicated.
All publications, patent applications, and issued patents mentioned herein are hereby incorporated in their entirety by reference. Citation of any reference is not an admission regarding any determination as to its availability as prior art to the claimed invention.
Herein, “comprising” means that other steps and other components which do not affect the end result can be added. This term encompasses the terms “consisting of” and “consisting essentially of.”
The delivery systems herein are comprised of a delivery composition and a protective composition. The delivery and protective compositions herein comprise essential components, as well as optional components. The essential and optional components of these compositions of the present invention are described in the following paragraphs.
Delivery Composition
The delivery composition herein is a composition for delivering an oral care substance

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