Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2002-12-18
2004-04-13
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S401000, C424S443000, C424S049000, C424S050000, C424S051000, C424S052000, C424S053000, C424S054000, C424S055000, C424S056000, C424S057000, C424S058000, C523S105000, C523S109000, C523S118000
Reexamination Certificate
active
06719995
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to systems for delivering cosmetic and therapeutic benefits to the oral cavity by applying low molecular weight polybutene to the teeth by means of an integral carrier, in one embodiment, a strip of material.
BACKGROUND OF THE INVENTION
Dental products by which various cosmetic and/or therapeutic actives are delivered to teeth and oral cavity have been previously known. Examples of such products include: brushing aids such as dentifrice products for delivery of anti-caries actives like fluoride; effervescent denture cleansing tablets, which require the artificial teeth to soak for a period of time, to remove plaque and debris; and mouthwashes containing breath fresheners or antibacterial actives. However, such conventional dental care products typically do not maintain actives in the oral cavity long enough to optimally enhance or prolong their therapeutic, prophylactic and/or cosmetic benefits.
The use of a dental strip has been recognized as a convenient and inexpensive way to deliver cosmetic and therapeutic benefits to the teeth and mucosal surfaces of the oral cavity. For example, dental whitening strips, where a whitening composition is applied to a strip and thereafter applied to the teeth to achieve sustained contact between the teeth and the oral care active, such as in WO 99/62472 to Wolf are known. However, these applications often employ elastomeric polymers as an adhesive, second layer. Such adhesives provide sustained release of an active but can result in a thick, gummy residue remaining in the mouth when the strip is removed from the teeth.
In order to provide a composition that achieves improved substantivity without leaving behind unwanted buildup of adhesive on the teeth and oral mucosa, the use of lower molecular weight polybutene applied by means of an integral carrier, in one embodiment a strip of material, is herein disclosed.
Polybutene is known as a component of denture adhesives and as a gum base. For example, U.S. Pat. No. 5,880,172, issued Mar. 3, 1999, to Rajaiah, et al., discloses a self-supporting denture adhesive that is peelable for easy removal, which incorporates polybutene as an optional ingredient. Also, U.S. Pat. No. 5,496,541, issued Mar. 5, 1996, to Cutler, relates to a dentifrice chewing gum and teaches the use of polybutene as an optional gum base. However, such applications often employ a non-flowable, high molecular weight polybutene in order to achieve the sought after benefits.
In the present invention, lower molecular weight polybutene and a cosmetic or therapeutic active are used in combination with a dental strip delivery system to provide a protective coating on the teeth. The lower molecular weight polybutene is a flowable liquid that is extremely substantive when applied to the teeth yet does not stick to the soft tissue of the oral cavity. The polybutene coating inhibits and prevents staining of the teeth and is suitable for delivering an active to treat the oral cavity. Upon removal of the strip from the teeth, unwanted gummy residue or buildup of the composition on the teeth and oral mucosa does not occur.
SUMMARY OF THE INVENTION
The present invention relates to systems for delivering a cosmetic or therapeutic active to the teeth and oral cavity using an integral carrier. In one embodiment the delivery system comprises: a first layer of a strip material; a second layer comprising polybutene with a molecular weight of about 300 to about 3000 releasably associated to the said strip material; and a cosmetic or therapeutic active associated with said second layer. The present invention is used to deliver therapeutic and cosmetic benefits to the oral cavity by directly applying the integral carrier to the teeth. The integral carrier may be of sufficient size that, once applied, the integral carrier overlaps with the oral soft tissues. This renders the system useful for delivering cosmetic and therapeutic actives directly to the gingival tissue, as well as the teeth.
The cosmetic and therapeutic actives incorporated within the second layer of the delivery system can be selected from the group consisting of anti-calculus agents, fluoride ion sources, stannous ion sources, whitening agents, anti-microbial, anti-plaque agents, anti-inflammatory agents, nutrients, antioxidants, anti-viral agents, anti-fungal agents, analgesic and anesthetic agents, H-2 antagonists, fragrances and sensates, components other than polybutene which deliver a clean feel to the teeth, pigments dyes, lakes and colorants, and mixtures thereof. When desired a viscosity modifier may optionally be incorporated in the second layer.
The present invention also relates to a method of delivering therapeutic and cosmetic actives to the oral cavity or teeth by using the delivery system herein to apply a composition comprising polybutene with a molecular weight of about 300 to about 3000 and one or more therapeutic or cosmetic actives to the teeth or hard surfaces of the oral cavity. Also disclosed is a method for inhibiting or preventing gingivitis, caries staining, fungi and bacteria and plaque build up in the oral cavity by using the delivery system disclosed herein to apply a composition comprising lower molecular weight polybutene (molecular weight from about 300 to about 3000) and a therapeutic or cosmetic active.
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Case Ann Maria
Ernst Lisa Catron
Glandorf William Michael
Ha Thinh Nguyen
Mayer Christopher Robert
Hiland Emelyn DeLeon
Krass Frederick
The Procter & Gamble & Company
Winslow Andrea L.
Zea Betty J.
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