Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2002-10-09
2004-10-05
Page, Thurman K. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S400000
Reexamination Certificate
active
06800295
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition in the form of a soluble sheet which has a variety of uses, particularly in the personal care field.
BACKGROUND OF THE INVENTION
The prior art discloses various uses for soluble films. For instance, soluble films have been used to enclose materials. U.S. Pat. No. 5,385,737 to Shigeno, et al. and U.S. Pat. No. 4,544,693 to Surgant disclose soluble capsules into which various substances can be placed.
Soluble films have also been used for cosmetic purposes. For example, U.S. Pat. No. 6,060,547 to Canter et al. discloses a water-in-oil emulsion film used to form a makeup foundation. Another cosmetic application of water soluble films is found in U.S. Pat. No. 4,126,142 to Saute, which discloses a face mask which is applied to the skin, allowed to dry, and then removed.
U.S. Pat. No. 5,948,430 to Zerbe, et al., discloses a soluble film for oral administration. The film is used for the delivery of materials via the mucous membranes, particularly the buccal mucosa.
Although means for forming films for various applications are known in the art, there is a need for a water soluble film which will bind surfactant and other ingredients, and which, when exposed to water, will dissolve and provide personal cleansing such as can be obtained from, for example, hand soap or body wash. There is also a need for a water soluble film to which skin care ingredients may be added and which will release such skin ingredients upon exposure to sufficient moisture.
SUMMARY OF THE INVENTION
The present invention is a composition in the form of a soluble sheet or film which has a variety of uses, particularly in the personal care field. Such sheets are preferably water soluble, which aids in their use in the personal care field. The water soluble sheets of this invention will bind surfactant and other ingredients, and which, when exposed to water, will dissolve and provide personal cleansing such as can be obtained from, for example, a soap bar or a liquid body wash.
An important component of these water soluble sheets is a so-called “base composition,” which includes a water soluble film forming polymer, a polyvinyl alcohol, and a humectant such as propylene glycol. Surfactant may be added to the liquid base composition so that, when the composition is dried into sheet form, the sheet will generate foam when exposed to water and have cleansing properties. At this stage, skin care ingredients may also be added to the base composition in addition to or in place of the surfactant. Moreover, volatile alcohols or hydrocarbons may also be incorporated into the liquid base composition to facilitate drying of the composition to form the flexible sheet product.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a water soluble sheet product formed from a novel base composition. Even without the addition of other ingredients, the base composition, if allowed to dry, will form a water soluble sheet. As used herein, all weights given represent the weight of the material in a 100% active form in the composition.
The base composition includes from about 0.75% to about 5% by weight of a water soluble polymer, from about 6.5% to about 23% by weight of polyvinyl alcohol, and from about 0.75% to about 12% be weight of a humectant, with the preferred humectant being propylene glycol. The remainder of the base composition is water. Up to about 2% by weight of magnesium aluminum silicate may also be added to the base composition to enhance its slip characteristics. However, magnesium aluminum silicate results in a more viscous base composition, which, in turn, effects the thickness of the resulting soluble sheet product.
The preferred water soluble polymer is polyvinylpyrrolidone (PVP), and the most preferred PVP is 2-pyrrolidone, 1-ethenyl-homopolymer having an average molecular weight of about 60,000 Daltons. Such PVP is available as PVP K-30 from International Speciality Products, in Wayne, N.J. Although it has been discovered that PVP is the water soluble polymer which works best in the base composition of the present invention, other water soluble polymers may be used in place of or in combination with PVP. These water soluble polymers include polyquaternium 10, magnesium aluminum silicate, VP/VA copolymer, ethyl ester of PVM/MA copolymer, and sodium magnesium silicate. A suitable polyquaternium 10 is available as Celquat CS 230M from National Starch in Bridgewater, N.J. A suitable VP/VA copolymer is available as PVA 735 from International Specialty Products in Wayne, N.J. A suitable ethyl ester of PVM/MA is available as Omnirez 2000 from International Specialty Products in Wayne, N.J. An acceptable sodium magnesium silicate is available as Veegum K from R. T. Vanderbilt in Norwalk, Conn. The level of water soluble polymer or combination of water soluble polymers used in the base composition should range from about 0.75% to about 5% by weight.
In the present invention, the polyvinyl alcohol functions as a film former, and it is used in conjunction with the water soluble polymer. In the preferred embodiment of the invention, the polyvinyl alcohol used has a hydrolysis of between about 87% and 90%. A suitable polyvinyl alcohol having the preferred hydrolysis range is available as AirVol polyvinyl alcohol supplied by Air Products and Chemicals, Inc. in Allentown, Pa. Either AirVol 540, having a hydrolysis of between about 87% and 89%, or AirVol 523S, having a hydrolysis of between about 87% and 90% is preferred. In the most preferred embodiment of the invention, AirVol 523S is used because it best enhances the solubility of the soluble sheet product. It has been found that a polyvinyl alcohol having a hydrolysis below 87% results in a sheet which is less soluble. Above 90%, the sheet again loses some solubility.
The preferred humectant is propylene glycol, which serves to aid the sheet product to absorb water. In addition to propylene glycol, other humectants which can be used as the humectant in the base composition of the present invention include: (1) glycerin; (2) dipropylene glycol; (3) glyceryl polymethracrylate; and (4) glyceryl polymethracrylate in combination with propylene glycol. The level of humectant used in the base composition is normally from about 0.75% to about 12% by weight. However, additional humectant can be added depending upon the end use and desired characteristics of the soluble sheet. However, the amount of humectant added should not adversely effect the formation of the soluble sheet product.
In the preferred embodiment of the base composition, from about 1.5% to about 2.5% by weight of PVP, from about 13.5% to about 14.5% by weight of polyvinyl alcohol, and from about 2.5% to about 3.5% of propylene glycol are used. In the most preferred embodiment, about 1.75% of a PVP having an average molecular weight of about 60,000 Daltons, about 13.91% of polyvinyl alcohol having a hydrolysis between about 89% and 90%, and about 2.94% of propylene glycol are used. The balance of the base composition is water.
In preparing the base composition of this invention, the water soluble polymer and water are placed into a heatable container. With constant agitation, polyvinyl alcohol is then slowly added to the water and water soluble polymer mixture. When the polyvinyl alcohol has become saturated (starts to swell), heat is applied until the mixture reaches about 180° F. The mixture is agitated throughout the heating process. Once the mixture has reached 180° F., heating is discontinued. At this point, the humectant is added. Preferably, agitation is continued until the mixture has cooled to about 120° F., although additives and water my be added to the base composition while it is still hot. The base composition can be stored in a tightly covered container. If it is to be stored for a long period of time prior to its use for formation of the sheet product, a preservative such as DMDM hydantion may be added. A suitable DMDM hydantion is available as Mackstat DM from McIntyre in University Park, Ill.
In accordance with the
George Konata M.
Page Thurman K.
Snell & Wilmer LLP
The Dial Corporation
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