Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Wearing apparel – fabric – or cloth
Reexamination Certificate
1999-05-03
2002-03-05
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Wearing apparel, fabric, or cloth
C424S404000, C424S407000, C514S846000, C514S847000, C514S887000
Reexamination Certificate
active
06352700
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to lotionized tissue and towel products which minimize irritation and redness and other deleterious effects common to the repeated use of such products on the skin.
Absorbent tissue and towel products, such as facial tissue, bath tissue and paper towels, wipes and nonwoven materials have been used to absorb body fluids and cleanse and dry the skin. It has long been recognized, however, that products such as these tend to abrade and dry-out the skin causing uncomfortable irritation and redness. For example, there are numerous pre-moistened wipe products which can be found in the marketplace. However, many of these contain volatile alcohol solutions which remove skin lipids and fats, causing dryness.
To reduce these deleterious effects, tissue products, e.g., tissue and towel products, wipes and nonwoven materials, have been provided with a variety of lotions and lubricant formulations enabling the products to better glide across the surface of the skin, and/or deposit lotions on the surface of the skin in an attempt to replenish lost natural skin oils. However, there exists in the art a need for products which more effectively address the drawbacks. While numerous products containing lubricants or lotions exist in the marketplace which attempt to address those problems, this invention is believed to constitute an advancement over those.
For example, lotionized facial tissue such as Puffs Plus and Kleenex® ColdCare™ with Lotion, are examples of commercial products which claim to be comforting and soothing to the skin due to their lotion formulas. The lotion can transfer to the skin in use. However, the facial tissue products are mostly used to wipe and remove nasal discharges, and inadequately address the problem as irritation, and red and inflamed skin on the nose as well as its surrounding skin in the upper lip area, still result upon repeated use.
Charming® Plus is an example of a commercial bathroom tissue containing lotion, which claims enhanced cleansing of the skin and reduced irritation and inflammation. The reduction in irritation and inflammation is achieved from the lubricity of the lotion. Again, however, improvement is needed.
It is an object of the invention, therefore, to provide improved absorbent tissue and towel products, such as facial tissue, bath tissue and paper towels, wipes and non-woven materials, such that skin irritation, inflamation and other adverse effects are reduced.
SUMMARY OF THE INVENTION
The invention, therefore, is directed to tissue and towel products, as well as other paper products such as wipes and non-woven materials, which minimize irritation and redness and other deleterious effects common to the repeated use of such products on the skin. A lotion which maintains the skin pH balance and provides a smooth, lubricious, non-greasy feeling layer on the skin, is transferred to the skin. More particularly, the invention relates to a tissue product treated with a lotion capable of maintaining skin pH balance comprising a skin pH balancing compound and a nongrease-feelng base lotion preferably containing an emollient and a retention/release agent as base ingredients. The base lotion has the effect of making the treated tissue product feel nongreasy and lubricious. Skin care benefits of the lotionized tissue product are expressed whether the product is used dry or prewetted with water.
We have discovered that existing lotionized tissue products are limited in their inability to maintain the pH balance of the skin. This, in turn, leads either directly, or indirectly to the various drawbacks attributable to their repeated use.
The human skin is divided into two basic layers, the dermis and the epidermis. The dermis is the deeper layer and is largely structural. The outermost layer next to the dermis, the epidermis, is comprised of four layers: stratum basal, stratum spinosum, stratum granulosum, and the top exposed surface, the stratum corneum. The stratum corneum (SC) is composed of layers of non-viable flat cells, each about 0.5 &mgr;m thick and about 30 to 40 &mgr;m long, with SC thickness ranging from about 6 to 15 &mgr;m. This layer of tightly bound cells is recognized as the body's principal barrier of defense against invasion of microorganisms, and the entry of topically applied substances into the body.
In 1928, Schade and Marchionini reported the existence of skin acidity and the importance of this mantle in preventing infection. They referred to the skin surface (SC) as an “acid mantle” having a protective role and preventing growth of many environmental bacteria and fungi. Today the factors regulating skin surface pH are still unknown. However, there is sufficient evidence to support the barrier function and self-disinfection of the skin's “acid mantle”. The pH value of human “acid mantle” is generally ranges from 4 to 6. On the other hand, the body's internal pH is about neutral, ranging from about 7.35 to about 7.46. Skin pH varies among different body areas and also depends on the skin moisture—skin areas with higher moisture having a higher pH.
Any cleansing method with soap, solvent or even using tap water (having a pH of about 8) tends to increase the pH of stratum corneum. For example, simply washing with an alkaline soap alone raises the skin pH, and the time required to return to normal skin pH value is between 30 minutes, for normal skin, and many hours for people with intolerance to soap.
Various reports have shown that skin alkalinization has negative effects, such as irritant dermatitis and optopic skin disease. Infant skin pH for the two weeks after birth is close to neutral. For this reason, the newborn skin's ability to control growth of microorganisms is low and may have low resistance to infection. Other reports have claimed that an increase in skin pH is an important contributing factor in diaper dermatitis. A recent study correlated skin pH with the severity of experimentally induced irritant dermatitis. It has been found that high skin pH coincides with high transepidermal water loss, which is one of the more sensitive parameters used to quantify an irritant response in the skin.
While products exist that are said to address the problems of skin irritation and inflamation, they inevitably fail to address the short term impact of various additives on the pH balance of the skin, i.e., the skin's acid mantle. To put this into perspective, one need only to consider conventional facial tissue, toilet tissue, napkin and paper towel products that are used for wiping dry or wet skin. Upon contact with skin, the tissue products transfer some of the chemicals present in the tissue to the skin surface. These additives may be detrimental to maintaining the skin's “acid mantle.” For example, a tissue product containing baking soda (a highly alkaline compound) is produced by KC/Scott (Kleenex® Cottonelle® Baking Soda—Advanced Personnel Hygiene). The transfer to the user's skin of such a highly alkaline compound is entirely inconsistent with maintaining the skin's acid mantle.
Thus, in accordance with one aspect of the present invention, there is provided a lubricious, nongreasy-feeling lotionized tissue, wipe or nonwoven material, whereby the lotion transfers to the skin during use to provide a breathable, smooth layer which acts to maintain the skin acid mantle and the proper skin moisture/vapor balance and which users find soothing to irritated or damaged skin, and which users may find soothing to irritated skin and which may facilitate healing of chapped skin and skin suffering from discomfort, such as diaper rash or hemorrhoids. Preferably, the skin pH balancing compound is an organic acid, a combination of an organic acid and the salt of an organic acid, or a buffer combination.
In accordance with another aspect of the present invention, there is provided a product treated with a lotion which, optionally, contains one or more of the following: a surfactant which aids in skin cleansing, and a medicinal agent, such as an antimicrobial
Awofeso Anthony O.
Fredricks Richard E.
Luu Phuong V.
Oriaran T. Philips
Schroeder Gary L.
Fort James Corporation
Page Thurman K.
Tran S.
LandOfFree
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