MXPA00002480A - A method for maintaining or improving skin health - Google Patents

A method for maintaining or improving skin health

Info

Publication number
MXPA00002480A
MXPA00002480A MXPA/A/2000/002480A MXPA00002480A MXPA00002480A MX PA00002480 A MXPA00002480 A MX PA00002480A MX PA00002480 A MXPA00002480 A MX PA00002480A MX PA00002480 A MXPA00002480 A MX PA00002480A
Authority
MX
Mexico
Prior art keywords
skin
composition
skin care
derivatives
user
Prior art date
Application number
MXPA/A/2000/002480A
Other languages
Spanish (es)
Inventor
Rijswijck Laura Graves Spalding Van
Gretchen Louise Elder
Mauricio Rolando Odio
Susan Baldwin
Michelle Denise Roseman
Kevin Eugene Grandison
Original Assignee
The Procter&Ampgamble Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Procter&Ampgamble Company filed Critical The Procter&Ampgamble Company
Publication of MXPA00002480A publication Critical patent/MXPA00002480A/en

Links

Abstract

Disclosed is a method for maintaining and/or improving skin health in the area of a wearer covered by an absorbent article, the method comprising:(a) applying to the wearer an absorbent article having a skin care composition that provides a therapeutic and/or protective skin benefit upon transfer to the skin;(b) transferring to the wearer at least a portion of the skin care composition during wear;and (c) repeating steps (a) and (b) with one or more additional articles with sufficient frequency to maintain or improve the skin covered by the absorbent article relative to skin covered by an equivalent absorbent article that does not comprise the skin care composition, and without the need for manual application of skin protective agents (e.g., by the caregiver or wearer). Also disclosed are detailed methods for assessing skin health.

Description

A METHOD FOR MAINTAINING OR IMPROVING SKIN HEALTH TECHNICAL FIELD The present invention relates to a method for maintaining or improving skin health in users of absorbent articles such as diapers, training pants, adult incontinence devices, feminine hygiene products and the like. More particularly, the application relates to a method comprising the repeated use of absorbent articles that deliver a composition on the user's skin, to provide a protective barrier and / or a therapeutic benefit to the skin.
BACKGROUND OF THE INVENTION Many types of disposable absorbent products are available, such as diapers, which have a high capacity to absorb urine and other exudates from the body. Disposable products of this type generally comprise some type of liquid-permeable upper sheet material, an absorbent core and a liquid-impermeable backsheet material. Although these types of absorbent structures can be highly efficient for the absorption of liquids, it is well recognized that prolonged use of these structures can induce the skin which is compromised in terms of being over hydrated or exposed to skin irritants commonly. found in body exudates. It is generally known that the skin beneath the absorbent articles is more susceptible to skin diseases, including diaper rash, erythema (ie, redness), heat rash, abrasion, marks on the skin, etc. pressure and the loss of the skin barrier. For example, CFR 333.503 defines the diaper rash as "an inflammatory condition of the skin in the diaper area (perineum, buttocks, lower abdomen, and inner thighs) caused by one or more of the following factors: moisture, occlusion, chafing, continuous contact with urine or feces or both, or chemical or mechanical irritation. " To address the interests of skin diseases associated with the use of absorbent articles, the caregiver often applies skin-protecting products such as Vaseline®, baby lotions, ointments, powders, etc., to the buttocks, a the genitals, the anus and / or other regions before placing the absorbent article on the user. This procedure usually involves the caregiver applying the protective skin product on their hands, and then rubbing it over the baby's skin. To eliminate the need for this waste, dirty, time consuming and easily forgotten process, there have been attempts to prepare absorbent articles containing a protective or therapeutic skin care substance on the top sheets of the article. U.S. Patent No. 3,585,998 to Hayford et al. Teaches a disposable baby diaper, an inner liner of which carries an arrangement of pressure-rupturable capsules containing baby oil. The patent teaches that it is desirable to break the capsules before using the diaper by applying pressure with household items such as confectioner's roller, iron, etc. The articles disclosed by this patent have serious disadvantages. Primarily, unless the capsules are broken by applying pressure before using the diaper or bandage, the skin care substance contained within the capsules is not either released at all or is released unevenly leaving some areas of the skin not covered. U.S. Patent No. 3,489,148 to Duncan et al. Teaches a baby diaper comprising a hydrophobic and oleophobic top sheet, wherein a portion of the top sheet is coated with a discontinuous film of oleaginous material. The main disadvantage of the diapers disclosed in the Duncan and others reference is that the hydrophobic and oleophobic top sheets are slow to promote the transfer of urine to the underlying absorbent cores. U.S. Patent No. 5,643,588 to Roe et al. • some of the interests presented by the previous absorbent articles that were designed to provide a protective material for the skin. In particular, Roe discloses an absorbent article whose top sheet is surface treated with a lotion comprising an emollient to facilitate cleaning of the faeces easier and other exudates and an agent which immobilizes the lotion in such a way that it does not migrate from he point of initial application. Although the prior art describes articles designed to supply • compositions for providing the benefits of skin care, the prior art has failed to describe a regimen that results in maintained or improved skin health in the regions of the user's body covered by the absorbent articles, wherein the The regimen does not require caregiver intervention in the form of manual application of skin care compositions. That is, the prior art has not recognized the importance of the repeated use of absorbent articles that automatically provide sufficient levels of a composition to the user's skin that allows the improvement or maintenance of skin health in the region of the skin. user covered by • 20 absorbent articles. Accordingly, it would be desirable to provide a method: (1) wherein the condition of the skin covered by the absorbent article is maintained in a healthy, natural, or improved condition to a healthier condition; and (2) that does not require intervention by the user or caregiver in the form of manual application of skin care agents 5.
Therefore, an object of the present invention is to provide a method for improving or maintaining the health of the skin of a user of the absorbent article comprising the repeated application of the disposable absorbent articles that automatically supply sufficient levels of a composition. . In this regard, an object of the present invention is to provide a method comprising the application of the absorbent articles having a composition on a surface that is in contact with the user, where the composition is capable of transferring to the user's skin and It is effective in improving or maintaining the health of the skin. These and other objects are obtained in accordance with the present invention, as will be readily apparent upon reading the following disclosure.
BRIEF DESCRIPTION OF THE INVENTION The present invention relates to a method for improving or maintaining the health of the skin in the area of a user covered by an absorbent article, the method comprising the following steps: a) applying to the user an absorbent article having a composition of care of skin that provides a therapeutic and / or protective benefit to the skin when transferred to the skin; b) transferring to the user at least part of the composition for skin care during use; and c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin covered by the absorbent article relative to the skin covered by an equivalent absorbent article that does not comprise the composition for skin care, and without the need for manual application of skin protective agents (for example, by the carer or the user).
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is an absorbent article in the form of a diaper according to the present invention. Figures 2a to 2c represent the regions of a user of an absorbent article that are determined by the rash and erythema. Figure 3a is a side view showing the placement of the skin analogue used in the transfer test of the skin care composition. Figure 3b is a plan view showing the placement of the skin analogue used in the transfer test of the skin care composition.
DETAILED DESCRIPTION OF THE INVENTION Definitions As used herein, the term "comprising" means that the various components, ingredients or steps may be jointly employed in practicing the present invention. Accordingly, the term "comprising" embraces the more restrictive terms "consisting essentially of" and "consisting of". As used herein, the term "maintained" skin health means preserving the natural state of healthy skin. The term "improved" skin health refers to the reduction in the extent of the adverse effects of the skin. These terms describe the health of the skin in the area covered by the absorbent articles. It will be recognized that the methods of the present invention can both maintain and improve the health of the skin in different regions of an individual user. As used herein, the term "skin care composition" refers to any composition comprising one or more agents which, when transferred from an article to the skin of the user, improve the smoothness of the skin. . The representative materials are discussed in detail below. As used herein, the term "treated article" means an absorbent article having a skin care composition in or capable of migrating toward at least one surface that is in contact with the user of the article. An "equivalent article that does not comprise a skin care composition" is an article that is substantially the same as the treated article, in terms of the top sheet, the back sheet, the absorbent core, the chassis design, folds , etc., but which does not comprise a composition for skin care that is transferred to the user during use. As used herein the term "surface in contact with the user" of an absorbent article is one or more surfaces of any of the components of the article that is in contact with the user at some time during the period of use. The surfaces that are in contact with the user include, but are not limited to, parts of the upper sheet, leg folds, waist region, side panels, fastening tabs, etc., which are in contact with the user during the use. Other terms are defined in the description where it is initially discussed. With respect to the composition for skin care, all percentages, ratios and proportions used herein are by weight unless otherwise specified.
Method to improve and / or maintain the health of the skin As discussed, the adverse effects of the skin that result from the obstructive nature of the absorbent articles are well recognized. Efforts have been made to overcome these negative attributes by preparing articles that provide beneficial compositions. However, the applicants are the first to recognize the benefit and a method comprising frequent cycles of cumulative supply of a skin care composition to the user's skin to improve or maintain skin health. In this regard, the present invention relates to a method for improving or maintaining the health of a user's skin in the area covered by an absorbent article, the method comprising the following steps: (a) applying to the user an absorbent article that have a composition for skin care that provides a therapeutic and / or protective benefit of the skin when transferred to the skin; (b) transferring to the user at least a part of the composition for skin care during use; (c) repeating steps (a) and (b) with one or more additional articles with sufficient frequency to maintain or improve the health of the skin in the area covered by the absorbent article relative to the skin covered by an absorbent article equivalent that does not comprise the composition for skin care, and without the need for manual application of skin protective agents (for example, by the carer or the user). Applicants have discovered that, surprisingly, maintaining or improving the health of the skin beneath the absorbent articles can be achieved coincidently (or "automatically") with repeated use, over a period of time (eg, several days), of the absorbent articles that are treated with a composition that is transferred to the user under conditions of normal use (for example, contact, movement, manipulation by the caregiver after the application of the article, body heat, etc.). In this way, or even prior attempts to address the skin diseases associated with the use of absorbent articles having generally described steps (a) or (b) of the present method, none of those attempts appreciated the importance of the step (c), which corresponds to the frequency cycles of the cumulative supply of a skin care composition to the user's skin to improve or maintain the health of the skin. Applicants have further discovered that the provision of relatively low levels of the composition with each article is sufficient to obtain the skin benefits that result from this novel method of cumulative delivery of the composition. The article used in the present methods provides an available source from which the skin care compositions transfer onto the skin continuously over time. As the composition is transferred, it accumulates on the surface of the skin to initiate and maintain its protective activity. As a used article is discarded and replaced by a new one, this cycle is repeated for the additional accumulation of the composition or above and beyond what an individual or simple article would have provided about itself. Certain of the ingredients for use in the composition are known to penetrate the stratum corneum (e.g., petrolatum, which is preferred for use herein). In this way, even when some amount of the composition is removed by cleaning, bathing, etc., or even if the treated items as described herein are used temporarily, some of the benefits of the composition of the skin will remain with the user. . Since the use of the treated articles is summarized before all the benefits of the composition that have dissipated, the user will derive the benefits, in terms of reduced erythema and rash, more quickly than would a user who has not used the articles treated. As indicated above, it is generally recognized that the skin beneath the absorbent articles is more susceptible to the degradation of that skin condition. Typically, the cutaneous manifestations of these skin conditions include redness (also referred to as erythema) and / or rash. As such, the applicants describe a method for maintaining or improving the health of the skin in the regions covered by an absorbent article, wherein the desired point of view of the method is the reduction or avoidance of erythema and / or rash when compare with skin covered by an equivalent absorbent article that does not comprise the composition for skin care. Erythema and rash are the very common and well documented adverse medical conditions present in the skin covered by absorbent articles. These conditions are easily determined by six expert classifiers. Therefore, the protocol to determine the maintenance or improvement of the health of the skin has the determination of the rash and / or erythema. The protocol for determining the reduction or avoidance of the rash and / or the erythema provided by the methods of the present invention is described in detail in the Test Methods section below. In summary, the purpose of the protocol is to determine whether the use of a test article reduces the frequency and / or severity of the rash and / or erythema on the skin, in the regions of the skin with diaper compared with an equivalent untreated article. The test method involves comparisons of endpoint parameters between 2 groups of subjects who are assigned to use the test or control product for 3 consecutive weeks (one week of baseline in which all subjects use the test). same control product that is included before starting the comparison part of the product of 3 weeks of the study). For this approach, the skin in the diaper region of the article users is examined twice a week at 3-4 day intervals by a trained clinical evaluator to evaluate the rash and erythema of the diaper using a defined scale . At the end of the study, the frequency and severity of the rash and erythema of the diaper are compared between the groups of the test and control product using the appropriate statistical procedures. In one aspect, the improvement manifests itself as a statistically significant difference in the erythema and / or rash at a level of 90% safety, with respect to the skin covered by an absorbent article which equivalent does not comprise the composition for skin care In this regard, it is preferred that the reduction or manifest itself at a level of 95% safety. Separately, it is recognized that one can observe large differences between the groups, (that is, in the mean) in the markers of the rash and / or erythema, still due to the great failure of inter-subject variability to observe the traditional differences statistically significant. In this respect, improvements of at least about 10% among the group (test control) means, although not necessarily statistically, that it can be recognized and appreciated by caregivers and users as providing the benefits of skin care. In this regard, the methods of the present invention will result in improvements in rash or erythema results of at least about 10%, more preferably at least about 15%, even more preferably at least about 20%. For the purposes of the present disclosure, the statistical or non-statistical improvements, defined above, in the condition of the skin with respect to either the rash or the erythema in one or more regions of the user for the study group as a whole, to any subgroup of gender or age or size of the study group, as described in the Test Methods section, are considered to provide the desired skin benefits of the present invention. Preferably, the methods of the present invention will provide both of the benefits of erythema and rash, in one or more regions of the user as described in the Test Methods section below. lll. Composition for skin care Although the specific composition or compositions for skin care delivered or dispensed (referred to herein as "skin care composition and" composition "according to the present method is not the critical factor in achieving the condition of the skin maintained. of the area below the absorbent article, it is apparent that the composition should provide either a non-occlusive, protective function (eg, a barrier relatively impermeable to liquid but permeable to vapor), to avoid overhydration of the skin and exposure of the skin to the materials contained in body exudates, or it should contain agents that provide, either directly or indirectly, the benefits of skin care, for example, indirect benefits include improved removal of skin irritants such as faeces or urine The composition can be in a variety of forms including, but not limited to emulsions, lotions, creams, ointments, plasters, powders, suspensions, encapsulates, gels and the like. As used herein, the term "effective amount" of a skin care composition refers to an amount of a particular composition which, when applied to or migrates to one or more of the surface or surfaces in contact with the skin. The body of an absorbent article or articles will be effective in providing a protective barrier and / or delivering a skin care benefit when delivered through the absorbent articles over time. Of course, the effective amount of the composition applied in the article will depend, up to a certain limit, on the particular composition used. However, the amount of the composition in at least a portion of the surface that is in contact with the body of the absorbent article will preferably vary from about 0.0078 mg / cm2 to about 12 mg / cm2, more preferably from about 0.16 mg / cm2 to about 6 mg / cm2, still more preferably from about 0.06 mg / cm2 to about 4 mg / cm2. These ranges are by way of illustration only and the skilled artisan will recognize that the nature of the composition will dictate the level that must be disposed thereon to achieve the desired benefits of the skin, and that these levels are determinable by routine experimentation at the light of the present disclosure. Although the level of the skin care composition applied to the absorbent article is an important aspect of the present methods, more important is the amount of the composition transferred to the user's skin during the use of one or more treated articles. Although the required level delivered to the skin to provide the desired skin benefits will depend to some degree on the nature of the composition employed, applicants have found that relatively low levels can be delivered while still providing the desired skin effects. This is especially true for preferred compositions, such as those described in Example 1. Another benefit of the present invention is the controlled application of the skin care composition to release low but effective levels of the required composition. This is in contrast to the typically sporadic manual application of skin care agents, where caregivers / users often apply significantly higher levels of material than they are needed. Excess manually added materials can adversely impact the fluid handling properties of the absorbent article, as a result of the transfer of the skin to the article. Actually, for certain materials, such as petrolatum, manually applied levels can actually result in • an occlusive effect, thus compromising the skin. One benefit of the methods herein is to provide a barrier to surface moisture while preventing skin occlusion (i.e., maintain the breathability of the skin). In this way, the methods of the present, which allow the controlled supply of the composition throughout the period of use, allow the transfer of the optimum levels of composition or skin to maintain and / or improve the health of the skin. skin. The method for determining the amount of composition for the • Skin care transferred to the user's skin after using one or more treated articles, in the Test Methods section below. With respect to the level of the skin care composition that is transferred to the user during the use of a treated absorbent article used during a period of about 3 hours (a typical daytime use time), particularly for compositions for the Preferred skin care such as those described in Example 1 is preferred where at least about 0.0016 mg / cm2, more preferably at least about 0.0078 mg / cm2, even more preferably at least 0 about 0.016 mg / cm2, of the composition is transferred to the skin over a period of use of three hours. Typically, the amount of the composition supplied by a treated article will be from about 0.0016 mg / cm2 to about 0.0078 mg / cm2, more preferably from about 0.0078 mg / cm2 to about 0.47 mg / cm2, even more preferably from about 0.016 mg / cm2 to about 0.31 mg / cm2 over a period of use of three hours.
For continuous use of the treated articles (in other words, changes occur according to normal usage patterns, which typically include changes every 3 to 4 hours during the day and a new item before sleeping at night) as for a period of 24 hours, it will be preferred that at least about 0.0047 mg / cm2, more preferably at least about 0.016 mg / cm2, even more preferably at least about 0.047 mg / cm2, of the composition be transferred to the skin of the user during the 24-hour period. Typically, the amount of composition delivered after a 24 hour period where the treated articles are applied at each change, will be from about 0.0047 mg / cm2 to about 2.79 mg / cm2, more typically from about 0.016 mg / cm2 to about 1.55. mg / cm2, even more typically from about • 0.047 mg / cm2 at approximately 0.93 mg / cm2. It will be recognized that of the numerous materials useful in the skin care compositions released to the skin according to the methods present, those which have been considered safe and effective skin care agents are logical materials to be used here. . These materials include the Category I assets defined by the Final Attempt Monograph on Products of Skin Protective Drugs for Human Use of the U.S. Federal Food and Drug Administration (FDA), which already includes: allantoin, aluminum hydroxide gel, calamine, 0 cocoa butter, dimethicone, cod liver oil (in combination), glycerin, kaolin, petrolatum, lanolin, oil mineral, shark liver oil, white petrolatum, talc, topical starch, zinc acetate, zinc carbonate, zinc oxide, and the like. Other potentially useful materials are Category III assets as defined by the Final Attempt Monograph on Products of Skin Protective Drugs for Human Use of the U.S. Federal Food and Drug Administration (FDA): which already includes: live yeast cell derivatives, aldioxa, aluminum acetate, microporous cellulose, cholecalciferol, colloidal oatmeal, cysteine hydrochloride, dexpantanol, Peruvian balsam oil, hydrolysates of protein, racemic methionine, sodium bicarbonate, Vitamin A, and the like. Many of the skin care ingredients in the FDA monograph are currently used in commercially available skin care products, such as Ointment A and D® Vaseline® Petrolatum Jelly, Diaper and Ointment Raspid Ointment care daily Desitin®, Gold Bond® medicated baby powder, Aquaphor® Health Ointment, Baby Magic® baby lotion, Johnson's Ultra Sensitive® baby cream, Johnson's baby lotion, lip balm, etc. These commercial products can be applied to the absorbent articles to create the treated articles for use in the present methods, either with or without modification of the product to facilitate the delivery by way of this novel method. As will be discussed below, the skin care compositions useful in the present methods preferably, but not necessarily, have a melting profile such that they are relatively immobile and located on the surface that is in contact with the user of the article. at room temperature, they are easily transferable to the user at body temperature, and are not yet completely liquid under extreme storage conditions. Preferably, the compositions are easily transferable to the skin by means of normal contact, movement of the user, and / or body heat. Because the composition is preferably substantially immobilized on the surface that is in contact with the body of the article, relatively low levels of the skin care composition are required to impart the desired skin care benefits. In addition, special barrier or wrapping materials may be unnecessary when packing treated articles useful in the methods of the present invention.
In a preferred embodiment, the skin care compositions useful herein are solid, or more frequently semi-solid, at 20 ° C, ie at room temperature. By "semi-solid" it is implied that the composition has a typical relocation of pseudoplastic or plastic liquids. When no shear is applied, the compositions may have the appearance of a semi-solid but may be flowed as the shear rate increases. This is due to the fact that, while the composition contains mainly solid component it also includes some minor liquid components. Preferably, the compositions of the present invention have a low shear viscosity between about 1.0 x 106 centipoise and about 1.0 x 108 centipoise. More preferably, the viscosity under zero shear stress is between about 5.0 x 106 and about 5.0 x 107 centipoise. As used herein, the term "low shear viscosity viscosity" refers to a viscosity measured at very low shear rates (eg, 1.0 sec "1) using the plate and cone viscometer (a suitable instrument that available from TA Instruments of New Castle, DE, as the model number CSL 100.) A person of ordinary skill in the art will recognize that other means than components with high melting point can be used (as discussed below) to provide the comparable measured viscosities for these compositions comprising these media which are measured by extrapolating a viscosity versus shear rate diagram for these compositions for a shear rate of zero at a temperature of about 20 ° C. Preferred compositions are less semisolid at room temperature to minimize the migration of the composition. They have a final melting point (100% liquid) above the storage conditions of "total effort", potential that can be higher than 45 ° C (for example, store in Arizona, cargo truck in Florida, etc.). ). Representative compositions having these fusion characteristics are described in detail in U.S. Patent No. 5,643,588 (Roe et al.), U.S. Patent No. 5,607,760 (Roe et al.), U.S. Pat. No. 5,609,587 and in U.S. Patent No. 5,635,191, the disclosure of each of which is incorporated herein by reference. Specifically, the preferred compositions will have the following fusion profile: Most Preferred Preferred Interval Feature % liquid at temperature 2-50 3-25 atmosphere (20 ° C)% liquid at temperature 25-95 30-90 body (37 ° C) Final melting point (° C) > 38 > Four. Five By being solid or semi-solid at ambient temperatures, these preferred compositions do not have a tendency to flow and migrate to a significant degree toward undesirable locations of the absorbent article to which they are applied. This means that less composition is required for skin care to impart the desirable therapeutic, protective and / or conditioning benefits. To increase the immobility of the preferred compositions, the viscosity of the formulated compositions should be as high as possible to prevent them from flowing into the article into the undesirable locations. Unfortunately, in some instances, higher viscosities may inhibit the transfer of the composition to the wearer's skin. Therefore, an equilibrium must be achieved in such a way that the viscosities are high enough to maintain compositions located on the surface of the article, but not so high to prevent transfer to the user's skin. The viscosities suitable for the compositions will typically vary from about 1 to about 5000 centipoise, preferably from about 5 to about 300 centipoise, • more preferably from about 5 to about 100 centipoises measured at 60 ° C, using a rotational viscometer (a suitable viscometer from Lab Line Instruments, Inc., of Melrose Park, IL, as Model 4537). The viscometer is operated at 60 rpm using a two-axis number. For compositions designed to provide a therapeutic benefit and / or skin protector, a useful active ingredient in these compositions is one or more skin protectants or emollients. As used herein, the term • "Emollient" is a material that protects against moisture and irritation, softens, softens, softens, coats, lubricates, moisturizes, or cleanses the skin. (It will be recognized that several of the asset monographs listed above are "emollients" as that term is used herein.) In a preferred embodiment, these emollients will have a plastic or fluid consistency at room temperature, i.e., at 20 °. C. Representative emollients useful in the present invention include, but are not limited to, emollients that are based on petroleum, fatty acids of sucrose ester; polyethylene glycol and its derivatives; humectants; type of fatty acid ester; type 0 polysiloxane; type of alkyl ethoxylates; fatty acid ester ethoxylates; type of fatty alcohol; type of polysiloxane; propylene glycol and its derivatives; glycerin and its derivatives; including glyceride, acetoglycerides and ethoxylated glycerides of C12-C28 fatty acids; triethylene glycol, and its derivatives; spermaceti and other waxes, fatty acids, and fatty alcohol ethers particularly those having from 12 to 28 carbon atoms in their fat chain, such as stearic acid; propoxylated fatty alcohols; lanolin and its derivatives; Caolina and its derivatives; and any of the skin care agents of monographs listed above; or mixtures thereof. Suitable oil-based emollients include those hydrocarbons, or mixtures of hydrocarbons, having chain lengths of 16 to 32 carbon atoms. Oil-based hydrocarbons that have these chain lengths include oil in mineral water also known as "liquid petrolatum" and petrolatum (also known as "mineral wax," "petroleum jelly," and "mineral jelly." Mineral oil usually it refers to lower viscosity mixtures of hydrocarbons having from 16 to 20 carbon atoms.The petrolatum usually refers to more viscous mixtures of hydrocarbons having 16 to 32 carbon atoms.The petrolatum and the mineral oil are the emollients in particular. Preferred for compositions of the present invention Suitable fatty acid ester emollients include those derived from C12-C28 fatty acids, preferably saturated C6-C22 fatty acids, and short-chain monohydric alcohols (Ci-Cs, preferably Ci-Cs.) Representative examples of these esters include methyl palmitate, methyl stearate, isopropyl laurate, isoprop myristate. ilo, isopropyl palmitate, ethylhexyl palmitatium and mixtures thereof. Suitable fatty acid ester emollients can also be derived from longer chain fatty alcohol esters (C12-C28, preferably C12-C16) and from shorter chain fatty acids, for example, lactic acid such as lauryl lactate and cetyl lactate. Suitable alkyl ethoxylate emollients include the C 1 -C 4 fatty alcohol ethoxylates which have an average degree of ethoxylation of from about 2 to about 30. Preferably, the fatty alcohol ethoxylate emollient is selected from the group consisting of of lauryl ethoxylate, cetyl and stearyl, and mixtures thereof, having an average degree of ethoxylation ranging from about 2 to about 23. Representative examples of these alkyl ethoxylates include laureth-3 (a lauryl ethoxylate having an average degree of ethoxylation of 3), laureth-23 (a lauryl ethoxylate having an average degree of ethoxylation of 23) ceteth-10 (a cetyl alcohol ethoxylate having an average degree of ethoxylation of 10) and steareth 10 (a stearyl alcohol ethoxylate having a average degree of ethoxylation of 10). These alkyl ethoxylate emollients are typically used in combination with petroleum-based emollients, such as petrolatum, at a weight ratio of emollients of alkyl ethoxylate to oil-based emollient of from about 1: 1 to about 1: 5, preferably from about 1: 2 to about 1: 4. Suitable fatty alcohol emollients include the C ^-C ^ fatty alcohols, preferably C? 6-C-18 fatty alcohols. Representative examples include cetyl alcohol, and stearyl alcohol, and mixtures thereof. These fatty alcohol emollients are typically used in combination with petroleum-based emollients, such as the petrolatum at a weight ratio of fatty alcohol emollient to oil-based emollient of from about 1: 1 to about 1: 5, preferably from about 1: 1 to approximately 1: 2. Other types of emollients suitable for use in the present invention include the polysiloxane compounds. In general, polysiloxane materials suitable for use in the present invention, include those having the monomeric siloxane units of the following structure: wherein and R2 for each monomeric independent siloxane unit can each independently be hydrogen or any of alkyl, aryl, alkenyl, alkaryl, arachidyl, cycloalkyl, halogenated hydrocarbon, or other radical. Any of these radicals can be substituted or unsubstituted. The radicals R1 and R2 of any particular monomer unit may differ from the corresponding functionalities of the next contiguous monomer unit. Additionally, the polysiloxane can be either a straight chain, a branched chain or have a cyclic structure. The radicals Ri and R2 can additionally independently be other hairless functionalities such as but not limited to siloxanes polysiloxanes, silanes and polysilanes. The radicals Ri and R2 may contain any of a variety of organic functionalities, including, for example, alcohol, carboxylic acid, phenyl and amine functionalities. Exemplary alkyl radicals are methyl, ethyl, propyl, butyl, pentyl, hexyl, octyl, decyl, octadecyl and the like. Exemplary alkenyl radicals are vinyl, allyl, and the like. Exemplary aryl radicals are phenyl, diphenyl, naphthyl and the like. Exemplary alkaryl radicals are toyl, guyl, ethylphenyl and the like. Exemplary aralkyl radicals are benzyl, alpha-phenylethyl, beta-phenylethyl, alpha-phenyl-butyl and the like. Exemplary cycloalkyl radicals are cyclobutyl, cyclopentyl, cycloexoyl, and the like. Exemplary alkylated hydrocarbon radicals are chloromethyl, bromoethyl, tetrafluoroethyl, fluoroethyl, trifluoroethyl, trifluoromethyl, exafluoroxynyl, and the like. The viscosity of the useful polysiloxanes can vary as widely as the viscosity of the polysiloxanes in general varies as long as the polysiloxane is able to flow or can be made to be flowable for application to the article. This includes, but is not limited to viscosity as low as 5 centistokes (at 37 ° C as measured by a glass viscometer) at approximately 20,000,000 centistokes. Preferably, the polysiloxanes have a viscosity at 37 ° C ranging from about 5 to about 5,000 centistokes, more preferably from about 5 to about 2,000 centistokes, most preferably from about 100 to about 1000 centistokes. The high viscosity polysiloxanes which by themselves are resistant to flow can be deposited effectively on the absorbent articles by such methods as, for example, emulsifying the polysiloxane in the surfactant or providing the polysiloxane in solution with the aid of a solvent such as hexane, listed for exemplary purposes only. Particular methods for applying the polysiloxane emollients to the absorbent articles are discussed in more detail hereinafter. Preferred polysiloxane compounds for use in the present invention are disclosed in U.S. Patent No. 5,059,282 (Ampulski et al.), Issued October 22, 1991, which is incorporated herein by reference. Particularly preferred polysiloxane compounds for use as emollients in the compositions of the present invention include polymethylsiloxane compounds with functional phenyl (e.g. Dow Corning 556 cosmetic grade fluid: polyphenylmethylsiloxane), dimethicone compounds, and dimethicones functionalized with cetyl or stearyl such as Dow 2502 and Dow 2503 polysiloxane fluids, respectively. In addition, substitution with functional phenyl or alkyl groups can be effectively substituted with amino, carboxyl, hydroxyl, ether, polyether, aldehyde, acetone, amide, ester and thiol groups. Of these effective substituent groups, the family of groups containing phenyl, amino, alkyl, carboxyl and hydroxyl groups are more preferred than the others; and most preferred are groups with functional phenyl. Suitable wetting agents include glycerin, propylene glycol, sorbitol, trihydroxy stearin, and the like. When present, the amount of the emollient that can be included in the composition will depend on a variety of factors, including the particular emollient involved, the desired skin benefits, other components in the composition and the like. The composition may comprise from about 0 to about 100% by total weight, of the emollient. Preferably, the composition comprises from about 10 to about 95%, more preferably from about 20 to about 80%, and most preferably from about 40 to about 75%, by weight, of the emollient. Another optional, but preferred, component of the therapeutic / skin protective compositions useful in the methods of the present invention is an agent capable of immobilizing the composition (including the emollient and / or other skin conditioning / protective agents) in the desired location in or on the treated article. Because certain of the preferred emollients in the composition have a plastic or fluid consistency at 20 ° C, they tend to flow or migrate even when subjected to modest shear stress. When applied to a surface that is in contact with the body or other location of an absorbent article, especially in a molten or melted state, the emollient will not primarily remain inside or on the treated region. Instead, the emollient will tend to migrate and flow into the unwanted regions of the article. Specifically, if the emollient migrates into the article, it may cause undesirable effects on the absorbency of the absorbent core due to the hydrophobic characteristics of many of the emollients and other skin conditioning agents used in compositions useful in the methods of the invention. present invention. This also means that much more emollient has to be applied to the article to achieve the desired therapeutic and / or protective benefits. Increasing the level of the emollient not only increases the cost, but also exacerbates the undesirable effect on core absorbency and unwanted transfer of the composition during processing / conversion of the treated articles. The immobilizing agent counteracts this tendency of the emollient to migrate or flow by keeping the emollient mainly located on the surface or in the region of the article to which the composition is applied. It is believed that this is due, in part, to the fact that the immobilizing agent raises the melting point and / or viscosity of the composition above that of the emollient. Since the immobilizing agent is also preferably miscible with the emollient (or solubilized in the emollient with the aid • of an appropriate emulsifier or dispersed therein), this traps the emollient on the surface of the surface that are in contact with the user of the article or in the region to which it is applied. It is also advantageous to "fix" the immobilizing agent on the surface that is in contact with the user or in the region of the article to which it is applied. This can be achieved by using immobilization agents which quickly dispose (ie, solidify) on the application to the article. In addition, the external cooling of the • bending treated through blowers, fans, cold rollers, etc., can accelerate the crystallization of the immobilization agent. In addition to being miscible with (or solubilized in) the emollient, the immobilizing agent will preferably have a melting profile that will provide a composition that is solid or semi-solid at room temperature. In this regard, the preferred immobilizing agents will have a melting point of at least about 35 ° C. This is such that the immobilization agent itself will not have a tendency to migrate or flow. Preferred immobilizing agents will have 0 melting points of about 40 ° C. Typically, the immobilization agent will have a melting point in the range from about 50 ° to about 150 ° C. When used, the immobilization agents useful for the present invention may be selected from any of a group of agents, while the preferred properties of the skin care composition provide the benefits described herein. Preferred immobilizing agents will comprise a member selected from the group consisting of C14-C22 fatty alcohols, C12-C22 fatty acids and C12-C22 fatty alcohol ethoxylates having an average degree of ethoxylation ranging from 2 to about 30. , and mixtures thereof. Preferred immobilizing agents include C 16 -C 8 fatty alcohols, more preferably selected from the group consisting of cetyl alcohol, stearyl alcohol, bene? N alcohol and mixtures thereof. (The linear structure of these materials can accelerate the solidification of the absorbent articles.) Mixtures of cetyl alcohol and stearyl alcohol are particularly preferred. Other preferred immobilizing agents include C 16 -C 8 fatty acids, more preferably selected from the group consisting of palmitic acid, stearic acid and mixtures thereof. Mixtures of palmitic acid and stearic acid are particularly preferred. Still other immobilizing agents include C16-C18 fatty alcohol ethoxylates having an average degree of ethoxylation ranging from about 5 to about 20. Preferably, the fatty alcohols, the fatty acids are linear. Importantly, these preferred immobilizing agents such as the C16-C8 fatty alcohols increase the rate of crystallization of the lotion causing the lotion to crystallize rapidly on the surface of the substrate. Other types of immobilizing agents that may be used herein include polyhydroxy fatty acid esters, polyhydroxy fatty acid amides, and mixtures thereof. Preferred amide esters will have 3 or more free hydroxy groups on the polyhydroxy moiety and are typically non-ionic in character. Because of the possible skin sensitivity of those who use articles to which the composition is applied, these esters and amides must also be relatively benign and non-irritating to the skin.
The polyhydroxy fatty acid esters suitable for use in the present invention will have the formula: • wherein R is a C5-C31 hydrocarbyl group preferably straight chain C7-C19 alkyl or alkenyl, more preferably straight chain C9-C17 alkyl or alkenyl, more preferably preferably straight chain Cn-C17 alkyl or alkenyl or mixtures thereof; and is a polyhydroxyhydrocarbyl moiety having a hydrocarbyl chain with al • minus two free hydroxyls directly connected to the chain, and n is at least 1. The groups Y can be derived from polyols such as glycerol, pentaerythritol; sugars such as refining, maltodextrose, galactose, sucrose, glucose, gylose, fructose, maltose, lactose, mannose and erythrose; sugar alcohols such as erythritol, gylitol, malitol, mannitol and sorbitol; and anhydrides of sugar alcohols such as sorbitan. A class of polyhydroxy fatty acid esters for use in the present invention comprises certain glyceryl monoesters, preferably the sorbitan esters of saturated C 16 -C 22 fatty acids. Because of the manner in which these are typically manufactured, these sorbitan esters usually comprise mixtures of mono-, di-, tri-, etc., esters. Representative examples of suitable sorbitan esters include sorbitan palmitates (eg, SPAN 40), sorbitan stearates (eg, SPAN 60), and sorbitan benehatos, which comprise one or more versions of mono-, di-, and triesters of these sorbitan esters, for example, sorbitan mono-, di- and tri-palmitate, sorbitan mono-, di- and tri-stearate, sorbitan mono-, di- and tri-behenate, as well as mono- - mixed di- and tri-fatty acid esters of bait. Mixtures of different sorbitan esters, such as sorbitan palmitates with sorbitan stearates, can also be used. Particularly preferred sorbitan esters are sorbitan stearates, typically as a mixture of mono-, di- and tri-esters (plus some tetra-ester) such as SPAN 60, and sorbitan stearates sold under the trade name GLYCOMUL- S by Lonza, Inc. Although these sorbitan esters typically contain mixtures of mono-, di- and tri-esters, plus some tetra-ester, mono-, di- and tri-esters are generally the predominant species in these mixtures. Another class of polyhydroxy fatty acid esters for use in the present invention comprises certain glyceryl monoesters, preferably glyceryl monoesters of saturated C-i6-C22 fatty acids such as glycerol monostearate, glyceryl monopalmitate and glyceryl monobearate. Again, like sorbitan esters, glyceryl monoester mixtures will typically contain some di and tri-ester. However, these mixtures should predominantly contain glyceryl ester mono species to be useful in the present invention. Another class of polyhydroxy fatty acid esters suitable for use in the present invention may comprise certain fatty acid esters of sucrose, preferably the fatty acid esters of C ^ -C ^. The sucrose monster and diester are particularly preferred and include sucrose mono- and di-stearate and sucrose mono- and di-laurate. The polyhydroxy fatty acid amides suitable for use in the present invention will have the formula: wherein R 1 is H, C 4 C hydrocarbyl, 2-hydroxyethyl, 2-hydroxypropyl, methoxyethyl, methoxypropyl or a mixture thereof, preferably C 1 -C 4 alkyl, methoxyethyl or methoxypropyl, more preferably C 1 or C 2 alkyl, or methoxypropyl , more preferably C1 alkyl (ie methyl) or methoxypropyl; and R2 is a C5-C31 hydrocarbyl group, preferably straight chain C7-C19 alkyl or alkenyl, more preferably, straight chain C9-C17 alkyl or alkenyl, most preferably straight chain C11-C17 alkyl or a mixture thereof; and Z is a polyhydroxyhydrocarbyl moiety having a linear hydrocarbyl chain with at least three hydroxyls directly connected to the chain. See U.S. Patent No. 5,174,927 (Honsa), issued December 29, 1992 (incorporated herein by reference), which discloses these polyhydroxy fatty acid amides, as well as their preparation. The Z portion will preferably be derived from a reduced sugar in a reductive amination reaction; more preferably glycityl. Suitable reduced sugars include glucose, fructose, maltose, lactose, galactose, mannose and gylose. High-shelled corn syrups, high fructose corn syrup, and high-maltose corn syrup can be used, as well as the individual sugars listed above. These corn syrups can produce mixtures of the sugar components for the Z portion. The Z portion will preferably be selected from the group consisting of CH2- (CH0H) n -CH20H, -CH (CH2OHH (CHOH) n-?] -CH2OH, -CH2OH-CH2- (CHOH) 2 (CHOR3) (CHOH) -CH2OH, wherein n is an integer from 3 to 5, and R3 is H or a cyclic or aliphatic monosaccharide, more preferably are glycityls where n In the above formula R1 can be, for example N-methyl, N-ethyl, N-propyl, N-isopropyl, N-butyl, N-2-hydroxyethyl, N -methoxypropyl or N-2-hydroxypropyl R2 can be selected to provide, for example, cocamides, stearamides, oleamides, lauramides, myristamides, capricamides, palmitamides, ceboamides, etc. The Z-portion can be 1-deoxyglucityl, 2-deoxyprythityl, 1-deoxylactyl, 1-doxygalactityl, 1-deoxymanityl, 1-deoxy-thiotriotityl, etc. The most preferred polyhydroxy fatty acid amides have the general formula : 0 wherein R 1 is methyl or methoxypropyl; R2 is a straight chain alkyl or alkenyl group of Cn-C? 7. These include N-lauryl-N-methyl glucamide N-lauryl-N-methoxypropyl glucamide, N- • cocoyl-N-methyl glucamide, N-cocoyl-N-methoxypropyl glucamide, n-palmityl-N-methoxypropyl glucamide, N-ceboyl -N-methyl glucamide, or N-ceboyl-N-methoxypropyl glucamide. As previously indicated, some of the immobilizing agents 5 require an emulsifier for solubilization in the emollient. This is particularly the case for certain of the glucamides such as N-alkyl-N-methoxypropyl glucamides having HLB values of at least 7. Suitable emulsifiers will typically include those having HLB values below about 7. In this respect , the sorbitan esters described above, such as the stearates of • 0 sorbitan, which have HLB values of about 4.9 or less have been found to be useful in solubilizing these glucamide immobilizing agents in the petrolatum. Other suitable emulsifying agents include steareth-2 (polyethylene glycol stearyl alcohol ethers which conform to the formula CH 3 (CH 2) 17 (OCH 2 CH 2) n OH, wherein n has an average value of 2), sorbitan triestarate, isosorbide laurate and glyceryl monostearate. The emulsifier may be included in an amount sufficient to solubilize the immobilizing agent in the emollient such that a substantially homogeneous mixture is obtained. For example, a mixture of approximately 1: 1 of N-cocoyl-N-methyl glucamide and petrolatum that will not normally melt in a single-phase mixture will melt in a single-phase mixture upon addition of 20% of a mixture of 1: 1 of Steareth-2 and sorbitan triestarate as the emulsifier. Other types of ingredients that can be used as immobilization agents, either alone, or in combination with the above-mentioned immobilization agents, include waxes such as carnauba, ozokerite, beeswax, candelilla, paraffin, ceresin, esparto, prayer wax, ouricuri, isoparaffin, and other known mineral and mineral waxes. The high melting point of these materials can help immobilize the composition on the desired surface or location in the article. The additionally microcrystalline waxes are effective immobilization agents. Microcrystalline waxes can help fix the low molecular weight hydrocarbons within the skin care composition. Preferably, the wax is a paraffin wax. An example of a particularly preferred alternating immobilization agent is a paraffin wax such as Paraffin S.P. 434 from Strahl and Pitsch Inc., PO Box 1098, West Babylon, NY 11704. The amount of the immobilizing agent that can be included in the composition will depend on a variety of factors, including the active (eg, emollients) involved, the particular immobilizing agent involved, if any, the other components in the composition, if emulsifier is required to solubilize the immobilizing agent in the emollient other components and similar factors. When present, the composition will typically comprise from about 5 to about 90% of the immobilizing agent. Preferably, the composition will comprise from about 5 to about 50%, more preferably from about 10 to about 40% of the immobilizing agent. Of course, it is highly desirable that at least a portion of the top sheet of the article be made of a hydrophilic material to promote the rapid transfer of liquids (eg, urine) through the topsheet. Similarly, it may be desirable for the composition to be sufficiently wettable to ensure that liquids will transfer through the topsheet rapidly. Alternatively, the hydrophobic skin care composition can be used, as long as it is applied in such a way that the fluid handling properties of the top sheet are adequately maintained. (For example, as discussed below, non-uniform application of the composition to the top sheet is a means to achieve this goal.) This decreases the likelihood that the exudates will flow out of the top sheet treated with the composition instead of the top sheet. be dragged through the upper sheet and be absorbed by the absorbent core. When a hydrophilic composition is desired, depending on the particular components used in the composition, a hydrophilic surfactant (or a mixture of hydrophilic surfactants) may, or may not, be required to improve the wettability. For example, some immobilization agents, such as N-cocoyl-N-methoxypropyl glucamide have HLB values of at least about 7 and are sufficiently wettable without the addition of the hydrophilic surfactant. Other immobilization agents such as C16-C18 fatty alcohols having HLB values below about 7 may require the addition of the hydrophilic surfactant to improve the wettability when the composition is applied to the top sheets of the article. Similarly, a hydrophobic emollient such as petrolatum may require the addition of a hydrophilic surfactant if the hydrophilic composition is desired. Of course, the interest around the wetting capacity is not its factor when the surface that is in contact with the user under consideration is different from the top sheet of the article or when the fluid handling properties of the top sheet are maintained. adequately by other means (for example, non-uniform application). Suitable hydrophilic surfactants will preferably be miscible with the other components of the skin care composition to form mixed mixtures. Because of the possible skin sensitivity of those who use disposable absorbent products to which the composition applies, these surfactants must also be relatively mild and non-irritating to the skin. Typically, these hydrophilic surfactants are nonionic to not only be irritating to the skin, but also to avoid other undesirable effects on any of the other structures within the treated article. For example, reductions in the tensile strength of tissue laminates, the adequacy of adhesive bond, and the like. Suitable nonionic surfactants can be substantially non-migratory after the composition is applied to the article and typically will have HLB values in the range of from about 4 to about 20, preferably from about 7 to about 20. To be non-migratory, these agents Nonionic surfactants will typically have melting temperatures higher than the temperatures commonly encountered during storage, shipping, marketing, and use of the disposable absorbent products, for example, at least about 30 degrees centigrade. In this regard, these nonionic surfactants will preferably have similar melting points to those of the immobilization agents described above. Suitable nonionic surfactants for use in the compositions that will be applied to the articles, at least in the discharge region of the diaper fluid, include alkyl glycosides; alkylquicoside ethers as described in U.S. Patent No. 4,011,389 (Langdon et al.), issued March 8, 1977, which is incorporated by reference; alkyl polyethoxylated esters such as Pegosperse 1000MS (available from Lonza, Inc., Fair Lawn, New Jersey), ethoxylated mono-, di- and / or tri-esters of C12-C18 fatty acids having an average degree of ethoxylation from about 2 to about 20, preferably from about 2 to about 10, such as TWEEN 60 (sorbitan ester of stearic acid having an average degree of ethoxylation of about 20) and TWEEN 61 (sorbitan ester of stearic acid having an average degree of ethoxylation of about 4), and the condensation products of the aliphatic alcohols with from about 1 to about 54 moles of ethylene oxide. The alkyl chain of the aliphatic alcohol is typically in a straight chain (linear) configuration and contains from about 8 to about 22 carbon atoms. Particularly preferred are the condensation products of the alcohols having an alkyl group containing from about 11 about 22 carbon atoms with from about 2 to about 30 moles of ethylene oxide per mole of alcohol. Examples of these ethoxylated alcohols include the condensation products of the myristyl alcohol with 7 moles of ethylene oxide per mole of alcohol, the condensation products of the coconut alcohol (a mixture of fatty alcohols having alkyl chains varying in length of 10). to 14 carbon atoms) with approximately 6 moles of Chilean oxide. A number of suitable ethoxylated alcohols are commercially available, including TERGITOL 15-S-9 (condensation product of C11-C15 linear alcohols with 9 moles of ethylene oxide), marketed by Union Carbide Corporation; KYRO EOB (condensation product of linear alcohols of C13-C15 with 9 moles of ethylene oxide), marketed by The Procter & Gamble Company), the surfactants of the trademark NEODOL marketed by Shell Chemical Co., in particular NEODOL 25-12 (condensation product of linear alcohols of C12-C15 with 12 moles of ethylene oxide) and NEODOL 23-6.5 T (condensation product of linear alcohols of C12-C13 with 6.5 moles of ethylene oxide that has been distilled (in the upper part) to remove certain impurities), and especially the surfactants of the PLURAFAC commercial m arca marketed by BASF Corp ., in particular PLURAFAC A-38 (a condensation product of a straight chain alcohol of C18 with 27 moles of ethylene oxide). (Certain hydrophilic surfactants, in particular ethoxylated alcohols such as NEODOL 25-12, may also function as alkyl ethoxylate emollients). Other examples of preferred ethoxylated alcohol surfactants include the ICI class of Brij surfactants and mixtures thereof, Brij 72 (ie, Steareth-2) and Brij 76 (ie, Steareth-10) being especially preferred. Also, mixtures of cetyl alcohol and stearyl alcohol ethoxylated at an average degree of ethoxylation of about 10 to about 20 can also be used as the hydrophilic surfactant. Another type of surfactant suitable for use in the composition includes Aerosol Ot, a dioctyl ester of sodium sulfosuccinic acid marketed by American Cyanamid Company. Yet another type of surfactant suitable for use in the composition includes silicon copolymers such as General Electric SF 1188 (a copolymer of a polydimethylsiloxane and a polyoxyalkylene ether) and General Electric SF 1228 (a polyether silicon copolymer). These silicon surfactants can be used in combination with the other types of hydrophilic surfactants discussed above, such as ethoxylated alcohols. These silicon surfactants have been found to be effective in concentrations as low as 0.1%, more preferably from about 0.25 to about 1.0%, by weight of the composition. Where a hydrophilic composition is desired, the amount of hydrophilic surfactant required to increase the wettability of the composition to a desired level will depend in part on the HLB value and the level of immobilizing agent, if any, used, the HLB value. of the surfactant used and similar factors. The composition may comprise from about 0.1 to about 50% of the hydrophilic surfactant when needed to increase the wettability properties of the composition. Preferably, the composition comprises from about 1 to about 25%, most preferably from about 10 to about 20%, of the hydrophilic surfactant when needed to increase wettability. The compositions may comprise other optional components typically present in emulsions, creams, ointments, lotions, powders, suspensions, etc. of this type. These optional components include water, viscosity modifiers, perfumes, antibacterial disinfectant actives, antiviral agents, vitamins, pharmaceutical actives, film formers, aloe vera, deodorants, opacity modifiers, astringents, solvents, preservatives and the like. In addition, stabilizers may be added to increase the shelf life of the composition such as cellulose derivatives, proteins and lecithin. All of these materials are well known in the art as additives to these formulations and may be employed in appropriate amounts within compositions of the present invention for use herein. If water-based skin care compositions are used, a preservative will be necessary. Suitable preservatives include propyl paraben, methyl paraben, benzyl paraben, benzylkonium alcohol, tribasic calcium phosphate, BHT, or acids such as citric, tartaric, maleic, lactic, malic, benzoic, salicylic, and the like. Suitable viscosity-increasing agents include alkyl galactomannan, silica, talc, magnesium silicate, sorbitol, colloidal silicon dioxide, magnesium aluminum silicate, zinc stearate, wool wax alcohol, sorbitol, sesquioleate, hydroxy cetyl ethyl cellulose , and other modified celluloses. Suitable solvents include propylene glycol, glycerin, cyclomethicone, polyethylene glycols, hexylene glycol, diol, and multi-hydroxy based solvents. Suitable vitamins include A, D-3, E, B-5 and E acetate.
IV. Absorbent Articles As used herein, the term "absorbent article" refers to devices that absorb and contain exudates from the body. The term "disposable" is used herein to describe absorbent articles that are not intended to be washed or restored or reused in another way as an absorbent article after a single use. Examples of disposable absorbent articles include feminine hygiene products such as sanitary panties, sanitary napkins, panty liners and tampons; diapers incontinence products; diaper bras; training shorts; and similar. Disposable absorbent articles typically comprise a liquid permeable topsheet, a liquid impermeable backsheet attached to the topsheet, and an absorbent core positioned between the topsheet and the backsheet. Disposable absorbent articles and their components, including the topsheet, the backsheet, the absorbent core, and any of the individual layers of these components, have a body-giving surface and a garment-giving surface. As used herein, "body-facing surface" means that surface of the article or component that is intended to be worn toward or adjacent to the user's body, while the "surface that gives the garment" is on the opposite side. and is intended to be worn towards or positioned adjacent to the wearer's clothing or undergarments when the disposable absorbent article is used.
The following description generally discusses the absorbent core materials of the topsheet and the backsheet that are useful in the disposable absorbent articles that are used in the methods of the present invention. It should be understood that this general description applies to these components of the specific absorbent articles shown in Figure 1 and described below, in addition to those of other disposable absorbent articles, which are generally described herein. In general, the absorbent core is capable of absorbing and retaining liquids (e.g., menses, urine, and / or other body exudates). The absorbent core is preferably compressible, conformable and non-irritating to the wearer's skin. The absorbent core can be manufactured in a wide variety of sizes and shapes (eg, rectangular, hourglass, oval, T-shaped, dog bone, asymmetric, etc.). In addition to the absorbent composites of the present invention, the absorbent core can include any of a wide variety of liquid absorbent materials commonly used in absorbent articles, such as crushed wood pulp, which is generally referred to as an air filter. Examples of other absorbent materials suitable for use within the absorbent core include accreted cellulose wadding, meltblown polymers, including coform; chemically hardened modified or crosslinked cellulosic fibers, synthetic fibers such as pleated polyester fibers, peat moss; tissue, including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; gelling absorbent materials; or any equivalent material or combinations of materials, or mixtures thereof. The configuration and construction of the absorbent core can also be varied (for example, the absorbent core can have zones of varying gauge, and / or have a profile to be thicker in the center, hydrophilic gradients; gradients of the absorbent composite of the present invention, superabsorbent gradients, or areas of lower average basis weight and lower average density, eg, acquisition zones, or may comprise one or more layers or structures). However, the total absorbent capacity of the absorbent core can be compatible with the charge of • Design and intended use of the absorbent article. In addition, the size and absorbent capacity of the absorbent core can be varied to encompass different uses such as diapers, incontinence pads, pantiliners, regular sanitary napkins, and nighttime sanitary napkins, and to suit users ranging from infants to adults. The absorbent core may include other absorbent components that are often used in the absorbent articles, for example, a dedusting layer, an acquisition or capillary action layer, or a secondary upper sheet to increase user comfort. The top sheet is preferably docile, soft-feeling, and non-irritating to the wearer's skin. In addition, the top sheet is permeable to liquid, allowing liquids (eg, menstruation and / or urine) to easily penetrate through its thickness: A suitable top sheet can be manufactured from a wide range of materials such as materials woven and non-woven (eg, a non-woven web of fibers), including nonwoven materials with openings; polymeric materials such as • 0 thermoplastic films formed with openings; plastic films with openings and hydroformed thermoplastic films; porous foams; cross-linked foams; crosslinked thermoplastic films; and thermoplastic canvases. Suitable woven and nonwoven materials may be composed of natural fibers (for example, wood or cotton fibers), synthetic fibers (for example, polymer fibers, such as polyester, polypropylene or polyethylene fibers), fibers of two or more. components, or from a combination of natural and synthetic fibers. When the top sheet comprises a nonwoven web, the web can be manufactured by a large number of known techniques. For example, the weft can be spun bonded, carded, wet-laid, melt-blown, hydroentangled, hydroformed, hydro-perforated, combinations of the above, or the like. The backsheet is preferably impervious to liquids (eg, menstruation and / or urine), and a thin plastic film is preferably comprised, although other flexible liquid impervious materials may also be used. As used herein, the term "flexible" refers to materials that are docile and that will readily conform to the contour and general shape of the human body. The backsheet prevents the exudates absorbed and contained within the absorbent core from wetting the articles that are in contact with the absorbent article, such as sheets, pants, pajamas and undergarments. The backsheet can thus comprise a woven or non-woven material, polymeric films such as polyethylene or polypropylene thermoplastic films, or composite materials such as a coated non-woven material or a non-woven film-coated material. A suitable backsheet is a polyethylene film having a thickness of from about 0.012 mm to about 0.051 mm. Exemplary polyethylene films are manufactured by Clopay Corporation of Cincinnati, Ohio, under the designation P18-1401 and by Tredegar Film Products of Terre Haute, Indiana, under the designation XP-39385. The backsheet is preferably embossed and / or finished without gloss to provide a more fabric-like appearance. The size of the backsheet is dictated by the size of the absorbent core and the exact design of the selected absorbent article. As discussed above, although it is preferred that the composition is continuously continuously transferred to the wearer's skin using the articles described herein that are relatively impervious to liquids such as urine and watery stools, it is also preferred that the composition be relatively vapor permeable to provide a non-occlusive barrier to the skin. In this respect, to further improve the condition of the skin in the user's region under the absorbent articles through currently disclosed methods, absorbent articles useful in those methods can also provide "breathability", to facilitate relatively lower relative humidity in the area between the skin and the absorbent article. Currently, attempts have been made that are aimed at improving or maintaining the health of the user's skin by allowing the over hydrated skin to dehydrate to a more acceptable level, allowing the air to reach the skin (thus minimizing the effects). potentials of the occlusion) and / or providing means to remove water vapor from the surface of the skin. Generally, these mechanisms are referred to as "breathability" or "vapor or moisture permeability". Specific examples include feminine hygiene products, such as catamenial products or so-called panty protection products as described in European Patent EP-A-0 104 906; European Patent EP-A-0 171 041; European Patent EP-A-0 710 471; the disclosure of each of which is incorporated herein by reference. These products generally have relatively low liquid storage capacity when compared to, for example, baby diapers or adult incontinence products, which have theoretical storage capacities greater than ten times the capacity of a product. for feminine hygiene. The "breathable" articles described in these references may be treated with the skin care composition as described herein, and these treated articles may be useful in the methods of the present invention. These respirable materials can be various types of wefts, such as films which are made permeable to air / vapor by perforation as described by absorbent core, U.S. Patent No. 5,628,737, which was issued in the name of Dobrin and others, on May 13, 1997, or exploiting the property of "microporosity" as described in European patent EP-A-0 238 200; European Patent EP-A-0 288 021; European Patent EP-A-0 352 802; European Patent EP-A-0 515 501; U.S. Patent No. 4,713,068, by which small gaps are created within the film similar to very small breaks. The international publication WO 94/23107; the international publication WO 94/28224; U.S. Patent No. 4,758,339 which was issued in the name of Yeo et al. on July 19, 1988; and European Patent EP-A-0,315,013, all disclose alternate breathable materials which may be fibrous textiles or nonwoven webs, with air / vapor easily penetrating through the relatively large pores of the structure. These webs, which are either treated or untreated with respect to improving their liquid impermeability properties, as described in European patent EP-A-0 196 654. In the international publication WO 95/16562 a laminate is described. of a non-woven material with a breathable film. Additional disclosures such as in the international publication WO 95/16746 relate to other materials that allow water molecules to diffuse therethrough. Also, combinations of various materials comprising several layers of any of the aforementioned elements are well known. The absorbent articles using any of the approaches described in these references (each of which are incorporated herein by reference) in combination with the delivery of a composition as described herein, can be used to carry out the methods of the present invention. invention. Indeed, a particularly preferred absorbent article for use in the present methods is described in detail in copending US patent application Serial No. 08 / 926,532 filed on September 10, 1997 by Eider et al. (Case P &G). 6823), the disclosure of which is incorporated herein by reference.
The back sheet and the top sheet are placed adjacent to the surface that gives the garment and the surface that it gives to the body, respectively, of the absorbent core. The absorbent core is preferably attached to the topsheet, backsheet, or both in any manner as known by attachment means (not shown in Figure 1) such as those well known in the art. However, embodiments of the present invention are contemplated wherein parts of the entire absorbent core are disengaged from either the top sheet, the back sheet, or both. For example, the backsheet and / or the topsheet can be secured to the absorbent core or to each other, by a continuous uniform adhesive layer, a patterned adhesive layer, or an array of separate lines, coils or dots of adhesives. The adhesives that have been found to be satisfactory are manufactured by H.B. Fuller Company of St. Paul Minnesota, under the designation HL-1258 or H-2031. The joining members preferably will comprise an open-pattern network of filaments of adhesives as disclosed in U.S. Patent No. 4,573,986, issued to Mientola et al., March 4, 1986, and which is incorporated herein by reference. . An exemplary attachment or binding means of an open filament pattern network comprises several lines of adhesive filaments twisted in a spiral pattern as illustrated by the apparatus and method shown in United States Patent No. 3,911,173. issued to Sprague, Jr. on October 7, 1975, United States Patent No. 4,785,996 issued to Zwieker et al. on November 22, 1978; and U.S. Patent No. 4,842,666 issued to Werenicz on June 27, 1989. Each of these patents is incorporated herein by reference. Alternatively, the joining means may comprise heat bonds, pressure joints, ultrasonic joints, mechanical dynamic joints, or any other suitable joining means or combinations of these joining means as are known in the art.
A preferred disposable absorbent article in which the surface that is in contact with the user is treated with a composition are diapers. As used herein, the term "diaper" refers to an absorbent article generally worn by infants, and incontinent persons, which is worn around the wearer's lower torso. In other words, the term "diaper" includes baby diapers, training pants, adult incontinence devices, and so on. Figure 1 is a plan view of the diaper 50 useful in the methods of the present invention in its flattened, non-contracted state (i.e., with the contraction induced by the elastic pulled out) with parts of the structure that are cut out to show more clearly the construction of the diaper 50 and with the part of the diaper 50 that gives away from the wearer (the outer surface) oriented towards the observer. As shown in Figure 1, the diaper 50 preferably comprises a liquid-permeable upper sheet 520, a liquid-impermeable backsheet 530 bonded to the upper sheet 520, an absorbent core 540 positioned between the upper sheet 520 and the back sheet 530 , the absorbent core 540 having a garment-facing surface 542, a body-facing surface 544, side edges 546, waist edges 548, and ears 549. The diaper 50 preferably further comprises elasticized leg folds. 550, a multiple elastic waist feature designated 560, and a generally multiple clamping system designated 570. The diaper 50 is shown in Figure 1 to have an outer surface 52, an inner surface 54 corresponding to the surface facing the body which is opposite the outer surface 52, a first waist region 56, a second waist region 58, and a periphery 51 that is defined by the outer edges of the diaper 20 in which they are designated 55 to the longitudinal edges and designated 57 to the end edges. (While the skilled artisan will recognize that a diaper is generally described in terms of having a pair of waist regions and a crotch region between the waist regions, in this application, for simplicity of terminology, the diaper 50 is described as having only waist regions that include a portion of the diaper that would typically be designed as part of the crotch region). The surface that faces the body 54 of the diaper 50 comprises that part of the diaper 50 that is placed adjacent the wearer's body during use. The body-facing surface 54 is generally formed by at least a portion of the blade exceeded 520 and other components that may be attached to the topsheet 520, such as the leg cuffs 550, as well as any of the regions a which the top sheet can not extend but are still in contact with the user, such as the waist feature 560, the side panels and the like. The outer surface 52 comprises that part of the diaper 50 that is positioned remote from the wearer's body (i.e., the outer surface 52 is generally formed by at least a portion of the back sheet 530 and other components that may be attached to the back sheet 530). The first waist region 56 and the second waist region 58 extend, respectively, from the end edges 57 of the periphery 51 to the lateral center line 53 of the diaper 50. Figure 1 also shows the longitudinal centerline 59. Figure 1 shows a preferred embodiment of 50 in which upper sheet 520 and back sheet 530 have length and width dimensions generally greater than those of absorbent core 540. Elasticized folds for leg 550 and back sheet 530 extend beyond edges of the absorbent core 540 to thereby form the periphery 51 of the diaper 50. The diapers of the present invention may have a number of well-known configurations, with the absorbent cores thereof being adapted to the present invention. The exemplary configurations are generally described in U.S. Patent No. 3,860,003 issued to Buell on January 14, 1975; U.S. Patent No. 5,151,092 issued to Buell et al. on September 29, 1992; U.S. Patent No. 5,221, 274 issued to Buell et al. On June 29, 1993. Each of these patents is incorporated herein by reference. Another diaper configuration to which the present invention can be readily adapted is described in co-pending United States patent application Serial No. 08 / 203,456, filed February 28, 1994 and incorporated herein by reference. The absorbent cores of the diapers described in these patents can be adapted to the light of the teachings herein to include the absorbent composite of the present invention as a gelling absorbent material described therein. A topsheet 520 that is particularly suitable for use in the diaper 50 is carded and thermally bonded by means well known to those skilled in the art of fabrics. A top sheet satisfactory for the present invention comprises short length polypropylene fibers having a denier of about 2.2. As used herein, the term "short length fibers" refers to those fibers having a length of at least about 16.9 mm. Preferably, the topsheet has a basis weight of about 14 to about 25 grams per square meter. A suitable top sheet is manufactured by Veratec, Inc., a division of Walpole, Mass, under the designation P-8. The upper sheet 520 of the diaper 50 is preferably made of a hydrophilic material to promote the rapid transfer of liquids (eg, urine), through the topsheet. If the top sheet of a hydrophobic material is made, preferably at least the top surface of the top sheet or a portion thereof, is treated to make it hydrophilic, so that liquids will transfer through the top sheet more quickly . This decreases the likelihood that the body exudates will flow out of the top sheet instead of being drawn through the top sheet and absorbed by the absorbent core. The top sheet can be made hydrophilic by treating it with a surfactant. Suitable methods for treating the topsheet with a surfactant include spraying the top sheet material with the surfactant and immersing the material within the surfactant. A more detailed discussion of this treatment and hydrophilic capacity is contained in U.S. Patent No. 4,988,344 entitled "Absorbent article with multilayer absorbent layers", issued to Reisinig et al. On January 29, 1991, and patent No. 4,988,345 entitled "Absorbent articles with fast-absorbing absorbent cores", issued to Reising on January 29, 1991., each of which is incorporated herein by reference. Alternatively, the topsheet may be in the form of a film formed with openings, which is preferred in absorbent articles for feminine hygiene. Films formed with openings are useful because they are permeable to body fluids and not yet absorbent and have a reduced tendency to allow liquids to re-pass and re-wet the wearer's skin. In this way, the surface of the formed film that is in contact with the body, remains dry, thus reducing dirt from the body and creating a more comfortable feeling for the user. Suitable formed films are described in U.S. Patent No. 3,929,135 (Thompson) issued December 30, 1975; U.S. Patent No. 4,324,246 (Mullane et al.) Issued April 13, 1982; U.S. Patent No. 4,342,314 (Radel et al.) Issued August 3, 1982; U.S. Patent No. 4,463,045 (Ahr et al.) Issued July 31, 1984; and United States Patent No. 5, 006,394 (Baird) issued April 9, 1991. Each of these patents is incorporated herein by reference. Top sheets of film formed with particularly preferred micro apertures are disclosed in U.S. Patent No. 4,609,518 (Curro et al.) Issued September 2, 1986 and U.S. Patent No. 4,629,643 (Curro et al.) Issued on December 16, 1986, which are incorporated by reference. The preferred top sheet for use in feminine hygiene products is the formed film described in one or more of the above patents and marketed in sanitary napkins by The Procter & amp;; Gamble Company of Cincinnati, Ohio as "DRI-WEAVE". The surface that gives the body of the top sheet of formed film can be hydrophilic to help the transfer of liquid through the upper sheet faster than if the surface of the body were not hydrophilic, to decrease the likelihood of the fluid Menstrual flow out of the upper sheet instead of flowing in and absorbed by the absorbent structure. In a preferred embodiment, surfactant is incorporated into the polymeric materials of the formed film topsheet as described in U.S. Patent Application Serial No. 07 / 794,745, Aziz et al., "Absorbent article having a nonwoven material and an aperture film cover sheet "filed November 19, 1991, which is incorporated by reference. Alternatively, the surface that gives the body of the topsheet can be made hydrophilic by treating it with a surfactant such as is described in U.S. Patent No. 4,950,254, incorporated herein by reference. In a preferred embodiment of a diaper as described herein, the backsheet 530 has a modified hourglass shape extending beyond the absorbent core at a distance of about 1.3 cm to about 6.4 (about 0.5 to about 2.5 inches) around of the total periphery of the diaper. The absorbent core 540 may be any size or shape compatible with the diaper 50. A preferred embodiment of the diaper 50 has an asymmetric modified T-shaped absorbent core 540 having ears in the first waist region but a generally rectangular in the second waist region. Exemplary absorbent structures for use as the absorbent core of articles useful in the present methods are described in U.S. Patent No. 4,610,678 entitled "High Density Absorbing Structures" issued to Weisman et al. On September 9, 1986; U.S. Patent No. 4,673,402 entitled "Absorbent Articles with Cores with Double Layers", issued to Wesiman et al. on June 16, 1987, U.S. Patent No. 4,88,231 entitled "Absorbent Core Having a Coating Dusting ", issued to Angstadt on December 19, 1989; U.S. Patent No. 4,834,735, entitled "High density absorbent members having acquisition zones of lower density and lower basis weight", issued to Alemany et al. on May 30, 1989. The absorbent core can further comprise the system dual core containing an acquisition / distribution core of chemically hardened fibers placed on an absorbent storage core as detailed in U.S. Patent No. 5,234,423 entitled "Absorbing article with elastic waist feature and increased absorbency", issued to Alemay et al. on August 10, 1993; and in U.S. Patent No. 5,147,345"High Efficiency Absorbent Articles for Incontinence Management", issued to Young LaVon and Taylor on September 15, 1992. All of these patents are incorporated herein by reference. In a preferred embodiment, the diaper 50 further comprises elastic folds for the leg 55 to provide improved containment of liquids and other exudates from the body; an elastic waist feature 560 that provides improved fit and containment; and a fastening system 570 which forms a lateral closure that maintains the first waist region 56 and the second waist region 58 in an overlapping configuration, such that lateral stresses are maintained around the circumference of the diaper. keep the diaper on the user. The diaper 50 may also comprise elasticized waistbands (not shown) and / or elasticized side panels (also not shown) in the waist regions 56 and 58 to provide an elastically extensible feature that provides a more comfortable and contoured fit and more effective application of the diaper 50. The elasticized folds for the leg 550 can be constructed in a number of different configurations, including those described in United States Patent No. 3,860,003; U.S. Patent No. 4,909,803 issued to Aziz et al. on March 20, 1990; U.S. Patent No. 4,695,278 issued to Lawson on March 22, 1987; and U.S. Patent No. 4,795,454 issued to Dragoo on January 3, 1989, each being incorporated herein by reference. Absorbent articles having elasticized folds that are treated with a composition that may be useful herein are disclosed in the co-pending United States patent application Serial No. 08 / 766,386 and the co-pending United States patent application. Serial Number 08 / 840,039, both of which are incorporated by reference. The elasticized waist feature preferably comprises an elasticised waistband (not shown) that can be constructed in a number of different configurations, including those described in U.S. Patent No. 4,515,595 issued to Kievit et al. On May 7, 985; U.S. Patent No. 5,026,364 issued to Robertson on June 25, 1991; and the previously referenced United States Patent No. 5,151,092 issued to Buell et al. on September 29, 1992, each of these references being hereby incorporated by reference. The elasticized side panels can be constructed in a number of configurations. Examples of diapers with elasticized side panels placed on the diaper ears (ear flaps) are disclosed in U.S. Patent No. 4,857,067 issued to Wood et al. On August 15, 1989; patent of the States No. 4,381, 781, issued to Sciaraffa et al. On May 3, 1983, United States Patent No. 4,983,753 issued to Van Gompel et al. On July 3, 1990; and in U.S. Patent No. 5,151,092, issued to Buell on September 29, 1992; each of which are incorporated herein by reference. Exemplary fastening systems 570 are disclosed in U.S. Patent No. 4,846,815 issued to Scripps on July 11, 1989; in U.S. Patent No. 4,894,060, issued to Nestegard on January 16, 1990; in U.S. Patent No. 4,946,527 issued to Battrell on August 7, 1990; U.S. Patent No. 3,848,594, issued Buell on November 19, 1974; in U.S. Patent No. B1 4,662,875, issued to Hirotsu et al. on May 5, 1987; and in U.S. Patent No. 5,151,092, issued to Buell et al. on September 29, 1992; each of which is incorporated herein by reference. The diaper 50 is applied to a wearer, placing one of the waist regions of the diaper, preferably the second waist region 58, under the wearer's back, and pulling the rest of the diaper 50 between the wearer's legs in such a way that the other waist region, preferably the first waist region 56, is placed across the front of the person. The clamping system is then applied to make a lateral closure. Of course, it will be recognized that any design of absorbent article can be used to carry out the methods of the present invention, as long as the skin care composition is applied to the article to be transferred to the skin during use. The above disclosure is for illustrative purposes only. The methods of the present invention may also employ training pants to effect the delivery of the desired skin care composition. The term "training pants", as used herein, refers to disposable garments that have fixed sides and leg openings designed for infant or adult users. Training pants (also referred to in the art as "pull-on" products) are placed in position on the user by inserting the user's legs into the leg openings and sliding the training pants into position around the lower torso of the leg. user. Suitable training pants are disclosed in U.S. Patent No. 5,246,433, issued to Hasse et al. On September 21, 1993; U.S. Patent No. 5,569,234 issued to Buell et al. on October 29, 1996; U.S. Patent No. 4,940,464 issued to Van Gompel et al. on July 10, 1990; and in U.S. Patent No. 5,092,861 issued to Nomura et al. on March 3, 1992, each of which is incorporated herein by reference. Another disposable absorbent article for use in the present methods • Are the items for incontinence. The term "incontinence article" refers to pads, undergarments (pads held in place by a suspension system of the same type, such as a belt, or the like), inserts for 5 absorbent articles, capacity enhancers for absorbent articles, trusses, bed pads, and the like, regardless of whether they are used by adults or other incontinent persons. Suitable incontinence articles are described in U.S. Patent No. 4,253,461 issued to Strickland et al. On March 3, 1981; U.S. Patent No. 4,597,760 and 4,597,761 issued to Buell, the aforementioned U.S. Patent No. 4,704,115; U.S. Patent No. 4,909,802 issued to Ahr et al .; U.S. Patent No. 4,964,860 issued to Gipson et al. on October 23, 1990; and PCT Publication No. WO 92/11830, The Procter & Gamble Company, published on July 23, 1992; each of which are incorporated herein by reference. Other disposable absorbent articles for use in the present methods are articles for feminine hygiene, such as sanitary napkins. Suitable feminine hygiene articles are disclosed in U.S. Patent No. 4,556,146 issued to Swanson et al. On December 3, 1985; U.S. Patent No. B1 4,589,876 issued to Van Tilburg on April 27, 1993; U.S. Patent No. 4,687,478 issued to Van Tilburg on August 18, 1997; U.S. Patent No. 4,950,264 issued to Osborn III on August 21, 1990; U.S. Patent No. 5,009,653 issued to Osborn III on April 23, 1991; U.S. Patent No. 5,267,992, issued to Van Tilburg on December 7, 1993; U.S. Patent No. 5,389,094 issued to Lavash et al. on February 14, 1995; U.S. Patent No. 5,413,568 issued to Road et al. on May 9, 1995; U.S. Patent No. 5,460,623 issued to Emenaker et al. on October 24, 1995; U.S. Patent No. 5,489,283 issued to Van Tilburg on February 6, 1996; U.S. Patent No. 5,569,231 issued to Emenaker et al. on October 29, 1996; and in U.S. Patent No. 5,620,430, issued to Bamber on April 15, 1997; each of which is incorporated herein by reference.
V. Treatment of articles with the composition.
In preparing the absorbent articles to carry out the methods of the present invention, the skin care composition is applied in such a manner that during use, at least some part of the composition will transfer from the treated article to the skin. of the user. That is, the skin care composition is either applied directly to one or more of the surfaces that are in contact with the user, or is applied in alternate locations or media such that the composition for care The skin is now available to transfer from one or more surfaces that are in contact with the user during use without intervention by the user or caregiver. (For example, the materials placed below the surface that is in contact with the user, encapsulated compositions, etc.) Of course, to effect the supply of the composition to those regions of the body most susceptible to skin diseases, it will be Preferred to include the composition on the part of the upper sheet and the folds that are in contact with the buttocks, genitals, intertriginous regions and the user's anus during use. Additionally, the composition can be applied to other regions of the article to supply one or more of the hip, abdomen, back, waist, sides, thighs, etc. of the user. Suitable methods include spraying, printing (eg, flexographic printing), coating (e.g., contact slot coating, gravure coating), extrusion, or combinations of these application techniques, e.g., spraying the composition for care of the skin on a rotating surface, such as calendering knee, which then transfers the composition to the desired portion of the article. The skin care composition can also be applied with a solid material via any of a variety of methods, for example extrusion. When applied to the top sheet of the article, the manner of applying the composition to the article should be such that the top sheet does not become saturated with the composition, at least in the region corresponding to the liquid discharge region of the article. , if the composition is hydrophobic by nature. If the top sheet becomes saturated with the composition of the liquid discharge region, there is a greater potential for the composition to block the openings of the top sheet, reducing the ability of the top sheet to transmit the liquid to the underlying absorbent core. . Also, saturation of the top sheet is not required to obtain the therapeutic and / or protective benefits. Similarly, saturation of other components of the treated article may not be necessary or desired to transfer sufficient composition for the desired benefits of the skin. Particularly suitable application methods will apply the composition primarily to the outer surface of the diaper upper sheet. The minimum level of the composition that is applied to the surface that is in contact with the article user is an effective amount to provide the • therapeutic, protective and / or skin conditioning benefits when the composition is supplied according to the present methods. The level of the composition applied will depend on several factors, including the component of the treated article, the relative amount of the surface area of the surface that is in contact with the untreated user with the composition, the content of the composition and the like. In general, with compositions that are relatively hydrophobic and that are to be applied to essentially all of the top sheet, the composition is preferably applied to the • top sheet of the article in an amount ranging from 0.016 mg / cm2 to approximately 2.33 mg / cm2, more preferably from approximately 0.16 mg / cm2 to approximately 1.55 mg / cm2. It will be recognized that higher levels of skin care composition 5 can be applied to other components of the article where fluid handling properties are not impacted (e.g., bends, waist band, side panels, etc.) It will also be recognized that for compositions that are relatively hydrophilic, higher levels can be used on the top sheet without adversely impacting the handling properties of the liquid up to 0 degree unacceptable. Conversely, higher levels of a hydrophilic composition may be undesirable when applied to components (eg, fold, waist) different from the top sheet to avoid the wicking effect or capillary action of the exudates towards the edges of the article. which can result in leaks. Because the composition is preferably substantially immobilized on the surface of the treated region, relatively small amounts of the composition are needed to reverse the desired benefits for skin care. Applicants believe that the ability to use low levels to impart the desired benefits to the skin is due to the fact that according to the methods described herein, the composition is supplied continuously, automatically, as the articles are carried. As indicated, the ability to use relatively low levels of the composition for skin care allows the top sheet of the article to maintain its liquid transfer properties in the liquid discharge region. The composition can be applied non-uniformly to the surface that is in contact with the user of the article. By "non-uniform" it is implied that the amount, location, distribution pattern, etc., of the composition may vary over the surface that is in contact with the user, and may vary more over specific regions of the article. For example, to maintain the liquid handling performance of the top sheet, it may be desired to apply the composition non-uniformly to the top sheet, particularly if the composition is hydrophobic in nature. In this regard, portions of the treated surface of the article (and regions thereof) may have a greater or lesser amount of composition, including portions of the surface that do not have any composition thereon. When the composition is relatively hydrophobic, in one of such preferred embodiment, the surface of the top sheet will have regions where no composition is applied, particularly in the areas of the top sheet that correspond to the crotch region of the article. As used herein, the crotch region of the article is the rectangle, defined below, that is longitudinally and laterally centered around the crotch point of the article. The "crotch point" is determined by placing the article in a user in a standing position and then placing an extendable filament around the legs in a configuration of Figure 8. The point in the article corresponding to the point of intersection of the filament is considered to be the crotch point of the article. (It is understood that the crotch point is determined by placing the absorbent article on a wearer in an intended manner and determining where the cross filament would contact the article.) With respect to incontinence devices (e.g., diapers, articles for adult incontinence), the length of the crotch region corresponds to 40% of the total length of the absorbent article (ie, in the dimension y). With respect to sanitary napkins, the length of the crotch region corresponds to 80% of the total length of the absorbent article. The width of the crotch region is equivalent to the width of the wider absorbent core component as measured at the crotch point. (As used herein, the "absorbent core" components are those materials involved with the acquisition, transport, distribution and / or storage of body fluids., the term absorbent core does not include the top sheet or the back sheet of the absorbent article.) By way of illustration, for an incontinence article having a length of 20 inches and a core width at the crotch point of 4 inches, The crotch region is the rectangle, centered at the crotch point, which has a length of 8 inches and a width of 4 inches. Surprisingly, although the topsheet or other components comprising the composition are treated non-uniformly (e.g., microscopic or macroscopic regions where composition is not applied), during the use of the article, the composition is transferred to the user even in the regions of the skin corresponding to the untreated regions within the upper sheet or other components. The amount and uniformity of the composition transferred to the skin is believed to depend on several factors, including, for example, the application pattern of the skin care composition, the contact of the skin of the wearer with respect to the skin. surface of the treated article, the heat generated from the user to improve the transfer of the composition, the properties of the composition, the materials constituting the composition, and the like. Where the composition is uniformly applied, any pattern can be used, including, for example, the application of small drops (obtained by way of, for example, sprinkling) discrete dots (obtained by way of, for example, gravure printing ), strips running in a longitudinal or lateral direction of the article (obtained by way of the coating by contact groove), spirals running in the longitudinal or lateral direction, etc., impressions with pattern, etc. In those embodiments where the top sheet comprises untreated, discrete regions, the percent of the open area of the top sheet region that corresponds to the crotch region of the article may vary widely. (As referred to herein, the "open area percent" of the top sheet is determined by (i) measuring the surface area of the top sheet lying on the crotch region, (ii) measuring the total surface area of the sheet. the region or regions not treated in this part of the upper sheet and (iii) dividing the measurement into (ii) by the measurement in (i) As used herein, "untreated" means a region of the upper sheet having less than about 0.0016 mg / cm2 of the composition In this respect the percent of the open area can be from about 1% to about 99%, from about 5% to about 95%, from about 10% to about 90%, of about 15% to about 85%, about 20% to about 80%, about 25% to about 75%, about 30% to about 70%, or about 35% to about 65%. open required for l The desired effect of the composition and the desired liquid handling properties of the top sheet will be dictated greatly by the characteristics of the composition (in particular the contents of the composition and its relative properties of hydrophobic capacity / hydrophilic capacity). One skilled in the art will appreciate that the percentage of the desired open area will be easily determined through routine experimentation. In general, with compositions that are relatively hydrophobic and that are to be applied in such a way that the regions of the top sheet are not coated with the composition, the composition is preferably applied to the top sheet of the article in an amount varying from about 0.0078 mg / cm2 to about 5.43 mg / cm2, more preferably from about 0.16 mg / cm2 to about 3.88 mg / cm2, even more preferably from about 0.62 mg / cm2 to about 3.1 mg / cm2. It will be recognized that for compositions that are relatively hydrophilic, added higher levels can be used without adversely impacting the liquid handling properties of the top sheet to an unacceptable extent. Of course, for items that have relatively high percentages of open areas in the crotch, higher added levels can be obtained without adversely affecting the handling of the liquid by the top sheet. In a preferred embodiment for carrying out the present methods, the topsheet of the articles used will comprise strips of composition running in the longitudinal direction of the article. These longitudinal strips (or spirals) are separated by longitudinal strips where little or nothing of the composition is applied to the upper sheet. In these embodiments, each strip of composition will typically have a width of about 0.1 inches to about 0.75 inches, more typically from about 0.1 inches to about 0.5 inches, and the width of strips that do not contain composition will typically be from about 0.1 inches to about 1 inch, more typically from about 0.15 to about 0.5 inches. These intervals are applicable to typical baby diaper designs. The larger products such as adult incontinence products, these intervals may be higher. The composition for skin care can also be applied in non-uniform patterns in other components of the article. In these cases, the open area is calculated by the rectangle defined by the perimeters of the composition for skin care. The composition can be applied to the article at any point during assembly. For example, the composition can be applied to the finished disposable absorbent product before it has been packaged. The composition can also be applied to a given component (for example, the top sheet, the folds, the sides, the waist, etc.), at the exchange site or by the material supplier, before it is combined with other materials. raw materials to form the finished disposable absorbent product. Again, the composition can be applied to other areas of the article such that the composition will migrate to one or more of the surfaces that are in contact with the user during use. The composition is typically applied from a molten substance thereof to the article. Since in a preferred embodiment, the composition melts at temperatures significantly above the ambient, it is usually applied as a hot composition to the article. Typically, the composition is heated to a temperature within the range of about 35 ° to about 150 ° C, preferably 40 ° to about 100 ° C, before being applied to the article. Once the molten composition has been applied to the article, it is allowed to cool and solidify. Preferably, the application process is designed to assist in the cooling / hardening of the composition. When applying the compositions to the articles, the methods of contact slot coating, spraying, gravure coating, extrusion coating are preferred. One of these methods involves slot coating the composition on the top sheet of the article after the top sheet is assembled with the other raw materials in a finished product.
SAW. TEST METHODS A. Evaluation of Erythema and Rash 1. Test Summary Two different diaper products for baby are evaluated to determine if there is a difference in the frequency and / or severity of the diaper rash and / or erythema in the diaper area. in an average baby population associated with the use of a test product (i.e., comprising a skin care composition on one or more of the surface that is in contact with the body) on that associated with the product of control (an equivalent product, with the exception that it does not contain composition for skin care). 2. Research plan 2.1. Study Design This study is conducted in a qualified clinical research organization (CRO) and must comply with good clinical practice guidelines (GCP). The study is a clinical trial of parallel group comparison, of double blindness, at random, in which both the trained skin classifier conducting the skin evaluations and the caregivers of the panelists will be unaware of the treatment assigned to the participants. of the study. A sufficient number of healthy babies will be recruited from a general population that resides in the geographic area of the clinical site to participate and complete this study in such a way that 200 babies, 100 per group, complete the study. Two groups of subjects will participate in this study. Both groups will include healthy babies, each comprising approximately 50% men and 50% women. The two groups will be balanced in diaper size and / or size (when diapers are appropriately sized). The two groups will consist of healthy babies who do not take medications for different conditions than those who are routine for that age, such as the common cold. All babies will present the type of skin on the Fitzpatrick scale of 1-11, and without evidence of serious dermatological conditions (eg, non-atopic). (Fitzpatrick l-lll skin types facilitate the classification of erythema). Some levels of erythema and diaper rash in the diaper region are permissible (defined under the exclusion criteria below) All infants who meet the enlistment criteria will be assigned to use the control product for one week (baseline At the end of a week, the babies will be randomly assigned to one of two possible groups, one group will remain in the control product for three weeks, the other group will use a trial product for a period of three weeks. such, the total duration of the test for both users of the control and test product is four weeks.At the point when the babies are randomly in two groups (Visit 2), the additional use of ointments, creams will not be allowed. , lotions, corn starch, or powder on the skin in the diaper area during the remaining period of the study.The use of soap, water, baby wipes or cleaning gels in the diaper changes and in the bathrooms. The skin condition of the babies will be evaluated in the following times: follow one week of baseline (Visit 2); twice a week for three weeks (Visits 3 to 8). Beginning with Visit 2, infants should be evaluated three hours (± 15 minutes) after being changed into a new diaper. (Preferably, this change being the first after the nighttime diaper). After Visit 2, subsequent visits should occur three to four days apart. 2. 2 Procedure Visit 1 (Enlistment): A. Eligibility will be determined based on the eligibility requirements listed below. B. Erythema and diaper rash evaluations will be conducted at four sites in the diaper area (genitals, internals, anus, and buttocks) to confirm the baby's acceptance of the test. Referring to Figures 2a, 2b, 2c, 2d, and 2e, the locations for the determination of erythema and rash classifiers are shown. Figure 2a shows the region 10 of the buttocks for determination in both men and women. Figure 2b shows the region 100 of the genital area of a female subject for the determination of erythema and rash. Figure 2b also shows the navel of a subject. For purposes of determining erythema and rash in the genital area of a female subject, the upper portion of region 100, shown as line 100a, is approximately 1 inch above the upper part of the lip opening . Figure 2c shows the region 200 of the genital area of a male subject for the determination of the erythema and the rash. Figure 2c also shows the umbilicus 210 of a subject. For purposes of determining erythema and rash in the genital area of a male subject, the upper portion of region 200, shown as line 200a, is approximately 1 inch above the top of the base of the penis. Figure 2d shows the region of year 300 for the determination of erythema and rash in both male and female subjects. Figure 2e shows the 400 regions of the intertrigino area of both the male and female subjects for the determination. OR Parents / babies receive the control product for the week-long baseline.
Visit 2 A. The baby is taken to the test site wearing a used diaper for three hours (± 15 minutes). B. The parents / baby proceeds with the skin classifier for the 0 evaluations of erythema and rash on the skin at the four sites in the diaper area (genitals, nerves, anus, and buttocks). • C. The baby is placed at random in any of the test or control group and product and instructions are given to eliminate the use of other lotions, creams, etc. 5 Visits 3 to 8 A. The baby is taken to the test site wearing a used diaper for three hours (± 15 minutes). B. The parents / baby proceeds with the skin classifier for the 0 evaluations of erythema and rash on the skin at the four sites in the diaper area (genitals, intertrigino, anus, and buttocks). O Compliance with the lotion restriction, etc. is confirmed. 2. 3. Study population 5 As indicated, it is expected that 200 babies will complete this study. Two groups of subjects will participate in this study, each group comprising approximately 50% men and 50% women. The two groups will be balanced in diaper size and / or size (when wearing appropriately sized diapers). The study population will consist of healthy babies who do not take medications for conditions other than those that are routine for this age, such as a cold / flu, with a skin type on the Fitzpatrick scale of 1-11, and without evidence of serious dermatological conditions (for example, not atopic) The presence of erythema and rash on the skin is permissible. 2. 3.1. Inclusion criteria Each baby must: • not have serious dermatological conditions in the diaper area. • be a full-time disposable diaper user. • have a caregiver willing to not use lotions, creams, powders or other preparations for the skin in the diaper area during the study.
The eligibility of each potential baby is also determined by compliance with a medical history and dermatology questionnaire. Subjects will be excluded from this study for one or more of the reasons listed below by the exclusion criteria. 2. 3.2 Exclusion criteria Babies are excluded from participation in the study if: • they do not meet the inclusion criteria. on the first visit these have a degree of diaper rash > 2.5. have diabetes or chicken pox. have psoriasis, ichthyosis. at Visit 1, these have a significant rash in the diaper area and whether it is the opinion of the Clinical Research Organization Principle investigator or the classifier that the baby should be excluded. the use of medications of any kind (oral antibiotics, antifungal agents, antihistamines, corticosteroids taken orally or applied topically to the skin), which in the opinion of the Researcher of the Principle of the Clinical Research Organization or classifier of the skin may have an influence on the skin of the baby in the diaper area. Do not adjust to the diaper as determined in Sight 1. Have any other medical condition that may compromise the study. They have experienced diarrhea within the previous four days. 2. 4 Test materials. The two treatment groups that will be included in this study are as follows: • Test Group: will use diapers that have a composition for skin care that is transferred to the user during use.
Control Group: they will use diapers equivalent to the Test group, but the diapers do not have composition for the skin care that is transferred to the user during use. • 2.5 Alietoriness Each subject will be assigned randomly, using a statistically valid randomization program, in Visit 2 for any control product or for the test product. The groups should be balanced by sex and age or diaper size. The twins (or multiple births) will be assigned to use the same product. • 2.6 Regimen and consent to treatment Babies will arrive at the research site at approximately the same time of the day for each visit. Babies are expected to use their assigned products only. Ointments, creams, lotions, or powders should not be used on the skin in the diaper area after Visit 2. Soap, water, baby wipes, or cleaning gels are allowed in diaper changes. The subjects must go to the site in such a way when their skin is evaluated, they will have been using a product for three hours (+/- 15min.). Preferably, it is immediately after the night diaper. In the event of an evacuation within three hours, the diaper should be changed as needed, and the skin evaluation should proceed as scheduled. 2. 7 Blindness The test is a parallel, randomized, double blind clinical comparison trial, in which a trained skin sorter conducting the skin evaluations, as well as the caregiver of the panelists, will be unaware of the treatment assigned to the participants in the study. 2. 8 Discontinuation / Termination of the Subject. • In addition to the exclusion criteria, a baby will be removed from the study due to: • Failing to appear for more than one visit. • Medication that is required which will have a significant effect on the condition of the baby's skin in the diaper area. 0 • They develop erythema or rashes from the diaper > 2.5 during the course of the study. • Non-compliance, if they wear their own diapers during the study, or if they use lotion, powder, etc. • Any illness that the Principle Researcher of the Clinical Research Organization decides may affect the results of the study. 2. 9 Observations and / or measurements • Skin evaluations will be conducted by a trained skin classifier who will be blinded as to the allocation of treatments for each subject. The same classifier must be used for all exams. The classifier must be experienced in evaluating the skin conditions of the baby in the region with the diaper, especially the diaper rash. Preferably, the classifier must be a nurse. The classifier will be separated from the area where the diapers are removed 5 so that the classifier will not see what diapers the babies are carrying.
In each examination period, each baby will be examined for erythema first, then for diaper rash, in 4 locations on the body (genitals, intertrigino, anus, and buttocks). The severity of the erythema and rash on the diaper will be each • evaluated using the rating scales shown below. A graphic representation of the four locations in the diaper are shown in Figures 2a to 2e. 3. Statistical Methods 3.1 Planned Statistical Analysis 0 For the purposes of the present disclosure, evidence of an improvement of the test product in rash or erythema is defined as a statistical or non-statistical difference (as defined above) in: (a) a more than the four skin classification locations for the study group as a whole; or (b) one or more of the four skin classification locations for any gender or age or subset of diaper size of the study group. The Baseline Visit will be defined as Visit 2; Subsequent visits to the Baseline Visit will be defined as Visits 3 through 8. For all parameters, separate analyzes will be made for each site. The same analyzes will be made on the degrees of severity of erythema (ie, redness) as • 0 for the degrees of severity of the diaper rash. The main interest comparison is between the treatment groups. The frequency of the diaper rash (or erythema) will be analyzed in two ways. First, the presence of the diaper rash (erythema) will be evaluated at any time during the course of the study. For each treatment group, the number and percentage of babies to whom the diaper rash (or erythema) was present (ie, the degree of severity of the diaper rash is greater than 0 at any subsequent visit to the baseline) and absent (ie, the degree of severity of the diaper rash is equal to 0 on each subsequent visit to the baseline) will be calculated. These dichotomous responses from the treatment group (ie, the presence or absence) will be analyzed by a quasi-square test. The effects of sex or age or diaper size should be investigated using the Mantel-Haenszel statistics or, if appropriate, a logarithmic linear or squared least-weighted model. The second way in which the frequency of the diaper rash (or erythema) will be analyzed is to evaluate the number of visits after the baseline in which the diaper rash (or erythema) was present for each subject (ie , the degree of diaper rash greater than 0). The number of visits after the baseline with the diaper rash (or erythema) will be analyzed using the linear logarithmic Poisson regression model. The effects of sex or age or diaper size should be investigated by incorporating these effects into the model. The severity of the diaper rash (or erythema) will be analyzed by evaluating the average severity of the diaper rash (or erythema) on all subsequent visits to the baseline. For each subject, the average of the degrees of severity of the rash per diaper (or erythema) of all subsequent visits to the baseline will be computed. These degrees of average severity will be analyzed using an analysis of the one-way variance model. A transformation (for example, logarithmic) can be done before the analysis to improve the distribution characteristics of the averages (that is, to improve the homogeneity of the variances of the treatment groups, to improve the normality of the analysis of the residuals of the variance ). Alternatively, a nonparametric analogue to one-way analysis of variance can be made (eg, the Wilcoxon Category Sum Test) if the analysis of the residuals of the variance does not fit adequately to a normal distribution and The variances of the treatment group are not sufficiently homogeneous. The effects of sex or age or diaper size should be investigated, incorporating these effects in the analysis of the model of variance.
ERITEMA CLASSIFICATION SCALE 0 None The skin is clear (may have some slight dryness) 0. 5 Light Tenuous to pink defined in a very small area (< 2%) 1. 0 Mild Tenue to pink defined in a small area (2-10%) or reddening defined in very small area (< 2%) 1. 5 Light / Light Tenuous to pink defined in a large area (> 10%) or reddening defined in small area (2 to 10%) or Very intense redness in very small area (< 2%) 2. 0 Moderate Redness defined in larger area (10-50%) or very intense redness in very small area (< 2%) with edema 2.5 Reddening Defined Moderate / Intense in very large area (> 50%) or Very intense redness in small area (2-10%) with edema 3.0 Severe redness / Very intense in greater area (> 10%) with edema SCRAP CLASSIFICATION SCALE None The skin is clear (it may have some very slight dryness and / or an individual papule but no erythema) 0.5 Light Erythema: Tenuous to pink defined in a very small area (< 2%). It may also have an individual papule; and may also have: Skin Integrity: some very light dryness M 1.0 Mild Erythema: Tenuous to pink defined in a small area (2-10%) or Reddening Defined in a very small area (< 2%) and / or Papules : A few disseminated papules (2-5) It may also have: 0 Skin integrity: Some light dryness or scab 1.5 Mild / Moderate Erythema: Tenuous to Pink Defined in a larger area • (> 10%) or Reddening Defined in small area (2-10%) or very intense redness in a very small area (< 2%) and / or 5 Papules: slightly scattered papules that cover an individual area or areas multiple (< 10%) may also have: Skin integrity: moderate dryness or crust • 2.0 Moderate Erythema: Redness Defined in large area (10-50%) or 0 very intense redness in a very small area (2%) and / or Papules / Pustules: areas of papules from individual to several, with 0-5 pustules. You may also have: 5 Skin integrity: some peeling or light edema. 2. 5 Moderate / Severe Erythema: Redness Defined in very large area (> 50%) or very intense redness in a small area (2-10%) and / or Papules / Pustules: larger areas (> 50%) of papules multiple or numerous pustules or both and / or may also have: Skin integrity: peeling or edema Moderate 3.0 Severe Erythema: very intense redness in large area (> 10%) and / or skin integrity: severe peeling, edema severe, erosion and ulceration. It may also have: Large areas of confluent papules or numerous pustules / vesicles.
B. Transfer of the composition for skin care to the skin of the user. Summary This method uses an analogous material from removable skin that is placed on a user's skin for a controlled period of time. After the skin analogue has been removed it is extracted using an appropriate solvent and the amount of the skin care composition deposited thereon is determined using known analytical methods. The method is described for use with baby diapers comprising skin care compositions, as defined herein. A person skilled in the art will recognize appropriate changes for other skin care compositions, absorbent articles, or user types.
Subjects • Numbers of approximately equal men and women should be selected using the following inclusion and exclusion criteria. Sufficient babies should be selected to ensure that there are at least fifteen subjects per condition and time of transfer who complete all aspects of the test.
Inclusion criteria • a. Healthy baby b. Caregiver willing not to use lotions, creams, powders or other preparations for the skin in the diaper area for the duration of the test. c. Infants who use disposable diapers full time d. Caregiver willing to give the baby a bath in the morning before the study and not again until the completion of the study. and. The caregiver will ensure that the child refrains from swimming from the morning before the study until after the completion of the study. F. Preferably, babies who have infrequent bowel movements.
Exclusion criteria a. The baby who has been sick within the last four days. b. Diarrhea (soft stools) at any time during the four days before the test. c. Medication which can increase the frequency of stools (for example, oral antibiotics, anti-fungal agents, corticosteroids). d. Damaged skin in or around the test site (eg, from sunburns, active skin lesions, or the like). and. Allergies or known irritations of the adhesives or the ingredients for the care of the skin.
Materials Transfer in vivo Skin analogue: Dermatological tape-TEGADERM No. 1622 W available from 3MHeaIth Cares, St.Paul, MN. Sample container: Glass jar with closure available from VWR Scientific, West Chester, PA as catalog number 15900-242. Ribbon release powder: Baby powder (comprising only talc and fragrance) available from Johnson & Johnson, New Brunswick, NJ: Surgical Gloves: Available from Best Manufacturing Co., Menlo GA, as a 6005PFM product. Extraction and Analysis Extraction Solvent: Dichloromethane, available from Sigma-Aldrich of St. Louis, MO as 27056-3. Stearyl alcohol: Aldrich 25876-8 1-Hexadecanol: Aldrich 25874-1 Matras supply: 10 ml. Gas chromatograph: Flame ionization detector, Hewlett Packard Model 5890, is suitable.
Column: Capillary column: Chrompack CP Sil-5 CB, melted silica capillary with a film thickness of 0.12 microns of 2 meters by 0.25 mm internal diameter (no substitutions). Instrumental Data System: Must be able to determine in a reproducible manner the areas of the peaks of interest.
Live transfer method A. Confirm from subjects' caregivers that the subject is bathed within the last 24 hours and that no lotions, powders, etc. have been applied to the diaper region of the subject's skin. who bathed B. Use surgical gloves, place the subject on the table and remove his diaper. O Flip the subject over his stomach. D. Remove the release liner from the TEGADERM tape and lightly rub J &J baby powder over the surface of the adhesive (use surgical gloves, or the like during application to avoid contamination of the tape). Provide sufficient powder so that there is a light coating of powder on all tape except the edges. (This stage is made to prevent the tape from adhering too aggressively to the child's skin). E. Figures 3a and 3b illustrate the placement location for the TEGADERM tape, showing in those figures as the tape 700. Apply the tape 700 to the right seat of the child. The tape 700 is to be applied to the highest point on the child's seat immediately adjacent to, but not in, the groove of the child's buttocks. A second tape 700 can be applied to measure the transfer in two increments of time or the effect of an additional diaper. If a second tape is used, apply tape 700 to the left seat using the procedure described above. F. Change the diapers according to the following protocol: 3 hours of transfer time to 1 diaper; 6 hours of transfer time to 2 diapers (change at 3 hours); 24 hours transfer time ad lib by the caregiver. For 24-hour transfer times the following additional instructions must be followed: 1. Use only water and a wet cloth to wet the diaper area for the duration of the test. Do not use baby towels, avoid touching the area around the tapes with your hands or with any cleaning implement. 2. Do not use skin care products (lotions, ointments, creams, soap, etc.) for the duration of the test. 3. Do not bathe the subject for the duration of the test. 4. Use only the test diapers. to register the time of each diaper change. 5. Record the time of any evacuation and cleaning of the subject with water and / or a wet cloth. G. Record the time of each diaper that was applied for all the test diapers. H. Remind the subject near the end of the predetermined transfer time. I. Remove the test diaper. If the child has had an evacuation, the study staff should remove the tape 700 and discard it (the subject must then complete the test and the data from which this subject is not included in the analysis). If the subject has urinated, the tape 700 will be acceptable for the analysis as described below. J. Personnel in the test facility should wear surgical gloves and remove the tape 700 by pulling the edge of the tape 700 with pliers and gently separating the remaining portion of the tape 700 from the skin. K. Place the used tape 700 in one of the glass jars and close the lid. Make sure the jar is labeled appropriately for later identification of the sample. L. Upon completion of the test collect all samples in the jars for analysis as described below. Extraction and Analysis This method is designed to be used with the preferred skin care composition, the skin care composition of Table 1. A person with ordinary skill in the art will recognize that adaptations may be necessary to extract and remove the skin. analyze the level of other compositions for skin care. In principle: 1) one of the main ingredients of the composition is extracted from the skin analog using a suitable solvent; 2) then gas chromatography techniques or other appropriate quantitative analytical techniques are used to determine the level of the main ingredient in the extract; 3) the amount of the skin care composition per unit area is calculated based on the amount of the main ingredient in the extract and the area of the tape. Internal standard / extraction solvent Prepare an internal standard / extraction solvent by weighing exactly 100 ± 2 mg of 1-hexadecanol in a small beaker. Dissolve the 1-hexadecanol in dichloromethane and transfer a one liter volumetric flask. Rinse the glass three more times with dichloromethane transferring each rinse portion to the volumetric flask. Fill the volumetric flask to the volume and mix well. This solution will be used to supply a standard internal skin care composition and extract of the tapes. When not in use, this container should be kept tightly capped to avoid evaporation of the solvent. Calibration standard Prepare a calibration standard of known concentration by weighing exactly (+0.1 mg) 10 +1 mg of stearyl alcohol in a 100 ml volumetric flask. Record the weight of the alcohol used. Add the standard internal solvent / extraction to the flask and mix until dissolved. Fill the volume and mix well. When not in use, this container should be kept tightly capped to avoid evaporation of the solvent. This solution will be used to determine the relative response of stearyl alcohol to the internal standard of 1 hexadecanol for instrument calibration. Preparation and calibration of the gas chromatograph All equipment must be installed, operated and maintained in accordance with the manufacturer's recommendations. Install the column and check all gas flows with the column oven at 100 ° C and the injection port and detector at operating temperatures. The GC will be operated under the following conditions: Carrier gas: Hydrogen (helium can be used); flow rate 1.5 ml / min Injection port: 325 ° C; vent flow divided 30 ml / min; straight through the lining with glass cloth plug; microsello Merlin. Injection volume: 2 μl divided FID detector: 350 ° C; Gas flow established according to the manufacturer's suggestions. Typical gas flows are 400 ml / minute for air, 30 ml / minute for hydrogen and 30 ml / minute for auxiliary gas (formation). Column oven: 100 ° C elevated at 15 ° C per minute up to 325 ° C; held for 10 minutes. Ensure all connections are tight and leak-free. Turn on the detector and allow it to stabilize. Condition the column at 325 ° C for 30 minutes. Clean the syringe with dichloromethane as needed. The syringe should also be rinsed with dichloromethane a few times before each injection. Make several runs in white with injections of dichloromethane to ensure that a good baseline is obtained and that no strange peaks are present in the chromatograph. If strange peaks are present or the baseline is not adequate, download the fault and correct the problem or problems. Calibrate the instrument using the previously prepared calibration standard. Consult the manufacturer's instructions for the data system for the appropriate sequence of operations. The calculations must be performed in a manner similar to that described in calculations below in order to provide the desired result. Sample analysis procedure 1) Remove the lid of the sample jar and add 10 ml of the extraction solvent solution / internal standard using the dispensing flask. Replace the lid and swirl the contents to ensure that the tape 700 is not adhering to the sides of the jar and that it is completely submerged in the solvent. Repeat for all samples. 2) Allow the samples to settle for 16 hours (typically done at night). 3) Arremolinar the contents of the jar to mix. Using a transfer pipette, transfer an aliquot of the sample extract to an appropriately labeled autosampler vial. Put a lid on the vial. Replace the lid of the jar and hold it until the tests are completed. Repeat for all samples. 4) Place the ampules on the autosampler in random order and start the analysis using the GC conditions described above. The first vial should be a sample of dichloromethane. Several "check" standards (approximately every 20 samples) must be placed throughout the march to verify correct operation. 5) After finishing the march, check each chromatogram to ensure the proper analysis. If a problem is suspected, discard the fault and correct it. Re-analyze the samples as needed. Calculations The total micrograms of stearyl alcohol in each sample extract were calculated based on the relative response of the stearyl alcohol peak to that of the internal 1-hexadecanol standard. The ratio of the peak areas is multiplied by the relative response factor (determined at the time of calibration of the instrument) and the micrograms of the internal standard in the extract to produce the total μg of stearyl alcohol in a sample. Calibration of the instrument Determine the relative response factor, instrumental, for the stearyl alcohol and the internal standard based on the areas of the stearyl alcohol peaks and 1-hexadecanol in the standard calibration chromatogram.
Area nst Weight sa Response factor (Rf) = XX 10 Weight nst Area sa Where Area nst: Peak area of the GC for the internal standard in the calibration standard Area sa: peak area of the GC for the stearyl alcohol in the Calibration standard Weight inst: Actual micrograms of the internal standard used to prepare the internal standard / extraction solvent. Weight sa: Micrograms of stearyl alcohol used to prepare the calibration standard. Calculations of the test sample Calculate the total micrograms of stearyl alcohol in each test sample using the peak areas from the chromatogram of the sample sample in the following equation: Area sa Weight nst Total μg SA = x Rf X Area ¡ nst 100 Where Area nst: GC for the internal standard in the test sample Area sa: GC peak area for stearyl alcohol in the test sample Weight nst: Micrograms of the internal standard used to prepare the internal standard / solvent for extraction. Report the amounts of the skin care composition transferred in mg / cm2 where: X μg of stearyl alcohol Transferred composition = (concentration of stearyl alcohol in the composition) X (tape area) For the method described above the concentration of stearyl alcohol in the composition is 41% and the tape patch measures 4.4 cm X 4.4 cm. Therefore Transferred composition: = (0.001 X μg stearyl alcohol) / (0.41 X 4.4 cm X 4.4 cm) 0.000126 X μg stearyl alcohol (mg / cm2) • VII Specific examples The following are specific illustrations of (a) treatment of upper sheets of the diaper with skin care compositions and (b) methods of the present invention using articles comprising those top sheets. Similar approaches can be used to treat other components to provide 0 items treated for use in the present methods.
Example 1: Preparation of an absorbent article having a topsheet comprising a skin care composition 5 A. Preparation of the skin care composition A skin care composition is made (composition A) mixing the following melted components together (i.e., liquid): petrolatum (available from Witco Corp., Greenwich, CT), stearyl alcohol (available from The Procter &Gamble Company, Cincinnati, OH as CO1897) and aloe extract (available from • 0 Madis Botanicals, Inc., South Hackensack, NJ as Veragel Lipoid in Kaydol). The percentages in pesos of its components are shown in Table 1 below: Table 1 B. Preparation of a treated article by contact groove coating The composition A is placed inside a heated tank operating at a temperature of 170 ° F. The composition is subsequently applied with a contact applicator (using, for example, a Meltex EP45 thermal fusion adhesive applicator head having 5 slots and operating at a temperature of 170 ° F) on the top sheet of an article in a strip pattern where the strips run in the longitudinal direction of the article. Specifically 5 strips are applied, each strip measuring 0.25 inches wide (ie, in the lateral direction of the articles) and 11.75 inches long at an equal level of 12 g / m2, 1.19 mg / cm2. The distance between the strips is 0.31 inches. The article to which the skin care composition is added in this example is the commercially available Pampers Premium (size 4) diapers available from Procter & Gamble, Cincinnati, OH: Example 2: Method to improve skin health A diaper is placed on a 20-pound baby who typically exhibits a moderate diaper rash and erythema over a period of 21 days using the diaper of example 1. The baby's diaper is changed from according to the caregiver's routine patterns. (Typical diaper patterns consist of changes every three to four hours during the day and the application of a new diaper before sleeping at night.) Intervention by the caregiver does not occur, in the form of manual application of protective products or Moisture repellents, during this period. During the 21-day period the subject is observed to have a reduced severity of rash and erythema.
Example 3: Method for improving skin health An active incontinent adult weighing 165 pounds who consistently uses absorbent articles and who persistently has mild erythema uses an adult incontinence product analogous to the diaper of Example 1 for a period of time of at least 5 days. The subject's article is changed according to the user's routine patterns. (Typical patterns of change consist of changes every four or five hours during the day and the application of a new item before going to sleep at night.) No intervention by the user, in the form of manual application of protective products or moisture repellents of the skin, during this period. At the end of the 5-day period the subject is observed to have reduced or resolved erythema. Example 4: Method for improving skin health A diaper is placed on a 32-pound baby who exhibits mild diaper rashes and erythema for a period of at least about 5 days using the diaper of Example 1 only during sleep at night. (That is, an untreated item is used throughout the day.) The baby's diaper is changed according to the caregiver's routine patterns. There is no intervention by the caregiver, in the form of manual application of protective products or skin moisture repellents, during this period. At the end of the 5-day period, the subject is observed to have a reduced or resolved rash or erythema. Example 5: Method for maintaining skin health A baby who weighs 25 pounds who does not exhibit a rash from a diaper or erythema is diagnosed with otitis media and is pre-enrolled in a course of systemic antibiotics.
Based on experience with conventional (untreated) diapers, the caregiver expects the baby to develop erythema and / or diaper rash that results from loose bowel movements. As a result, diapers such as those described in Example 1 are used continuously throughout the period of administration of the antibiotic. The intervention of the caregiver does not occur, in the form of the manual application of protective products or repellents of skin moisture, during this period. Throughout the period of administration of the antibiotic, the subject does not exhibit erythema or rash per diaper.

Claims (54)

1. A method for improving and / or maintaining skin health of a user in the area covered by an absorbent article, the method comprising the following steps: (a) applying the user of an absorbent article having a composition for the care of skin that provides a therapeutic and / or protective benefit to the skin upon transfer to the user's skin, wherein the absorbent article comprises a liquid-permeable topsheet; (b) transferring to the user at least a part of the composition for skin care during use; and (c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin in the area covered by the absorbent article, in relation to the skin covered by an article equivalent absorbent which does not comprise the composition for skin care; where the composition for the care of semi-solid or solid skin to 20 ° C and comprises: (i) from about 5 to about 95% of an emollient; and (ii) from about 5 to about 95% of one or more agents capable of immobilizing the emollient on or within the article, one or more of the immobilizing agents having a melting point of at least about 35 ° C.
The method according to claim 1, wherein the absorbent articles comprising a composition for skin care are applied to the user at each change of the article.
3. The method according to claim 1, wherein the absorbent articles that do not comprise a skin care composition are applied to a user intermittently.
4. The method according to claim 1, wherein the articles comprising a composition for skin care are applied to the user only when they sleep at night.
The method according to claim 1, wherein the absorbent articles comprising a skin care composition are applied to a user whose skin is compromised and are used often enough to reduce the rash and / or erythema. on the skin.
6. The method according to claim 1, wherein steps (a) and (b) are repeated at least once per day for at least 4 days.
The method according to claim 1, wherein the skin care composition comprises a petroleum-based emollient selected from the group consisting of mineral oil, petrolatum, and mixtures thereof.
8. The method according to claim 7, wherein the skin care composition comprises petrolatum.
The method according to claim 1, wherein the improvement in skin health in the area of a user covered by the absorbent articles having a composition for skin care, in relation to the skin covered by Equivalent absorbent articles that do not comprise the composition for skin care, is manifested in terms of the reduction or nullification of erythema and / or rash.
The method according to claim 9, wherein the skin in the area of a wearer covered by the absorbent articles having a skin care composition shows an improvement in skin health of at least 10% with respect to the skin covered by equivalent absorbent articles that does not comprise the skin care composition, as measured by the frequency and / or severity of the rash and / or erythema.
The method according to claim 10, wherein the skin shows an improvement in skin health of at least 15%, as measured by the frequency and / or severity of the rash and / or erythema.
The method according to claim 1, wherein in step (b), at least about 0.0016 mg / cm2 of the skin care composition is transferred to the user during use of the article treated with the composition for skin care.
13. The method according to claim 12, wherein in step (b), at least about 0.0078 mg / cm2 of the skin care composition is transferred to the wearer's skin during use of the article treated with the skin care composition.
The method according to claim 13, wherein in step (b), at least about 0.016 mg / cm2 of the skin care composition is transferred to the wearer's skin during the use of the treated article with the composition for skin care.
The method according to claim 14, wherein in step (b), from about 0.0016 mg / cm2 to about 0.78 mg / cm2 of the skin care composition is transferred to the user during use of the article treated with the composition for skin care.
The method according to claim 1, wherein the skin care composition transferred to the user comprises a member selected from the group consisting of oil-based emollients.; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
17. The method according to claim 16, wherein the skin care composition comprises petrolatum.
18. The method according to claim 1, wherein the skin care composition is applied to the liquid permeable topsheet such that one or more regions of the topsheet are not treated with the composition for the skin care.
The method according to claim 18, wherein the skin care composition is applied to the topsheet in the form of a plurality of strips that are separated by a plurality of strips that do not have the composition for the skin. skin care.
20. A method for improving and / or maintaining skin health in the area of a user covered by an absorbent article, the method comprising the following steps: (a) applying the user of an absorbent article having a composition for the skin care applied non-uniformly thereto which provides a therapeutic and / or protective benefit to the skin upon transfer to the wearer's skin, wherein the absorbent article comprises a liquid-permeable topsheet; (b) transferring to the user at least a part of the composition for skin care during use; and (c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin covered by the absorbent article, relative to the skin covered by an equivalent absorbent article that does not understand the composition for skin care.
The method according to claim 20, wherein the skin care composition is applied to the liquid permeable topsheet such that one or more regions of the topsheet are not treated with the composition for the skin care.
22. The method according to claim 21, wherein the skin care composition is applied to the topsheet in the form of a plurality of strips that are separated by a plurality of strips that do not have the composition for the skin. skin care.
23. The method according to claim 20, wherein the absorbent articles comprising a skin care composition are applied to a user whose skin is compromised and are worn often enough to reduce the rash and / or erythema on the skin. the skin.
24. The method according to claim 20, wherein the skin care composition transferred to the user comprises a member selected from the group consisting of petroleum-based emollients; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
25. A method for improving and / or maintaining skin health in the area of a user covered by an absorbent article, the method comprising the following steps: (a) applying to the user of an absorbent article having a composition for the skin care that provides a therapeutic and / or protective benefit to the skin by transferring it to the user's skin, wherein the absorbent article comprises a liquid-permeable topsheet and wherein the composition for skin care is present on the skin. top sheet in an amount of about 0.0078 mg / cm2 to about 12 mg / cm2; (b) transferring to the user at least a part of the composition for skin care during use; and (c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin covered by the absorbent article, relative to the skin covered by an equivalent absorbent article that does not understand the composition for skin care.
26. The method according to claim 25, wherein the skin care composition is applied to the liquid permeable topsheet such that one or more regions of the topsheet are not treated with the composition for the skin. skin care.
27. The method according to claim 26, wherein the skin care composition is applied to the topsheet in the form of a plurality of strips that are separated by a plurality of strips that do not have the composition for the skin. skin care.
The method according to claim 25, wherein the absorbent articles comprising a skin care composition are applied to a user whose skin is compromised and are worn often enough to reduce the rash and / or erythema on the skin. the skin.
29. The method of claim 25, wherein the skin care composition transferred to the user comprises a member selected from the group consisting of petroleum-based emollients; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
30. A method for improving and / or maintaining the health of the skin in the area of a user covered by an absorbent article, the method comprising the steps • following: (a) applying to the user of an absorbent article having a skin care composition that provides a therapeutic and / or protective benefit to the skin upon transfer to the user's skin, wherein the absorbent article comprises surfaces that are in contact with the user such as a liquid-permeable top sheet, folds, waistband, and side panels, and wherein the skin care composition is applied to the top sheet and at least one additional surface that is in contact with the user; 0 (b) transferring to the user at least a part of the composition for skin care during use; and (c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin covered by the absorbent article, relative to the skin covered by an equivalent absorbent article that No. 5 comprises the composition for skin care.
31. The method according to claim 30, wherein the skin care composition is applied to the liquid permeable topsheet such that one or more regions of the topsheet are not treated with the composition for the care of the skin. the skin.
32. The method according to claim 31, wherein the skin care composition is applied to the topsheet in the form of a plurality of strips that are separated by a plurality of strips that do not have the composition for the skin. skin care.
33. The method according to claim 30, wherein the absorbent articles comprising a composition for skin care are applied to a user whose skin is compromised and are frequently worn. • enough to reduce the rash and / or erythema on the skin.
34. The method according to claim 30, wherein the skin care composition transferred to the user comprises a member 5 selected from the group consisting of petroleum-based emollients; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and 0 derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; 5 shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
35. A method for improving and / or maintaining skin health in the area of a user covered by an absorbent article, the method comprising the following steps: (a) applying the user of an absorbent article having a composition for the skin care that provides a therapeutic and / or protective benefit to the skin by transferring it to the user's skin; (b) transferring to the user at least a part of the composition for skin care during use; and (c) repeating steps (a) and (b) with one or more additional articles often sufficient to maintain or improve the health of the skin in the area covered by the absorbent article, in relation to the skin covered by an article equivalent absorbent which does not comprise the composition for skin care.
36. The method according to claim 35, wherein the absorbent articles comprising a composition for skin care are applied to the user at each change of the article.
37. The method according to claim 35, wherein the absorbent articles that do not comprise a skin care composition are applied to a user intermittently.
38. The method according to claim 35, wherein articles comprising a composition for skin care are applied to the user only when they sleep at night.
39. The method according to claim 35, wherein the absorbent articles comprising a skin care composition are applied to a user whose skin is compromised and are used often enough to reduce the rash and / or erythema. on the skin.
40. The method according to claim 35, wherein steps (a) and (b) are repeated at least once per day for at least 4 days.
41. The method according to claim 35, wherein the maintenance or improvement in the health of the skin of a user in the area covered by the absorbent articles having a composition for skin care, in relation to the skin. covered by equivalent absorbent articles that do not comprise the composition for skin care, is manifested in terms of the reduction or nullification of the erythema and / or rash.
42. The method according to claim 41, wherein skin in the area covered by the absorbent articles having a composition for skin care show an improvement of at least 10% in relation to the skin covered by absorbent articles. equivalents that do not comprise the composition for skin care, as measured by the frequency and / or severity of the rash and / or erythema.
43. The method according to claim 42, wherein the skin shows an improvement in skin health of at least 15% relative to the skin covered by equivalent absorbent articles that do not comprise the composition for the care of the skin. skin, as measured by the frequency and / or severity of the rash and / or erythema.
44. The method according to claim 35, wherein in step (b), at least about 0.0016 mg / cm2 of the skin care composition is transferred to the user during use of the article treated with the composition. for skin care.
45. The method according to claim 44, wherein in step (b), at least about 0.0078 mg / cm2 of the skin care composition is transferred to the wearer's skin during the use of the treated article. with the composition for skin care.
46. The method according to claim 45, wherein in step (b), at least about 0.016 mg / cm2 of the skin care composition is transferred to the user's skin during the use of the treated article with the composition for skin care.
47. The method according to claim 46, wherein in step (b), from about 0.0016 mg / cm2 to about 0.78 mg / cm2 of the skin care composition is transferred to the user during use of the article. treated with the composition for skin care.
48. The method according to claim 35, wherein the skin care composition transferred to the user comprises a member selected from the group consisting of oil-based emollients.; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
49. The method according to claim 48, wherein the skin care composition comprises petrolatum.
50. The method according to claim 35, wherein the article of step (a) comprises: A) a back sheet impervious to liquid; B) a liquid-permeable upper sheet having a body-facing surface and a garment-facing surface, wherein at least a portion of the top sheet comprises the composition for skin care and wherein the composition for skin care is semi-solid or solid at 20 ° C; and C) an absorbent core positioned between the top sheet and the back sheet.
51. The method according to claim 35, wherein the skin care composition transferred to the user comprises a member selected from the group consisting of petroleum-based emollients; emollients of the fatty acid ester type; emollients of the alkyl toxylate type; emollients of fatty acid ester ethoxylate; emollients of the fatty alcohol type; emollients of the polysiloxane type; acid grades of sucrose ester; polyethylene glycol and derivatives thereof; sorbitol and derivatives thereof; trihydroxysterin and derivatives thereof; propylene glycol and derivatives thereof; glycerin and derivatives thereof; triethylene glycol and derivatives thereof; spermaceti and other waxes; fatty acids; fatty alcohol ethers; propoxylated fatty alcohols; fatty esters of polyhydric alcohols; lanolin and its derivatives; kaolin and its derivatives; allantoin; aluminum hydroxide gel; calamine; cocoa butter; cod liver oil; kaolina; lanolin; mineral oil; shark liver oil; white petrolatum; talcum powder; topical starch; zinc acetate; zinc carbonate; zinc oxide; live yeast cell derivatives; aldioxa; aluminum acetate; microporous card; cholecalciferol; colloidal oatmeal; cysteine hydrochloride; Decantanol; balsam oil from Peru; protein hydrosylates; methionineracemic; sodium bicarbonate; Vitamin A; and mixtures thereof.
52. The method according to claim 51, wherein the skin care composition comprises petrolatum.
53. The method according to claim 50, wherein the skin care composition is applied to the liquid permeable topsheet such that one or more regions of the topsheet are not treated with the composition for the skin. skin care.
54. The method according to claim 53, wherein the skin care composition is applied to the topsheet in the form of a plurality of strips that are separated by a plurality of strips that do not have the composition for the skin. skin care.
MXPA/A/2000/002480A 1997-09-10 2000-03-10 A method for maintaining or improving skin health MXPA00002480A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08926532 1997-09-10

Publications (1)

Publication Number Publication Date
MXPA00002480A true MXPA00002480A (en) 2001-06-26

Family

ID=

Similar Documents

Publication Publication Date Title
CA2302377C (en) A method for maintaining or improving skin health
JP4439728B2 (en) Proton donating active ingredient in absorbent products
US6710223B1 (en) Method for improving skin condition
JP4926355B2 (en) Articles having movable breathable skin care compositions
JP2002505916A (en) Disposable absorbent products having skin care compositions containing enzyme inhibitors
MXPA00002480A (en) A method for maintaining or improving skin health
MXPA00002482A (en) A method for improving skin condition
MXPA00008933A (en) Proton donating actives in absorbent articles
MXPA00002481A (en) Disposable absorbent articles providing a skin condition benefit