WO2000074643A1 - Batons de soins de la peau - Google Patents

Batons de soins de la peau Download PDF

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Publication number
WO2000074643A1
WO2000074643A1 PCT/US2000/015198 US0015198W WO0074643A1 WO 2000074643 A1 WO2000074643 A1 WO 2000074643A1 US 0015198 W US0015198 W US 0015198W WO 0074643 A1 WO0074643 A1 WO 0074643A1
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WO
WIPO (PCT)
Prior art keywords
skm
composition
care
stick
skin
Prior art date
Application number
PCT/US2000/015198
Other languages
English (en)
Inventor
Jocelyn Elaine Mcosker
Thomas Robert Hanser
Ronald Dean Cramer
Nancy Christine Irvan
James Patrick Ebel
Original Assignee
The Procter & Gamble 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 & Gamble Company filed Critical The Procter & Gamble Company
Publication of WO2000074643A1 publication Critical patent/WO2000074643A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/342—Alcohols having more than seven atoms in an unbroken chain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0216—Solid or semisolid forms
    • A61K8/0229—Sticks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/31—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/37—Esters of carboxylic acids
    • A61K8/375—Esters of carboxylic acids the alcohol moiety containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • skm under an absorbent article is susceptible to many skm problems, such as diaper rash or diaper dermatitis, erythema (redness), heat rash, abrasion, pressure marks, wrinkled appearance, roughness, chaffing and diminished skm barrier function
  • Diaper rash or diaper dermatitis is an inflammatory skm condition, which is generally associated with prolonged and repeated exposure to u ⁇ ne and feces.
  • diaper rash has been linked to a multitude of other factors m association with u ⁇ ne and feces, such as moisture, bacte ⁇ a and/or yeast activities and by-products, pH, enzyme and protease activities.
  • the compromised skm (i.e., skm showing the problems desc ⁇ bed above) is predisposed to bacte ⁇ a or yeast infections, most commonly caused by Staphylococcus aureus or Candida albicans. Additionally, higher pH favors bacte ⁇ al growth, which not only further lr ⁇ tates the skm but also produces bacte ⁇ al by-products that blocks the sweat ducts and leads to heat rash. While these skm conditions are most common m infants, they may also develop in other susceptible individuals who use absorbent articles for an extended pe ⁇ od to tend to personal needs or health conditions, such as incontinence, menstruation, bed- ⁇ dden illness, old age.
  • Another approach is to apply a topical cream, ointment, lotion or paste to the affected skin.
  • This procedure usually provides some degree of physical barrier protection to the skm against direct contact with irritants
  • the barrier approach may be occlusive in itself, thus not very effective once a full blown case of diaper dermatitis has developed
  • the excess cream/omtment may transfer to the absorbent article or other clothing, such as undergarment, leading to reduced absorbency of the article or stained clothing. This procedure is also time-consuming and often forgotten.
  • Diaper rash creams or ointments are customarily applied to the skm by hand. Often a sticky residual cream/omtment remains on the reusable container's opening or the caregiver's hands. Since the cream/omtment composition often has a thick, greasy and tacky consistency in order to adhere to the skm when applied, the residual composition is not easily removed from the container or the hands. Therefore, this practice may increase the incidences of cross contamination between infants.
  • the skm care composition may contain bar ⁇ er substances, skm conditioning agents or emollients, and other skm care ingredients that provide the desired skm benefits
  • the skm care composition may be a solution, emulsion or suspension.
  • a good dispersion of the ingredients m the skin care composition is highly desirable.
  • a "good" dispersion means the ingredients are uniformly dispersed in the medium, and is stable, i.e., no substantial coalescence, agglomeration, stratification, or settling with time. Uniform distribution of the ingredients minimizes the variations in product quality and assures that every application of the product to the skm delivers a sufficient amount of the skm care ingredients to achieve efficacy.
  • Coalescence, agglomeration, stratification and gravitational settling are often observed when the insoluble or noncompatible components are dispersed in a Newtonian fluid, particularly when the density difference between the dispersed components and the medium is large.
  • commercial diaper rash creams or ointments comprise zinc oxide particles dispersed in an organic medium.
  • Zinc oxide has a density of 5.7 gm/cm 3 while the density of orgamcs is generally about 0.9 gm/cm 3 . This large difference in densities leads to separation and processing problems.
  • coalescence, agglomeration, stratification and settling often cause problems in storage, transportation and processing of a composition.
  • the coalescence, agglomeration, stratification and settling can occur in the holding tank.
  • the agglomerates, formed either m the holding tank or along the process tend to get hung up in va ⁇ ous elements having small diameters (such as pipes, valves, slots) along the processing line.
  • This "bridging" problem often results in clogged orifices, slots, small openings and/or narrow pipes, and can severely reduce or even stop the flow of the composition through the processing equipment
  • Agitation or turbulent flow can redisperse the components and avoid or minimize agglomeration and settling problems. It is known that the flow of a liquid through a pipe or like elements may be laminar or turbulent. The transition from a laminar flow to a turbulent flow depends on the properties of the fluid, its velocity and the diameter of the pipe. However, agitation, velocity and pipe diameter are processing parameters that are constrained to a limited range for a given piece of equipment Variations of these parameters within the equipment- limiting range often fail to solve the problem.
  • the skin care sticks may be distributed and stored under various conditions, ranging from ambient temperature (i.e., about 20°C) to "stressful" storage temperature (e.g., warehouse in A ⁇ zona, car trunk in Florida, etc.), the storage stability is another important characte ⁇ stic of the skm care compositions in the stick form
  • the stick compositions need to have dimensional stability in storage such that the sticks do not flow or soften substantially
  • the stick compositions also need to remain stable (i.e., resistant to separation) in storage such that the components are "locked-m" an as manufactured, substantially uniform distribution in the stick.
  • a va ⁇ ety of rheological agents such as dispersing agents, thickeners, and thixotropic agents, can be added to such compositions to alter the viscosity and other rheological properties of the compositions, and to improve the stability of the dispersions such that fairly stable dispersions can be maintained for various process conditions and end-use situations.
  • compositions containing skm care ingredients for topical applications are well known in the personal care products area, such as cosmetics and toiletries. Creams or ointments containing zinc oxide particles, antimicrobials, and/or protease inhibitors are also known. These compositions have traditionally been prepared as oil-m-water or water-m-oil emulsions. These emulsions do not provide the optimal condition for diaper rash treatment, particularly when the composition is delivered via a vehicle such as an absorbent article. The absorbent core element may draw the aqueous phase away from the surface of the article, leading to reduced delivery of skm care composition and/or reduced absorbency of the article.
  • Non-emulsion, anhydrous compositions are also known, which typically include volatile liquid carriers, such as si cone or common solvents.
  • volatile liquid carriers such as si cone or common solvents.
  • the volatile materials can irritate or burn the skm and the irritating or burning effects are especially acute when skm is already injured or compromised due to chronic exposure to body waste, lr ⁇ tants, etc. Additionally, the vapors from the volatile materials can become entrapped between the skm and the absorbent article worn close to the skm, further exacerbating the lrntating and burning effects.
  • solid or semi-solid compositions can be produced by adding solidifying agents or hardeners to the compositions.
  • the compositions typically contain at least one liquid volatile component or water in the composition for the glide/slip property necessary for topical application.
  • solidifying agents or hardeners should be incorporated into the composition m limited amount because too much solidifying agents or hardeners will render the compositions too hard (or too solid) to have the glide or slip property for topical application.
  • skm care composition should be applied at a level of more than 1 mg per square centimeters. It is generally believed that such application level is required in order to deliver a minimal amount of a skm care composition to achieve skm benefits
  • U.S. Patent No. 4,556,560 issued on December 3, 1985 to Buckingham and U.S. Patent No. 5,110,593 issued on May 5, 1992 to Benford.
  • Products containing the FDA monographed sk care ingredients are commercially available, such as A and D® Ointment, Vaselme® Petroleum Jelly, Desitin® Diaper Rash Ointment and Daily Care ointment, Gold Bond® Medicated Baby Powder, Aquaphor® healing Ointment,
  • Baby Magic® Baby Lotion, Johnson's Ultra Sensitive® Baby Cream have a major disadvantage that they are creams or omtments, i.e., they are flowable at room temperature. As such, these commercial creams or omtments fail to provide a convenient delivery vehicle (e.g., in the form of a solid stick) capable of delivering a very small yet effective amount of the skin care composition efficiently and aesthetically.
  • a convenient delivery vehicle e.g., in the form of a solid stick
  • a skm care composition in the stick form which provides an efficient delivery vehicle for depositmg a very low level of a skm care composition to the skin directly.
  • the stick also provides an aesthetically pleasing delivery of the skm care composition to the skin while avoiding messy hands which is the common results of direct manual applications.
  • the sticks can deliver a thm, substantially clear or barely visible layer of a skm care composition having a non-tacky and non-greasy feel to the skm.
  • a skm care stick which provides controlled delivery of an very small yet effective amount of a skm care composition to the skm
  • the skm care compositions are solids or semi-solids at ambient temperature (i.e., 20°C) and can be delivered to skm easily, smoothly, uniformly and cleanly to provide excellent efficacy and cosmetically pleasing aesthetics.
  • the skm care composition has a melting temperature of at least about 40°C, so that it has good high temperature stability for maintaining the stick form even at stressful storage temperature.
  • the skm care compositions may comprise one or more skm care ingredients m an oleaginous medium.
  • the skm care compositions may contain other optional ingredients, such as rheological agents, surfactants and lubricants.
  • the method comp ⁇ ses applying a thm layer of a skm care composition in a stick form wherein the skin care composition is effective at a very low level of application
  • the skm care compositions may, optionally, contain skm care ingredients dist ⁇ aded uniformly therein.
  • the present invention relates to skm care compositions in the form of solid sticks for maintaining and improving the condition of the skm, especially redness in the areas under an absorbent article.
  • the skin care stick provides an efficient and aesthetically pleasing delivery vehicle for topically applying a very low level of the skm care composition to the skin and to achieve efficacy.
  • the stick composition should have a desired hardness so as to maintain dimensional stability and is capable of transferring a very small and effective amount of the skm care composition to the skm du ⁇ ng use
  • the skm care composition comprises a substantially anhydrous, oleaginous medium (typically an emollient) and, optionally, a solidifying agent (or a hardener).
  • a substantially anhydrous, oleaginous medium typically an emollient
  • a solidifying agent or a hardener
  • Other skm care ingredients may be included.
  • rheological agents may also be included to suspend the particulate skm care ingredients and maintain the stability of the skm care composition.
  • the preferred skm care composition for the present invention are solid or semi-solid at room temperature, and preferably are plastic or partially fluid at skm temperature so that the are suitable for efficient and aesthetic topical application to the skm from a stick form.
  • the compositions preferably have storage stability at various storage conditions and the compositions preferably are substantially stable dispersions in the melt form to avoid or minimize processing/manufacturing problems and to minimize separation during storage at elevated temperatures.
  • the present invention also relates to methods of maintaining and or improving the skm condition, especially the redness associated with chronic exposure of the skm to body waste, moisture, irritants, etc.
  • the stick composition can be topically applied to the skm, depositing a thm, substantially clear or barely visible layer of the skm care composition. It is surprising to find that the stick composition is capable of controlled delivery to the skm a very small amount of the composition (in the range of about 0 015 mg/cm 2 to about 1.0 mg/cm 2 ), which is significantly lower than the amount normally recommended or delivered to the skm by other skm care compositions. It is also surprising to find that the composition is effective in maintaining and improvmg skm condition at such a low application level.
  • the present mvention further relates to methods for manufacturing the skm care stick compositions of the present invention. DETAILED DESCRIPTION OF THE INVENTION
  • the term “comprising” means that the various components, ingredients, or steps can be conjointly employed in practicing the present invention. Accordingly, the term “comprising” encompasses the more restrictive terms “consisting of and “consisting essentially of.
  • the term "diapered skm” or “skm m diapered area” means skm m areas under an absorbent article when the article is worn,
  • the absorbent articles include diapers, training pants, sanitary napkins, pantylmers, incontinence pads, etc.
  • the term “diapered skm” or “skm in diapered area” also means skm that are subjected to repeated or chronic exposures, or one or more acute episodes of exposure, to body waste, moisture, irritants, etc.
  • skm care ingredient means a substance or a mixture of substances, when applied to a subject's skm, either alone or incorporated mto a skm care composition, provides skm condition benefits such as actual or perceived changes in appearance, cleanliness and attractiveness.
  • the term is also directed to substances that soothe, calm, or promote feelings of relief or well-being when applied to the skm, e.g., the ingredients used aromatherapy.
  • the term "effective amount" of the skm care composition means an amount large enough to significantly or positively bring about the desired effect or to modify the condition to be treated such that the skin appears cleaner, more attractive or in better condition.
  • the terms "dermatologically acceptable” or “safe” means the amount of a skm care composition or the components therem is low enough that it produces no undue (i.e., at a reasonable benefit to ⁇ sk ratio) side effects, such as toxicity, imtation, or allergic response, in a general population.
  • activation of a rheological agent means the rheological agent undergoes some chemical or physical changes to form a rheological structure which effectuates the changes m rheological properties of the composition.
  • the skin care compositions of the present invention provides va ⁇ ous skm benefits directed to maintain and or improve the skm condition of the skm areas under an absorbent article or chronic exposure to body waste, moisture, lr ⁇ tants, etc. It is preferred that the skm care composition should provide a protective, and preferably non-occlusive function (e.g., a relatively liquid impervious but vapor pervious bar ⁇ er) to avoid skm overhydration and skm exposure to materials contained in body exudates; an abrasion minimizing function to reduce skm irritation in the areas where the absorbent article is m contact with the wearer's skm; or contains ingredients that deliver, either directly or indirectly, skm care benefits.
  • a protective, and preferably non-occlusive function e.g., a relatively liquid impervious but vapor pervious bar ⁇ er
  • direct benefits may be directed towards overhydration reduction, redness reduction or skin conditioning, and indirect benefits may be directed towards removal or reduction of skm irritants in body exudates.
  • the skm care composition contains emollients that protect or improve the skm condition against chaffing, roughness, wrinkled appearance or itchiness.
  • the skm care composition preferably has a smooth, silky, non-gramy skm feel to minimize abrasion of sensitive or compromised skm due to conditions such as chaffing, roughness, or rashes.
  • a preferred skm care composition for the present mvention has the following characteristics: first, the composition should be a solid or semi-solid at ambient temperature (i.e., about 20°C) so that it has the required dimensional stability to form a stick and enables the composition to be topically applied to the skm, second, the composition is readily transferable to the skm via direct topical application for a highly efficient and esthetically pleasing delivery; third, the composition is preferably, but not required to be, plastic or fluid at skm temperature (i.e., about 34°C to about 36°C) to facilitate the transfer to the skm by providing additional glide, slip or lub ⁇ cation; fourth, the composition should preferably be a stable dispersion in its melt form (i.e., at least about 40°C) in order to avoid coalescence, stratification, agglomeration and settling of the components dispersed therein and minimize the processing or manufactu ⁇ ng problems; and finally, the composition should also be stable under various storage conditions (e.g.
  • the stable skin care composition of the present invention comprises a medium (typically an emollient), and optionally, a solidifying agent, at least one skm care ingredient, and/or at least one rheological agent incorporated therein.
  • the skm care ingredients of the present invention are generally water-soluble solids, bemg insoluble or partially soluble in the substantially anhydrous, oleaginous medium. Oil-soluble skm care ingredients, such as Vitamin A, D, E and K, and the like, are also withm the scope of the present invention.
  • the skm care ingredients may be predispersed m a carrier prior to mixing with the composition or be incorporated into the composition directly with agitation.
  • the skm care composition of the present invention typically comp ⁇ ses a substantially anhydrous, oleaginous medium.
  • substantially anhydrous means the composition typically contains about 10% or less water, preferably about 5% or less water, more preferably about 1% or less water, even more preferably 0.5% or less water.
  • the anhydrous nature of the medium avoids overhydration of the already susceptible or compromised skm that has been chronically exposed to a high relative humidity micro-environment, for example, under an absorbent article.
  • the anhydrous nature of the medium avoids the wickmg effect of the highly absorbent diaper core, which may preferentially draw the composition towards the core, interfering with the absorbency of the core and keeping the composition away from the topsheet surface and the wearer's skm.
  • Skm Care compositions suitable for use in the present mvention are descnbed m U.S. Patent Applications Se ⁇ al Nos. 08/926,532 and 08/926,533, each filed on September 10, 1997; in U.S. Patent Applications Senal Nos. 09/041,509, 09/041,232 and 09/041,266, each filed on March 12, 1998; U.S. Patent No. 5,607,760 issued March 4, 1997 and U.S. Patent No. 5,609,587 issued March 11, 1997, both issued to Roe; U.S. Patent No. 5,635,191 issued June 3, 1997 and U.S. Patent No. 5,643,588 issued July 1, 1997, both issued to Roe et al.; the disclosures of each of which are hereby incorporated by reference.
  • the skin care compositions useful in the present invention preferably have a meltmg profile such that they are solid or semi-solid at room temperature, are readily transferable to the skm, and have good stability under stressful storage conditions.
  • the compositions are easily transferable to the skm by way of contact, shear and/or body heat.
  • the melting profile of the skm care composition favorably provides sufficient liquid component at skin and/or body temperature, so that the stick composition glides more smoothly when applied to the skin and the stick composition is at least partially transferred to the skin.
  • transfer of the skin care composition to the skm is enhanced by the liquid component withm the semi-solid stick composition, possibly due to the flowability of the liquid component.
  • the liquid component provides additional lubricating effect such that the stick composition glides over the skm more smoothly under shear
  • the viscosity of the stick compositions should be as high as possible to enhance the dimensional stability of the composition in the stick form.
  • compositions preferably have a final meltmg point above potential "stressful" storage conditions that can be greater than 45°C (e.g., warehouse in Arizona, car trunk in Florida, etc.).
  • preferred compositions preferably have the following melt profile:
  • compositions are at least semi-solid at room temperature for transferabihty and dimensional stability.
  • the skin care compositions useful herem are solid, or semi-solid at ambient temperature, i.e., at 20°C.
  • the term "semisohd", as used herein, means that the composition has a rheology typical of pseudoplastic or plastic liquids. When no shear is applied, the composition can have the appearance of an immobile solid, but the composition can be made to flow as the shear rate is increased. This is due to the fact that, while the composition contains p ⁇ ma ⁇ ly solid components, it also includes some mmor liquid components.
  • compositions of the present mvention have a zero shear viscosity between about 1.0 X 10" centipoise and about 1.0 X 10° centipoise. More preferably, the zero shear viscosity is between about 5.0 X 10° centipoise and about 5.0 X 10 ' centipoise
  • rheological agents may be incorporated into the composition to suspend the particulate ingredients and maintain the stability of the dispersion
  • the medium of the present invention generally exhibits the flow characteristics of a Newtonian fluid.
  • the medium may not maintain a stable dispersion or prevent the dispersed ingredients from agglomeration, stratification, settling and/or bridging effects. These effects may lead to failure to produce a uniform product.
  • a suitable rheological agent should modify the flow characteristics of the composition m the melt form to that of a plastic or pseudoplastic fluid.
  • the rheological agent preferably increases the elastic modulus of the composition to at least about 5 dyne/cm 2 when measured at 77°C under an oscillation frequency of 10 rad/sec and a shear strain of 0.2%.
  • the composition in the melt form has an elastic modulus in the range from about 5 to about 5,000 dyne/cm 2 , more preferably from about 10 to about 3,000 dyne/cm 2 , and most preferably from about 100 to about 1000 dyne/cm 2 .
  • the apparent viscosity of the melt composition containing the rheological agent should preferably be m the range from about 1 to about 100,000 centipoise, more preferably from about 5 to about 50,000 centipoise, and most preferably from about 50 to about 2,000 centipoise, when measured under the same conditions.
  • the resultant composition is a substantially stable dispersion having the ingredients substantially uniformly dispersed therein.
  • the stabilized composition is substantially free of excessively large agglomerates, stratification, settling and/or bridging effects. Therefore, the stabilized composition can flow through processing equipment easily and produces stick products of substantially uniform dist ⁇ bution of ingredients.
  • a "slush” process may be used to prepare the stick composition of the present invention (See Preparation Section). It is found that the slush process can also produce a substantially uniform stick composition, even in the absence of a rheological agent.
  • some rheological agents are fine solid particles m the oleaginous medium which may further enhance the smooth skin feel or lubricity of the skm care composition.
  • some rheological agents such as fumed silica particles, are very small spherical particles that tumble or roll under shear, thus providing additional lubricity when the stick composition is applied to the skm.
  • some rheological agents such as organoclays, have a laminar structure wherein the layers may slip under shear, thus providing additional smooth skin feel.
  • Hardness of sticks can be determined by a texture analysis (see Test Methods section). Accordmg to the texture analysis used herem, the hardness of the stick is the maximum resistive force encountered by a probe m a 7 millimeter stroke.
  • the skin care sticks of the present mvention preferably have a hardness of about 100 g/mm to about 2500 g/mm, more preferably from about 500 g/mm to about 2000 g/mm, even more preferably from about 1000 g/mm to about 1500 g/mm.
  • the stick form of the present mvention provides an effective and aesthetically pleasing delivery vehicle for the skm care composition
  • the stick composition is applied to the skm areas covered by diapers or other absorbent articles or to skm areas that are subjected to chronic or acute exposures of body exudates, moisture, irritants, etc.
  • the stick composition deposits a thm, substantially clear or barely visible layer of coating on the skin, which, surp ⁇ smgly, is sufficient to deliver an effective amount of the skm care ingredients to the skin Generally, 2 to 4 passes across a given area delivers sufficient amount of the composition to provide the desired skm benefits
  • This application method typically deposits from about 0.015 mg/cm 2 to about 1 0 mg/cm 2 of the skm care composition on the skm.
  • the stick should preferably be applied twice daily: during diaper changes before and after overnight sleep, more preferably the stick should additionally be applied after a bowel movement (BM) or a bath, and even more preferably the stick should be applied at every diaper change.
  • Cleansing the skm before applymg the stick composition is not required. Though cleansing by the conventional methods using non-ir ⁇ tating skm cleansing agents, such as soap, water, cleansing gel, or wipes, is permitted generally, and is recommended after a BM.
  • the skm care stick can be applied from one to twelve times daily, preferably every time or every other time the absorbent article is changed or checked
  • the frequency of article changes vary depending on the diet and health of the infant, the habit of the caregiver, and the activities and routine of the mfant. Accordmg to normal use pattern, this mcludes changes every 3 to 4 hours durmg the day and a fresh article after a bath or a BM and just before overnight sleep.
  • the application frequency may also vary depending on the seventy of the condition being treated, the progress of the treated skm, the frequency and duration of past dermatitis and rash incidence, and the average length of exposure of skm to body exudates.
  • the application frequency is at least about once every 8 hours, preferably about once every 6 hours, more preferably about once every 4 hours and most preferably about once every 3 hours.
  • the skm care stick may preferably be applied at regular intervals of about every 2 hours to every 12 hours, preferably about every 3 to every 8 hours, more preferably about every 4 to every 6 hours.
  • Application at regular intervals maximizes the skm condition benefits because this method ensures a minimal amount of skm care composition is present on the skm.
  • application at fixed intervals are not required to achieve skm condition benefits
  • Another preferred method is to apply the skm care stick twice m a 24 hours period, preferably before and after overnight sleep.
  • the skm care stick is capable of controlled delivery of a small yet effective amount of the skm care composition to positively b ⁇ ng about the desired skin benefits.
  • the amount of skm care composition delivered to the skm is preferably at least about 0.015 mg/cm 2 , more preferably at least about 0.075 mg/cm 2 , and still more preferably 0.15 mg/cm 2 , per episode of application. In each episode of application, the entire skm area needing care is covered by a thm, barely visible layer of the skm care composition via 2 to 4 passes of the stick across the skm.
  • Nonlimitmg examples of such skm areas include buttocks, anal, crotch, genital and hip areas.
  • the amount of composition delivered per episode of application preferably ranges from about 0.015 mg/cm 2 to about 1.0 mg/cm 2 , more preferably at least about 0 075 mg/cm 2 to about 0.75 mg/cm 2 , and still more preferably 0.15 mg/cm 2 to about 0.50 mg/cm 2 .
  • Diaper rash creams or omtments have always been applied to the skm as a thick coating to provide a barrier or protection against irritants, etc.
  • the effective amount for those rash creams or ointments have always been set for at least about 1 mg/cm 2 per application. It is found, surprisingly, that a very small amount (such as those desc ⁇ bed above) of the present composition is sufficient to impart observable skm care benefits.
  • the stick form and its hardness provide a convenient and controlled topical delivery vehicle for the skm care composition.
  • the solid or semi-solid consistency at ambient temperature in combination with the partial meltmg at or near skin temperature provide the transferabihty to skm a small and controlled amount of the present composition that cannot not be achieved by hand application of creams or ointments.
  • the caregiver may apply a greater amount of the composition when infrequent changes or applications are anticipated, such as before a nap or the last application of the day just before overnight sleep.
  • delivery of low levels of the present compositions at relatively infrequent intervals e.g., as few as once or twice a day
  • the present composition is also suitable for intermittent use, for example, as part of a maintenance or prevention regimen.
  • the amount of skm care composition providing desired skm benefits will also vary with the seventy of the condition being treated, its progress, the total surface area involved, the potency of the ingredients or other components in the composition, the past history of dermatitis and rash mcidence,
  • the amount of skm care composition delivered to the skm per 24 hour penod is preferably at least about 0.045 mg/cm 2 , more preferably at least about 0.2 mg/cm 2 , and still more preferably at least about 0.45 mg/cm 2 .
  • the amount of composition delivered per 24 hour penod ranges from about 0.045 mg/cm 2 to about 3 mg/cm 2 , more preferably at least about 0.15 mg/cm 2 to about 1.5 mg/cm 2 , and still more preferably 0.45 mg/cm 2 to about 0.95 mg/cm 2 .
  • the present mvention may also provide controlled delivery to adult skm of a small and effective amount of a skm care composition which may provide desired skm benefits.
  • the present mvention may be applied to mamtam and or improve adult skm condition and or appearance m areas under an absorbent article, as well as m other areas of the body for skm conditions such as roughness, chaffing, wrinkled appearance, and uneven pigmentation.
  • skm care ingredients may be incorporated into the skm care compositions to provide various skm benefits, such as reduction in redness, improvement in skm appearance and or condition, formation of a barrier or protective layer, or reduction of irritants in body waste.
  • a host of skm care ingredients can be incorporated into a carrier and applied to the skm, either by hand or via a delivery system.
  • These ingredients include bamer substances (petrolatum), skin conditioning agents (oil, lanolm), proton donating agents, protease and/or enzyme inhibitors, and antimicrobials.
  • the skm care composition may also contain humectants (glycerin, sorbitol), vitamins, skm soothing agents (such as aloe vera, or other ingredients of herbal, botanical or mineral o ⁇ gm), or multi-functional agents, such as zinc oxide.
  • humectants glycerin, sorbitol
  • vitamins such as aloe vera, or other ingredients of herbal, botanical or mineral o ⁇ gm
  • multi-functional agents such as zinc oxide.
  • a wide va ⁇ ety of topically effective ingredients can be incorporated to the stable composition of the present mvention.
  • the skm care ingredient can provide visible benefits to the condition of the occluded skm under an absorbent article or the compromised skin due to chronic exposures to hostile micro- environment.
  • the skm care ingredients may be uniformly dispersed throughout the composition as insoluble particulates.
  • the skm care ingredients may be solubihzed in the oleaginous composition of the present mvention.
  • the resultant composition is stable (i.e., resistant to separation, coalescence, agglomeration, stratification and/or settlmg), has a consistency that renders it readily transferable to the skm, and is suitable for topical application to the skm via a delivery vehicle, such as a stick.
  • matenals that have been deemed safe and effective skm care ingredients are logical matenals for use herem.
  • Such matenals include Category I and Category III actives as defined by the U.S. Food and Drug Administration's (FDA) Tentative Final Monograph on Skm Protectant Drug Products for Over-the-Counter Human Use (21 C.F.R. ⁇ 347). It will be recognized that several of the monographed actives listed below are "emollients" as defined herem.
  • Category III actives presently mclude: live yeast cell de ⁇ vatives, aldioxa, aluminum acetate, microporous cellulose, cholecalciferol, colloidal oatmeal, cysteme hydrochlo ⁇ de, dexpanthenol, Peruvean balsam oil, protein hydrolysates, racemic methionme, sodium bicarbonate, Vitamin A, and the like.
  • These monographed matenals are known to provide multiple skm benefits, such as skm protectant, itch prevention, imtation prevention, via vanous mechanisms.
  • the skm care ingredients suitable for the present invention may also mclude, but are not limited to, pH control agents or proton donating ingredients, such as pH buffer systems, ammonium- neutralizing agents, organic acids, polyme ⁇ c acids, inorganic acids, and their salts; anti-microbials; enzyme inhibitors; protease inhibitors; anti-coenzymes, chelating agents; and anti-bodies.
  • pH control agents or proton donating ingredients such as pH buffer systems, ammonium- neutralizing agents, organic acids, polyme ⁇ c acids, inorganic acids, and their salts; anti-microbials; enzyme inhibitors; protease inhibitors; anti-coenzymes, chelating agents; and anti-bodies.
  • proton donating agents are desc ⁇ bed m U.S Application Se ⁇ al No 09/041,509, by McOsker et al. filed on March 12, 1998, and are incorporated herem by reference.
  • protease inhibitors can be divided mto two general classes: the protemases and the peptidases.
  • protemases act on specific mtenor peptide bonds of protems and peptidases act on peptide bonds adjacent to a free ammo or carboxyl group on the end of a protem and thus cleave the protem from the outside.
  • the protease inhibitors suitable for use m the present mvention mclude, but are not limited to, protemases such as senne proteases, metalloproteases, cysteme proteases, and aspartyl protease, and peptidases, such as carboxypepidases, dipeptidases and ammopepidases.
  • protease inhibitors are descnbed in U.S. Application Senal No. 09/041,232, by Rourke et al filed on March 12, 1998, U.S. Patent No. 5,091,193 issued to Enjolras et al, on February 25, 1992, and U. S. Patent No. 4,556,560 issued to Buckingham on December 3, 1985, all are incorporated by reference herem.
  • Enzyme inhibitors are designed to inhibit specific enzymatic activities of vanous classes of proteases. Specifically useful for the present mvention are inhibitors that mteract with those proteolytic and hpolytic enzymes commonly present in feces, such as lipases, esterases, diesterases, ureases, amylases, elastases, nucleases.
  • the enzyme inhibitors suitable for use in the present mvention include, but are not limited to, chelating agents which bind to metal cofactors of specific enzymes, antibodies raised for specific enzymes, enzyme inhibitors for vanous enzymes or coenzymes, preferably of the proteolytic type, such as trypsin, chymotrypsin, aminopeptidase and elastase, senne, cysteme, lipases, bile salts (acting as coenzymes that enhance the activities of lipases), amylases, and/or ureases.
  • the skm care ingredients m the present mvention should preferably mclude at least one of the following: zmc oxide, talc, starch, allantom, hexamidme and its salts and denvatives, hexamidme dnsethionate, and its salts, tnacetin, phytic acid, ethylenediamme tetraacetic acid (EDTA), phenylsulfonyl fluondes such as 4-(2-ammoethyl)-benzenesulfonylfluo ⁇ de hydrochlonde, chitosan, and mixtures thereof.
  • the skm care compositions suitable for the present mvention may contain skm care ingredients m a concentration of about 0.001%> to about 70% by weight, typically about 0.01% to about 45%), more typically about 0.1% to about 25%, and most typically about 0.1% to about 10%>. Ingredients may be used smgly or as a mixture of ingredients m a "cocktail". Because of the vanety of enzyme and protease inhibitors used m the present mvention, the effective concentration of each inhibitor should be separately determined, as known to those skilled m the art.
  • the mgredients are substantially insoluble m the composition, they exist as particulates suspended m the composition.
  • the average particle size of the mgredients plays an important role m suspendmg the ingredient particles in the composition.
  • the particles should be substantially free of excessively large agglomerates, i.e., there is negligible amount of agglomerates larger than 1000 microns.
  • the average particle size of the skm care ingredients should preferably be less than about 1000 microns, preferably less than about 100 microns, and more preferably less than about 50 microns.
  • the predispersant mixture preferably compnses a dispersant fluid and optionally, a wetting agent.
  • the wetting agent is typically a surfactant having a hydrophihc end, which interacts with the functional groups on the surface of the ingredient particles, and a lipophihc end, which is compatible with the oil-based medium of the present composition
  • the wetting agent along with external forces applied (such as shear, agitation), facilitates the break-up of the clumps of the skm care mgredients and the mixing or dispersion of the particulate mgredients in the composition
  • the wettmg agent bemg a hydrophilic-lipophi c, surfactant-type matenal, b ⁇ dges the interfaces between the particulate ingredients and the oleaginous medium of the present composition.
  • the dispersant fluid can serve as a diluent and/or a wettmg agent for predispersmg the particles
  • the dispersant fluid preferably is miscible with the oleagmous medium of the present composition.
  • Nonlimitmg examples of the dispersant fluid include mmeral oil, dimethicone and other sihcones, esters, preferably the condensation products of C r C 22 alcohols with C,-C 22 acids.
  • the predispersion preferably has a high solid or particle content m the range of 50%> to 99% by weight solids, more preferably from 60% to 90% by weight solids, and most preferably from 70% to 80%) by weight solids. Vanous grinding and/or milling techniques known m the art are sometimes used m the predispersmg process to break down the particle size and disperse the particles.
  • the ingredient is zmc oxide dispersed, as insoluble particles, m the oleagmous composition of the present invention. More preferably, the zmc oxide particles are prepared as a predispersion.
  • the skm care composition comp ⁇ ses from about 1 wt% to about 70 wt%> of the zmc oxide predispersion, preferably from about 3 wt% to about 50 wt%, more preferably from about 5 wt% to about 30 wt%.
  • the predispersion has preferably from about 90 wt% to about 50 wt% zmc oxide, from about 1 wt% to about 50 wt% dispersant fluid and from about 0.1 wt% to about 10 wt% wetting agent.
  • a preferred embodiment comp ⁇ ses about 75 wt% zmc oxide particles dispersed m about 22 wt% of a dispersant fluid such as those desc ⁇ bed above and about 3wt% of a polyglyceryl ester wetting agent.
  • Suitable zmc oxide predispersion is available from Kobo Products, Inc., S. Plamfield, NJ.
  • the zmc oxide particles of the present mvention typically consist of agglomerates of pnmary particles.
  • the particle size of the agglomerates ranges from about 0.1 to about 300 microns and the average agglomerate size is about 1.0 microns.
  • the average particle size of the pnmary particles is about 0.12 microns.
  • the agglomerate comp ⁇ ses about 5 to about 8 pnmary particles.
  • a hydrophobic modification can be applied to the zmc oxide particles to "wet" the surface of the particles.
  • surfactants are actually attached to the surface of the zmc oxide particles under high temperature or pressure.
  • the rheological agents should provide sufficient modification to the rheological properties of the compositions to be able to maintain stable dispersions of ingredient particles therein. Because the present compositions are complex mixtures of components, the modifications of the rheological properties operate under complex interactions and mechanisms. It is surpnsing to find that the stability and processabihty of a composition are closely dependent on the elastic modulus and apparent viscosity of the composition m the melt form.
  • the elastic moduli measured at 10 rad/sec frequency and 0.2% strain are used to charactenze the compositions (see Test Methods section). It is found that the elastic modulus of the composition in the melt (measured at the melt processing temperature of about 77°C) correlates with the stability and processabihty of the composition.
  • the preferred elastic modulus of a stable composition in the melt phase is m the range of at lease about 5 to about 5000 dynes/cm 2 , preferably from about 10 to about 3000 dynes/cm 2 , and more preferably from about 20 to about 2000 dynes/cm 2 .
  • the apparent viscosity of the composition is charactenzed by measurements at 0.1 rad/sec at two temperatures including the processing temperature (i.e., about 77°C or 170°F) and the "stressful" storage temperature (i.e., about 45°C) (see Test Methods section).
  • the apparent viscosity of the melt composition is preferably from about 1 centipoise to 100,000 centipoise, more preferably from about 5 centipoise to about 50,000 centipoise, and even more preferably from about 50 centipoise to about 2000 centipoise.
  • the composition in the melt phase m the absence of added rheological agents, exhibits substantially Newtonian rheology, which is known to result in agglomeration, and consequently, bridging and settling of the suspended particles.
  • an "effective amount" of one or more rheological agents is added to the composition to change the rheological properties of the melt composition to a plastic or pseudoplastic fluid.
  • the term "effective amount" of a rheological agent means an amount of the rheological agent which is capable of producing a skm care composition having the desired rheological properties under the processing condition and of maintaining a stable dispersion.
  • stable dispersion means the skm care composition shows no visible stratification or significant phase separation for at least about 20 minutes, preferably for at least 4 hours, more preferably for at least about 8 hours, under stationary condition, at or above melt temperature, and the skm care composition shows no visible stratification or separation at vanous storage temperatures up to about 45°C for at least about 1 months, preferably for at least about 6 months, more preferably for at least about 12 months
  • the rheological agents can be insoluble particles m the substantially anhydrous, oleaginous compositions of the present invention. These particulate rheological agents are typically in the form of finely divided, small particles having an average particle size of about 100 microns and a solubility m the composition of less than 10%, preferably less than 5% by weight. However, the particle size may vary depending on the type of agent, the mechanism to provide rheological effects, the activation or preparation of the rheological agent, and other like factors. It is recognized that the rheological agents need not be solid particles in the medium. The rheological agents may be miscible or partially miscible with the medium. It is also recognized that the rheological agents may function as solidifying agents or hardeners as well. It is further recognized that the rheological agents may be incorporated mto the composition singly or as mixtures of various rheological agents.
  • the preparation and or activation of the rheological agents may involve, but is not limited to, the following steps: reduction in agglomerates by milling, grinding, agitation or other methods known m the art; and activation by methods known m the art, such step being dependent upon the type of rheological agent used
  • Some rheological agents may also function as solidifying agents to provide a solid or semi-solid composition at ambient temperature (i.e., about 20°C) such that the composition is hardened to form a stick with sufficient dimensional stability.
  • ambient temperature i.e., about 20°C
  • the resultant composition should not be so hardened as to interfere with its transferabihty to the skin that comes mto contact with the composition.
  • the rheological agents comprise from about 0.1% to about 25% by weight of the total composition, preferably from about 0.25% to about 10% by weight, and more preferably from about 0.5% to about 5% by weight of the total composition.
  • Type A Rheological Agents preferably from about 0.1% to about 25% by weight of the total composition, preferably from about 0.25% to about 10% by weight, and more preferably from about 0.5% to about 5% by weight of the total composition.
  • a skin care composition modified by this type of rheological agent typically exhibits a substantially "flat" rheological profile with respect to temperature Specifically, the apparent viscosity of the composition does not change substantially over the temperature range from about the processing temperature to room temperature.
  • a solidifying agent may be added to produce a solid or semi-solid composition at room temperature.
  • a preferred rheological agent of this type for use herein is fumed silica, either surface- treated or untreated.
  • Untreated fumed silica is available commercially under the trade name CAB- O-SIL M-5 and HS-5, from Cabot Corporation, Tuscola, IL.
  • More preferred for use herein is surface-treated fumed silica.
  • Even more preferred is a fumed silica selected from the group consisting of polyalkylsiloxane treated fumed silica, t ⁇ alkylsilamzed fumed silica, dialkylsilamzed fumed silica, and mixtures thereof.
  • fumed silica selected from the group consisting of polydimethylsiloxane treated fumed silica, tnmethylsilamzed fumed silica, dimethyldisilamzed fumed silica, and mixtures thereof.
  • the fumed silicas typically have active hydroxyl groups, and it may be desirable to treat these fumed silicas such that the characteristics of the hydroxyl groups are altered.
  • a useful method of treatment is to coat the fumed silicas with a nonpolar organic compound such as a polyalkylsiloxane, preferably a polydimethylsiloxane, to render the hydroxyl groups less active.
  • a polydimethylsiloxane treated fumed silica useful herein is available commercially under the trade name CAB-O-SIL TS-720, by Cabot Corporation, Tuscola, IL.
  • Another useful method of treatment is to chemically react the hydroxyl groups of the fumed silica with a silamzing agent, e.g., dimethyldichlorosilane or hexamethyldisilizane.
  • the chemically treated fumed silicas have the free hydroxyl groups replaced with an oxygen-silicon bond of the silamzing agent.
  • a tnmethylsilamzed fumed silica useful herein is available commercially under the trade name CAB-O-SIL TS-530, and a dimethylsilanized fumed silica useful herem is available commercially under the trade name CAB-O-SIL TS-610, both by Cabot Corporation, Tuscola, IL
  • the fumed silica and treated fumed silica generally exist as agglomerates m the composition with a volume weighted average particle size of from about 0.001 micron to about 100 microns, preferably from about 0.005 micron to about 50 microns, and more preferably from about 0.01 microns to about 10 microns.
  • the agglomerated configuration is the most efficient for lnterparticle interactions, which form the network structure that thickens and stabilizes the dispersion.
  • organoclays such as bentonites and hecto ⁇ tes that have been treated (i.e., coated) with various organic compounds to render the clays less polar.
  • organoclays are preferably made from a smectic clay platelet having a fatty chain organic compound bonded to its faces, and leaving the edges free to form hydrogen bonds.
  • the fatty chains provide dispensability m the oleaginous medium, while the edge-to-edge hydrogen bonding of the platelets provides dispersion stability.
  • Nonlimitmg examples include quaternium- 18 hectontes, stearalkonium hecto ⁇ tes, quatern ⁇ um-18 bentonites, quatern ⁇ um-18 benzalkomum bentonites, stearalkonium bentonites, and their mixtures with at least one member selected from the group consisting of with mmeral oil, propylene carbonate, isopropyl palmitate, cyclomethicone, caster oil, lanolm, propylparaben, and C12-C15 alkyl benzoate.
  • organoclays or mixtures are available from Rheox, Inc., Hightstown, NJ, under the general trade names of BENTONE and BENTONE GEL.
  • BENTONE 38 (a quatermum-18 hecto ⁇ te)
  • BENTONE 27 (a stearalkonium hecto ⁇ te)
  • BENTONE 34 (a quatern ⁇ um-18 bentomte).
  • Metal fatty acid soaps are also useful herein.
  • soaps made from the combination of at least one metal ion selected from the group consisting of aluminum, magnesium, zmc and lithium, and at least one fatty acid ester having a chain length of 10 to 28 carbon atoms, preferably of 12 to 22 carbon atoms, such as stearates, behenates, laurates and palmitates.
  • More preferred for use herein are aluminum/magnesium hydroxide stearates, which are hydrophobic platelets formed from the complexation between steanc acid and alummum magnesium hydroxide in alternate layers. The platelet structure swells m the oil, thereby changes the rheological characte ⁇ stics of the composition.
  • the viscosity of the composition is fairly constant over a broad temperature range. This allows for enhanced stability of the dispersion over the temperature range of the present invention.
  • the alummum magnesium hydroxide stearate is available from Giulmi Corporation, Bound Brook, NJ, under the general name of GILUGEL.
  • Also useful herein are calcium silicates and treated calcium silicates. Common forms of calcium silicates include CaS ⁇ 0 3 , CaS ⁇ 0 4 (OH) 2 , CaS ⁇ 0 5 (OH) 4 .
  • the calcium silicates can be treated with a wide variety of nonpolar organic compounds to render the materials more hydrophobic and less reactive.
  • Useful calcium silicates that are commercially available include the following: HUBERSORB (Huber Corp., Harve de Grace, MD), and MICRO-CEL (Cehte Corp., Denver, CO).
  • HUBERSORB Hapan Corp., Harve de Grace, MD
  • MICRO-CEL Cehte Corp., Denver, CO
  • Other silicates such as magnesium silicate, or magnesmm/alummum silicate are also useful herein.
  • rheological agents denved from natural sources, such as cholesterol and hydrogenated lecithin, and anionic surfactants such as DEA (diethanolamide) Oleth-3 phosphate.
  • anionic surfactants such as DEA (diethanolamide) Oleth-3 phosphate.
  • a skm care composition modified by this type of rheological agent typically exhibits a temperature-dependent rheological profile. Specifically, the apparent viscosity of the composition increases as the temperature decreases from the processing temperature to room temperature. That is, Type B rheological agent functions like a solidifying agent. Inclusion of a separate solidifying agent to produce a solid or semi-solid composition at room temperature is optional when Type B rheological agent is used.
  • vanous organic derivatives of castor oil such as THIXCIN R, THIXATROL ST, and the like.
  • the principal constituent of these castor oil derivative is glyceryl t ⁇ s- 12-hydroxystearate.
  • Vanous inorganic derivatives of castor oil are also useful herein, such as THIXCIN GR, THIXATROL GST, THIXSEAL 1084, and the like. All these castor oil derivatives or mixtures thereof are available from Rheox, Inc., Hightstown, NJ.
  • Nonlimitmg examples are polymethacrylates, methacrylate/styrene copolymers, which can optionally be crosslmked a common crosslmkmg agent, polyethylene, ethylene and acrylic acid or vmyl acetate copolymers, polyisobutylene, poly- ⁇ -olefins, bi or t ⁇ -component copolymers of styrene and ethylene, propylene, butylene, Nylon 66 and hydrophobic cellulose derivatives.
  • Nonlimitmg examples include polyethylene oxide ethers derived from C 8 -C 22 alcohols, preferably ceteth-10 (polyoxyethylene 10 cetyl ether), steareth-21 (polyoxyethylene stearyl ether) and mixtures thereof; ethoxylated or propoxylated alcohols or alkyl phenols, having preferably C 8 -C 22 alkyl chains and preferably from about 6 to about 25 ethylene oxide or propylene oxide groups; mono- and di- fatty acid esters of ethylene glycol; fatty acid monoglyce ⁇ de; sorbitan; mono- and di- C 8 -C 22 fatty acids; polyoxyethylene sorbitan; and mixtures thereof.
  • waxes such as carnauba, ozokente, beeswax, candehlla, paraffin, ceresm, esparto, ouncuri, rezowax, lsoparaffin, silicone waxes, polyethylene waxes, and other known mmed and mmeral waxes. Additionally microcrystallme waxes are also effective rheological agents.
  • a preferred wax is a paraffin wax such as Paraffin S.P. 434 from Strahl and Pitsch Inc., West Arabic, NY.
  • nonlimitmg examples also useful herein, without specific regard to the rheology- temperature profiles are diethanlolamides; methylethylamides; and amphote ⁇ c surfactants such as dialkylammo propionic acid; alkyl galactomannan, zmc stearate, sorbitan sesquioleate, cetyl hydroxy ethyl cellulose and other modified celluloses Emollients
  • a useful ingredient m these compositions is one or more skm protectants or emollients.
  • emollient means a mate ⁇ al that protects against wetness or imtation, softens, soothes, supples, coats, lubncates, moistu ⁇ zes, protects and or cleanses the skm;
  • protecting means a matenal which protects injured or exposed skm or mucous membrane surface from harmful or annoying stimuli.
  • these emollients will have either a plastic or liquid consistency at ambient temperatures, i.e., 20°C.
  • emollients useful in the present mvention include, but are not limited to, emollients that are petroleum-based; sucrose ester fatty acids; polyethylene glycol and denvatives thereof; humectants; fatty acid ester type; alkyl ethoxylate type; fatty acid ester ethoxylates; fatty alcohol type; polysiloxane type; propylene glycol and denvatives thereof; glycerine and denvatives thereof, including glycende, acetoglyce ⁇ des, and ethoxylated glyce ⁇ des of C12-C28 fatty acids, tnethylene glycol and denvatives thereof; spermaceti or other waxes; fatty acids; fatty alcohol ethers, particularly those havmg from 12 to 28 carbon atoms m their fatty cham, such as steanc acid; propoxylated fatty alcohols; other fatty esters of polyhydroxy alcohols; lanol
  • Suitable petroleum-based emollients mclude those hydrocarbons, or mixtures of hydrocarbons, havmg cham lengths of from 16 to 32 carbon atoms.
  • Petroleum based hydrocarbons havmg these cham lengths mclude mineral oil (also known as “liquid petrolatum”) and petrolatum (also known as “mmeral wax,” “petroleum jelly” and “mmeral jelly”).
  • Mmeral oil usually refers to less viscous mixtures of hydrocarbons havmg from 16 to 20 carbon atoms.
  • Petrolatum usually refers to more viscous mixtures of hydrocarbons having from 16 to 32 carbon atoms.
  • Petrolatum and mmeral oil are particularly preferred emollients for compositions of the present mvention.
  • Suitable fatty acid ester type emollients include those de ⁇ ved from C12-C28 fatty acids, preferably C16-C22 saturated fatty acids, and short cham (C j -Cg, preferably C1 -C3) monohydnc alcohols.
  • Representative examples of such esters mclude methyl palmitate, methyl stearate, isopropyl laurate, isopropyl mynstate, isopropyl palmitate, ethylhexyl palmitate and mixtures thereof.
  • Suitable fatty acid ester emollients can also be de ⁇ ved from esters of longer cham fatty alcohols (C12- 28, preferably C ⁇ -C ⁇ ) and shorter cham fatty acids e.g., lactic acid, such as lauryl lactate and cetyl lactate.
  • Suitable alkyl ethoxylate type emollients mclude 2-C22 fatty alcohol ethoxylates havmg an average degree of ethoxylation of from about 2 to about 30.
  • the fatty alcohol ethoxylate emollient is selected from the group consisting of lauryl, cetyl, and stearyl ethoxylates, and mixtures thereof, havmg an average degree of ethoxylation ranging from about 2 to about 23.
  • alkyl ethoxylates include laureth-3 (a lauryl ethoxylate havmg an average degree of ethoxylation of 3), laureth-23 (a lauryl ethoxylate havmg an average degree of ethoxylation of 23), ceteth-10 (a cetyl alcohol ethoxylate havmg an average degree of ethoxylation of 10) and steareth-10 (a stearyl alcohol ethoxylate havmg an average degree of ethoxylation of 10).
  • these alkyl ethoxylate emollients are typically used m combination with the petroleum-based emollients, such as petrolatum, at a weight ratio of alkyl ethoxylate emollient to petroleum-based emollient of from about 1:1 to about 1:5, preferably from about 1:2 to about 1:4.
  • Suitable fatty alcohol type emollients mclude C12-C22 fatty alcohols, preferably C ⁇ -C ⁇ g fatty alcohols. Representative examples mclude cetyl alcohol and stearyl alcohol, and mixtures thereof. When employed, these fatty alcohol emollients are typically used m combination with the petroleum-based emollients, such as petrolatum, at a weight ratio of fatty alcohol emollient to petroleum-based emollient of from about 1:1 to about 1:5, preferably from about 1:1 to about 1:2.
  • emollients for use herem include polysiloxane compounds.
  • suitable polysiloxane matenals for use m the present invention mclude those havmg monomenc siloxane units of the following structure:
  • R and R for each independent siloxane monomenc unit can each independently be hydrogen or any alkyl, aryl, alkenyl, alkaryl, arakyl, cycloalkyl, halogenated hydrocarbon, or other radical. Any of such radicals can be substituted or unsubstituted. R ⁇ and R ⁇ radicals of any particular monomenc unit may differ from the corresponding functionalities of the next adjoining monomenc unit. Additionally, the polysiloxane can be either a straight cham, a branched chain or have a cyclic structure. The radicals R!
  • R ⁇ can additionally independently be other silaceous functionalities such as, but not limited to siloxanes, polysiloxanes, silanes, and polysilanes.
  • the radicals R* and R ⁇ may contain any of a vanety of organic functionalities including, for example, alcohol, carboxyhc acid, phenyl, and amme 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 tolyl, xylyl, ethylphenyl, and the like.
  • Exemplary aryl radicals are benzyl, ⁇ -phenylethyl, ⁇ -phenylethyl, ⁇ - phenylbutyl, and the like.
  • Exemplary cycloalkyl radicals are cyclobutyl, cyclopentyl, cyclohexyl, and the like.
  • Exemplary halogenated hydrocarbon radicals are chloromethyl, bromoethyl, tetrafluoroethyl, fluoroethyl, t ⁇ fluoroethyl, t ⁇ fluorotloyl, hexafluoroxylyl, and the like.
  • Viscosity of polysiloxanes useful for the present mvention may vary as widely as the viscosity of polysiloxanes in general vary, so long as the polysiloxane is flowable or can be made to be flowable for application to the absorbent article.
  • This m cludes, but is not limited to, viscosity as low as 5 centistokes (at 37°C as measured by a glass viscometer) to about 20,000,000 centistokes.
  • the polysiloxanes have a viscosity at 37°C rangmg 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.
  • High viscosity polysiloxanes which themselves are resistant to flowing can be effectively deposited upon the absorbent articles by such methods as, for example, emulsifying the polysiloxane m surfactant or providmg the polysiloxane in solution with the aid of a solvent, such as hexane, listed for exemplary purposes only. Particular methods for applymg polysiloxane emollients to absorbent articles are discussed m more detail hereinafter.
  • Preferred polysiloxanes compounds for use m the present mvention are disclosed m U.S. Patent 5,059,282 (Ampulski et al), issued October 22, 1991, which is incorporated herem by reference.
  • Particularly preferred polysiloxane compounds for use as emollients m the compositions of the present invention mclude phenyl-functional polymethylsiloxane compounds (e.g., Dow Corning 556 Cosmetic-Grade Fluid: polyphenylmethylsiloxane) and cetyl or stearyl functionalized dimethicones such as Dow 2502 and Dow 2503 polysiloxane liquids, respectively.
  • Suitable fatty ester type emollients also include polyolpolyesters as described in U.S. Patent 5,609,587, issued to Roe on March 11, 1997, the disclosure of which is incorporated herein by reference.
  • Exemplary polyols mclude, but are not limited to, polyhyd ⁇ c compounds such as pentaeryth ⁇ tol; sugars such as raffmose, maltodextrose, galactose, sucrose, glucose, xylose, fructose, maltose, lactose, mannose and erythrose; and sugar alcohols such as erythntol, xyhtol, mahtol, manmtol and sorbitol.
  • Such polyols are estenfied with fatty acids and/or other organic radicals having at least two carbon atoms and up to 30 carbon atoms.
  • preferred polyolpolyester emollients of the present invention have substantially all (e.g. at least about 85%) of the hydroxyl groups estenfied.
  • Particularly preferred are sucrose polyolpolyesters such as sucrose polycottonate, sucrose polysoyate, and sucrose polybehenate. Mixtures of such polyolpolyesters are also suitable emollients for the present invention.
  • Suitable humectants include glycerine, propylene glycol, sorbitol, tnhydroxy steann, and the like.
  • the amount of emollient that can be mcluded in the composition will depend on a va ⁇ ety of factors, including the particular emollient mvolved, the skm benefits desired, the other components m the composition and like factors.
  • the composition will compnse from 0 to 100%), by total weight, of the emollient.
  • the composition will compnse from about 10 to about 95%), more preferably from about 20 to about 80%>, and most preferably from about 40 to about 75%o, by weight, of the emollient.
  • Another optional, preferred component of the present skm care compositions is an agent capable of providing hardness to the solidified composition. Because some of the preferred emollients in the composition have a plastic or liquid consistency at 20°C, they do not have the required hardness or dimensional stability for the stick form.
  • the solidifying agents can be added to counter this tendency of the emollient to flow or soften. Without intending to be bound by theory, this is believed to be due, in part, to the fact that the solidifying agent raises the meltmg point and/or viscosity of the composition above that of the emollient.
  • the solidifying agent is preferably miscible with the emollient (or solubihzed in the emollient with the aid of an appropriate emulsifier or dispersed therein), it entraps the lower meltmg emollient.
  • the solidifying agent preferably has a meltmg profile that will provide a composition that is solid or semisolid at ambient temperature.
  • preferred solidifying agents will have a meltmg point of at least about 35°C. This is so the solidifying agent itself will not have a tendency to migrate or flow.
  • Preferred solidifying agents will have meltmg points of at least about 40°C.
  • the solidifying agent will have a meltmg point m the range of from about 50°C to about 150°C.
  • the solidifying agent It is also advantageous to "microscopically" lock or entrap the emollient withm the solidifying agent. This can be accomplished by using solidifying agents which tend to form fine crystals or have high crystallmity (for example, a microcrystallme wax). Upon cooling, the solidifying agent forms multiple seeds or nuclei, from which the crystalline structures grow, and entrap the emollients. In addition, outside cooling of the treated article via blowers, fans, cold rolls, etc. can speed up crystallization of the solidifying agent.
  • certain type of rheological agents can produce solid or semi-solid compositions at ambient temperature. And some emollients m combination with the skm care ingredients and rheological agents can also produce solid or semi-solid compositions at ambient temperature.
  • solidifymg agents useful herem can be selected from any of a number of agents, so long as the protease-inhibiting properties of the skm care composition provide the skm benefits descnbed herem.
  • Preferred solidifymg agents will compnse a member selected from the group consisting of C14-C22 fatty alcohols, C12-C22 fatty acids, and C12-C22 fatty alcohol ethoxylates havmg an average degree of ethoxylation rangmg from 2 to about 30, and mixtures thereof.
  • Preferred solidifymg agents m clude C j g-
  • Cj8 fatty alcohols most preferably crystalline high meltmg matenals selected from the group consisting of cetyl alcohol, stearyl alcohol, behenyl alcohol, and mixtures thereof. (The lmear structure of these matenals can speed up solidification on the treated absorbent article.) Mixtures of cetyl alcohol and stearyl alcohol are particularly preferred.
  • Other preferred solidifying agents mclude C j g-C j g fatty acids, most preferably selected from the group consisting of palmitic acid, steanc acid, and mixtures thereof. Mixtures of palmitic acid and stea ⁇ c acid are particularly preferred.
  • Still other preferred solidifymg agents mclude C j g-C ⁇ fatty alcohol ethoxylates havmg an average degree of ethoxylation ranging from about 5 to about 20.
  • the fatty alcohols, fatty acids and fatty alcohols are l ear.
  • these preferred solidifymg agents such as the C 16"Ci8 f ⁇ tty alcohols mcrease the rate of crystallization of the composition causmg the composition to crystallize rapidly onto the surface of the substrate.
  • esters and amides will have three or more free hydroxy groups on the polyhydroxy moiety and are typically noniomc m character. Because of the possible skm sensitivity of those usmg articles to which the composition is applied, these esters and amides should also be relatively mild and non-irntating to the skm.
  • Suitable polyhydroxy fatty acid esters for use in the present mvention will have the formula:
  • R is a C5-C31 hydrocarbyl group, preferably straight chain C7-C19 alkyl or alkenyl, more preferably straight cham C9-C17 alkyl or alkenyl, most preferably straight cham Cu-C j y alkyl or alkenyl, or mixture thereof;
  • Y is a polyhydroxyhydrocarbyl moiety havmg a hydrocarbyl cham with at least 2 free hydroxyls directly connected to the cham; and n is at least 1.
  • Suitable Y groups can be de ⁇ ved from polyols such as glycerol, pentaerythntol; sugars such as raffinose, maltodextrose, galactose, sucrose, glucose, xylose, fructose, maltose, lactose, mannose and erythrose; sugar alcohols such as erythntol, xylitol, mahtol, manmtol and sorbitol; and anhydndes of sugar alcohols such as sorbitan.
  • polyols such as glycerol, pentaerythntol
  • sugars such as raffinose, maltodextrose, galactose, sucrose, glucose, xylose, fructose, maltose, lactose, mannose and erythrose
  • sugar alcohols such as erythntol, xylitol, mahtol, manmtol and sorb
  • One class of suitable polyhydroxy fatty acid esters for use m the present mvention compnses certain sorbitan esters, preferably the sorbitan esters of C16-C22 saturated fatty acids.
  • these sorbitan esters usually compnse mixtures of mono-, di-, t ⁇ -, etc. esters.
  • suitable sorbitan esters mclude sorbitan palmitates (e.g., SPAN 40), sorbitan stearates (e.g., SPAN 60), and sorbitan behenates, that compnse one or more of the mono-, di- and t ⁇ -ester versions of these sorbitan esters, e.g., sorbitan mono-, di- and t ⁇ -palmitate, sorbitan mono-, di- and t ⁇ -stearate, sorbitan mono-, di and tn-behenate, as well as mixed tallow fatty acid sorbitan mono-, di- and t ⁇ -esters.
  • sorbitan esters can also be used, such as sorbitan palmitates with sorbitan stearates.
  • Particularly preferred sorbitan esters are the sorbitan stearates, typically as a mixture of mono-, di- and t ⁇ -esters (plus some tetraester) such as SPAN 60, and sorbitan stearates sold under the trade name GLYCOMUL-S by Lonza, Inc.
  • these sorbitan esters typically contain mixtures of mono-, di- and t ⁇ -esters, plus some tetraester, the mono- and di-esters are usually the predommant species m these mixtures.
  • glyceryl monoesters preferably glyceryl monoesters of C16-C22 saturated fatty acids such as glyceryl monostearate, glyceryl monopalmitate, and glyceryl monobehenate.
  • glyceryl monoester mixtures will typically contain some di- and t ⁇ ester.
  • sucrose monoesters and diesters are particularly preferred and mclude sucrose mono- and di-stearate and sucrose mono- and di- laurate.
  • Suitable polyhydroxy fatty acid amides for use in the present mvention will have the formula:
  • R C — N — Z wherem R IS H, C1-C4 hydrocarbyl, 2-hydroxyethyl, 2-hydroxypropyl, methoxyethyl, methoxypropyl or a mixture thereof, preferably C1-C4 alkyl, methoxyethyl or methoxypropyl, more preferably C j or C2 alkyl or methoxypropyl, most preferably C j alkyl (i.e., methyl) or methoxypropyl; and R ⁇ is a C5-C31 hydrocarbyl group, preferably straight cham C7-C19 alkyl or alkenyl, more preferably straight cham C9-C17 alkyl or alkenyl, most preferably straight cham Cji-
  • the Z moiety preferably will be denved from a reducing sugar m a reductive ammation reaction; most preferably glycityl.
  • Suitable reducmg sugars include glucose, fructose, maltose, lactose, galactose, mannose, and xylose.
  • High dextrose corn syrup, high fructose corn syrup, and high maltose corn syrup can be utilized, as well as the individual sugars listed above. These corn syrups can yield mixtures of sugar components for the Z moiety.
  • the Z moiety preferably will be selected from the group consisting of -CH 2 -(CHOH) n -CH 2 OH, -CH(CH 2 OH)-[(CHOH) n ( ]-CH OH, -CH 2 OH-CH 2 -(CHOH) 2
  • (CHOR 3 )(CHOH)-CH2 ⁇ H where n is an mteger from 3 to 5, and R is H or a cyclic or aliphatic monosacchande. Most preferred are the glycityls where n is 4, particularly -CH -(CHOH) -CH OH.
  • R* can be, for example, N-methyl, N-ethyl, N-propyl, N-isopropyl,
  • R ⁇ can be selected to provide, for example, cocamides, stearamides, oleamides, lauramides, my ⁇ stamides, capncamides, palmitamides, tallowamides, etc.
  • the Z moiety can be 1-deoxygluc ⁇ tyl, 2-deoxyfructityl, 1- deoxymaltityl, 1-deoxylactityl, 1-deoxygalactityl, 1-deoxymann ⁇ tyl, 1-deoxymaltotnotityl, etc.
  • the most preferred polyhydroxy fatty acid amides have the general formula:
  • R! is methyl or methoxypropyl
  • R ⁇ is a CJ J-C ⁇ straight-cham alkyl or alkenyl group.
  • 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-tallowyl-N-methyl glucamide, or N-tallowyl-N-methoxypropyl glucamide.
  • some of the solidifymg agents may require an emulsifier for solubihzation m the emollient.
  • an emulsifier for solubihzation m the emollient.
  • certain of the glucamides such as the N-alkyl-N-methoxypropyl glucamides havmg hydrophilic lipophihc balance (HLB) values of at least about 7.
  • HLB hydrophilic lipophihc balance
  • Suitable emulsifiers will typically mclude those havmg HLB values below about 7.
  • the sorbitan esters previously descnbed, such as the sorbitan stearates, havmg HLB values of about 4.9 or less have been found useful in solubihzing these glucamide solidifymg agents m petrolatum.
  • emulsifiers m include steareth-2 (polyethylene glycol ethers of stearyl alcohol that conform to the formula CH3(CH2)i7(OCH2CH2) n OH, where n has an average value of 2), sorbitan tnstearate, isosorbide laurate, and glyceryl monostearate.
  • the emulsifier can be mcluded m an amount sufficient to solubihze the solidifymg agent m the emollient such that a substantially uniform mixture is obtained.
  • mgredients that can be used as solidifymg agents, either alone, or m combination with the above-mentioned solidifymg agents, mclude waxes such as carnauba, ozokente, beeswax, cande lla, paraffin, ceresin, esparto, ouncun, rezowax, lsoparaffm, and other known mined and mmeral waxes.
  • the high melt pomt of these matenals can help immobilize the composition on the desired surface or location on the article.
  • microcrystalline waxes are effective solidifymg agents.
  • Microcrystalline waxes can aid m "locking" up low molecular weight hydrocarbons withm the skm care composition
  • the wax is a paraffin wax.
  • An example of a particularly preferred alternate solidifymg agent is a paraffin wax such as Parrafrn S.P. 434 from Strahl and Pitsch Inc. West Arabic, NY. Synthetic waxes such as those denved from polyethylene may also be used herem.
  • the amount of the optional solidifying agent that can be mcluded m the composition will depend on a va ⁇ ety of factors, including the mgredients (e g., emollients) used, the particular solidifymg agent used, if any, the other components in the composition, whether an emulsifier is required to solubihze the solidifymg agent m the other components, and like factors.
  • the composition will typically compnse from about 5 to about 90% of the solidifymg agent.
  • the composition will compnse from about 5 to about 50%, most preferably from about 10 to about 40%, of the solidifymg agent.
  • Other Optional Components e.g., emollients
  • Compositions can compnse other components typically present m emulsions, creams, ointment, lotions, suspensions, etc. of this type. These components mclude water, disinfectants, antibactenal agents, antiviral agents, vitamins, pharmaceutical mgredients, suspendmg agents, film formers, perfumes, deodorants, opacifiers, astringents, solvents, preservatives, and the like.
  • stabilizers can be added to enhance the shelf life of the composition such as cellulose denvatives, protems and lecithin. All of these matenals are well known m the art as additives for such formulations and can be employed in approp ⁇ ate amounts m the compositions for use herem.
  • Suitable preservatives mclude propyl paraben, methyl paraben, benzyl alcohol, benzalkomum, tnbasic calcium phosphate, BHT, or acids such as cit ⁇ c, tartanc, maleic, lactic, malic, benzoic, salicylic, and the like.
  • Suitable viscosity increasing agents mclude some of the agents desc ⁇ bed as effective solidifying agents.
  • Suitable solvents include propylene glycol, glycerine, cyclomethicone, polyethylene glycols, hexalene glycol, diol and multi-hydroxy based solvents.
  • Suitable vitamins m include A, D 3 , E, B 5 and E acetate.
  • the skm care compositions of the present invention are complex chemical mixtures with complex rheological properties. Variables such as degree of agitation, cooling rate, pumping rate and filling rate can affect the rheological properties of the melt composition and the quality/uniformity of the final product.
  • the order and manner of mixing the vanous components of the present invention is not particularly cntical. It is found that the components may be thoroughly mixed to form a substantially uniform composition at temperatures rangmg from about 40°C to about 100°C. Agitation and external heat are generally required. Sometimes, viscous heat generated from agitation may raise the temperature sufficiently such that a substantially uniform dispersion of components can be achieved. It is preferred that the rheological agent be added to the medium with agitation such that the rheological agent is mixed uniformly and/or activated (i.e., form a rheological structure).
  • the particulate matenals and the predispersant are pre-mixed m a separate step before being added to the composition.
  • predispersion of zmc oxide or other skm care mgredients are not required. These mgredients can be mixed with the earner directly under proper conditions, such as small, step-wise additions under sufficient agitation
  • a substantially uniform stick composition can be produced by adding rheological agents to the composition.
  • Rheological agents such as suspending agents and/or thickeners, may be added to facilitate the dispersion of the mgredients and prevent the ingredients from settling out of the composition.
  • the rheological agents modify the properties of the melt composition, such as higher viscosity, yield value, and elastic modulus. These agents may also provide additional hardness to the solidified stick composition.
  • a substantially uniform stick composition can be produced by a "slush” process. After the composition becomes substantially uniform, the composition is allowed to cool with stirring. Stirnng keeps the components from substantial coalescence or agglomeration, keeps the solid particles (such as skm care ingredients) suspended, and minimizes separation or settling. When the composition appears to have reached a "slush” consistency, the slush is poured in to a mold or stick casing and allowed to cool and solidify into a stick form.
  • the term "slush” or “slush consistency” means the melt composition has partially solidified to form a mixture of solids and liquid.
  • the slush should preferably contain from about 5% to about 70% solids, more preferably from about 10% to about 60% solids, even more preferably from about 20%) to about 50%) solids
  • a slush consistency is reached at the temperature range from about 45°C to about 75°C, preferably from about 50°C to about 65°C, and even more preferably from about 50°C to about 55°C.
  • the composition exhibits a higher viscosity and yield value than the melt state, and the settling of the suspended ingredients is greatly reduced. It is found that filling the mold or stick casing m the slush state and subsequently cooling to room temperature can successfully prevent the separation and settling of the ingredients.
  • the distribution of the ingredients is substantially uniform through the mold or stick casmg.
  • the hardness or softness of the stick may be controlled by varying the components or the amount thereof, particularly the solidifying agents, the solid ingredient particles, and/or the solid rheological particles. It is also found that varying the duration and intensity of the agitation during the slush phase can also affect the hardness of the solidified stick.
  • the skm care composition can be processed in the solid or semi- solid state using forming processes known m the art.
  • the suitable forming temperature varies with the specific ingredients or compositions, the dependence of the apparent viscosity of the composition on temperature and shear, the processing equipment and the operating parameters used, etc.
  • the forming temperature typically ranges from about 20°C to about 100°C.
  • the sticks may be formed by an extrusion process through a shaped die to a three dimensional form suitable for topical application to the skm, without using molds or casings.
  • the sticks may be extruded mto a mold or casing to achieve the desired three dimensional form.
  • Other methods known in the art for forming high viscosity, solid or semi-solid substances are also applicable here Nonlimitmg examples of solid or semi-solid state forming processes mclude stamping, forging and moldmg.
  • Hardness is measured using a Texture Technologies TA.XT2I Texture Analyzer (5 Kg capacity and 0.1 g force resolution) and associated Windows software, Texture Expert Exceed from Stable Micro Systems, LTD.
  • the Texture Analyzer is fitted with a ! ⁇ inch Stainless Steel Spherical Probe; TA-8 from Texture Technologies is a suitable probe that was used for these tests.
  • Samples were evaluated m the Skm Care Stick casings dunng this study.
  • the casing is filled to the top edge (level) with the skm care composition to be tested, according to the Preparation Method described below.
  • the stick casing is positioned under the V* inch spherical probe and the probe is lowered such that it just contacts the surface of the composition in the casing.
  • the probe is then moved downward into the sample at a constant rate of 0.1 mm sec, while measuring force and distance. Probe travel is stopped when a force of 250 grams is attained.
  • Hardness is defined as the slope of the force versus distance curve and is expressed m “g/mm” units. Hardness values were obtained by measuring the slope of this curve between 100 and 200 grams; the curves for these compositions were quite linear withm this force range.
  • the temperature of the room and the composition should be maintained at about 65-75°F during the course of the measurement. Hardness has been found to relate strongly to the complex modulus of the material, which is a combination of the viscous and elastic moduli of the material.
  • Rheological Measurements a. Elastic Modulus Measurements The rheological properties (such as elastic modulus, viscosity) of the composition m the melt form are measured using a viscometer (available from TA Instruments of New Castle, DE as model number CSL 100) in an oscillation mode. The measurements are conducted using a cone- and-plate measuring system, having a diameter of 40 mm and a gap of 60 microns. The measurement commences after about 100 seconds waiting time. And the measurements are conducted at two temperatures. 77°C and 40°C. b. Apparent Viscosity Measurements
  • the apparent viscosity is measure at 77°C and 40°C usmg a rotational viscometer (available from Brookfield Engmee ⁇ ng Laboratones, Inc. of Middleboro, MA as Model DV-3). The viscometer is operated at a shear rate of 10 rpm using a number 2 spmdle. c. Zero Shear Viscosity Measurements
  • zero shear viscosity can be obtained by extrapolating a viscosity versus shear rate plot to a shear rate of zero.
  • the extrapolation method often does not fully and accurately describe the material.
  • the "zero shear viscosity” can be approximated by a viscosity measured at very low shear rates.
  • zero shear viscosity is the value measured by a cone and plate viscometer (available from TA Instruments of New Castle,
  • the skm care stick is prepared by filling the stick casing or mold with a skm care composition m the slush state and allowing the composition to solidify in the stick casing.
  • the top surface of the stick is shaved and rounded to provide a smooth surface.
  • Each stick is cleaned, labeled and weighed.
  • the caregiver is instructed to apply the stick composition to the diapered skm at diaper changes, which typically include changes every 3 to 4 hours dunng the daytime and a fresh diaper after bath or BM and just before overnight sleep.
  • the number of diaper changes is recorded in a diary over a 7 days study period At the end of the 7 days study, the sticks and the diaries are collected from the participants.
  • the used stick with remaining composition therein is weighed The difference between the initial and final weight of the stick is divided by the number of diaper changes and the total skm area covered (i.e., about 200 cm 2 ), and averaged over the number of participants successfully completed the study to obtain the average amount transferced per diaper change.
  • This in vivo study demonstrates the efficacy of the present invention.
  • the study consists of a two-week pre-testing, normalizing penod, followed by a two-week testing period, during which the caregiver applied the stick composition to baby's skm in the diapered areas.
  • the caregiver is required to evaluate the skm redness and record it m a diary at every diaper change during the four-week study.
  • a five-level skm redness grading scale is used, details of which is described below.
  • Enough panelists I e., Size 4 babies
  • each panelist is assigned to a test group or a control group, so that each group has as similar a mix of panelists as possible.
  • the study is conducted blmd with respect to product identification.
  • the caregiver of a panelist in the test group is given a stick containing a test composition and instructions m proper technique for applying the test compositions.
  • the panelist's diaper is to be changed according to the usual pattern of the caregiver, and the stick composition is to be applied to the diapered skm at the following times: the last diaper change just before overnight sleep, the first diaper change m the morning, after BM and after bath
  • the stick is to be applied to the panelist's skm m areas under the diaper, including sides/hips, anus and buttocks
  • the amount delivered to the skin should be limited such that a thm, barely visible layer is deposited. Typically, 2 to 4 passes of the stick over each area delivers suitable amount of the composition to the skm.
  • the caregiver of a panelist m the control group is instructed to merely mamtam usual diaper changing routine and pattern, and not to apply skin protectant, moisture repellent or rash treatment of any kind during the study
  • cleaning with soap or cleansing gels, water, and/or baby wipes is permitted at diaper changes, at bath and after BM.
  • the skm in the diapered area of each panelist is evaluated by the caregiver and recorded in a diary throughout the study period.
  • a skm care stick is prepared by combining the following components using conventional mixing techniques, such as that described heremabove.
  • the skm care stick is applied to the skm area covered by a diaper or other absorbent articles.
  • the stick delivers an effective amount of skm care mgredients to the skm as a thin, substantially clear or barely visible coating.
  • the stick should preferably be used at every diaper change. Thoroughly cleaning of the skm before applying the stick composition is permitted but nor required.
  • EXAMPLE 2 A skin care stick is prepared by combining the following components using conventional mixing techniques, such as that described heremabove.
  • the skm care stick is applied to the skm area covered by a diaper or other absorbent articles.
  • the stick delivers an effective amount of skm care ingredients to the skm as a thm, substantially clear or barely visible coating.
  • the stick should preferably be used at every diaper change. Thoroughly cleaning of the skm before applymg the stick composition is permitted but nor required.
  • EXAMPLE 3 A skm care stick is prepared by combining the following components using conventional mixing techniques, such as that described heremabove.
  • the skm care stick is applied to the skm area covered by a diaper or other absorbent articles.
  • the stick delivers an effective amount of skm care ingredients to the skm as a thm, substantially clear or barely visible coating.
  • the stick should preferably be used at every diaper change. Thoroughly cleaning of the skm before applymg the stick composition is permitted but nor required.
  • the skm care composition and method of the present invention are tested accordmg to the in vivo testing protocol described above.
  • a 5-level grading scale (such as that described above) is used to assess the skm condition m diapered areas.
  • a score of zero or one is generally considered as "problem-free" by the parents or caregivers. And the score increases as the skm redness increases.
  • the average scores of diapered skm, either untreated or treated with the compositions of the present invention, over a 4 weeks period are illustrated below.
  • composition 2 is as described m Example 2; and c. Composition 3 is as described in Example 3;

Abstract

L'invention concerne des compositions de soins de la peau sous forme de bâtons solides destinés à entretenir et à améliorer l'état de la peau, notamment les rougeurs des zones situées sous un article absorbant. Le bâton de soins fournit un moyen d'administration efficace et esthétiquement agréable permettant d'appliquer localement sur la peau une très petite quantité de la composition et d'obtenir des résultats. La composition en bâton présente une dureté recherchée permettant de maintenir une stabilité dimensionnelle, et permet d'appliquer sur la peau une quantité très faible mais efficace de la composition de soins. L'invention concerne également des procédés permettant d'améliorer l'état de la peau, notamment les rougeurs associées à l'exposition chronique de la peau aux déchets corporels, à l'humidité, à des irritants etc. Le procédé consiste à appliquer une fine couche de la composition de soins sous forme de bâton et à obtenir des résultats avec de faibles quantités. Le procédé concerne en outre des procédés de fabrication des compositions de soins de la peau sous forme de bâton.
PCT/US2000/015198 1999-06-04 2000-06-02 Batons de soins de la peau WO2000074643A1 (fr)

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US7285570B2 (en) 2003-04-17 2007-10-23 The Procter & Gamble Company Compositions and methods for regulating mammalian keratinous tissue
WO2011073345A2 (fr) 2009-12-17 2011-06-23 L'oreal Utilisation d'un ou de plusieurs composés adhésifs sensibles à la pression à titre d'agents pour le traitement de la transpiration chez l'homme
WO2011073356A2 (fr) 2009-12-17 2011-06-23 L'oreal Utilisation d'une composition cosmétique comprenant au moins un polymère élastomère filmogène pour traiter la transpiration humaine
US9333165B1 (en) 2014-12-09 2016-05-10 L'oreal Cream to powder cosmetic compositions
WO2016100809A1 (fr) * 2014-12-18 2016-06-23 The Procter & Gamble Company Composition cosmétique anhydre pour application topique
US20220304449A1 (en) * 2021-03-24 2022-09-29 JPL Products LLC Facial treatment systems and methods

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WO2003000205A1 (fr) * 2001-06-22 2003-01-03 Unilever Plc Compositions d'apres-shampooing
US6831046B2 (en) 2001-06-22 2004-12-14 Unilever Home & Personal Care Usa, Division Of Conopco, Inc. Hair conditioning compositions in stick or bar form containing cationic surfactant and fatty alcohol
EP1284128A1 (fr) 2001-08-17 2003-02-19 L'oreal Stick antitranspirant anhydre
US7425321B2 (en) 2001-08-17 2008-09-16 L'oreal S.A. Anhydrous antiperspirant stick
US7285570B2 (en) 2003-04-17 2007-10-23 The Procter & Gamble Company Compositions and methods for regulating mammalian keratinous tissue
US8063097B2 (en) 2003-04-17 2011-11-22 The Procter & Gamble Company Compositions and methods for regulating mammalian keratinous tissue
WO2011073356A2 (fr) 2009-12-17 2011-06-23 L'oreal Utilisation d'une composition cosmétique comprenant au moins un polymère élastomère filmogène pour traiter la transpiration humaine
WO2011073345A2 (fr) 2009-12-17 2011-06-23 L'oreal Utilisation d'un ou de plusieurs composés adhésifs sensibles à la pression à titre d'agents pour le traitement de la transpiration chez l'homme
US9333165B1 (en) 2014-12-09 2016-05-10 L'oreal Cream to powder cosmetic compositions
WO2016094110A1 (fr) 2014-12-09 2016-06-16 L'oreal Compositions cosmétiques crème-poudre
WO2016100809A1 (fr) * 2014-12-18 2016-06-23 The Procter & Gamble Company Composition cosmétique anhydre pour application topique
CN106999406A (zh) * 2014-12-18 2017-08-01 宝洁公司 用于局部施用的无水化妆品组合物
CN106999406B (zh) * 2014-12-18 2020-09-08 宝洁公司 用于局部施用的无水化妆品组合物
US20220304449A1 (en) * 2021-03-24 2022-09-29 JPL Products LLC Facial treatment systems and methods

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