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WO1994009796A1 - Creme tamponnee pour le traitement de l'erytheme fessier du nourrisson - Google Patents

Creme tamponnee pour le traitement de l'erytheme fessier du nourrisson Download PDF

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Publication number
WO1994009796A1
WO1994009796A1 PCT/US1993/009869 US9309869W WO9409796A1 WO 1994009796 A1 WO1994009796 A1 WO 1994009796A1 US 9309869 W US9309869 W US 9309869W WO 9409796 A1 WO9409796 A1 WO 9409796A1
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WO
WIPO (PCT)
Prior art keywords
concentration
weight
cream
skin cream
buffered
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US1993/009869
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English (en)
Inventor
Murray Jack Sibley
Donald Ernest Hartung
Rosalyn Ruland
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
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
Priority claimed from US08/130,113 external-priority patent/US5362488A/en
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Publication of WO1994009796A1 publication Critical patent/WO1994009796A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/80—Polymers containing hetero atoms not provided for in groups A61K31/755 - A61K31/795

Definitions

  • the present invention relates generally to a buffered skin cream for use in connection with diaper rash.
  • diaper rash also known as diaper dermatitis.
  • diaper dermatitis One of the most common skin problems with infants relates to diaper rash, also known as diaper dermatitis.
  • diaper dermatitis One study conducted with infants less than two years of age concluded that almost two-thirds of all infants suffer from diaper rash of some degree. Approximately 10% of all infants can have their diaper rash classified as being moderate, with another 5% of the infants having diaper rash which could be classified as severe.
  • infants under two months of age can urinate up to 20 times per day. Thereafter, infants can urinate up to 8 times a day. In addition, infant defecation typically occurs several times a day.
  • Diaper rash may predispose an infant to irritation and infection.
  • the two most common types of infection are those associated with yeast and bacteria.
  • the most common yeast infection is caused by Candida albicans.
  • the most common bacterial infection is caused by Staphylococcus aureus.
  • the principle function of these products has been to act as a protectant, such that any affected area is protected against further direct contact with urine or feces.
  • the most widely used protective ingredient has been zinc oxide. While many preparations contain zinc oxide in concentrations of approximately 10% by weight, some of the more popular brands have zinc oxide concentrations of approximately 40% by weight. Unless otherwise stated, the percentage concentrations of ingredients is understood to refer to precent by weight.
  • the zinc oxide is formulated with an oily substance such as petrolatum. Consequently, although such a diaper rash compound provides an effective protective layer, it is greasy, messy to apply, and not easily removed from the hands or the baby's bottom. Although removal can be affected with mineral oil, having to wash one's hands with mineral oil is inconvenient. Additionally, zinc oxide products have a distinctive smell due to their oil base, with this smell being offensive to some users of the product.
  • the typical anhydrous, hydrophobic ointment prevents urine or feces from coming into direct contact with the skin by their being repelled from the ointment surface. As such, the product acts as a barrier, inhibiting any penetration into the diaper rash product by any liquid.
  • a diaper rash product is British Patent No. 1 ,357,731.
  • That patent discloses a unique powder composition, which can be incorporated into a hydrophobic ointment.
  • a buffer system is provided to buffer the composition at a pH of from 5.5 to 7.5, and preferably from 6 to 7.
  • That patent discloses that a citric acid/sodium citrate buffering system does not have superior buffering capacity when compared with other buffering systems.
  • This patent further discloses that "succinic acid/sodium succinate has 30% more buffering capacity than a citric acid/sodium citrate" buffer system.
  • This patent purports to treat diaper rash by inhibiting the deleterious effects of the enzyme lipase action on the skin, said inhibition being achieved by incorporating a inhibitory agent of said lipase action into a barrier like carrier, said carrier having the characteristics of being relatively hydrophobic in nature thereby forming an effective barrier to the skin against urine and feces.
  • the instant invention does not disclose nor claim use of lipase inhibitory agents.
  • the instant invention is further distinguished from the Buckingham patent in that the present invention specifically claims use of a buffering system to neutralize acidic conditions. Buckingham neither teaches nor claims any buffering system. Further the instant invention is set apart from the Buckingham patent in the nature of the carrier material employed in the formation of the so-called skin barrier. In the case of Buckingham, specifically disclosed are water-in-oil types of emulsions. In contrast to Buckingham, the instant invention specifically discloses and claims use of oil-in-water type emulsions in the formation of the barrier material.
  • the instant invention does not require, teach nor claim encapsulation of Dimethicone, one of the ingredients in the claimed composition.
  • Other studies such as one published in The Practitioner. Vol. 210:824-828 (1973), discuss a boric acid/borax buffer system for use as a diaper rash product.
  • studies conducted during the 1970's brought about concerns of boron toxicity such that products containing boric acid had to be reformulated thereby eliminating boric acid as an ingredient.
  • a buffered skin cream comprising stearic acid, a linear polydimethylsiloxane polymer, a non-ionic emulsifier composed of a mixture of cetearyl alcohol and its ethoxylate, mineral oil, aloe vera, sodium citrate, citric acid, a naturally derived, non-ionic, water soluble polymer, a blend of propylene glycol, diazolidinyl urea, methyl paraben, and propyl paraben, and water.
  • the sodium citrate and citric acid cooperate to form a buffering system having a pH in the range of between 4.0 and 6.5. More preferably the sodium citrate and citric acid cooperate to form a buffering system having a pH in the range of between 5.0 and 5.5. Most preferably the sodium citrate and citric acid cooperate to form a buffering system having a pH of 5.2.
  • the naturally derived, non-ionic water-soluble polymer preferably is nonoxynyl hydroxyethylcellulose. Additionally, the skin cream has a neutral olfactory sensation. The viscosity of the skin cream is in the range of between 100,000 centipoise and 2,000,000 centipoise. Additionally, the skin cream is soluble in soap and water. Furthermore, the stearic acid has a saponification value of between 197 and 200, and an iodine value of not more than 1. Still further, the mineral oil is a light mineral oil with a specific gravity of between 0.818 and 0.880.
  • a buffered skin cream comprising stearic acid having a saponification value of between 197 and 200, and an iodine value of not more than 1 , with the stearic acid also of a concentration of about 10% by weight, a linear polydimethylsiloxane polymer of a concentration of about 20% by weight, a non-ionic emulsifier, said emulsifier being of a concentration of about 8% by weight, light mineral oil with a specific gravity of between 0.818 and 0.880 of a concentration of about 4% by weight, aloe vera of a concentration of about 1% by weight, sodium citrate of a concentration of about 3% by weight, citric acid of a concentration of about 0.5% by weight, water of a concentration of about 47% by weight, a naturally derived, non-ionic water soluble polymer of a concentration of about 0.5% by weight, and a blend of propylene glycol, diazolidinyl urea, methyl paraben
  • the sodium citrate and citric acid preferably will cooperate to form a buffering system having a pH in the range of between 4.0 and 6.5. More preferably the sodium citrate and citric acid cooperate to form a buffering system having a pH in the range of between 4.5 and 6.0. Most preferably sodium citrate and said citric acid cooperate to form a buffering system having a pH of between 5.0 and 5.5. Buffering capacity is independent of Dimethicone concentrations.
  • the buffered skin cream preferably includes aloe vera and anhydrous lanolin.
  • One aspect of the present invention provides an effective, easy to apply and remove diaper rash cream having a buffering system to maintain the pH of the product at approximately the natural skin pH.
  • the present invention is concerned with a buffered skin cream for use primarily in the treatment of diaper rash.
  • the present invention could also be used in an attempt to prevent diaper rash by inhibiting contact with the skin of either feces or urine.
  • the preventative aspect of the product occurs solely due to the buffering capacity and to the protectant included in the formulation of the cream.
  • the buffered diaper rash cream embodiments of this invention are comprised of an oil-in-water emulsion which incorporates a simple and safe buffering system. More specifically, the buffering system of the present invention is comprised of citric acid and sodium citrate. Although the buffering system is relatively simple, the system's capacity is sufficient to maintain the pH of the cream relatively close to the normal pH of skin, despite the addition of significant amounts of either, or both, alkaline and acidic materials, such as ammonia and hydrochloric acid. Since the buffered cream embodiments of this invention are oil-in-water emulsions, the product can be easily removed from the skin or clothing by washing with soap and water. Additionally, the product does not leave a greasy feeling on the skin.
  • the diaper rash cream of this invention possess excellent protective qualities comparable to those associated with leading diaper rash treatment products, particularly the well known ointments.
  • the diaper rash cream embodiment of this invention is spread on sufficiently thick over the affected area to allow a good coating of the area to be protected.
  • the infant may then be diapered in either cloth or disposable diapers.
  • the area can be cleaned, preferably with soap and water, and thereafter allowed to dry before reapplication of the diaper rash cream and re-diapering.
  • Non-ionic emulsifier composed of a mixture of cetearyl alcohol and its ethoxylate 8%
  • Aloe vera 2% A blend of propylene glycol, diazolidinyl urea, methyl paraben and propyl paraben 1 %
  • Purified water 37.5% A skin cream according to this invention is prepared in the following manner. Turning to Table 1 , the first five listed ingredients are combined and then heated to between 65-75°C, preferably to between 70-72°C. (Solution A). The water is then separately heated to between 65-75°C, and also preferably to between 70-72°C. As the water is heating the non-ionic water soluble polymer is added and the resultant solution agitated (Solution B).
  • both liquids When the temperatures of both liquids are in the desired range, they are combined. This is best achieved by slowly adding, with vigorous agitation, Solution B to Solution A. Care must be taken that the oil solution not begin to solidify at this time, so it may be easier to add the water solution to the oil solution.
  • the temperature is maintained in the range of 65-75 ⁇ C, preferably to between 70-72°C, and vigorous agitation continues for about 15-20 minutes.
  • the combined solution is then cooled.
  • the buffering system consisting of sodium citrate and citric acid, is preferably first added.
  • the aloe and blend of preservatives are added. However, this addition should occur when the temperature of the solution is less than 55°C. Water is then added to the achieve the desired volume and relative concentration of the individual components. The product will begin to thicken once its temperature is between 45-50°C.
  • the first component namely the non-ionic emulsifier is Promulgen D
  • Promulgen D is a blend of a fatty alcohol (cetearyl alcohol) and a polyethyleneglycol ether of cetaryl alcohol.
  • Promulgen D is a product distributed by Amerchol Corporation, Edison, New Jersey, U.S.A.
  • the linear polymer is the protectant associated with this invention.
  • the protectant is Dow Corning 200 Fluid, 12,500 centistokes.
  • This Dimethicone compound is a linear polydimethylsiloxane polymer which is not readily water soluble and has an average kinematic viscosity of 12,500 centistokes.
  • polydimethylsiloxane polymers can also be employed in the formulations of the instant invention.
  • Such other polydimethylsiloxane polymers include Dimethicone having an average kinematic viscosity of 100 centistokes.
  • the lightweight mineral oil functions as an emollient in the preferred cream embodiment.
  • An emollient serves to reduce the greasy feeling associated with use of Dimethicone.
  • the stearic acid functions as a thickener.
  • the blend of propylene glycol, diazolidinyl urea, methyl paraben and propyl paraben in the preferred embodiment of the invention is Germaben HE, a preservative system.
  • Germaben HE is distributed by Sutton Laboratories of Chatham, New Jersey U.S.A.
  • the naturally derived water soluble polymer in the preferred embodiment of the invention is Amercell HM-1500 a thickener comprising nonoxynyl hydroxyethylcellulose.
  • Amercell 1500 is distributed by Amerchol Corporation of Edison, New Jersey, U.S.A. Hydroxypropylmethylcellulose could also be utilized as a thickener in place of nonoxynyl hydroxyethylcellulose, however, the Amercell HM-1500 is a more effective thickener in the cream of this invention than is hydroxypropylmethylcellulose.
  • a representative range of the formula composition for the buffered diaper rash cream embodiment of the invention is set forth in Table 2.
  • the buffered cream composition noted in Table 2, having a Dimethicone concentration in the range of about 1 - 30% by weight, has an acceptable viscosity and pH range of about 100,000 to 2,000,000 centipoise and about 4.0 to 6.5 respectively. These compositions will have a more preferred viscosity and pH range of about 150,000 - 1 ,500,000 centipoise and 4.5 - 6.0, respectively. The compositions will have a most preferred viscosity and pH in the range of about 250,000 - 1 ,000,000 centipoise and 5.0 - 5.5, respectively.
  • the expected method of preparation of the buffered diaper rash cream formulation was to add the sodium citrate and the citric acid to the water and heat the solution to between 70-75°C. The oil phase was then added at the same temperature and the product was agitated. Unexpectedly, no emulsification appeared to have occurred. Once agitation was stopped, the product separated into two distinct layers.
  • the linear polymer is the protectant associated with this invention.
  • the linear polydimethylsiloxane polymer protectant employed is Dow Corning 200 Fluid, 12,500 centistokes. This Dimethicone compound is not readily water soluble and has an average kinematic viscosity of 12,500 centistokes. (It will be readily appreciated by those skilled in the art that other larger or smaller linear polydimethylsiloxane polymers could also be used).
  • the blend of propylene glycol, diazolidinyl urea, methyl paraben and propyl paraben in the preferred embodiment of the invention is Germaben HE, a preservative system.
  • the pH for the buffered cream is between 4.0 and 6.5. More preferably the pH of the cream is between 5.0 and 5.5, and most preferably the pH is 5.2.
  • the ingredients of Table 1 were combined, except that the naturally derived non-ionic, water soluble polymer was omitted.
  • the resultant cream did not exhibit the proper viscosity. Additionally, increasing the concentration of stearic acid to obtain an acceptable viscosity resulted in the stearic acid having to be increased more than two-fold. Even then, the resultant cream did not possess the desirable properties of the cream associated with the invention.
  • the ingredients of Table 1 were combined as shown in Table 1.
  • the resultant cream exhibited a pH of between 5 and 5.5, typically 5.2.
  • Tests conducted with a Brookfield viscometer at spindle 4, 3 rpm, for two minutes disclosed a viscosity of 200,000 centipoise.
  • the resultant diaper rash cream was acceptable for use on human skin. Under typical room temperature conditions the cream of this invention is a thick, viscous cream which is non-pourable.
  • the diaper rash cream embodiment of this invention having the formulation of Table 1 , as well as modified compositions having 5%, 10%, and 30% Dimethicone concentrations, was compared with Desitin which is a leading diaper rash ointment having zinc oxide as its protectant.
  • Desitin is distributed by the Consumer Health Care Division of Pfizer, Inc. of New York, New York, U.S.A.
  • the first step was to weigh a clean, glass microscope slide ("original slide weight"). A coating of the sample to be tested was uniformly applied to one half of one side of the clean slide. The coated slide was then weighed ("original coated slide weight”). The coated slide then had its coated portion immersed in 100 ml. of purified water.
  • the beaker with the partially immersed slide was then placed in a 400°C oven for 1 hour. After that time the slide was removed from the water and had its uncoated portions dried. The dried slide was then weighed, left at room temperature for 2 hours, and then weighed again ("final slide weight"). All samples were tested twice.
  • the percentage of absorption indicates how much of the cream or ointment was removed by the water where "% absorption" is less than 100, or how much water was able to be absorbed as a percentage of the cream's weight where "% absorption" is greater than 100. In those cases, for example, a "% absorption" determination of 200 would mean that the cream was able to absorb its own weight in water, or in effect to double its weight due to apparent absorption. As set forth below in Table 6, it will be noted that over time, while relatively little change occurred with respect to the weight of the ointment layer (in fact it lost some weight), the cream of this invention unexpectedly apparently absorbed the liquid into the cream as shown by the increase in weight.
  • the buffered diaper rash cream of this invention is effective in preventing diaper rash. It is also easy to use since it may be washed off with soap and water.
  • the buffered diaper rash cream is aromatically and tactilely pleasing.
  • the cream may be applied directly to the skin, either by hand or via wipes.
  • the cream preferably appears whitish in its dispenser, but rubs on translucent.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Detergent Compositions (AREA)

Abstract

L'invention concerne une crème tamponnée pour la peau, contenant un polymère polydiméthylsiloxane linéaire, un émulsifiant non ionique, de l'aloès ordinaire, une huile minérale, du citrate de sodium, de l'acide citrique, un mélange de propylène glycol, d'imidazolidinylurée, de méthylparaben et de propylparaben, et de l'eau. Le tamponnage de la crème est dû à l'incorporation d'acide citrique et de citrate de sodium dans la composition de celle-ci. Grâce à ce système de tamponnage, la crème présente un pH préféré compris entre environ 4,5 et 6,0 et, idéalement, un pH d'environ 5,2 qui neutralise les produits secondaires acides et basiques de l'urine et des matières fécales. La crème présente une viscosité préférée comprise entre 100 000 et 2 000 000 centipoises et une viscosité préférée d'environ 250 000 à 1 000 000 centipoises. Cette crème peut être facilement enlevée avec de l'eau et du savon, et elle peut être utilisée pour prévenir et traiter l'érythème fessier du nourrisson.
PCT/US1993/009869 1992-10-23 1993-10-13 Creme tamponnee pour le traitement de l'erytheme fessier du nourrisson Ceased WO1994009796A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US96564192A 1992-10-23 1992-10-23
US965,641 1992-10-23
US08/130,113 US5362488A (en) 1992-10-23 1993-10-06 Buffered diaper rash cream
US130,113 1993-10-06

Publications (1)

Publication Number Publication Date
WO1994009796A1 true WO1994009796A1 (fr) 1994-05-11

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/009869 Ceased WO1994009796A1 (fr) 1992-10-23 1993-10-13 Creme tamponnee pour le traitement de l'erytheme fessier du nourrisson

Country Status (2)

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MX (1) MX9306540A (fr)
WO (1) WO1994009796A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996024329A1 (fr) * 1995-02-10 1996-08-15 The Procter & Gamble Company Compositions de soins corporels et serviettes les contenant
US5980904A (en) * 1998-11-18 1999-11-09 Amway Corporation Skin whitening composition containing bearberry extract and a reducing agent
US6149934A (en) * 1999-04-23 2000-11-21 Kimberly-Clark Worldwide, Inc. Absorbent article having a lotionized bodyside liner
US6749860B2 (en) 2000-12-22 2004-06-15 Kimberly-Clark Worldwide, Inc. Absorbent articles with non-aqueous compositions containing botanicals
US6756520B1 (en) 2000-10-20 2004-06-29 Kimberly-Clark Worldwide, Inc. Hydrophilic compositions for use on absorbent articles to enhance skin barrier
EP1800647A1 (fr) * 2005-12-20 2007-06-27 Cognis IP Management GmbH Mélange émollient pour compositions cosmétiques et pharmaceutiques
US7771735B2 (en) 2000-12-22 2010-08-10 Kimberly-Clark Worldwide, Inc. Absorbent articles with compositions for reducing irritation response
CN109303718A (zh) * 2017-07-26 2019-02-05 安徽中医药大学 一种用于防治婴儿红臀的纯中药复方湿巾及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4536399A (en) * 1982-10-13 1985-08-20 Norcliff Thayer, Inc. Use of fumed silica for treating oily skin and acne
US4855129A (en) * 1986-11-25 1989-08-08 Bayer Aktiengesellschaft Skin-protecting or skin-care composition
US4904524A (en) * 1988-10-18 1990-02-27 Scott Paper Company Wet wipes

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4536399A (en) * 1982-10-13 1985-08-20 Norcliff Thayer, Inc. Use of fumed silica for treating oily skin and acne
US4855129A (en) * 1986-11-25 1989-08-08 Bayer Aktiengesellschaft Skin-protecting or skin-care composition
US4904524A (en) * 1988-10-18 1990-02-27 Scott Paper Company Wet wipes

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996024329A1 (fr) * 1995-02-10 1996-08-15 The Procter & Gamble Company Compositions de soins corporels et serviettes les contenant
US5980904A (en) * 1998-11-18 1999-11-09 Amway Corporation Skin whitening composition containing bearberry extract and a reducing agent
US6149934A (en) * 1999-04-23 2000-11-21 Kimberly-Clark Worldwide, Inc. Absorbent article having a lotionized bodyside liner
US6756520B1 (en) 2000-10-20 2004-06-29 Kimberly-Clark Worldwide, Inc. Hydrophilic compositions for use on absorbent articles to enhance skin barrier
US6749860B2 (en) 2000-12-22 2004-06-15 Kimberly-Clark Worldwide, Inc. Absorbent articles with non-aqueous compositions containing botanicals
US7771735B2 (en) 2000-12-22 2010-08-10 Kimberly-Clark Worldwide, Inc. Absorbent articles with compositions for reducing irritation response
EP1800647A1 (fr) * 2005-12-20 2007-06-27 Cognis IP Management GmbH Mélange émollient pour compositions cosmétiques et pharmaceutiques
CN109303718A (zh) * 2017-07-26 2019-02-05 安徽中医药大学 一种用于防治婴儿红臀的纯中药复方湿巾及其制备方法

Also Published As

Publication number Publication date
MX9306540A (es) 1995-01-31

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