Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/10—Antimycotics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
  • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

• the present application relates to using a substance capable of buffering within the pH range 2.0 - 5.5, for preparing a skin-occlusive or mucous membrane-occlusive article for preventing skin irritations and lesions caused by Candida albicans.
• a substance capable of buffering within the pH range 2.0 - 5.5 for preparing a skin-occlusive or mucous membrane-occlusive article for preventing skin irritations and lesions caused by Candida albicans.
• absorbent articles such as diapers and sanitary napkins, wound dressings, such as bandages surgical tapes and plasters, gloves, prostheses and indwelling catheters.
• Candida albicans may constitute a major problem in connection with using skin-occlusive, mucous membrane-occlusive and absorbent articles such as diapers, pantyliners, sanitary napkins and wound dressings.
• Candida albi- cans has been found to correlate with severity of diaper dermatitis (Benjamin L, Pediatrician 1987, suppl. 1, p. 21 - 26).
• There are investigators that give C. Albicans a primary causative role in some expressions of diaper dermatitis (Leyden J and Kligman AM, Arch. Dermatol. 1978, vol 114, p. 56 - 59).
• pH appears to be a major source of confusion and contradiction in the context of Candida ecology.
• Candida carriage in vivo can occur readily over a broad range of pH. pH may be a factor of significance in the pathological status of C. albicans in vivo, but it does not exert its influence by affecting growth of the fungus, i.e. the rate of increase of its biomass (Odds FC, Candida and Candidosis. A review and bibliography. 2 nd ed. 1988, Bailliere Tindall).
• Dimorphism the ability of C. albicans to exist in a blastospore and a filamentous form, is reported to be influenced by pH (Buffo et al., Mycopathologia, vol. 85 (1984), p.
• WO 98/57677 and EP 0 202 126 both disclose that a neutral or a slightly alkaline pH in connection with using absorbent articles may lead to skin irritation and problems with odorous substances. According to the documents these problems are caused by Upases and proteinases present on the skin and the problems can be overcome by decreasing the pH of the absorbent article. The documents do not give any particular information about problems caused by Candida or how to reduce the virulence of Candida albicans.
• a skin-occlusive or mucous membrane-occlusive article such as an absorbent article (a diaper, a sanitary napkin, a pantyliner or a wound dressing, such as a bandage), a plaster, a surgical tape, said article containing a pharmaceutically acceptable non-toxic and non-irritating substance capable of buffering within the pH range 2.0 - 5.5, is used to for preventing skin irritations and lesions caused by Candida albicans.
• the present invention relates to using an ingredient capable of buffering within the pH range 2.0 - 5.5, for preparing a skin-occlusive article for preventing skin irritations and lesions caused by Candida albicans.
• Any pharmaceutically acceptable, non-toxic and non-irritating ingredient capable of buffering within the specified range can be used.
• suitable buffering ingredients are superab- sorbent particles showing a level of neutralisation within the range of 20 - 50 %, and pharmaceutically acceptable, non-toxic and non-irritating buffering solutions, such as organic salt buffering solutions, for example an acetate buffer or a citrate buffer.
• the buffering solution can be directly added to the skin-occlusive or mucous membrane-occlusive article.
• a pharmaceutically acceptable gel con- taining the buffering solution can be added.
• suitable gels include gels normally used for pharmaceutical purposes, such as agarose.
• an acid buffering substance according to the present invention is added to a skin- occlusive article.
• skin-occlusive article or “mucous membrane-occlusive article” relates to an article, which is intended to cover the skin or mucous membranes of a person.
• a skin-occlusive article or mucous membrane- occlusive article according to the present invention can be an absorbent article, such as a diaper, a sanitary napkin, a pantyliner or a wound dressing, a surgical tape, a plaster, gloves, prostheses or indwelling catheters. It is not critical for the invention how the acid buffering substance is added, and accordingly it can be added to the skin-occlusive article in many different ways.
• Examples of suitable methods for adding the acid buffering substance to the skin occlusive article are administration of a solution containing the acid buffering substance, or administration of said substance as a powder or gel.
• the administration can be carried out in connection with manufacturing said article or after said article has been manufactured.
• the term "pharmaceutically acceptable antifungal agent” relates to compounds normally used to treat Candida infections, such as imidazole derivatives, nystatin and ciclopirox olamine. These compounds are added to the skin- occlusive or mucous membrane-occlusive article in amounts corresponding to common therapeutical doses.
• Figure 1 shows an example of a diaper to which an acid buffering substance can be added in accordance with the invention
• Figure 2 discloses the natural distribution of skin surface pH on volar forearms in 15 females. The observations are mean values of left and right arm;
• Figure 3 presents a diagram showing pH development of patch sites before, during and after wearing a patch buffered with an acid buffering substance and a regular reference patch;
• Table I presents results from visual assessment of skin reaction to Candida albicans infection.
• Table II shows growth of Candida albicans 24 hours after inoculation.
• the diaper 100 disclosed in figure 1 comprises a liquid-permeable outer layer 1, for example made of a fibre fabric or a perforated plastic film, a liquid-impermeable outer layer 2, for example made of a plastic film or a hydrophobic fibre fabric, and finally an absorbent body 3 enclosed between the outer layers 1, 2.
• a liquid-permeable outer layer for example made of a fibre fabric or a perforated plastic film
• a liquid-impermeable outer layer 2 for example made of a plastic film or a hydrophobic fibre fabric
• the diaper is intended to surround the lower part of the trunk of the wearer like a pair of absorbing pants. It is therefore designed with two end parts 4, 5 as well as a narrower crutch part 6 between the end parts, which when the diaper is used is intended to be arranged in the crutch of the wearer between the legs.
• adhesive flaps 7 are arranged close to the rear waist edge 8. Upon use, the adhesive flaps are fastened to the front part 5 of the diaper, close to the front waist edge 9, in order to hold the diaper together around the waist of the wearer.
• the diaper according to figure 1 comprises pretightened elastic means 10, which may consist of elastic strings, elastic threads, elastic foam or another suitable material.
• the elastic means 10 are, for the sake simplicity, shown in outstreched condition. However, as soon as the stretching ceases they contract and form elastic bands in the diaper.
• the absorbent body 3 in the example shown in figure 1 is formed by two layers 11, 12, an upper liquid-receiving layer 11 and a lower layer 12 which spreads and distributes the liquid.
• the upper liquid-receiving layer must quickly be able to receive a large amount of liquid within a short amount of time, i.e. have a higher instantaneous liquid absorption capability, but the lower storage and distribution layer 12 must have a high liquid distribution capability and be able to drain liquid out from the receiving layer 11 and distribute this liquid in the storage and distribution layer 12.
• the differences between the layers 11, 12 can be accomplished by density differences. A more compressed fibre structure distributes the liquid better than a corresponding fibre structure having a lower density.
• Such a low-density structure has a higher instantaneous liquid absorption capability and a lower distribution capability due to its larger pore size.
• Different absorption capabilities can also be achieved by using different fibre structures having different characteristics.
• chemically produced cellulose fluff pulp shows better distribution characteristics compared to, for instance, mechanically or chemi-thermomechanically produced pulp, such as chemi-thermomechanical pulp (CTMP).
• CMP chemi-thermomechanical pulp
• a fibre structure containing chemically stiffened cellulose fibres shows a higher instantaneous liquid absorption ability but a lower d stribution ability compared to conventional chemical pulp.
• Other materials suitable as receiving layers 11 can be a wadding of natural fibres or a fluffy nonwoven material.
• a partially neutralised superabsorbent is admixed in the upper liquid-receiving layer 11 of the absorbent body 3.
• This superabsorbent act as a acid buffering substance in accordance with the present invention.
• a conventional superabsorbent is admixed in the lower liquid storage and distribution layer 12 of the absorbent body. It is advantageous to put a conventional super- absorbent in the lower liquid storage layer 12, because a conventional superabsorbent has a higher total absorption capacity compared to a partially neutralised and pH-regulating superabsorbent.
• the invention also comprises other embodiments of the absorption body.
• the absorbent body may contain both partially neutralised superabsorbents and conventional superabsorbents, and both the superabsorbents can be equally distributed in both the upper and lower absorbent layers.
• both the superabsorbents can be equally distributed in both the upper and lower absorbent layers.
• the superabsorbent material also acts as a pH-regulating substance in accordance with the present invention.
• the experimental patches were made of common diaper materials and punched out as circular disks with a diameter of 70 mm.
• the outer side of polyethylene and the inner side (that will be placed towards the skin) of nonwoven polypropylene were glued together with a 10 mm edge around the inner circular core of 50 mm diameter.
• the inner core consisted of approximately 0.85 g cellulose pulp and approximately 0.15 g of superabsorbent polymer (IM 7100 and E127/97, Clairant GmbH, DE).
• the superabsorbent polymer was a polyacrylic acid, which was adjusted to either pH 4.5 or 6.0. It acts as a strong buffering system. 10 4 cells per ml C. albicans were suspended in a physiological saline solution.
• the C. albicans strain used was type H29, kindly provided by Professor Lars Edebo, Department of Microbiology, Sahlgrenska University Hospital, Goteborg, SE. Cells were grown on Sabouraud's glucose agar at 37°C for 24 hours before use.
• a modification of the Williamson- Kligman scrub technique was used for assessment of the resident skin microflora and the added C. albicans.
• a stainless steel ring with an internal diameter of 2.6 cm and covering a skin area of 5.5 cm was used.
• One millimetre of sterile 0.075 M phosphate buffer (pH 7.9) containing 0.1% Triton X-100 was poured into the ring, and the skin was gently rubbed with a blunt sterile glass rod for one minute and the fluid was removed with a Pasteur pipette (Faerge- mann J. Mapping the Fungi of the Skin. Handbook of Non-invasive Methods and the Skin, chapter 10.2, CRC Press, 1995).
• Serial dilutions were performed in PBS and samples from the dilutions were plated out. Plates were incubated at 37°C and read after 48h.
• the paired t test was used to test for statistical significance between pH differences, differences in number of Candida organisms. The differences in observed skin le- sions were tested by a sign test.
• the skin surface pH of the 15 volunteers was measured at the start and varied be- tween 4.5 and 6.0.
• the mean value was 5.2.
• the results are shown in figure 2.

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Epidemiology (AREA)
• Engineering & Computer Science (AREA)
• Medicinal Chemistry (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Oncology (AREA)
• Communicable Diseases (AREA)
• Materials Engineering (AREA)
• Organic Chemistry (AREA)
• Hematology (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Absorbent Articles And Supports Therefor (AREA)
• Materials For Medical Uses (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Applications Claiming Priority (3)

Publications (1)

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• 1999
  • 1999-12-02 SE SE9904387A patent/SE521431C2/sv not_active IP Right Cessation
• 2000
  • 2000-11-06 EP EP00981984A patent/EP1233746A1/en not_active Withdrawn
  • 2000-11-06 CA CA002392102A patent/CA2392102A1/en not_active Abandoned
  • 2000-11-06 WO PCT/SE2000/002165 patent/WO2001039582A1/en active IP Right Grant
  • 2000-11-06 AU AU19063/01A patent/AU778633B2/en not_active Ceased
  • 2000-11-06 JP JP2001541326A patent/JP2003515544A/ja active Pending
  • 2000-11-06 SK SK788-2002A patent/SK7882002A3/sk unknown
  • 2000-11-06 BR BR0016005-9A patent/BR0016005A/pt not_active Application Discontinuation
  • 2000-11-06 RU RU2002117294/15A patent/RU2002117294A/ru unknown
  • 2000-11-06 MX MXPA02005211A patent/MXPA02005211A/es active IP Right Grant
  • 2000-11-06 KR KR1020027007092A patent/KR20020060249A/ko not_active Application Discontinuation
  • 2000-11-06 PL PL00355410A patent/PL355410A1/xx not_active Application Discontinuation
  • 2000-12-01 CO CO00092011A patent/CO5251413A1/es not_active Application Discontinuation

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