Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
• • 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
  • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
  • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
  • A61K47/38—Cellulose; Derivatives thereof
• • 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
  • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
  • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
  • A61L26/0023—Polysaccharides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders

Definitions

• the present invention relates to a pharmaceutical gel Which may be used for the topical treatment of burns, cuts, wounds, abrasions and the like and to a method of treatment of burned skin.
• compositions comprising one or more active ingredient in an inert pharmaceutical carrier.
• the active ingredient is typically an antibiotic such as neomycin sulphate or micronized silver sulphadiazine an anti-bacterial agent such as cetrimide chlorhexidine gluconate or dibromopropamide isethionate, and for minor burns a local anaesthetic such as lignocaine or a mixture of such ingredients.
• an antibiotic such as neomycin sulphate or micronized silver sulphadiazine
• an anti-bacterial agent such as cetrimide chlorhexidine gluconate or dibromopropamide isethionate
• a local anaesthetic such as lignocaine or a mixture of such ingredients.
• the inert carrier or vehicle is commonly selected having regard to the solubility of the active constituent to be carried and for those mentioned above is usually a paraffin base ointment or an oil-in-water emulsion cream.
• a paraffin base ointment or an oil-in-water emulsion cream.
• lanolin and petrolatum bases have been used.
• Aqueous gels, such as those formed with hydroxy methyl cellulose or polyacrylic acid have not hitherto found favour for treatment of injuries where there is skin lesion or for burns.
• each of the active ingredients performs its expected function.
• the inert carrier in many such preparations acts as a barrier to moisture transpiration.
• compositions hitherto used cause stains to dressings or linen (e.g. Furacin stains yellow, silver sulfadiazine stains black) and some cause pain on application (e.g. sulfamylon and to a lesser degree silver sulphadiazine) and/or have a degree of toxic reaction.
• the present invention consists in a composition for use in the treatment of burns, cuts, wounds, abrasions and the like consisting of a heat sterilizeable aqueous gel comprising a pharmaceutically acceptable glycol and a cellulose derivative which is heat sterilizeable.
• the glycol is propylene glycol, and comprises from 20-30% W/V of the composition.
• the cellulose derivative is hydroxy ethyl cellulose and is used in an amount of less than 4% W/V of the composition.
• the composition comprises an antiseptic or an antibiotic or a topical corticosteroid or a combination of one or more of such agents.
• the invention consists in a method for treatment of a burn comprising the step of topical application of a composition according to the first aspect.
• an adherent flexible set jelly is formed, the depth and strength of which can be controlled by the number of coats applied. Once formed the jelly acts as an effective barrier to contamination and mechanical interference.
• composition as a treatment for burns has reduced the number of skin grafts that would otherwise have been necessary and has inhibited or prevented the formation of hypertrophic scar tissue so that most patients retain full (normal) muscle movement after healing.
• the coating allows for normal growth of facial hair in the male and on completion of re-epithelisation the coating lifts off spontaneously.
• compositions according to the invention are colourless and may be applied liberally to a patient without staining of clothes.
• the composition can be heat sterilized by autoclaving and is believed to exert an inherent bacteriostatic action and to have a degree of activity against a range of viruses or mycellia. It is effective as the sole agent in the treatment of clean superficial burns, cuts, wounds, abrasions and the like.
• compositions according to the invention are their ability to accept a wide range of agents which can be added for treatment of contaminated or infected wounds in accordance with sensitivity patterns revealed by bacterial culture for the individual patient.
• the composition includes one or more antibiotic, or antiseptic or other agent.
• the jelly greatly augments penetration of non-vital tissue such as burn eschar and granulations by antibiotics and other agents and in the case of burns allows the effective destruction of pathogenic flora from burned areas by carrying the active agent to the depths of the burn. Release of the active agent is thought to be controlled by the physical nature of the gel.
• a preferred composition in accordance with the invention is:
• Ethylene glycol is usually considered to be pharmacologically unacceptable.
• Propylene glycol is preferred as the glycol component of the composition. However it is believed that other pharmaceutically acceptable glycols having more than three carbon atoms could be substituted for propylene glycol.
• the hydroxy ethyl cellulose is importantly a heat sterilizable substance which forms a gel with water and the amount required is chosen having regard to the desired consistency of the gel. From 0.5 to 4% W/V is a preferred range and more preferably from 1% to 3% W/V. Other gel-forming heat sterilizable celluloses may be used. However hydroxy ethyl cellulose available from A.C. Hatrick under the name Natrosol was found to more readily form a gel of suitable and smooth consistency with the propylene glycol and in contrast to hydroxy methyl cellulose and was found to retain a satisfactory gel structure after sterilization by autoelaving.
• the inclusion of sodium chloride in the composition is optional and also serves to reduce stinging when the gel is applied on raw areas.
• the amount of salt present is preferably within the range of 0-2%.
• the formulation hydroxy ethyl cellulose is first dispersed in the formulation propylene glycol.
• the salt, if any, is dissolved in the formulation water which is heated to approximately 60 C.
• the hydroxy ethyl cellulose/propylene glycol dispersion is then stirred slowly into the water. Stirring and heating is maintained until thickened.
• the composition is then bottled and heat sterilized.
• the gel compositions according to the present invention may also contain one or more specific additives such as the following:-
• Antiseptic which may be present in an amount from 0.02 to 1.0% w/v of the composition. Suitable examples are chlorhexidine acetate or chlorhexidine gluconate.
• Antibiotic which may be present in an amount from 0.1 to 0.4% w/v of the composition.
• a suitable example is gentamicin sulphate.
• Topical corticosteroid which has a variety of functions but in particular is an anti-inflammatory agent, and may be present in an amount of up to 1% w/w of the composition and preferably of from 0.4 to
• OMPI burns, acute uticaria, insect bites and the like. Symptomatic relief occurs within several minutes and inflammation is typically suppressed within 24 hours.
• compositions according to the invention may be used as the main dressing agent in both major and minor burns and in the management of wounds such as varicose ulcers and bedsores. It is envisaged that such compositions could also be used in dermalogical preparations with the addition of suitable specific additives and for household use in the treatment of minor burns, sunburn, cuts, wounds, abrasions and the like.
• the jelly When applied with tulle gras under gladwrap in closed dressings, the jelly maintains its physical state for up to five days and thus prevents adherance of dressings to raw surfaces and allows dressings to be carried out without gross discomfort and pain, thus minimising the need for dressings under general anaesthetic.
• the jelly When used in repeated applications to exposed surfaces the jelly dries to a flexible impervious coating, reacts with the surface exudate of the wound and thereafter forms a firm bond which can be soaked off readily if desired, or left ' insitu to peel off spontaneously when re-epithelisation has occurred. Whilst insitu the coating is a highly effective barrier against bacterial contamination and mechanical abrasion. Crusting and scab formation is prevented and normal hair growth is permitted. (This is particularly pertinent in burns in the beard area of the male face). The jelly is effective in burns of the face and perineam, and in the after care of facial dermabrasion; greatly increasing patient comfort and greatly reducing the chance of bacterial contamination.
• the jelly has been found to minimise the formation of hypertrophic scar formation in resolved deep dermal burns and in small areas of full thickness burns healed by secondary intention. It also promotes the formation of dense well vascularised sterile granulating as graft bed, graft take has been improved dramatically and secondary scar hypertrophy and graft contractures across flexor surface has been shown to be greatly reduced.
• the jelly When applied to fresh wounds exhibiting capillary ooze eg. Graft donor sites and area of fresh dermabrasion, the jelly has Tzseen found to produce effective haemostasis within a few minutes, after application under tulle gras and application of pressure, thus eradicating the presence of dried blood clot, a source of discomfort and possible medicine for bacterial propogation.
• the burns were assessed as mid and deep dermal with margins of superficial burn and areas of probable full thickness. In total the burned area was estimated as 12% of the body surface area.
• the hand dressing was to be changed daily, and all other dressings second daily.
• the possibility of a future skin graft was explained to the patient, he refused absolutely to consider submitting himself to surgery, became intransigent and several days later signed himself out of hospital. Arrangements were made for him to be managed as an outpatient in the hospital casualty department. The regime detailed above was continued. Random bacteriological swabs were taken weekly.
• the patient had been coated with Silver Sulfadiazine at Hospital A and on admission a mixed flora of organisms including staphylococcus aureus and psuedomonas was cultured from multiple swabs.
• the patient was barrier nursed and the regime of soaking with sterile magnesium sulfate solution and dressings with sofratulle, jelly with 40 mgs gentamycin/lOOmls, gladwrap, occlusive dressings was instituted.
• the hands were dressed in sterile plastic bags and the neck and perineam were kept open and dressed with jelly/gentamycin 80mgs/l00mls.
• the problem presented in this case was the need to graft approximately 60% of the body surface area with a maximum of 30% available donor area with the areas of partial skin loss to be restored before the 30% donor area could be realised.
• sheet grafts were tailored to shape and applied and tied over the proflavine wool saturated in jelly/40mgs gentamycin. Dressings continued as before on all other areas, the patient being nursed on a Streicher frame.
• the tie over dressings allowed access to the other areas for a continuation of the dressing regime at intervals of 48 hours.
• the grafted areas were taken down usually after 7 or 8 days. In all instances the graft take was satisfactory and the inter graft granulations remained healthy and free of pathogens. In many instances healthy epithelial outgrowth from the graft patches was noted at the time of the first dressing.
• Bacteriological swabs showed a mixed flora of organisms including psuedomonas and a multiresistant staph, aureus.
• Bacteriological culture revealed a mixed growth of organisms including profuse staph, aureus. Sensivity tests showed this organism to be sensitive to gentamycin and the established routine detailed above was instituted using jelly/80mgs gentamycin/lOOmls, tulle and occlusive dressings twice daily until culture showed no growth and the inflammation, pain and fever had subsided after five days. The concentration of gentamycin was reduced to 40mgs/l00mls and dressings were carried out daily and then second daily. There

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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)
• Epidemiology (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Engineering & Computer Science (AREA)
• Dermatology (AREA)
• Inorganic Chemistry (AREA)
• Materials Engineering (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicinal Preparation (AREA)
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Cited By (19)

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Citations (5)

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• 1983
  • 1983-06-21 US US06/584,941 patent/US4604384A/en not_active Expired - Lifetime
  • 1983-06-21 WO PCT/AU1983/000081 patent/WO1984000111A1/en not_active Ceased
  • 1983-06-21 JP JP58501970A patent/JPS59501159A/ja active Granted
  • 1983-06-21 EP EP83901885A patent/EP0112852B1/en not_active Expired
  • 1983-06-21 DE DE8383901885T patent/DE3376957D1/de not_active Expired
• 1987
  • 1987-09-30 MY MYPI87002505A patent/MY102101A/en unknown

Patent Citations (5)

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