Pharmaceutical gel composition

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai

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514171, A61K 3156

Patent

active

046043845

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD OF THE INVENTION

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.


BACKGROUND ART

The treatment of burns, and especially of major burns, leaves much to be desired. It is difficult to avoid the formation of keloid tissue with consequent contractures and detrimental effect on muscle movement recovery. Combating infection is also difficult, particularly when the site of infection is shielded for example by burn eschar.
In the treatment of burns it is usual to combat infection by use of 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.
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. For minor injuries, 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.
In pharmaceutical compositions of the type discussed each of the active ingredients performs its expected function. In addition to acting as a vehicle for the active ingredient, the inert carrier in many such preparations acts as a barrier to moisture transpiration.
As a general rule neither the active ingredient nor the vehicle plays any therapeutic part in skin regrowth. Possible exceptions are the use in such compositions of paraffin which has been said to promote the rapid formation of granulation tissue and the inclusion in some compositions of allantoin which has been said to aid tissue regeneration.
Many of the 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.


DISCLOSURE OF THE INVENTION

According to one aspect 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.
For preference the glycol is propylene glycol, and comprises from 20-30% W/V of the composition. Desirably the cellulose derivative is hydroxy ethyl cellulose and is used in an amount of less than 4% W/V of the composition. For preference also the composition comprises an antiseptic or an antibiotic or a topical corticosteroid or a combination of one or more of such agents.
According to a second aspect 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.
When an aqueous gel according to the invention is applied to a burned, cut, wounded or abraded skin surface 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.
Surprisingly, use of the 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.
Preferred compositions according to the in

REFERENCES:
patent: 4131677 (1978-12-01), Shen et al.
patent: 4360518 (1982-11-01), Rovee et al.
patent: 4393076 (1983-07-01), Noda et al.

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