Aerosol ointment compositions for topical use

Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid

Reexamination Certificate

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Details

C424S078050, C424S078070, C514S063000, C514S944000, C514S945000, C514S937000, C514S938000

Reexamination Certificate

active

06214318

ABSTRACT:

BACKGROUND OF THE INVENTION
U.S. Pat. No. 4,422,887 to Spitzer et al discloses aerosol synthetic polymer—liquefied propellant compositions which when expelled from an aerosol container form cold pad polymeric foamed structures whose temperature is initially at least 30° C. below the ambient temperature at which the cold formed structure is formed, said formed structures containing open and/or closed cells which may contain an additive which is deposited in the pores and/or walls of the foamed structure as the foamed structure is formed. The aforedescribed prior art aerosol compositions when expelled on a surface exert a pronounced cooling effect on said surface until the propellant component thereof is completely evaporated.
The essential ingredients of the aerosol compositions of the above-mentioned U.S. Pat. No. 4,422,887 are:
a. a film-forming synthetic polymer in an amount within the range from about 2% to about 30% by weight of the composition;
b. at least one liquefied propellant boiling below −10° C.;
c. the total propellant being in an amount within the range from about 50% to about 90% by weight of the composition; and having a heat vaporization of at least 55 calories per gram; the propellant being capable of dissolving the synthetic polymer at least in the presence of a co-solvent that is soluble in the propellant and in solutions of the synthetic polymer in the propellant at ambient temperature; and
d. at least one nonsolvent that is soluble in the propellant but in which the synthetic polymer is insoluble in an amount within the range from about 1% to about 85% by weight of the composition;
the composition forming on volatilization of propellant at ambient temperature a coherent formed structure containing open and/or closed cells, and having a temperature at least 30° C. below ambient temperature.
SUMMARY OF THE INVENTION
The present invention relates to an aerosol composition consisting essentially of the ingredients of an ointment-liquefied propellant composition which when expelled from an aerosol container onto damaged tissue provides a cold ointment which exerts a therapeutic effect on said tissue in contact therewith.
The cooling effect provided by the expelled composition of this invention is controlled so as to provide relief of pain for a desirable period of time but not too cold to cause discomfort or tissue damage.
Thus, an object of this invention is to provide a therapeutic ointment composition which when expelled from an aerosol container is cold enough to provide a cooling effect for pain relief but not too cold as to cause discomfort to damaged tissue to which the ointment is applied, said ointment also exerting a therapeutic effect on damaged tissue in contact therewith.
A further object is an ointment that can deliver appropriate medication as well as a cooling effect where it is applied.
Another object of the invention is to provide a cold ointment for the temporary relief of hemorrhoids which when applied to the swollen inflamed tissue provides a cooling effect and quickly relieving pain and itching as well as effecting shrinking of swollen inflamed tissue.
A still further object of the invention is an ointment for the treatment of sunburn.
Another object of the invention is a cold anti-itch ointment as well as one that provides relief from arthritic pain.
Another object of the invention is an antifungal ointment.
An object of this invention is an antibacterial ointment.
An additional object of the invention is to provide a cold ointment that is initially unctious, but dries to leave a deposit that is neither greasy nor oily.
More particularly, the present invention relates to novel aerosol compositions that enhance the therapeutic action of an ointment by instantly producing, upon topical application thereof, a sustained cooling effect which provides fast relief from pain and itching as well as a tendency to shrink swollen, inflamed tissue in advance of the slower action of any medication present in the ointment, said aerosol composition consisting essentially of from about 10 to about 60 percent by weight of ointment ingredients and from about 40 to about 90 percent by weight of liquefied propellant that is predominantly a non-polar propellant, i.e., at least about 80% by weight of the non-polar propellant and where the sum of the ointment ingredients and the propellant equals 100 percent by weight of the composition.
In another embodiment, applicants' invention is directed to a therapeutic aerosol composition for topical use consisting of (a) from about 10 to about 60 percent by weight of the ingredients of an ointment and (b) from about 40 to about 90 percent by weight of liquefied propellant, where at least about 80 percent by weight of the liquefied propellant is a non-polar propellant or mixture of non-polar propellants selected from the group consisting of a hydrocarbon propellant and a fluorocarbon propellant and the sum of ingredients from (a) and (b) equals 100 percent by weight of the composition, the composition when expelled from an aerosol device containing the composition depositing as an ointment having a solid or semi-solid consistency and a temperature between about −5° C. and +5° C.
Preferably, the ointment ingredients constitute from 35 to 100 percent by weight of an oil phase and from 0 to about 65 percent by weight of an aqueous phase based on the weight of the ointment ingredients and the oil phase of the ointment does not flow below about 35° C. The oil phase includes ingredients selected from the group consisting of oils, and oil soluble ingredients, the oil soluble ingredients including adjuvants, topical therapeutic agents, oil soluble emulsifiers, and thickening agents for the oils and oil soluble ingredients, where the oils and oil-soluble ingredients are soluble in the propellant. The aqueous phase includes water, water-soluble emulsifying agents and may also include topical therapeutic agents, humectants and alcohols.
Also, the present invention relates to a novel method for enhancing the therapeutic effect of a solid or semi-solid ointment which consists of dissolving and/or dispersing:
(a) from about 10 to about 60 percent by weight of an ointment that contains an oil phase and may contain an aqueous phase in the form of an emulsion, where the oil phase of the ointment does not flow below about 35° C., in
(b) about 40 to about 90 percent by weight of a liquefied propellant that is at least 80 percent non-polar propellant in an aerosol container, whereby a solid or semi-solid deposit is formed when a portion of the composition is expelled and this deposit placed in contact with injured tissue it provides instant relief from pain and itching as the result of its sustained cold, thereby enhancing the performance of the ointment with its slower action medications.
The compositions used in the practice of this invention consist essentially of an ointment, i.e., a solid or semisolid component, dissolved and/or dispersed in a liquefied propellant in a suitable aerosol container. The product is expelled from the aerosol container either as a deposit confined to a small area or as a spray covering a wider area, depending on the application. Thus, to relieve hemorrhoids the deposit should be confined to a small area, while to relieve sunburn a wider area is likely to be more convenient.
The expelled therapeutic composition for this invention will feel cold due to the evaporation of the propellant. A substantial portion of the propellant that is expelled should initially be part of the deposit, so that there is a continuing cooling action as the propellant gradually evaporates. It is also important that the deposit have a comparatively high density and that it be applied thickly.
The temperature of the expelled deposit should be initially in the range of about −5° C. to about +5° C. In this range the deposit can have the therapeutic effects that are the objects of this invention while not being so cold as to cause pain or tissue damage. Suitable liquefied nonpolar propellants that can be

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