WO2005048946A2 - Treatment for burn victims and animal carcasses - Google Patents

Treatment for burn victims and animal carcasses

Info

Publication number
WO2005048946A2
WO2005048946A2 PCT/US2004/038094 US2004038094W WO2005048946A2 WO 2005048946 A2 WO2005048946 A2 WO 2005048946A2 US 2004038094 W US2004038094 W US 2004038094W WO 2005048946 A2 WO2005048946 A2 WO 2005048946A2
Authority
WO
WIPO (PCT)
Prior art keywords
medicament
foam
formulation
antibacterial
foaming agent
Prior art date
Application number
PCT/US2004/038094
Other languages
French (fr)
Other versions
WO2005048946A3 (en
Inventor
Alekha K. Dash
Original Assignee
Creighton University
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
Application filed by Creighton University filed Critical Creighton University
Publication of WO2005048946A2 publication Critical patent/WO2005048946A2/en
Publication of WO2005048946A3 publication Critical patent/WO2005048946A3/en

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Classifications

    • 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
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Definitions

  • the subject invention is directed to methods for treating burn victims, to methods for reducing bacterial contamination in animal carcasses, and to formulations useful in these methods.
  • a burn is an injury usually caused by either fire, heat, radiation, electricity, or a caustic agent.
  • the American Burn Association estimated over 1 million burn injuries in the year 2000. Burns can be classified into two major categories including partial and full thickness burns. Partial thickness burns are burns that affect the epidermis and the dermis, while full thickness burns are those which include damage to the subcutaneous layers. Davis et al . , "Topical Treatment of Burns
  • Burns can also be classified into three classes according to the degree of severity.
  • First and second degree burns are partial thickness burns.
  • First degree burns affect the epidermis
  • second degree burns affect both the epidermis and the dermis.
  • Third degree burns are full thickness burns that penetrate into the deep tissues of the body. Burn injuries are usually treated with debridement, biologic wound coverings, early excision and grafting, temporary wound closure with biological or synthetic dressings, and application of antimicrobials.
  • Antimicrobials such as sulfadiazine and mafenide acetate, are used in topical creams for the treatment of burns.
  • the present invention relates to a method for applying a medicament to a surface of a burn victim.
  • the method includes providing a medicament formulation that includes a medicament, a foaming agent, and a film- forming agent .
  • the method further includes applying the medicament formulation as a collapsible foam to the surface of the burn victim.
  • the present invention also relates to a medicament formulation that includes a medicament, a foaming agent, and a film-forming agent.
  • the present invention also relates to a method for reducing bacterial contamination in animal carcasses.
  • the method includes providing a foam formulation that includes a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses.
  • the present invention also relates to an antibacterial foam formulation that includes a foaming agent, a film-forming agent, and an antibacterial carboxylic acid.
  • Figure 1 is a graph showing the effect of gelatin and chitosan on the stability of foam formulations in accordance with the present invention.
  • Figure 2 is a graph showing the effect of cetrimide concentration on the stability of foam formulations in accordance with the present invention.
  • Figure 3 is a graph showing the effect of chitosan concentration on the stability of foam formulations in accordance with the present invention.
  • Figures 4A-4C are scanning electron micrographs at 75X ( Figure 4A) , 1000X ( Figure 4B) , and 2000X magnification (Figure 4C) of dried foam-films without mafenide acetate .
  • Figures 5A-5C are scanning electron micrographs at 75X ( Figure 5A) , 1000X ( Figure 5B) , and 2000X magnification (Figure 5C) of dried foam-films containing 1% (w/v) mafenide acetate in accordance with the present invention.
  • Figures 6A-6C are scanning electron micrographs at 75X ( Figure 6A) , 1000X ( Figure 6B) , and 2000X magnification (Figure 6C) of dried foam-films containing 2% (w/v) mafenide acetate in accordance with the present inven ion.
  • Figure 7 is a graph showing in vitro release of mafenide acetate from foam-film delivery systems of the present invention.
  • Figure 8 is a graph showing the effect of a 2% (v/v) lactic acid-containing foam formulation of the present invention on E. coli counts on beef surfaces.
  • Figure 9 is a graph showing the effect of a 2% (v/v) acetic acid-containing foam formulation of the present invention on E. coli counts on beef surfaces.
  • the present invention in one aspect thereof, relates to a method for applying a medicament to a surface of a burn victim.
  • the method includes providing a medicament formulation that includes a medicament, a foaming agent, and a film-forming agent.
  • the method further includes applying the medicament formulation as a collapsible foam to the surface of the burn victim.
  • "Burn victim”, as used herein, is meant to refer to mammals, such as humans, other primates, dogs, rats, and mice, who have suffered a burn injury.
  • the burn injury can be the result of exposure to fire, heat, radiation, electricity, or a caustic agent.
  • the burn injury can be a partial thickness burn injury (e.g., those involving only the epidermal layers, those involving only the dermal layers, or those involving both the epidermal and dermal layers) , or the burn injury can be a full thickness burn injury (e.g., those which include damage to subcutaneous layers) .
  • the burn injury can be a first, second, or third degree burn injury.
  • the method involves applying a medicament formulation to the surface of the burn victim, preferably to at least a portion of the site or sites of the burn injury.
  • the medicament formulation includes a medicament, a foaming agent, and a film-forming agent. Suitable medicaments for use in the medicament formulation include those which are conventionally used in the topical treatment of burn injuries.
  • such medicaments can be antibacterial agents, such as naturally-occurring antibacterial agents or synthetic antibacterial agents.
  • Suitable antibacterial agents include those which are effective against gram-positive bacteria, those which are effective against gram-negative bacteria, as well as those which are effective against both gram-positive and gram- negative bacteria.
  • mafenide acetate, sulfadiazine, and combinations thereof are suitable for used as antibacterial agents in the medicaments of the present invention.
  • the amount of medicament used in the medicament formulation can vary depending on the nature of the medicament, on the nature of the other components of the formulation, on the severity of the burn, etc.
  • the' medicament formulation can contain from about 0.1% to about 20% (e.g., from about 0.2% to about 10%, from about 0.5% to about 5%, from about 0.5% to about 3%, and/or from about 1% to about 2%) of antibacterial agent (weight-to- volume) .
  • Foaming agent is meant to include any material which is capable of forming a semi- stable, collapsible foam, for example, a collapsible foam which has a weight loss of less than about 80% (e.g., less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%) over more than about 20 minutes (e.g., over more than about 30 minutes, over more than about 40 minutes, over more than about 50 minutes, over more than about 1 hour) when delivered via conventional foaming apparatuses (e.g., Airspray International's F-2 finger pump foamer) .
  • conventional foaming apparatuses e.g., Airspray International's F-2 finger pump foamer
  • a foam is to be deemed to be collapsible if the foam has a weight loss of greater than 80% in under about 24 hours, such as in under about 12 hours, in under about 6 hours, in under about 4 hours, in under about 3 hours.
  • Suitable foaming agents include surfactants, such as cationic surfactant.
  • the foaming agent can be a quaternary ammonium cationic surfactant (e.g., a compound having the formula R X N + (R 2 ) (R 3 ) (R 4 ) X", where R 1 represents a long chain substituted or unsubstituted alkyl group having from 8 to 25 carbon atoms, such as an alkyl group having the formula CH 3 (CH 2 ) n -, where n is an integer from about 8 to about 25, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20; R 2 , R 3 , and R 4 independently represent a substituted or unsubstituted alkyl group having from 1 to 4 carbons, such as in the case where at least one of R 2 , R 3 , and R 4 represents a methyl group, where at least two of R 2 , R 3 , and R 4 represent methyl groups, or each of R 2 , R 3 , and R 4 represents a methyl group; and X " represents a suitable quaternary
  • a suitable cationic surfactant for use in the medicament formulations of the present invention is cetrimide (cetyl trimethyl ammonium bromide, CH 3 (CH 2 ) 15 N + (CH 3 ) 3 Br " ) .
  • the amount of foaming agent used in the medicament formulation can vary depending on the nature of the foaming agent, on the nature of the other components of the formulation, on the desired rate of release of the medicament from the foam, on the nature of the medicament employed, on the severity of the burn, etc.
  • the medicament formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.25%, and/or from about 0.1% to about 0.2%) of foaming agent (weight-to- volume) .
  • the medicament formulation of the present invention also includes a film-forming agent, such as chitosan and other film-forming, water- soluble derivatives of chitin.
  • the amount of film-forming agent used in the medicament formulation can vary depending on the nature of the film-forming agent, on the nature of the other components of the formulation, on the desired thickness of the film, on the nature of the medicament employed, on the severity of the burn, etc.
  • the medicament formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.3%, and/or from about 0.1% to about 0.25%) of film-forming agent (weight-to-volume) .
  • the medicament formulation of the present invention can optionally include other components (i.e., in addition to the medicament, foaming agent, and film- forming agent) .
  • the medicament formulation can be formulated in sterile water, which can contain various buffering agents.
  • the medicament formulation can further include acetic acid in an amount (volume-to-volume) of from about 0.1% to about 5% (e.g., from about 1% to about 3% and/or about 2%) .
  • the medicament formulation can further include gelatin (e.g., Type A gelatin), for example, to increase the thickness of the foam.
  • the medicament formulations of the present invention can further include lactic acid.
  • the medicament formulations of the present invention can further include a long chain carboxylic acid, such as a long chain carboxylic acid having 18 or more carbon atoms.
  • the medicament formulations of the present invention can be substantially free from long chain carboxylic acids, such as long chain carboxylic acids having 18 or more carbon atoms. Still additionally or alternatively, the medicament formulations can be substantially free of peroxy carboxylic acids and/or peroxides. Still additionally or alternatively, the medicament formulations can be substantially free of iron, such as in the case where the medicament formulations contain less than about 0.01 ⁇ M free iron, contain less than 0.01 ⁇ M free iron, contain less than about 0.005 ⁇ M free iron, contain less than about 0.001 ⁇ M free iron, and/or contain no measurable amount of free iron.
  • "Free iron" has the meaning ascribed to it in U.S. Patent Application Publication No.
  • the medicament formulations of the present invention can be provided in dry powder form (e.g., containing medicament, foaming agent, film-forming agent, and, optionally, other dry components) , in which case the medicament formulation can be mixed with an appropriate amount of sterile water (or buffer solution or other suitable sterile aqueous solvent) prior to foaming and application to the surface of the burn victim.
  • the medicament formulations of the present invention can be provided in the form of a solution.
  • the solution can be in concentrated form or in a fully- diluted form (i.e., ready for foaming).
  • the medicament formulations of the present invention can be provided in the form of a foam.
  • the method of the present invention involves applying the medicament formulation as a collapsible foam to the surface of the burn victim.
  • the foam can be applied by any suitable method, such as by spraying, misting, sputtering, immersion etc.
  • the foam can be applied in a single application, in two or more applications, or continuously over the course of any suitable period of time, such as about 30 minutes, about 1 hour, about 2-12 hours, about one day, about 2 days, about 3 days, about one week, about two weeks, or about a month or more.
  • the foam can be applied at any suitable thickness (e.g., from about 0.2 mm to about a cm or more) .
  • the thickness of the foam can be adjusted (depending on the nature and concentration of the medicament, on the nature and concentration of the foaming agent, on the nature and concentration of the film-forming agent, on the nature and concentrations of optional components (e.g., gelatin), if any, and on the apparatus used to produce the foam) so that, when the foam collapses, the film-forming agent produces a thin, smooth, and/or substantially continuous film on the surface to which the foam is applied.
  • the present invention in another aspect thereof, relates to a method for reducing bacterial contamination in animal carcasses. The method includes providing a foam formulation comprising a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses.
  • Animal carcasses are meant to include complete and partial carcasses of recently- slaughtered animals (e.g., chicken, turkey, duck, goose, and other poultry carcasses; porcine carcasses; bovine carcasses; etc.).
  • animal carcasses is meant to include undissected, substantially undissected, and dissected portions of recently-slaughtered animals (e.g., chicken halves, chicken quarters, chicken legs, chicken thighs, chicken breasts, chicken wings, chicken organs, and combinations thereof; sides of beef, quarters of beef, beef organs, and combinations thereof; etc.) .
  • “Surface”, as used in this context, is meant to include outer surfaces as well as inner surfaces (e.g., body and other cavities) of the aforementioned animal carcasses, as well as any portion of such surfaces.
  • the foam formulation includes a foaming agent and a film-forming agent.
  • Foaming agent is meant to include any material which is capable of forming a semi- stable, collapsible foam, for example, a collapsible foam which has a weight loss of less than about 80% (e.g., less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%) over more than about 20 minutes (e.g., over more than about 30 minutes, over more than about 40 minutes, over more than about 50 minutes, over more than about 1 hour) when delivered via conventional foaming apparatuses (e.g., Airspray International's F-2 finger pump foamer) .
  • conventional foaming apparatuses e.g., Airspray International's F-2 finger pump foamer
  • a foam is to be deemed to be collapsible if the foam has a weight loss of greater than 80% in under about 24 hours, such as in under about 12 hours, in under about 6 hours, in under about 4 hours, in under about 3 hours.
  • Suitable foaming agents include surfactants, such as a cationic surfactant.
  • foaming agent can be a quaternary ammonium cationic surfactant (e.g., a compound having the formula R 1 N + (R 2 ) (R 3 ) (R 4 ) X " , where R 1 represents a long chain substituted or unsubstituted alkyl group having from 8 to 25 carbon atoms, such as an alkyl group having the formula CH 3 (CH 2 ) n -, where n is an integer from about 8 to about 25, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20; R 2 , R 3 , and R 4 independently represent a substituted or unsubstituted alkyl group having from 1 to 4 carbons, such as in the case where at least one of
  • R 2 , R 3 , and R 4 represents a methyl group, where at least two of R 2 , R 3 , and R 4 represent methyl groups, or each of R 2 , R 3 , and R 4 represents a methyl group; and X " represents a suitable anion, such as a halide (e.g., Cl", Br " , or I" ) .
  • a suitable cationic surfactant for use in the foam formulations of the present invention is cetrimide (cetyl trimethyl ammonium bromide, CH 3 (CH 2 ) 15 N + (CH 3 ) 3 Br " ) .
  • the amount of foaming agent used in the foam formulation can vary depending on the nature of the foaming agent, on the nature of the other components of the formulation, etc.
  • the foam formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.25%, and/or from about 0.1% to about 0.2%) of foaming agent (weight-to-volume) .
  • the foam formulation of the present invention also includes a film-forming agent, such as chitosan and other film-forming, water-soluble derivatives of chitin.
  • the amount of film-forming agent used in the foam formulation can vary depending on the nature of the film-forming agent, on the nature of the other components of the formulation, on the desired thickness of the film, etc.
  • the foam formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.3%, and/or from about 0.1% to about 0.25%) of film-forming agent (weight- to-volume) .
  • the foam formulation useful in methods of the present invention for reducing bacterial contamination in animal carcasses can further include an antibacterial carboxylic acid.
  • antibacterial carboxylic acids can be naturally-occurring antibacterial carboxylic acids or synthetic antibacterial carboxylic acids.
  • Suitable antibacterial carboxylic acids include those which are effective against gram-positive bacteria, those which are effective against gram-negative bacteria, as well as those which are effective against both gram- positive and gram-negative bacteria.
  • acetic acid, lactic acid, and combinations thereof are suitable for used as antibacterial carboxylic acids in the foam formulations of the present invention.
  • the amount of antibacterial carboxylic acid used in the foam formulation (when they are employed) can vary depending on the nature of the antibacterial carboxylic acid, on the nature of the other components of the formulation, etc.
  • the foam formulation can contain from about 0.1% to about 20% (e.g., from about 0.2% to about 10%, from about 0.5% to about 5%, from about 0.5% to about 3%, and/or from about 1% to about 2%) of antibacterial carboxylic acid (volume-to-volume) .
  • the foam formulation of the present invention can optionally include other components (i.e., in addition to the foaming agent, film-forming agent, and optional antibacterial carboxylic acid) .
  • the foam formulation can further include water, which can contain various buffering agents, salts, and/or other solutes.
  • the foam formulations of the present invention can further include gelatin (e.g., Type A gelatin), for example, to increase the thickness of the foam.
  • the foam formulations of the present invention can further include a long chain carboxylic acid, such as a long chain carboxylic acid having 18 or more carbon atoms.
  • the foam formulations of the present invention can be substantially free from long chain carboxylic acids, such as long chain carboxylic acids having 18 or more carbon atoms.
  • the foam formulations can be substantially free of peroxy carboxylic acids and/or peroxides.
  • the foam formulations can be substantially free of iron, such as in the case where the foam formulations contain less than about 0.01 ⁇ M free iron, contain less than 0.01 ⁇ M free iron, contain less than about 0.005 ⁇ M free iron, contain less than about 0.001 ⁇ M free iron, and/or contain no measurable amount of free iron.
  • free iron as used herein, has the meaning ascribed to it in U.S. Patent Application Publication No. US2002/0015697, which is hereby incorporated by reference .
  • the foam formulations of the present invention can be provided in dry powder form (e.g., containing foaming agent, film-forming agent, optional antibacterial carboxylic acid, and, optionally, other dry components) , in which case the foam formulation can be mixed with an appropriate amount of water (or buffer solution or other suitable aqueous solvent) prior to foaming and application to the surface the animal carcasses.
  • dry powder form e.g., containing foaming agent, film-forming agent, optional antibacterial carboxylic acid, and, optionally, other dry components
  • the foam formulation can be mixed with an appropriate amount of water (or buffer solution or other suitable aqueous solvent) prior to foaming and application to the surface the animal carcasses.
  • the foam formulations of the present invention can be provided in the form of a solution.
  • the solution can be in concentrated form or in a fully- diluted form (i.e., ready for foaming).
  • the foam formulation of the present invention can be provided in the form of a foam.
  • the method of the present invention involves applying the foam formulation as a collapsible foam to a surface of the animal carcasses.
  • the foam can be applied by any suitable method, such as by spraying, misting, sputtering, immersion, etc.
  • the foam can be applied in a single application, in two or more applications, or continuously over the course of any suitable period of time.
  • the foam can be sprayed onto the animal carcass surface and permitted to remain there for from 10 seconds to 5 minutes, such as between 30 seconds and a minute.
  • the foam can be applied at any suitable thickness (e.g., from about 0.2 mm to about a cm or more) .
  • the thickness of the foam can be adjusted (depending on the nature and concentration of the foaming agent, on the nature and concentration of the film-forming agent, on the nature and concentrations of optional components (e.g., gelatin) , if any, and on the apparatus used to produce the foam) so that, when the foam collapses, the film- forming agent produces a thin, smooth, and/or substantially continuous film on the surface to which the foam is applied.
  • the present invention is further illustrated by the following examples.
  • Example 1 Stability of Various Foam Formulations
  • cetrimide a cationic surfactant
  • the antibacterial formulation consisted of an aqueous solution ' of either 2% (v/v) of L-lactic acid or acetic acid in deionized water, gelatin, low molecular weight chitosan, and a cationic surfactant (cetrimide) .
  • An Airspray International F2 finger pump foamer was used to produce a foam from the above solution. Stability of the foam was measured gravimetrically by monitoring the weight loss of the foam with time.
  • FIG. 1 is a graph showing the effect of gelatin and chitosan on the stability of the foam. As Figure 1 shows, the presence of gelatin does not adversely affect the stability of the foam. Moreover, it was observed that, while the presence of gelatin enhanced foam thickness, chitosan was responsible for the formation of a thin and uniform film after collapse of the foam. Acetic and lactic acid were both stable in the formulation at least for a period of two months .
  • Figure 2 is a graph showing the effect of cetrimide concentration on the stability of the foam. As Figure 2 shows, the cetrimide concentration has little effect on the stability of the foam.
  • Figure 3 is a graph showing the effect of chitosan concentration on the stability of the foam. As Figure 3 shows, the concentration of chitosan in the formulation has only a negligible effect on the foam's stability.
  • Example 2 Preparation and Characterization of Mafenide Acetate-Containing Foam Formulations
  • a solution containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), and mafenide acetate 2% (w/v) was prepared.
  • a second solution, containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), and mafenide acetate 1% (w/v) was also prepared.
  • a third solution containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), but without mafenide acetate, was also prepared.
  • An Airspray International F2 finger pump foamer was used to produce foams from the above three solutions. Surface topography of the films with and without mafenide acetate was determined using a scanning electron microscope. Scanning electron micrographs of dried foam-films without mafenide acetate are presented in Figure 4A (75X magnification) , Figure 4B (1000X magnification) , and Figure 4C (2000X magnification) .
  • Example 3 Effect of Chitosan-Containing Foams on E. coli Counts on Beef Surfaces
  • the antibacterial properties of the formulations described in Example 1 were evaluated using E. coli as the test organism. Briefly, antibacterial foam formulations containing an aqueous solution of either 2% (v/v) of L-lactic acid or 2% (v/v) of acetic acid in deionized water, low molecular weight chitosan, and a cationic surfactant (cetrimide) were prepared. Spray formulations containing 2% (v/v) of L-lactic acid or acetic acid in deionized water were also prepared. Each of the above foam and spray formulations was applied to beef surfaces, and its effect on E. coli counts was evaluated. The results are presented in Figures 8 and 9. As Figures 8 and 9 show, lactic acid and acetic acid foam-film formulations substantially reduced the growth of E. coli on beef surfaces relative to their counterpart spray solutions.

Abstract

Disclosed is a method for applying a medicament to a surface of a burn victim. The method includes providing a medicament formulation that includes a medicament, a foaming agent, and a film-forming agent. The method further includes applying the medicament formulation as a collapsible foam to the surface of the burn victim. Also disclosed is a method for reducing bacterial contamination in animal carcasses. The method includes providing a foam formulation that includes a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses.

Description

METHODS FOR TREATING BURN VICTIMS AND FOR REDUCING BACTERIAL CONTAMINATION IN ANIMAL CARCASSES AND FOAM-FILM FORMULATIONS USEFUL THEREIN
The present application claims the benefit of U.S. Provisional Patent Application Serial No. 60/520,184, filed November 15, 2003, and of U.S. Provisional Patent Application Serial No. 60/625,899, filed November 8, 2004, which provisional patent applications are hereby incorporated by reference.
FIELD OF THE INVENTION The subject invention is directed to methods for treating burn victims, to methods for reducing bacterial contamination in animal carcasses, and to formulations useful in these methods. BACKGROUND OF THE INVENTION
A burn is an injury usually caused by either fire, heat, radiation, electricity, or a caustic agent. The American Burn Association estimated over 1 million burn injuries in the year 2000. Burns can be classified into two major categories including partial and full thickness burns. Partial thickness burns are burns that affect the epidermis and the dermis, while full thickness burns are those which include damage to the subcutaneous layers. Davis et al . , "Topical Treatment of Burns
Wounds, " U.S. Pharmacist, 39-53 (January 1984) . Burns can also be classified into three classes according to the degree of severity. First and second degree burns are partial thickness burns. First degree burns affect the epidermis, and second degree burns affect both the epidermis and the dermis. Third degree burns are full thickness burns that penetrate into the deep tissues of the body. Burn injuries are usually treated with debridement, biologic wound coverings, early excision and grafting, temporary wound closure with biological or synthetic dressings, and application of antimicrobials. Antimicrobials, such as sulfadiazine and mafenide acetate, are used in topical creams for the treatment of burns. These antimicrobial topical creams are applied mechanically, and the mechanical application of the creams frequently causes the burn patient immense pain and discomfort . A need exists for methods of treating burn victims and for topical antimicrobial formulations that can be applied to burn victims without causing as much pain and discomfort. The present invention is directed, in part, to addressing this need. The failure of decontamination techniques to eliminate naturally occurring microbes adequately during the processing of poultry/meat concerns members of the food industry, governmental health officials, and consumers . Studies have shown that a number of bacteria can survive the slaughter■ and packaging processes. These bacteria include E. coli. Salmonella, Pseudomonas , Enterobacteriaceae , and Campylobacter. During processing, these surviving bacteria can spread from carcass to carcass and be transmitted to human consumers of the product. The problems of poultry/meat contamination and the difficulties in decontamination have been discussed, for example, in Izat et al . , "Incidence and Level of Campylobacter jejuni in Broiler Processing," Poultry Sci. , 67:1568-1572 (1988); Dickson et al . , "Microbiological Decontamination of Food Animal Carcasses by Washing and Sanitizing Systems: A Review," J. Food Prot . , 55:133-140 (1992); and James et al . , "Effects of Chlorination of Chill Water on the
Bacteriological Profile of Raw Chicken Carcasses and Giblets," J. Am. Vet. Med. Assoc. 200:60-63 (1992) ("James"), which are hereby incorporated by reference. Currently, commercial processing facilities use chlorinated water chilling (hydrocooling) to decrease product temperature and reduce the microbial load of poultry, for example, as discussed in James, which is hereby incorporated by reference. Briefly, following evisceration, carcasses are subjected to an inside- outside bird wash and then are hydrocooled at 4°C for one hour in circulating water tanks containing low levels (50 ppm) of residual chlorine. Despite the reductions in microbial load resulting from the use of hydrocooling techniques, methods for further reducing bacterial contamination and cross-contamination in animal carcasses are needed, and the present invention is directed, in part, to addressing this need. SUMMARY OF THE INVENTION
The present invention relates to a method for applying a medicament to a surface of a burn victim. The method includes providing a medicament formulation that includes a medicament, a foaming agent, and a film- forming agent . The method further includes applying the medicament formulation as a collapsible foam to the surface of the burn victim. The present invention also relates to a medicament formulation that includes a medicament, a foaming agent, and a film-forming agent. The present invention also relates to a method for reducing bacterial contamination in animal carcasses. The method includes providing a foam formulation that includes a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses. The present invention also relates to an antibacterial foam formulation that includes a foaming agent, a film-forming agent, and an antibacterial carboxylic acid. BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a graph showing the effect of gelatin and chitosan on the stability of foam formulations in accordance with the present invention. Figure 2 is a graph showing the effect of cetrimide concentration on the stability of foam formulations in accordance with the present invention. Figure 3 is a graph showing the effect of chitosan concentration on the stability of foam formulations in accordance with the present invention. Figures 4A-4C are scanning electron micrographs at 75X (Figure 4A) , 1000X (Figure 4B) , and 2000X magnification (Figure 4C) of dried foam-films without mafenide acetate . Figures 5A-5C are scanning electron micrographs at 75X (Figure 5A) , 1000X (Figure 5B) , and 2000X magnification (Figure 5C) of dried foam-films containing 1% (w/v) mafenide acetate in accordance with the present invention. Figures 6A-6C are scanning electron micrographs at 75X (Figure 6A) , 1000X (Figure 6B) , and 2000X magnification (Figure 6C) of dried foam-films containing 2% (w/v) mafenide acetate in accordance with the present inven ion. Figure 7 is a graph showing in vitro release of mafenide acetate from foam-film delivery systems of the present invention. Figure 8 is a graph showing the effect of a 2% (v/v) lactic acid-containing foam formulation of the present invention on E. coli counts on beef surfaces. Figure 9 is a graph showing the effect of a 2% (v/v) acetic acid-containing foam formulation of the present invention on E. coli counts on beef surfaces.
DETAILED DESCRIPTION OF THE INVENTION The present invention, in one aspect thereof, relates to a method for applying a medicament to a surface of a burn victim. The method includes providing a medicament formulation that includes a medicament, a foaming agent, and a film-forming agent. The method further includes applying the medicament formulation as a collapsible foam to the surface of the burn victim. "Burn victim", as used herein, is meant to refer to mammals, such as humans, other primates, dogs, rats, and mice, who have suffered a burn injury. The burn injury can be the result of exposure to fire, heat, radiation, electricity, or a caustic agent. The burn injury can be a partial thickness burn injury (e.g., those involving only the epidermal layers, those involving only the dermal layers, or those involving both the epidermal and dermal layers) , or the burn injury can be a full thickness burn injury (e.g., those which include damage to subcutaneous layers) . The burn injury can be a first, second, or third degree burn injury. The method involves applying a medicament formulation to the surface of the burn victim, preferably to at least a portion of the site or sites of the burn injury. The medicament formulation includes a medicament, a foaming agent, and a film-forming agent. Suitable medicaments for use in the medicament formulation include those which are conventionally used in the topical treatment of burn injuries. Illustratively, such medicaments can be antibacterial agents, such as naturally-occurring antibacterial agents or synthetic antibacterial agents. Suitable antibacterial agents include those which are effective against gram-positive bacteria, those which are effective against gram-negative bacteria, as well as those which are effective against both gram-positive and gram- negative bacteria. Illustratively, mafenide acetate, sulfadiazine, and combinations thereof are suitable for used as antibacterial agents in the medicaments of the present invention. The amount of medicament used in the medicament formulation can vary depending on the nature of the medicament, on the nature of the other components of the formulation, on the severity of the burn, etc. For example, in the case where the medicament is mafenide acetate or another antibacterial agent, the' medicament formulation can contain from about 0.1% to about 20% (e.g., from about 0.2% to about 10%, from about 0.5% to about 5%, from about 0.5% to about 3%, and/or from about 1% to about 2%) of antibacterial agent (weight-to- volume) . "Foaming agent", as used herein, is meant to include any material which is capable of forming a semi- stable, collapsible foam, for example, a collapsible foam which has a weight loss of less than about 80% (e.g., less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%) over more than about 20 minutes (e.g., over more than about 30 minutes, over more than about 40 minutes, over more than about 50 minutes, over more than about 1 hour) when delivered via conventional foaming apparatuses (e.g., Airspray International's F-2 finger pump foamer) . As used in this context, a foam is to be deemed to be collapsible if the foam has a weight loss of greater than 80% in under about 24 hours, such as in under about 12 hours, in under about 6 hours, in under about 4 hours, in under about 3 hours. Suitable foaming agents include surfactants, such as cationic surfactant. Illustratively, the foaming agent can be a quaternary ammonium cationic surfactant (e.g., a compound having the formula RXN+(R2) (R3) (R4) X", where R1 represents a long chain substituted or unsubstituted alkyl group having from 8 to 25 carbon atoms, such as an alkyl group having the formula CH3(CH2)n-, where n is an integer from about 8 to about 25, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20; R2, R3, and R4 independently represent a substituted or unsubstituted alkyl group having from 1 to 4 carbons, such as in the case where at least one of R2, R3, and R4 represents a methyl group, where at least two of R2, R3, and R4 represent methyl groups, or each of R2, R3, and R4 represents a methyl group; and X" represents a suitable anion, such as a halide (e.g., Cl", Br", or I") . One illustrative example of a suitable cationic surfactant for use in the medicament formulations of the present invention is cetrimide (cetyl trimethyl ammonium bromide, CH3 (CH2) 15N+ (CH3) 3 Br") . The amount of foaming agent used in the medicament formulation can vary depending on the nature of the foaming agent, on the nature of the other components of the formulation, on the desired rate of release of the medicament from the foam, on the nature of the medicament employed, on the severity of the burn, etc. For example, the medicament formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.25%, and/or from about 0.1% to about 0.2%) of foaming agent (weight-to- volume) . As discussed above, the medicament formulation of the present invention also includes a film-forming agent, such as chitosan and other film-forming, water- soluble derivatives of chitin. The amount of film-forming agent used in the medicament formulation can vary depending on the nature of the film-forming agent, on the nature of the other components of the formulation, on the desired thickness of the film, on the nature of the medicament employed, on the severity of the burn, etc. For example, the medicament formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.3%, and/or from about 0.1% to about 0.25%) of film-forming agent (weight-to-volume) . The medicament formulation of the present invention can optionally include other components (i.e., in addition to the medicament, foaming agent, and film- forming agent) . Illustratively, the medicament formulation can be formulated in sterile water, which can contain various buffering agents. The medicament formulation can further include acetic acid in an amount (volume-to-volume) of from about 0.1% to about 5% (e.g., from about 1% to about 3% and/or about 2%) . Additionally or alternatively, the medicament formulation can further include gelatin (e.g., Type A gelatin), for example, to increase the thickness of the foam. As another illustrative example, the medicament formulations of the present invention can further include lactic acid. As still another illustrative example, the medicament formulations of the present invention can further include a long chain carboxylic acid, such as a long chain carboxylic acid having 18 or more carbon atoms. Alternatively, the medicament formulations of the present invention can be substantially free from long chain carboxylic acids, such as long chain carboxylic acids having 18 or more carbon atoms. Still additionally or alternatively, the medicament formulations can be substantially free of peroxy carboxylic acids and/or peroxides. Still additionally or alternatively, the medicament formulations can be substantially free of iron, such as in the case where the medicament formulations contain less than about 0.01 μM free iron, contain less than 0.01 μM free iron, contain less than about 0.005 μM free iron, contain less than about 0.001 μM free iron, and/or contain no measurable amount of free iron. "Free iron", as used herein, has the meaning ascribed to it in U.S. Patent Application Publication No. US2002/0015697, which is hereby incorporated by reference . The medicament formulations of the present invention can be provided in dry powder form (e.g., containing medicament, foaming agent, film-forming agent, and, optionally, other dry components) , in which case the medicament formulation can be mixed with an appropriate amount of sterile water (or buffer solution or other suitable sterile aqueous solvent) prior to foaming and application to the surface of the burn victim. Alternatively, the medicament formulations of the present invention can be provided in the form of a solution. The solution can be in concentrated form or in a fully- diluted form (i.e., ready for foaming). Still alternatively, the medicament formulations of the present invention can be provided in the form of a foam. As discussed above, the method of the present invention involves applying the medicament formulation as a collapsible foam to the surface of the burn victim. The foam can be applied by any suitable method, such as by spraying, misting, sputtering, immersion etc. The foam can be applied in a single application, in two or more applications, or continuously over the course of any suitable period of time, such as about 30 minutes, about 1 hour, about 2-12 hours, about one day, about 2 days, about 3 days, about one week, about two weeks, or about a month or more. The foam can be applied at any suitable thickness (e.g., from about 0.2 mm to about a cm or more) . For example, the thickness of the foam can be adjusted (depending on the nature and concentration of the medicament, on the nature and concentration of the foaming agent, on the nature and concentration of the film-forming agent, on the nature and concentrations of optional components (e.g., gelatin), if any, and on the apparatus used to produce the foam) so that, when the foam collapses, the film-forming agent produces a thin, smooth, and/or substantially continuous film on the surface to which the foam is applied. The present invention, in another aspect thereof, relates to a method for reducing bacterial contamination in animal carcasses. The method includes providing a foam formulation comprising a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses. "Animal carcasses", as used herein, are meant to include complete and partial carcasses of recently- slaughtered animals (e.g., chicken, turkey, duck, goose, and other poultry carcasses; porcine carcasses; bovine carcasses; etc.). Illustratively, "animal carcasses" is meant to include undissected, substantially undissected, and dissected portions of recently-slaughtered animals (e.g., chicken halves, chicken quarters, chicken legs, chicken thighs, chicken breasts, chicken wings, chicken organs, and combinations thereof; sides of beef, quarters of beef, beef organs, and combinations thereof; etc.) . "Surface", as used in this context, is meant to include outer surfaces as well as inner surfaces (e.g., body and other cavities) of the aforementioned animal carcasses, as well as any portion of such surfaces. The foam formulation includes a foaming agent and a film-forming agent. "Foaming agent", as used herein, is meant to include any material which is capable of forming a semi- stable, collapsible foam, for example, a collapsible foam which has a weight loss of less than about 80% (e.g., less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%) over more than about 20 minutes (e.g., over more than about 30 minutes, over more than about 40 minutes, over more than about 50 minutes, over more than about 1 hour) when delivered via conventional foaming apparatuses (e.g., Airspray International's F-2 finger pump foamer) . As used in this context, a foam is to be deemed to be collapsible if the foam has a weight loss of greater than 80% in under about 24 hours, such as in under about 12 hours, in under about 6 hours, in under about 4 hours, in under about 3 hours. Suitable foaming agents include surfactants, such as a cationic surfactant. Illustratively, foaming agent can be a quaternary ammonium cationic surfactant (e.g., a compound having the formula R1N+(R2) (R3) (R4) X", where R1 represents a long chain substituted or unsubstituted alkyl group having from 8 to 25 carbon atoms, such as an alkyl group having the formula CH3(CH2)n-, where n is an integer from about 8 to about 25, such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20; R2, R3, and R4 independently represent a substituted or unsubstituted alkyl group having from 1 to 4 carbons, such as in the case where at least one of
R2, R3, and R4 represents a methyl group, where at least two of R2, R3, and R4 represent methyl groups, or each of R2, R3, and R4 represents a methyl group; and X" represents a suitable anion, such as a halide (e.g., Cl", Br", or I" ) . One illustrative example of a suitable cationic surfactant for use in the foam formulations of the present invention is cetrimide (cetyl trimethyl ammonium bromide, CH3 (CH2) 15N+ (CH3) 3 Br") . The amount of foaming agent used in the foam formulation can vary depending on the nature of the foaming agent, on the nature of the other components of the formulation, etc. For example, the foam formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.25%, and/or from about 0.1% to about 0.2%) of foaming agent (weight-to-volume) . As discussed above, the foam formulation of the present invention also includes a film-forming agent, such as chitosan and other film-forming, water-soluble derivatives of chitin. The amount of film-forming agent used in the foam formulation can vary depending on the nature of the film-forming agent, on the nature of the other components of the formulation, on the desired thickness of the film,, etc. For example, the foam formulation can contain from about 0.01% to about 2% (e.g., from about 0.03% to about 1%, from about 0.05% to about 0.5%, from about 0.05% to about 0.3%, and/or from about 0.1% to about 0.25%) of film-forming agent (weight- to-volume) . The foam formulation useful in methods of the present invention for reducing bacterial contamination in animal carcasses can further include an antibacterial carboxylic acid. Illustratively, such antibacterial carboxylic acids can be naturally-occurring antibacterial carboxylic acids or synthetic antibacterial carboxylic acids. Suitable antibacterial carboxylic acids include those which are effective against gram-positive bacteria, those which are effective against gram-negative bacteria, as well as those which are effective against both gram- positive and gram-negative bacteria. Illustratively, acetic acid, lactic acid, and combinations thereof are suitable for used as antibacterial carboxylic acids in the foam formulations of the present invention. The amount of antibacterial carboxylic acid used in the foam formulation (when they are employed) can vary depending on the nature of the antibacterial carboxylic acid, on the nature of the other components of the formulation, etc. For example, the foam formulation can contain from about 0.1% to about 20% (e.g., from about 0.2% to about 10%, from about 0.5% to about 5%, from about 0.5% to about 3%, and/or from about 1% to about 2%) of antibacterial carboxylic acid (volume-to-volume) . The foam formulation of the present invention can optionally include other components (i.e., in addition to the foaming agent, film-forming agent, and optional antibacterial carboxylic acid) . Illustratively, the foam formulation can further include water, which can contain various buffering agents, salts, and/or other solutes. As another illustrative example, the foam formulations of the present invention can further include gelatin (e.g., Type A gelatin), for example, to increase the thickness of the foam. As still another illustrative example, the foam formulations of the present invention can further include a long chain carboxylic acid, such as a long chain carboxylic acid having 18 or more carbon atoms. Alternatively, the foam formulations of the present invention can be substantially free from long chain carboxylic acids, such as long chain carboxylic acids having 18 or more carbon atoms. Still additionally or alternatively, the foam formulations can be substantially free of peroxy carboxylic acids and/or peroxides. Still additionally or alternatively, the foam formulations can be substantially free of iron, such as in the case where the foam formulations contain less than about 0.01 μM free iron, contain less than 0.01 μM free iron, contain less than about 0.005 μM free iron, contain less than about 0.001 μM free iron, and/or contain no measurable amount of free iron. As noted above, "free iron", as used herein, has the meaning ascribed to it in U.S. Patent Application Publication No. US2002/0015697, which is hereby incorporated by reference . The foam formulations of the present invention can be provided in dry powder form (e.g., containing foaming agent, film-forming agent, optional antibacterial carboxylic acid, and, optionally, other dry components) , in which case the foam formulation can be mixed with an appropriate amount of water (or buffer solution or other suitable aqueous solvent) prior to foaming and application to the surface the animal carcasses.
Alternatively, the foam formulations of the present invention can be provided in the form of a solution. The solution can be in concentrated form or in a fully- diluted form (i.e., ready for foaming). Still alternatively, the foam formulation of the present invention can be provided in the form of a foam. As discussed above, the method of the present invention involves applying the foam formulation as a collapsible foam to a surface of the animal carcasses. The foam can be applied by any suitable method, such as by spraying, misting, sputtering, immersion, etc. The foam can be applied in a single application, in two or more applications, or continuously over the course of any suitable period of time. For example, the foam can be sprayed onto the animal carcass surface and permitted to remain there for from 10 seconds to 5 minutes, such as between 30 seconds and a minute. The foam can be applied at any suitable thickness (e.g., from about 0.2 mm to about a cm or more) . For example, the thickness of the foam can be adjusted (depending on the nature and concentration of the foaming agent, on the nature and concentration of the film-forming agent, on the nature and concentrations of optional components (e.g., gelatin) , if any, and on the apparatus used to produce the foam) so that, when the foam collapses, the film- forming agent produces a thin, smooth, and/or substantially continuous film on the surface to which the foam is applied. The present invention is further illustrated by the following examples.
EXAMPLES
Example 1 -- Stability of Various Foam Formulations Preliminary studies showed that cetrimide, a cationic surfactant, produced the most stable foam, as compared to anionic and non-ionic surfactants. Accordingly, cetrimide was used in further studies. The antibacterial formulation consisted of an aqueous solution' of either 2% (v/v) of L-lactic acid or acetic acid in deionized water, gelatin, low molecular weight chitosan, and a cationic surfactant (cetrimide) ., An Airspray International F2 finger pump foamer was used to produce a foam from the above solution. Stability of the foam was measured gravimetrically by monitoring the weight loss of the foam with time. The acetic acid and lactic acid content of the foam was determined by USP method. Figure 1 is a graph showing the effect of gelatin and chitosan on the stability of the foam. As Figure 1 shows, the presence of gelatin does not adversely affect the stability of the foam. Moreover, it was observed that, while the presence of gelatin enhanced foam thickness, chitosan was responsible for the formation of a thin and uniform film after collapse of the foam. Acetic and lactic acid were both stable in the formulation at least for a period of two months . Figure 2 is a graph showing the effect of cetrimide concentration on the stability of the foam. As Figure 2 shows, the cetrimide concentration has little effect on the stability of the foam. Figure 3 is a graph showing the effect of chitosan concentration on the stability of the foam. As Figure 3 shows, the concentration of chitosan in the formulation has only a negligible effect on the foam's stability.
Example 2 -- Preparation and Characterization of Mafenide Acetate-Containing Foam Formulations A solution containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), and mafenide acetate 2% (w/v) , was prepared. A second solution, containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), and mafenide acetate 1% (w/v) , was also prepared. A third solution, containing chitosan 0.22% (w/v), acetic acid 2% (v/v), cetrimide 0.13 % (w/v), but without mafenide acetate, was also prepared. An Airspray International F2 finger pump foamer was used to produce foams from the above three solutions. Surface topography of the films with and without mafenide acetate was determined using a scanning electron microscope. Scanning electron micrographs of dried foam-films without mafenide acetate are presented in Figure 4A (75X magnification) , Figure 4B (1000X magnification) , and Figure 4C (2000X magnification) .
Scanning electron micrographs of dried foam-films with 1% (w/v) mafenide acetate are presented in Figure 5A (75X magnification) , Figure 5B (1000X magnification) , and Figure 5C (2000X magnification) . Scanning electron micrographs of dried foam-films with 2% (w/v) mafenide acetate are presented in Figure 6A (75X magnification) , Figure 6B (1000X magnification) , and Figure 6C (2000X magnification) . The scanning electron microscopic studies indicated the formation of smooth and uniform films upon the drying of these foams. The in vitro releases of mafenide acetate from the above foam-film delivery systems were studied using an ion-pairing chromatographic method (Dash et al . , "Ion Pairing Chromatographic Method for the Analysis of Mafenide Acetate," J. Chromatocrraphy, 708: 83-88 (1995), which is hereby incorporated by reference) . More particularly, in vitro release of mafenide acetate was carried out in Sorensen ' s • phosphate buffer (pH 7.4) at 37°C, and the following chromatographic conditions were employed to assay mafenide acetate: column: C-18 Spherisorb column; mobile phase: methanol :phosphate buffer (65:35 % v/v) containing 0.04% (w/v) of 1- heptanesulfonic acid monohydrate; flow rate: 1.0 ml/min; detection: UV at 270 nm. The results are presented in Figure 7. Referring to Figure 7, it can be seen that the in vitro release of mafenide acetate from the films is relatively rapid and dependent on drug load.
Example 3 -- Effect of Chitosan-Containing Foams on E. coli Counts on Beef Surfaces The antibacterial properties of the formulations described in Example 1 were evaluated using E. coli as the test organism. Briefly, antibacterial foam formulations containing an aqueous solution of either 2% (v/v) of L-lactic acid or 2% (v/v) of acetic acid in deionized water, low molecular weight chitosan, and a cationic surfactant (cetrimide) were prepared. Spray formulations containing 2% (v/v) of L-lactic acid or acetic acid in deionized water were also prepared. Each of the above foam and spray formulations was applied to beef surfaces, and its effect on E. coli counts was evaluated. The results are presented in Figures 8 and 9. As Figures 8 and 9 show, lactic acid and acetic acid foam-film formulations substantially reduced the growth of E. coli on beef surfaces relative to their counterpart spray solutions.
Although preferred embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions and the like can be made without departing from the spirit of the invention and these are therefore considered to be within the scope of the invention as defined in the claims which follow.

Claims

What Is Claimed Is:
1. A method for applying a medicament to a surface of a burn victim, said method comprising: providing a medicament formulation comprising a medicament, a foaming agent, and a film-forming agent; and applying the medicament formulation as a collapsible foam to the surface of the burn victim.
2. A method according to claim 1, wherein the medicament is an antimicrobial agent.
3. A method according to claim 1, wherein the medicament is an antibacterial agent.
4. A method according to claim 1, wherein the medicament is selected from the group consisting of mafenide acetate, sulfadiazine, and combinations thereof.
5. A method according to claim 1, wherein the medicament is mafenide acetate.
6. A method according to claim 1, wherein the medicament is sulfadiazine.
7. A method according to claim 1, wherein the foaming agent is a surfactant .
8. A method according to claim 1, wherein the foaming agent is a cationic surfactant.
9. A method according to claim 1, wherein the foaming agent is a quaternary ammonium cationic surfactant
10. A method according to claim 1, wherein the foaming agent is cetrimide.
11. A method according to claim 1, wherein the film-forming agent is a chitosan.
12. A method according to claim 1, wherein the medicament formulation further includes gelatin.
13. A medicament formulation comprising: a medicament; a foaming agent; and a film-forming agent.
14. A medicament formulation according to claim 13, wherein said medicament is an antimicrobial agent.
15. A medicament formulation according to claim 13, wherein said medicament is an antibacterial agent.
16. A medicament formulation according to claim 13, wherein said medicament is selected from the group consisting of mafenide acetate,, and combinations thereof.
17. A medicament formulation according to claim 13, wherein said medicament is mafenide acetate.
18. A medicament formulation according to claim 13, wherein said medicament is sulfadiazine.
19. A medicament formulation according to claim 13, wherein said foaming agent is a surfactant.
20. A medicament formulation according to claim 13, wherein said foaming agent is a cationic surfactant.
21. A medicament formulation according to claim 13, wherein said foaming agent is a quaternary ammonium cationic surfactant.
22. A medicament formulation according to claim 13, wherein said foaming agent is cetrimide.
23. A medicament formulation according to claim 13, wherein said film-forming agent is a t chitosan.
24. A medicament formulation according to claim 13 , wherein said medicament formulation further includes gelatin.
25. A method for reducing bacterial contamination in animal carcasses, said method comprising: providing a foam formulation comprising a foaming agent and a film-forming agent; and applying the foam formulation as a collapsible foam to a surface of the animal carcasses.
26. A method according to claim 25, wherein the foaming agent is a surfactant .
27. A method according to claim 25, wherein the foaming agent is a cationic surfactant.
28. A method according to claim 25, wherein the foaming agent is a quaternary ammonium cationic surfactant.
29. A method according to claim 25, wherein the foaming agent is cetrimide.
30. A method according to claim 25, wherein the film-forming agent is a chitosan.
31. A method according to claim 25, wherein the foam formulation further includes an antibacterial carboxylic acid.
32. A method according to claim 25, wherein the foam formulation further includes acetic acid.
33. A method according to claim 25, wherein the foam formulation further includes lactic acid.
34. A method according to claim 25, wherein the foam formulation further includes gelatin.
35. An antibacterial foam formulation comprising: a foaming agent; a film-forming agent; and an antibacterial carboxylic acid.
36. An antibacterial foam formulation according to claim 35, wherein said foaming agent is a surfactant.
37. An antibacterial foam formulation according to claim 35, wherein said foaming agent is a cationic surfactant .
38. An antibacterial foam formulation according to claim 35, wherein said foaming agent is a quaternary ammonium cationic surfactant.
39. An antibacterial foam formulation according to claim 35, wherein said foaming agent is cetrimide.
40. An antibacterial foam formulation according to claim 35, wherein said film-forming agent is a chitosan.
41. An antibacterial foam formulation according to claim 35, wherein said antibacterial carboxylic acid is acetic acid.
42. An antibacterial foam formulation according to claim 35, wherein said antibacterial carboxylic acid is lactic acid.
43. An antibacterial foam formulation according to claim 35, wherein said antibacterial foam formulation further includes gelatin.
44. An antibacterial foam formulation according to claim 35, wherein said antibacterial foam formulation is substantially free of long-chain carboxylic acids.
45. An antibacterial foam formulation according to claim 35, wherein said antibacterial foam formulation is substantially free of peroxy carboxylic acids and peroxides.
46. An antibacterial foam formulation according to claim 35, wherein said antibacterial foam formulation is substantially free of iron.
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