Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
  • A61K31/716—Glucans
  • A61K31/724—Cyclodextrins
• • 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
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/16—Emollients or protectives, e.g. against radiation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/12—Antivirals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P39/00—General protective or antinoxious agents
  • A61P39/02—Antidotes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P39/00—General protective or antinoxious agents
  • A61P39/04—Chelating agents
• • 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
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus

Definitions

• Embodiments of the present invention relate to methods and devices for protecting against toxic agents.
• Depleted uranium or U-238 (“DU")
• DU Depleted uranium
• U-238 is a toxic, heavy metal byproduct of uranium enrichment that gives the world uranium suitable for use in nuclear weapons and reactor fuel. It is also used in munitions, ballast for airplanes, tank armor and other products.
• the material in armor-piercing munitions ignites and burns on impact at temperatures of several thousand degrees Celsius. Burning particles or dust of uranium oxide aerosol are created and may be carried considerable distances by winds.
• a safe, inexpensive, and simple foundation technology capable of extremely broad protection and treatment against many threat agents is needed. This requires a technology that manifests highly diverse binding capabilities.
• chitosan is useful for adsorbing and/or binding to heavy metals, radioisotopes and other toxic agents.
• chitosan and derivatives thereof may be included or suspended in lotions, gels or skin creams that are applied to skin.
• a suspension of chitosan in a cosmetically acceptable carrier is packaged in a portable container, e.g., a tube or bottle, for use on the skin to periodically inactivate toxic agents held on a person's skin.
• the chitosan hereof may be ingested for internal interaction and inactivation of toxic agents within the gastrointestinal tissue. When wastes are expelled, the toxic agents are retained on the chitosan and prevented from causing damage or harm.
• pathogen or "pathogens” is intended to refer to any bacterium, virus or other microorganism that can cause disease.
• activate or “inactivating” is intended to refer to rendering a toxic agent ineffective at causing disease or harmless to animals or humans.
• Chitosan a chemical derivative of chitin (the second most abundant materia! in the earth's biomass), appears to fulfill the need for broad-based binding abilities while satisfying requirements for safety and applicability.
• Chitosan is a partially N-deacetylated derivative of chitin, a polysaccharide found in the shell of crustaceans such as shrimp, crabs and lobsters, insects or moilusks. It is consists of 2-acetamido-2- deoxy-D-glucopyranose units linked together by 1 ,4-glycosidic bonds. Chitosan has an excellent selectivity and affinity to heavy metal anions and cations.
• chitosan As described herein, generally refers to a deacetyiated derivative of chitin.
• chitosan may include both ideal chitosan, which is a linear polysaccharide of 2-acetamido-2-deoxy-D-glucopyranose, as well as any chitin/chitosan co-poiymer such as linear polysaccharides composed of randomly distributed ⁇ -(1-4)-linked D-giucosamine (deacetyiated unit) and N-acetyl-D- glucosamine (acetylated unit).
• Chemical modification or derivatization of chitosan may be useful for modifying or enhancing the bioactivity of native chitosan. Accordingly, various embodiments of the present invention may comprise chemically modified chitosan or chitosan derivatives.
• Chitosan preparations are potentially capable of binding a myriad of toxic agents whether chemicai, radioactive or microbial.
• Chitosans and chitosan salts have a remarkable binding affinity for bacteria, viruses, endotoxins, proteins, heavy metals and other chemical agents.
• Chttosan's safety profile for humans and animals has long been demonstrated. It has been used in Asian cultures as a wound healing material for generations, is a primary ingredient in FDA approved medical devices (most recently as a hemorrhage control dressing deployed for US troops), and is FDA GRAS approved as a food additive.
• Chitosans have been used in large quantities as a water purification fiocculent and have been used to combat viral and fungai infections in plants.
• Chitosan is a known effective chelator of heavy metal ions and thus may be an ideal candidate for binding uranium and other heavy metal isotopes of great threat potential.
• the invention provides a methods for protecting against and/or removing toxic agents from human or animal skin such methods comprising applying a topical formulation to a portion of skin, wherein the topical formulation comprises chitosan or a derivative thereof and a cosmetically acceptable carrier.
• Skin compositions based on chitosan may be applied with minimal or no skin irritation for long periods. These compositions may covalently bind or chelate the salts of heavy metal radioactive isotopes that exist in solution, gas or as aerosolized microparticles. Chitosan is not absorbed through the skin and may prevent adsorption of these agents into tissues.
• a suspension of chitosan in a cosmetically acceptable carrier is packaged in a portable container, e.g., a tube or bottle, for use on the hands to periodically inactivate toxic agents held on a person's skin.
• a portable container e.g., a tube or bottle
• chitosan compositions may form a protective hydrogel that can be washed off with water. These compositions could be routinely applied prior to anticipated exposure. Alternatively, they could be used to bind and remove toxic agents from previously exposed skin or wounds. Chitosan's diverse binding characteristics may be ideal for protecting against a broad range of heavy metal isotopes.
• Cosmetic formulation entails an active component and the excipie ⁇ ts
• compositions according to the invention also comprise a iiquid, solid or semi-solid physiologically and cosmetically acceptable vehicle or carrier.
• a suitable vehicle under the invention, may act variously as solvent, diluent or dispersant for the constituents of the composition, and allows for the uniform application of the constituents to the surface of the skin at an appropriate dilution. It will be apparent to the skilled artisan that the range of possible vehicles is very broad.
• compositions according to this invention may comprise water as a vehicle, and/or at least one physiologically and cosmetically acceptable vehicle other than water.
• water comprises a vehicle in compositions under the invention, preferably the water is deionized.
• Vehicles other than water that can be used in compositions under the invention may be liquids or solids, including emoliients, various solvents, powders, and humectants.
• Carriers, including water may be used singly or in combination.
• Suitable carriers may include, but are not limited to, the following examples: water castor oil, ethylene glycol monobutyl ether, diethylene glycol monoethyl ether, com oil, dimethyl sulfoxide, ethylene glycol, isopropanoi, soybean oil, glycerin, soluble collagen, zinc oxide, titanium oxide, talc, Kaolin, hyaluronic acid.
• the active constituents of the skin care compositions according to the invention may be soluble or insoluble in a liquid carrier. If the active constituents are soluble in the carrier, the carrier acts as solvent for the active ingredient.
• the active constituents are insoluble in the carrier, they are dispersed in the carrier by means of, for example, a suspension, emulsion, gel, cream or paste, and the like.
• a preferred vehicle to act as solvent and/or diluent for the active constituents is water.
• Various oils such as vegetable oils obtained from any of corn, sunflower, saffiower, soybean, canola, and the like, may also be used as a vehicle, either alone or in combination.
• Various oils may also be used in combination with water following emulsification.
• composition may optionally comprise other cosmetic actives and excipients, obvious to those skilled in the art including, but not limited to, fillers, emulsifying agents, antioxidants, surfactants, film formers, chelating agents, gelling agents, thickeners, emollients, humectants, moisturizers, vitamins, minerals, viscosity and/or rheology modifiers, sunscreens, keratolytics, depigmenting agents, retinoids, hormonal compounds, alpha-hydroxy acids, alpha-keto acids, anti-mycobacterial agents, antifungal agents, antimicrobials, antivirals, analgesics, lipidic compounds, anti- allergenic agents, H1 or H2 antihistamines, anti-inflammatory agents, anti-irritants, antineoplastics, immune system boosting agents, immune system suppressing agents, anti-acne agents, anesthetics, antiseptics, insect repellents, skin cooling compounds, skin protectants, skin penetration enhancer
• compositions according to the invention may also comprise an acid including, but not limited to, acetic acid and citric acid.
• concentration of the acid may be adjusted slightly to provide a suitable pH. !n the case of the skin composition, the preferred pH is in the range of 6.0 to 8.0; more preferably the pH is in the range of
• chitosan and/or derivatives thereof may be included or suspended in a topical formulation for protecting against and/or removing toxic agents from human or animal skin.
• the topical formulation may be a cream, lotion, spray or gel.
• the toxic agents targeted by the topical formulation may include one or more pathogens.
• the toxic agents may include one or more viruses or bacteria.
• the topical formulation may be capable of substantially inactivating the pathogens.
• the topical chitosan formulation may be capable of substantially sequestering toxic agents.
• the topical chitosan formula may be capable of substantially chelating one or more heavy metals, or radioactive agents.
• the topical chitosan formulation may be applied to a portion of human or animal skin to protect against and/or remove toxic agents the portion of skin.
• the topical chitosan formulation may be applied prior to an exposure to the toxic agents.
• the topicai chitosan formulation may be applied after to an exposure to the toxic agents, in additional embodiments, the topical formulation may be removed to remove the toxic agents from the skin.
• the invention further provides methods for removing toxic agents from human or animal gastrointestinal tissue, such methods comprising ingesting a therapeutic formulation, wherein the therapeutic formulation comprises chitosan or a derivative thereof and a physiologically acceptable carrier.
• chitosan preparations could be given to bind radioactive isotopes in the gut to prevent or reduce adsorption of these agents locally and systemically, and then usher these agents quickly out of the Gl tract via a variety of common methods.
• the therapeutic formulation may be in the form of a liquid, pill or lozenge.
• the therapeutic chitosan formulation may be capable of substantially sequestering toxic agents.
• the therapeutic chitosan formula may be capable of substantially chelating one or more heavy metals, or radioactive agents.
• physiologically acceptable generally refers to a material that does not interfere with the effectiveness of an IRO compound and that is compatible with a biological system such as a cell, cell culture, tissue, or organism.
• a biological system such as a cell, cell culture, tissue, or organism.
• the biological system is a living organism, such as a vertebrate.
• carrier generally encompasses any excipient, diluent, filler, salt, buffer, stabilizer, solubilizer, oil, lipid, lipid containing vesicle, microspheres, liposomal encapsulation, or other material well known in the art for use in pharmaceutical formulations. It will be understood that the characteristics of the carrier, excipient, or diluent will depend on the route of administration for a particular application. The preparation of pharmaceutically acceptable formulations containing these materials is described in, e.g., Remington's Pharmaceutical Sciences, 18th Edition, ed. A. Gennaro, Mack Publishing Co., Easton, PA, 1990. [0039] In additional embodiments of the present invention, a therapeutic chitosan formulation may be administered via a catheter or enema.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Medicinal Chemistry (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Organic Chemistry (AREA)
• Epidemiology (AREA)
• Dermatology (AREA)
• Toxicology (AREA)
• Communicable Diseases (AREA)
• Oncology (AREA)
• Molecular Biology (AREA)
• Virology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Engineering & Computer Science (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Cosmetics (AREA)

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• 2010
  • 2010-03-19 CA CA2755833A patent/CA2755833A1/en not_active Abandoned
  • 2010-03-19 US US13/257,040 patent/US20120010167A1/en not_active Abandoned
  • 2010-03-19 JP JP2012500996A patent/JP2012521357A/ja active Pending
  • 2010-03-19 WO PCT/US2010/027984 patent/WO2010108098A1/en not_active Ceased

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