Applicator devices (1), kits, systems, and methods of using such devices for treating one or more body surface conditions (e.g., warts, Molluscum contagiosum, conjunctivitis, otitis) are provided. The applicator device facilitate topical administration of a controllable amount of a pharmaceutical composition to a desired area of an affected body surface (e.g., skin, eye, ear, nose, mouth, anus, vagina). The applicator device includes an ampule (60) containing the pharmaceutical composition, the ampule being positioned within a tube (50). Squeezing the tube breaks the ampule, releasing the pharmaceutical composition. The applicator device includes a filter (30) that permits passage of fluid and inhibits passage of broken ampule shards. The applicator device includes a dispensing tip (20) through which the pharmaceutical composition pass.
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
2.
COMPOSITIONS, METHODS AND SYSTEMS FOR THE TREATMENT OF CUTANEOUS DISORDERS
Provided herein are devices, systems, kits and methods for treating skin conditions, ailments or diseases, such as skin warts. In some examples, a device for treating warts comprises a reservoir that includes a cantharidin formulation, and an applicator device in fluid communication with the reservoir that delivers the cantharidin formulation to a subject.
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes DetailsAccessories therefor
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
A61J 7/00 - Devices for administering medicines orally, e.g. spoonsPill counting devicesArrangements for time indication or reminder for taking medicine
A61K 8/92 - Oils, fats or waxesDerivatives thereof, e.g. hydrogenation products
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/30 - Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
The present disclosure is based on the development of improved clinical protocols for administering an anti-cancer peptide having the sequence of SEQ ID NO: 1, or a pharmaceutically acceptable salt thereof (“Peptide A”), to a subject (e.g., for the treatment of a skin cancer, such as basal cell carcinoma (BCC)). Methods provided herein allow for the safe and effective treatment of skin cancers, including BCC, in a minimally invasive manner. In certain embodiments, methods provided herein allow for administration of Peptide A to a skin cancer lesion (e.g., BCC lesion) on a subject with no significant treatment-related adverse events (TRAEs), e.g., TRAEs such as burning and/or pain at the injection site.
The invention provides synthetic methods for the preparation of cantharidin and analogs thereof. In one aspect, the invention provides an improved Diels-Alder cycloaddition to generate a key intermediate en route to cantharidin and analogs thereof. In certain embodiments, the new Diels-Alder reaction involves reacting Compound (2) in the presence of furan, and in the absence of acid or increased pressure, in an aprotic polar solvent with slight warming, to yield Compound (1) in favorable yield and exo-endo ratio. In another aspect, the invention also provides a new Diels-Alder reaction between compounds of Formula (III) and furan to yield compounds of Formula (IV), which can then be transformed into cantharidin or analogs thereof. In yet another aspect, the invention describes a new palladium-mediated carbonylation providing another key intermediate en route to cantharidin and analogs thereof. In addition to synthetic methods, present invention also provides compounds (i.e., intermediates) useful in the synthesis of cantharidin and analogs thereof. Compounds provided herein may have biological activity, and therefore may be used in the treatment of diseases or conditions (e.g., infectious diseases and skin conditions).
C07D 495/22 - Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains four or more hetero rings
C07D 333/38 - Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
Tools (100) for crushing an ampule (146) contained within an applicator (102) for a therapeutic are disclosed herein. The ampule crush tool may be configured to rest on an incline relative to a flat surface. Further, the ampule crush tool may include a spill reservoir (122) for collecting a volume of the therapeutic expelled during an ampule crushing operation. Additionally, the ampule crush tool may form a fully enclosed cavity such that the ampule crush tool may contain the therapeutic even when the therapeutic is expelled from the ampule along an unpredictable trajectory. The ampule crush tool may also be shaped to orient an ampule-containing applicator in a suitable orientation within the ampule crush tool.
Tools (100) for crushing an ampule (146) contained within an applicator (102) for a therapeutic are disclosed herein. The ampule crush tool may be configured to rest on an incline relative to a flat surface. Further, the ampule crush tool may include a spill reservoir (122) for collecting a volume of the therapeutic expelled during an ampule crushing operation. Additionally, the ampule crush tool may form a fully enclosed cavity such that the ampule crush tool may contain the therapeutic even when the therapeutic is expelled from the ampule along an unpredictable trajectory. The ampule crush tool may also be shaped to orient an ampule-containing applicator in a suitable orientation within the ampule crush tool.
Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
A61K 9/00 - Medicinal preparations characterised by special physical form
Provided herein are devices, systems, kits and methods for treating skin conditions, ailments or diseases, such as skin warts. In some examples, a device for treating warts comprises a reservoir that includes a cantharidin formulation, and an applicator device in fluid communication with the reservoir that delivers the cantharidin formulation to a subject.
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes DetailsAccessories therefor
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
05 - Pharmaceutical, veterinary and sanitary products
35 - Advertising and business services
Goods & Services
Pharmaceutical products and preparations for the treatment of dermatological diseases Retail services through direct solicitation by distributors directed to end users featuring pharmaceuticals
Applicator devices (1), kits, systems, and methods of using such devices for treating one or more body surface conditions (e.g., warts, Molluscum contagiosum, conjunctivitis, otitis) are provided. The applicator device facilitates topical administration of a controllable amount of a pharmaceutical composition to a desired area of an affected body surface (e.g., skin, eye, ear, nose, mouth, anus, vagina). The applicator device includes an ampule (40) containing the pharmaceutical composition, the ampule being positioned within a tube (50). Squeezing the tube breaks the ampule, releasing the pharmaceutical composition. The applicator device includes a filter (30) that permits passage of fluid and inhibits passage of broken ampule shards. The applicator device includes a dispensing tip (20) through which the pharmaceutical composition passes.
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
Compiling and analyzing statistics, data and other sources of information concerning pharmaceuticals to assist healthcare providers and patients for cost management purposes; business administration of reimbursement services concerning pharmaceuticals
Compiling and analyzing statistics, data and other sources of information concerning pharmaceuticals to assist healthcare providers and patients for cost management purposes; business administration of reimbursement services concerning pharmaceuticals
Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
Compiling and analyzing statistics, data and other sources of information concerning pharmaceuticals to assist healthcare providers and patients for cost management purposes; business administration of reimbursement services concerning pharmaceuticals
The invention provides synthetic methods for the preparation of cantharidin and analogs thereof. In one aspect, the invention provides an improved Diels-Alder cycloaddition to generate a key intermediate en route to cantharidin and analogs thereof. In certain embodiments, the new Diels-Alder reaction involves reacting Compound (2) in the presence of furan, and in the absence of acid or increased pressure, in an aprotic polar solvent with slight warming, to yield Compound (1) in favorable yield and exo-endo ratio. In another aspect, the invention also provides a new Diels-Alder reaction between compounds of Formula (III) and furan to yield compounds of Formula (IV), which can then be transformed into cantharidin or analogs thereof. In yet another aspect, the invention describes a new palladium-mediated carbonylation providing another key intermediate en route to cantharidin and analogs thereof. In addition to synthetic methods, present invention also provides compounds {i.e., intermediates) useful in the synthesis of cantharidin and analogs thereof. Compounds provided herein may have biological activity, and therefore may be used in the treatment of diseases or conditions {e.g., infectious diseases and skin conditions).
C07D 495/22 - Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains four or more hetero rings
24.
Quantification and preparation of pharmaceutical grade cantharidin
The present disclosure provides methods for purifying a solution comprising cantharidin and cantharidin-associated impurities. A method to purify the solution can comprise recrystallization or sublimation, for example. The purified cantharidin can be analyzed using a detection method comprising a stationary phase and one or more mobile phases.
G01N 21/33 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
Applicator devices (1), kits, systems, and methods of using such devices for treating one or more body surface conditions (e.g., warts, Molluscum contagiosum, conjunctivitis, otitis) are provided. The applicator device facilitates topical administration of a controllable amount of a pharmaceutical composition to a desired area of an affected body surface (e.g., skin, eye, ear, nose, mouth, anus, vagina). The applicator device includes an ampule ( 40 ) containing the pharmaceutical composition, the ampule being positioned within a tube ( 50 ). Squeezing the tube breaks the ampule, releasing the pharmaceutical composition. The applicator device includes a filter ( 30 ) that permits passage of fluid and inhibits passage of broken ampule shards. The applicator device includes a dispensing tip ( 20 ) through which the pharmaceutical composition passes.
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
A61K 47/00 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
Methods of treating one or more skin lesions using cantharidin as well as associated compositions, treatment regimens, kits, devices, and systems are provided. A method of treating a subject having one or more skin lesions may involve administering a composition comprising cantharidin to one or more skin lesions. The method may allow for the efficacious treatment of the skin lesion(s) with minimal or no adverse side effects (e.g., severe adverse side effects, permanent damage of the dermal tissue, scarring, excessive blistering of skin surrounding the lesion, elevated plasma cantharidin concentration, systemic exposure to cantharidin). The efficacy and/or safety of the treatment may be due, to certain features of the composition and/or prolonged exposure of the skin lesion(s) to cantharidin. The methods described herein may be used for a wide variety of cutaneous disorders, including skin disorders that primarily affect the epidermis of skin.
A61K 8/368 - Carboxylic acidsSalts or anhydrides thereof with carboxyl groups directly bound to carbon atoms of aromatic rings
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
The present disclosure provides methods for purifying a solution comprising cantharidin and cantharidin-associated impurities. A method to purify the solution can comprise recrystallization or sublimation, for example. The purified cantharidin can be analyzed using a detection method comprising a stationary phase and one or more mobile phases.
G01N 21/33 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
A61K 31/357 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
30.
Compositions, methods and systems for the treatment of cutaneous disorders
Devices, systems, methods, and kits for treating cutaneous diseases, such as warts, with a cantharidin formulation are generally described. The cantharidin formulations, described herein, may have many advantages over traditional cantharidin formulations, including removal of highly volatile and corrosive solvents, improved safety, and improved compatibility with common plastics for ease of delivery. The devices, systems, methods, and kits can be used for the precise application of the cantharidin formulation for the treatment of cutaneous diseases and other topical indications. Treatment of cutaneous diseases with cantharidin, using the devices, systems, methods, and/or kits may have many advantages over traditional therapies, including high single application efficacy, lack of scaring, and a mild pain profile.
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes DetailsAccessories therefor
A61K 31/343 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61J 7/00 - Devices for administering medicines orally, e.g. spoonsPill counting devicesArrangements for time indication or reminder for taking medicine
A61J 1/20 - Arrangements for transferring fluids, e.g. from vial to syringe
31.
COMMERCIALLY VIABLE SYNTHESIS OF CANTHARIDIN AND BIOACTIVE CANTHARIDIN DERIVATIVES
Provided herein are devices, systems, kits and methods for treating skin conditions, ailments or diseases, such as skin warts. In some examples, a device for treating warts comprises a reservoir that includes a cantharidin formulation, and an applicator device in fluid communication with the reservoir that delivers the cantharidin formulation to a subject.
A61M 35/00 - Devices for applying media, e.g. remedies, on the human body
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
A61K 31/34 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
