US20110130705A1 - Therapy for vitiligo - Google Patents

Therapy for vitiligo Download PDF

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Publication number
US20110130705A1
US20110130705A1 US12/934,024 US93402409A US2011130705A1 US 20110130705 A1 US20110130705 A1 US 20110130705A1 US 93402409 A US93402409 A US 93402409A US 2011130705 A1 US2011130705 A1 US 2011130705A1
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alpha
phe
msh
nle
trp
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Philippe Wolgen
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Clinuvel Pharmaceuticals Ltd
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Clinuvel Pharmaceuticals Ltd
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Priority claimed from AU2008901461A external-priority patent/AU2008901461A0/en
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Assigned to CLINUVEL PHARMACEUTICALS LIMITED reassignment CLINUVEL PHARMACEUTICALS LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: WOLGEN, PHILIPPE
Publication of US20110130705A1 publication Critical patent/US20110130705A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • A61K31/37—Coumarins, e.g. psoralen
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
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    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13—Cyclosporins
    • A—HUMAN NECESSITIES
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A—HUMAN NECESSITIES
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/33—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin
    • A61K38/34—Melanocyte stimulating hormone [MSH], e.g. alpha- or beta-melanotropin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0616—Skin treatment other than tanning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/665—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin
    • C07K14/68—Melanocyte-stimulating hormone [MSH]
    • C07K14/685—Alpha-melanotropin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0661—Radiation therapy using light characterised by the wavelength of light used ultraviolet

Definitions

  • the present invention relates to a therapy for vitiligo.
  • the present invention provides a pharmaceutical composition comprising an alpha melanocyte stimulating hormone (alpha-MSH) analogue either alone or in combination with one or more corticosteroid, immunosuppressant, anti-inflammatory agent and/or photochemotherapeutic agent for the treatment or prevention of vitiligo.
  • alpha-MSH alpha melanocyte stimulating hormone
  • Vitiligo is a chronic skin condition that causes loss of pigment, including melanin, resulting in irregular pale patches of skin.
  • the precise etiology of vitiligo is complex and not fully understood although there is some evidence to suggest it is caused by a combination of auto-immune, genetic and environmental factors.
  • Vitiligo may also be caused by stress factors that affect the immune system, causing the body to react or respond by “eliminating” or gradually loose the ability to produce and release melanin, skin pigment. Further, Vitiligo on the scalp may also affect the colour of the hair leaving white patches or streaks, with similar effects observed for facial and body hair.
  • vitiligo patches can be hidden with makeup or other cosmetic solutions. If the affected person is pale-skinned, the patches can be made less visible by avoiding sunlight and the sun tanning of unaffected skin. However, exposure to sunlight may also cause the melanocytes to regenerate to allow the pigmentation to come back to its original colour.
  • Treatment options include medical treatments, surgical therapies and adjunctive treatments.
  • Pharmaceuticals include topical steroid therapy, topical or oral psoralen phototherapy and depigmentation.
  • Surgical therapies include skin grafts, melanocyte transplantations and micropigmentation or tattooing, while adjunctive therapies include sunscreens and cosmetics.
  • phototherapy involves exposing an individual to narrow band UV-B light (NB-UVB) resulting in skin re-pigmentation.
  • NB-UVB narrow band UV-B light
  • phototherapy provides an effective short-term treatment option, repetitive exposure to NB-UVB light is needed to achieve continuous re-pigmentation.
  • frequency of exposure to NB-UVB light varies from individual to individual, repetitive exposure may result in unwanted side-effects including mild burning, blistering and skin irritations.
  • UV-B increases the risk of inducing skin malignancies, e.g squamous cell carcinomas and basal cell carcinomas
  • skin malignancies e.g squamous cell carcinomas and basal cell carcinomas
  • High Levels of Ultraviolet B Exposure Increase the Risk of Non-Melanoma Skin Cancer in Psoralen and Ultraviolet A-Treated Patients] [Mayo Clinics update].
  • Topical corticosteroid therapy has a reported success rate of up to 56%, however, long-term use of corticosteroids can result in thinning of the skin, stretch marks, and dilation of blood vessels. Further, treatment with oral or topical psoralen plus UVA (PUVA) has proven successful, however, patients need to ingest or apply psoralen before receiving the light treatment, and long term use of oral PUVA for the treatment of psoriasis has been associated with an increased incidence of skin cancer.
  • PUVA topical psoralen plus UVA
  • a method for treating or preventing vitiligo in a subject comprising administering to the subject a therapeutically or prophylactically effective amount of an alpha-MSH analogue.
  • an alpha-MSH analogue for the manufacture of a prophylactic or therapeutic agent for the treatment or prevention of vitiligo in a subject.
  • the method further comprises administering to the subject one or more agents selected from the group consisting of corticosteroids, immunosuppressants, anti-inflammatory agents and a photochemotherapeutic agents.
  • a pharmaceutical composition for treating or preventing vitiligo comprising an alpha-MSH analogue and one or more agents selected from the group consisting of corticosteroids, immunosuppressants, anti-inflammatory agents and a photochemotherapeutic agents together with a pharmaceutically acceptable carrier or diluent.
  • a method for treating or preventing vitiligo in a subject comprising administering to the subject a therapeutically or prophylactically effective amount of a pharmaceutical composition according to the third aspect of the invention.
  • a fifth aspect of the present invention there is provided the use of an effective amount of a pharmaceutical composition according to the third aspect of the invention for the manufacture of a prophylactic or therapeutic medicament for the treatment or prevention of vitiligo in a subject.
  • Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • X and Y are present at a weight ratio of 2:5, and are present in such ratio regardless of whether additional components are contained in the compound.
  • a weight percent of a component is based on the total weight of the formulation or composition in which the component is included.
  • contacting is meant an instance of exposure by close physical contact of at least one substance to another substance.
  • contacting can include contacting a substance, such as a pharmacologic agent, with a cell.
  • a cell can be contacted with a test compound, for example, an analogue of alpha-MSH, by adding the agent to the culture medium (by continuous infusion, by bolus delivery, or by changing the medium to a medium that contains the agent) or by adding the agent to the extracellular fluid in vivo (by local delivery, systemic delivery, intravenous injection, bolus delivery, or continuous infusion).
  • the duration of contact with a cell or group of cells is determined by the time the test compound is present at physiologically effective levels or at presumed physiologically effective levels in the medium or extracellular fluid bathing the cell.
  • prophylactic treatment means the administration of an active compound or composition to a subject at risk for an undesirable condition.
  • the condition can include a disease, disorder or reaction, or a predisposition to a disease, disorder or reaction.
  • Prophylactic treatment can range from a reduction in the risk for the condition or of the severity of the condition to the complete prevention of the condition.
  • therapeutic treatment and “treating” mean the administration of an active compound or composition to a subject having an undesirable condition such as a disease, disorder or reaction.
  • Therapeutic treatment can range from reduction in the severity of the condition in the subject to the complete recovery of the subject from the condition.
  • induce means initiating a desired response or result that was not present prior to the induction step.
  • induce also includes the term “potentiate”.
  • intermittent means administering an active compound or composition in a series of discreet doses over a determined period, e.g., a period of sustained release comprising of greater than 24 hours of an alpha-MSH analogue for up to 3 months.
  • potentiate means sustaining a desired response at the same level prior to the potentiating step or increasing the desired response over a period of time.
  • melanogenesis as used herein is defined as the ability of a subject to produce melanins by melanin-producing cells, or melanocytes.
  • tissue includes in particular the skin of a subject.
  • the invention pertains to methods and compositions for treatment of vitiligo utilising an alpha-MSH analogue.
  • a method for treating or preventing vitiligo in a subject comprising administering to the subject a therapeutically or prophylactically effective amount of an alpha-MSH analogue.
  • an alpha-MSH analogue for the manufacture of a prophylactic or therapeutic agent for the treatment or prevention of vitiligo in a subject.
  • the method further comprises administering to the subject one or more agents selected from the group consisting of corticosteroids, immunosuppressants, anti-inflammatory agents and a photochemotherapeutic agents.
  • a pharmaceutical composition for treating or preventing vitiligo comprising an alpha-MSH analogue and one or more agents selected from the group consisting of corticosteroids, immunosuppressants, anti-inflammatory agents and a photochemotherapeutic agents together with a pharmaceutically acceptable carrier or diluent.
  • a method for treating or preventing vitiligo in a subject comprising administering to the subject a therapeutically or prophylactically effective amount of a pharmaceutical composition according to the third aspect of the invention.
  • a fifth aspect of the present invention there is provided the use of an effective amount of a pharmaceutical composition according to the third aspect of the invention for the manufacture of a prophylactic or therapeutic medicament for the treatment or prevention of vitiligo in a subject.
  • the subject is a human or domestic animal subject. Most preferably the subject is a human subject.
  • treatment with the alpha-MSH analogue commences as early as possible following appearance of the condition.
  • Alpha-MSH is released from UVR exposed keratinocytes in human skin following exposure to ultraviolet radiation. It is understood to act on the melanocortin-1-receptors (MC1R) to, exclusively in melanocytes, induce synthesis of the brownish-black melanin pigment. MC1R are expressed on keratinocytes as well as number of other cells including, but not exclusively, immunological cells such as dendritic/Langerhans cells, neutrophils, microglia and monocytes as well as astrocytes, and endothelial cells.
  • M1R melanocortin-1-receptors
  • Nle 4 -D-Phe 7 - ⁇ -MSH can induce melanin synthesis in human volunteers.
  • Nle 4 -D-Phe 7 - ⁇ -MSH contains two amino acid substitutions and is approximately 10 to 1,000-fold more potent than the native hormone at inducing pigmentation in experimental systems such as the frog skin bioassay or in cultured human keratinocytes.
  • alpha-MSH analogue as used herein is defined as a derivative of alpha-MSH which exhibits agonist activity for the melanocortin-1 receptor (MC1R), the receptor to which alpha-MSH binds to initiate the production of melanin within a melanocyte.
  • Such derivatives include derivatives in which (i) one or more amino acid residues are deleted from the native alpha-MSH molecule at the N-terminal end, the C-terminal end, or both; and/or (ii) one or more amino acid residues of the native alpha-MSH molecule are replaced by another natural, non-natural or synthetic amino acid residue; and/or (iii) an intramolecular interaction forms as a cyclic derivative
  • alpha-MSH analogue any alpha-MSH analogue is contemplated in the methods described herein.
  • Several derivatives of alpha-MSH have been synthesized.
  • the alpha-MSH analogues described in U.S. Pat. Nos. 4,457,864, 4,485,039, 4,866,038, 4,918,055, 5,049,547, 5,674,839 and 5,714,576 and Australian Patents Nos. 597630 and 618733, which are herein incorporated by reference for their teachings with respect to alpha-MSH analogues and their synthesis thereof, can be used herein.
  • the alpha-MSH analogue may be a compound as disclosed in Australian Patent No. 597630, selected from compounds of the formula:
  • R 1 is absent; n-Pentadecanoyl, Ac, 4-phenylbutyryl; Ac-Gly-, Ac-Met-Glu, Ac-Nle-Glu-, or Ac-Tyr-Glu-;
  • W is -His- or -D-His-;
  • X is -Phe-, -D-Phe-, -Tyr-, -D-Tyr-, or -(pNO 2 )D-Phe 7 -;
  • Y is -Arg- or -D-Arg-;
  • Z is -Trp- or -D-Trp-;
  • R 2 is —NH 2 ; -Gly-NH 2 ; or -Gly-Lys-NH 2 .
  • the alpha-MSH analogue may be selected from cyclic analogues which are disclosed in Australian Patent No. 618733 where an intramolecular interaction (such as a disulfide or other covalent bond) exists (1) between the amino acid residue at position 4 and an amino acid residue at position 10 or 11, and/or (2) between the amino acid residue at position 5 and the amino acid residue at position 10 or 11.
  • an intramolecular interaction such as a disulfide or other covalent bond
  • the alpha-MSH analogue may be a linear analogue as disclosed in U.S. Pat. No. 5,674,839, selected from the group consisting of
  • the alpha-MSH analogue may also be a cyclic analogue as disclosed in U.S. Pat. No. 5,674,839, selected from the group consisting of
  • the alpha-MSH analogue can be any organic compound.
  • the alpha-MSH analogue can be any organic compound.
  • alpha-MSH analogue is:
  • the alpha-MSH analogue is [Nle 4 , D-Phe 7 ]-alpha-MSH.
  • the pharmaceutical composition according to the first aspect of the invention further comprises one or more agents selected from the group consisting of corticosteroids, immunosuppressants, anti-inflammatory agents and photochemotherapeutic agents.
  • the corticoseriod according to the invention may be selected from the group consisting of mometasone furoate, betamethasone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone and cortisone. It is particularly preferred that the corticosteroid is mometasone furoate or betamethasone.
  • the immunosuppressant according to the invention may be selected from the group consisting of cytostatics including cytotoxic antibiotics, alkylating agents and antimetabolites, antibodies, glucocorticoids, drugs acting on immunophilins including cyclosporine, tacrolimus and sirolimus, interferons, azathioprine, 5-fluorouracil and opioids. It is particularly preferred that the immunosuppressant is selected from the group consisting of tacrolimus, betamethasone, azathioprine and levamisole.
  • the anti-inflammatory agent according to the invention may be selected from the group consisting of betamethasone, cortisone. It is particularly preferred that the anti-inflammatory agent is betamethasone or cortisone.
  • the photochemotherapeutic agent according to the invention is psoralen.
  • corticosteroids may act as an immunosuppressant and/or anti-inflammatory agent.
  • the dipropionate salt of betamethasone (trade name Diprosone) is a glucocorticoid which acts as both an immunosuppressant and an anti-inflammatory agent.
  • a method for treating or preventing vitiligo in a subject comprising administering to the subject a therapeutically or prophylactically effective amount of a pharmaceutical composition according to the first aspect of the invention.
  • the method according to the second aspect of the invention further comprises the step of exposing the subject to an effective amount of ultra-violet A light (UVA) when the pharmaceutical composition administered to the subject comprises one or more photochemotherapeutic agents.
  • UVA ultra-violet A light
  • UV ultra-violet
  • the pharmaceutical composition is administered to the subject prior to exposure to UVA light.
  • composition according to the invention may be administered in a sustained-release delivery system as disclosed in International Patent Application No. PCT/AU2005/000181 (WO 2006/012667), or topically using a transdermal delivery system as disclosed in International Patent Application No. PCT/AU2005/001552 (WO 2006/037188).
  • the actual preferred amounts of the alpha-MSH analogue and corticosteroid, immunosuppressant, anti-inflammatory agent and/or photochemotherapeutic agent will vary according to the specific compounds being utilized, the particular compositions formulated, the mode of application, and the particular situs and subject being treated. Dosages for a given host can be determined using conventional considerations, e.g. by customary comparison of the differential activities of the subject compounds and of a known agent, e.g. by means of an appropriate conventional pharmacological protocol.
  • Physicians and formulators skilled in the art of determining doses of pharmaceutical compounds, will have no problems determining doses for prophylactically or therapeutically treating vitiligo by administration of an amount of a pharmaceutical composition of the invention by the methods described herein.
  • the pharmaceutical composition is administered in an amount which is effective to prophylactically or therapeutically treat vitiligo.
  • any of the alpha-MSH analogues useful herein can be administered to a subject using a variety of administration or delivery techniques known in the art. It is desirable to maintain low concentrations (eg concentrations of 0.001 ng to 10 ng/ml) of the alpha-MSH analogue in the plasma of the subject in the treatment of vitiligo.
  • the alpha-MSH analogue is administered in a prolonged release formulation such as described in WO 2006/012667, the disclosure of which is included herein by cross reference. Therefore, the mode of administration will depend upon the subject to be treated and the alpha-MSH analogue selected.
  • the alpha-MSH analogues can be administered orally or parenterally.
  • oral is used herein to encompass administration of the compounds via the digestive tract.
  • parenteral is used herein to encompass any route of administration, other than oral administration, by which the alpha-MSH analogue is introduced into the systemic circulation which includes, but is not limited to, intravenous, intramuscular, subcutaneous, intraperitoneal, intradermal, ocular, inhalable, rectal, vaginal, transdermal, topical, buccal, sublingual, or mucosal administration.
  • mucosal encompasses the administration of the compounds by methods that employ the mucosa (mucous membranes) of the human body such as, but not limited to, buccal, intranasal, gingival, vaginal, sublingual, pulmonary, or rectal tissue.
  • transdermal encompasses the administration of the compounds that go into the skin or go through the skin using formulations such as, but not limited to, transdermal formulations, buccal patches, skin patches, or transdermal patches.
  • topical encompasses administration by applying conventional topical preparations such as creams, gels, or solutions for localized percutaneous delivery and/or by solution for systemic and/or localized delivery to areas such as, but not limited to the eye, skin, rectum, and vagina.
  • delivery systems composed of devices or compositions containing an alpha-MSH analogue together with one or more corticosteroid, immunosuppressant, anti-inflammatory agent or photochemotherapeutic agent can be manufactured that allow for the controlled-release, extended-release, modified-release, sustained-release, pulsatile-release, or programmed-release delivery of the active components in order to maintain concentration of the active components in the plasma of the subject.
  • drugs or active pharmaceutical ingredients can be delivered for hours, weeks, or months following a single administration.
  • Drug-delivery devices include, but are not limited to pumps, needle-free injectors, metered-dose inhalers, and the like.
  • Transdermal compositions with or without penetration enhancers include but are not limited to transdermal patches, microneedles, and transdermal formulations that achieve drug delivery using inotophoresis, sonophoresis, electroporation, thermoporation, perfusion, adsorption and absorption.
  • Other delivery systems include, but are not limited to, biodegradable of non-biodegradable rods or other shaped implants, fibers, microparticles, microspheres, microcapsules, nanospheres, nanocapsules, porous silicon nanoparticles, in situ gelling formulations, in situ bolus forming compositions, quick dissolving tablets and the like, buccal patches, films, tablets, capsules, osmotic pressure driven formulations, liquid filled capsules, liposomes and other lipid based compositions and the like, pegalation and the like, hydrogel formulations, emulsions, microemulsions, and suspensions.
  • polymeric delivery systems can be microparticles including, but not limited to microspheres, microcapsules, nanospheres and nanoparticles comprising biodegradable polymeric excipients, non-biodegradable polymeric excipients, or mixtures of polymeric excipients thereof, or the polymeric delivery systems can be, but not limited to rods or other various shaped implants, wafers, fibers, films, in situ forming boluses and the like comprising biodegradable polymeric excipients, non-biodegradable polymeric excipients, or mixtures thereof.
  • These systems can be made from a single polymeric excipient or a mixture or blend of two or more polymeric excipients.
  • a suitable polymeric excipient includes, but is not limited to, a poly(diene) such as poly(butadiene) and the like; a poly(alkene) such as polyethylene, polypropylene, and the like; a poly(acrylic) such as poly(acrylic acid) and the like; a poly(methacrylic) such as poly(methyl methacrylate), a poly(hydroxyethyl methacrylate), and the like; a poly(vinyl ether); a poly(vinyl alcohol); a poly(vinyl ketone); a poly(vinyl halide) such as poly(vinyl chloride) and the like; a poly(vinyl nitrile), a poly(vinyl ester) such as poly(vinyl acetate) and the like; a poly(vinyl pyridine) such as poly(2-vinyl pyridine), poly(5-methyl-2-vinyl pyridine) and the like; a poly(styren
  • the polymeric excipient of the delivery system includes a biocompatible, non-biodegradable polymer such as, for example, a silicone, a polyacrylate; a polymer of ethylene-vinyl acetate; an acyl substituted cellulose acetate; a non-degradable polyurethane; a polystyrene; a polyvinyl chloride; a polyvinyl fluoride; a poly(vinyl imidazole); a chlorosulphonate polyolefin; a polyethylene oxide; or a blend or copolymer thereof.
  • a biocompatible, non-biodegradable polymer such as, for example, a silicone, a polyacrylate; a polymer of ethylene-vinyl acetate; an acyl substituted cellulose acetate; a non-degradable polyurethane; a polystyrene; a polyvinyl chloride; a polyvinyl fluoride; a poly(viny
  • the polymeric excipient includes a biocompatible, biodegradable polymer such as, for example, a poly(lactide); a poly(glycolide); a poly(lactide-co-glycolide); a poly(lactic acid); a poly(glycolic acid); a polylactic acid-co-glycolic acid); a poly(caprolactone); a poly(orthoester); a poly(phosphazene); a poly(hydroxybutyrate) or a copolymer containing a poly(hydroxybutarate); a poly(lactide-co-caprolactone); a polycarbonate; a polyesteramide; a polyanhydride; a poly(dioxanone); a poly(alkylene alkylate); a copolymer of polyethylene glycol and a polyorthoester; a biodegradable polyurethane; a poly(amino acid); a polyetherester; a polyacetal
  • the end group of the poly(lactide-co-glycolide), poly(lactide), or poly(glycolide) is not a carboxylic acid, for example, an ester, then the resultant polymer is referred to herein as blocked or capped.
  • the unblocked polymer conversely, has a terminal carboxylic group.
  • linear lactide/glycolide polymers are used; however star polymers can be used as well.
  • high molecular weight polymers can be used for medical devices, for example, to meet strength requirements.
  • low molecular weight polymers can be used for drug-delivery and vaccine delivery products where resorption time and not material strength is as important.
  • the lactide portion of the polymer has an asymmetric carbon.
  • Commercially racemic DL-, L-, and D-polymers are available.
  • the L-polymers are more crystalline and resorb slower than DL-polymers.
  • copolymers of glycolide and DL-lactide or L-lactide are available.
  • homopolymers of lactide or glycolide are available.
  • the amount of lactide and glycolide in the polymer can vary.
  • the biodegradable polymer contains 0 to 100 mole %, 40 to 100 mole %, 50 to 100 mole %, 60 to 100 mole %, 70 to 100 mole %, or 80 to 100 mole % lactide and from 0 to 100 mole %, 0 to 60 mole %, 10 to 40 mole %, 20 to 40 mole %, or 30 to 40 mole % glycolide, wherein the amount of lactide and glycolide is 100 mole %.
  • the biodegradable polymer can be poly(lactide), 85:15 poly(lactide-co-glycolide), 75:25 poly(lactide-co-glycolide), or 65:35 poly(lactide-co-glycolide) where the ratios are mole ratios.
  • the biodegradable polymer when the biodegradable polymer is poly(lactide-co-glycolide), poly(lactide), or poly(glycolide), the polymer has an intrinsic viscosity of from 0.15 to 1.5 dL/g, 0.25 to 1.5 dL/g, 0.25 to 1.0 dL/g, 0.25 to 0.8 dL/g, 0.25 to 0.6 dL/g, or 0.25 to 0.4 dL/g as measured in chloroform at a concentration of 0.5 g/dL at 30° C.
  • the amount of alpha-MSH analogue, corticosteroid, immunosuppressant, anti-inflammatory agent and/or photochemotherapeutic agent that is encapsulated or incorporated in the biodegradable polymer will vary depending upon the selection of the biodegradable polymer, the encapsulation or incorporation technique, and the amount of active pharmaceutical ingredients to be delivered to the subject.
  • the amount of active pharmaceutical ingredients encapsulated in the microcapsule, implant, or rod can be up to 50% by weight of the delivery system.
  • the amount of active pharmaceutical ingredients encapsulated in the microcapsule, implant, or rod can be from 5 to 60, 10 to 50%, 15 to 40%, or 15 to 30% by weight of the delivery system.
  • the amount of active pharmaceutical ingredients in the formulation can be from 0.001 to 10%, or 0.05 to 5% by weight of the formulation.
  • the pharmaceutically-acceptable component can include, but is not limited to, a fatty acid, a sugar, a salt, a water-soluble polymer such as polyethylene glycol, a protein, polysaccharide, or carboxmethyl cellulose, a surfactant, a plasticizer, a high- or low-molecular-weight porosigen such as polymer or a salt or sugar, or a hydrophobic low-molecular-weight compound such as cholesterol or a wax.
  • the delivery system comprises an implant or rod, wherein the alpha-MSH analogue is [Nle 4 , D-Phe 7 ]-alpha-MSH in the amount from 15% to 45% by weight of the implant or rod, wherein the rod or implant comprises poly(lactide) or poly(lactide-co-glycolide) such as, for example, 85:15 poly(lactide-co-glycolide).
  • the delivery system can be administered subcutaneously to the subject.
  • the duration of administration can vary depending upon the amount of active pharmaceutical ingredients that are encapsulated and the biodegradable polymer selected.
  • the delivery system is administered subcutaneously to the subject and releases the active pharmaceutical ingredients for a period of at least 2, 4, 6, 8, 10 or 12 days.
  • the delivery system releases the active pharmaceutical ingredients in the subject for at least 1, 2 or 3 months.
  • the delivery system releases the active pharmaceutical ingredients in the subject for 10 days, 15 days, 20 days, 25 days, or 30 days.
  • the pharmaceutical composition is administered to a subject when skin lesions are active.
  • active lesion means incipient vitiligo lesions of the skin, or incipient loss of pigmentation of the skin, migrating areas of depigmentation of the skin. Active lesions show clinically daily, weekly and monthly pigmentation (‘disclolouring’) changes over time.
  • compositions can be prepared using techniques known in the art.
  • the composition is prepared by admixing the alpha-MSH analogue and corticosteroid, immunosuppressant and/or anti-inflammatory agent with a pharmaceutically-acceptable carrier.
  • admixing is defined as mixing the two components together so that there is no chemical reaction or physical interaction.
  • admixing also includes the chemical reaction or physical interaction between the alpha-MSH analogue, corticosteroid, immunosuppressant and/or anti-inflammatory agent and the pharmaceutically-acceptable carrier.
  • Pharmaceutically-acceptable carriers are known to those skilled in the art. These most typically would be standard carriers for administration to humans, including solutions such as sterile water, saline, and buffered solutions at physiological pH.
  • Molecules intended for pharmaceutical delivery may be formulated in a pharmaceutical composition.
  • Pharmaceutical compositions may include carriers, thickeners, diluents, buffers, preservatives, surface active agents and the like in addition to the molecule of choice.
  • Pharmaceutical compositions may also include one or more active ingredients such as antimicrobial agents, anti-inflammatory agents, anesthetics, and the like.
  • Preparations for administration include sterile aqueous or non-aqueous solutions, suspensions, and emulsions.
  • non-aqueous carriers include water, alcoholic/aqueous solutions, emulsions or suspensions, including saline and buffered media.
  • Parenteral vehicles if needed for collateral use of the disclosed compositions and methods, include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils.
  • Intravenous vehicles if needed for collateral use of the disclosed compositions and methods, include fluid and nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. Preservatives and other additives may also be present such as, for example, antimicrobials, anti-oxidants, chelating agents, and inert gases and the like.
  • Formulations for topical administration may include ointments, lotions, creams, gels, drops, ointments, suppositories, sprays, liquids and powders.
  • Conventional pharmaceutical carriers, aqueous, powder or oily bases, thickeners and the like may be necessary or desirable.
  • the active pharmaceutical ingredients can be admixed under sterile conditions with a physiologically acceptable carrier and any preservatives, buffers, propellants, or absorption enhancers as may be required or desired.
  • compositions for topical applications e.g., viscous compositions that can be creams or ointments, as well as compositions for nasal and mucosal administration.
  • the formulation can be in the form of a drop, a spray, an aerosol, or a sustained release format.
  • the spray and the aerosol can be achieved through use of the appropriate dispenser.
  • the sustained release format can be an ocular insert, erodible microparticuiates, swelling mucoadhesive particulates, pH sensitive microparticulates, nanoparticles/latex systems, ion-exchange resins and other polymeric gels and implants (Ocusert, Alza Corp., California; Joshi, A., S. Ping and K. J. Himmelstein, Patent Application WO 91/19481). These systems maintain prolonged drug contact with the absorptive surface preventing washout and nonproductive drug loss.
  • the pharmaceutical composition according is administered to a human or domestic animal subject.
  • the subject is a human subject.
US12/934,024 2008-03-27 2009-03-27 Therapy for vitiligo Abandoned US20110130705A1 (en)

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US11622994B2 (en) 2008-03-27 2023-04-11 Clinuvel Pharmaceuticals Limited Therapy for vitiligo
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