WO2007109248A2 - Traitement ou prévention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du récepteur de leukotriène et de la vitamine e - Google Patents

Traitement ou prévention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du récepteur de leukotriène et de la vitamine e Download PDF

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Publication number
WO2007109248A2
WO2007109248A2 PCT/US2007/006854 US2007006854W WO2007109248A2 WO 2007109248 A2 WO2007109248 A2 WO 2007109248A2 US 2007006854 W US2007006854 W US 2007006854W WO 2007109248 A2 WO2007109248 A2 WO 2007109248A2
Authority
WO
WIPO (PCT)
Prior art keywords
vitamin
ltra
alpha
hyperpigmentation
scarring
Prior art date
Application number
PCT/US2007/006854
Other languages
English (en)
Other versions
WO2007109248A3 (fr
Inventor
Larry Schlesinger
Original Assignee
Larry Schlesinger
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 Larry Schlesinger filed Critical Larry Schlesinger
Priority to CA002646969A priority Critical patent/CA2646969A1/fr
Priority to AU2007227286A priority patent/AU2007227286A1/en
Priority to EP07753480A priority patent/EP1996185A2/fr
Publication of WO2007109248A2 publication Critical patent/WO2007109248A2/fr
Publication of WO2007109248A3 publication Critical patent/WO2007109248A3/fr

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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 present invention is related to a novel use of a combination administration of a leukotriene receptor antagonist and vitamin E to treat or prevent scarring. Additionally, the present invention is related to a novel use of a combination administration of a leukotriene receptor antagonist and vitamin E to treat or prevent capsular contractures, which are a common side effect of breast enhancement surgery. Further, the present invention is related to a novel use of a combination administration of a leukotriene receptor antagonist and vitamin E to treat or prevent hyperpigmentation.
  • Capsular contracture is a known "side effect" commonly related with breast enhancement surgery. Capsular contracture is actually considered to be more of an exaggeration of a normal physiologic response than a side effect, and it is a thickened periprosthetic scar which engulfs the breast implant, thereby resulting in an unnaturally hard breast. Additionally, the shape of the breast can be distorted and physical pain can result from the capsular contracture.
  • People with certain skin types are predisposed to hyperpigmentation after a traumatic event to their skin. This is particularly true for surgical procedures, laser phototherapy, dermabrasion, and other cosmetic procedures that may traumatize the skin.
  • U.S. Patent Application Publication No. US2003/0207932 discloses a topical composition for the prevention of post-traumatic hyperpigmentation, comprising a leukotriene receptor antagonist, melatonin, menthol, benzyl alcohol, polysorbate 80, and trisoleooxymethylmethylamino-1-ethane sulfonic acid.
  • U.S. Patent No. 6,951,869 is directed to a method of preventing or treating scarring or capsular contractures by the administration of a leukotriene receptor antagonist to a subject in need of treatment.
  • the present invention is directed towards a method of treating or preventing capsular contracture, treating or preventing scarring, or treating or preventing hyperpigmentation in a patient in need thereof, comprising administering to the patient at least one leukotriene receptor antagonist (LTRA) and vitamin E 1 in amounts that are therapeutically effective at preventing or treating the aforementioned conditions.
  • LTRA leukotriene receptor antagonist
  • the administration may be sequential, simultaneous, or concomitant, or the administration may be completed over a time period in which one of the agents (i.e., the LTRA or the vitamin E) is administered alone according to a first course of therapy, and thereafter the second agent is administered (with or without continuing the treatment with the first agent) in a second course of therapy.
  • the present invention is directed to administering one or more LTRAs (which include, but are not limited to, acitazanolast, iralukast, montelukast, pranlukast, verlukast, zafiriukast, and zileuton) and vitamin E, to a subject for the treatment and/or prevention of capsular contracture and/or scarring and/or hyperpigmentation.
  • LTRAs include, but are not limited to, acitazanolast, iralukast, montelukast, pranlukast, verlukast, zafiriukast, and zileuton
  • zafiriukast are the most preferred.
  • vitamin E herein includes a substance belonging to the group of ⁇ -, ⁇ -, ⁇ >, ⁇ -, ⁇ 1-, ⁇ 2- and ⁇ -tocophero!s, their dl, d and I forms and their structural analogues, such as tocotrienols; the corresponding derivatives, e.g., esters, produced with organic acids; and mixtures thereof.
  • Preferred vitamin E substances include tocopherols, tocotrienols and tocopherol derivatives with organic acids such as acetic acid, propionic acid, bile acid, lactic acid, pyruvic acid, oxalic acid, malic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, cinnamic acid, mandefic acid, polyethylene glycol succinate and salicylic acid.
  • Particularly preferred vitamin E substances include alpha-tocopherol, alpha-tocopheryl acetate, alpha-tocopheryl acid succinate, alpha-tocopheryl polyethylene glycol 1000 succinate and mixtures thereof.
  • the LTRA and the vitamin E of the present invention may be administered in any conventional form suitable for oral, rectal, topical, parenteral, ocular, pulmonary or nasal administration, and the like, or it may also be administered through inhalation means.
  • Preferred administration is oral and/or topical.
  • Topical administration includes skin application and application to internal body surfaces, including via impregnation on or in an implant.
  • Topical dosage forms include any form suitable for topical, e.g., transdermal, application, and include but are not limited to, gels, solutions, suspensions, lotions, pastes, creams, ointments, aerosols, dusting powders, patches, and the like.
  • administration forms may be presented in unit dosage form and may be prepared by any of the methods well-known in the art of pharmacy.
  • the active agent is typically present in an amount of from 1 to 99% by weight, based upon the total weight of the formulation, for example from 10 to 50% by weight.
  • daily dosage of a LTRA (when the course of therapy calls for an LTRA) may preferably be 5 to 250 mg.
  • Daily dosage of vitamin E when the course of therapy calls for vitamin E may be 10 to 10,000 IU, preferably 500 to 5000 IU.
  • Routes of administration and dosage forms of vitamin E are well-known in the art.
  • LTRA 5 mg, more preferably 10 mg, and most preferably 20 mg of LTRA is administered twice daily.
  • the administration of LTRA is preferably started prior to a surgical procedure, preferably up to 30 days prior.
  • LTRA is preferably administered for at least 7 days following the completion of the surgical procedure.
  • an effective amount of vitamin E preferably 1000 to 5000 IU per day, most preferably about 2000 IU per day, is added to the therapeutic regimen as a second course of therapy.
  • the second course of therapy including the LTRA and vitamin E continues for at least 30 days, preferably for at least 60 days, and most preferably for 90 days or more.
  • the dosage of the LTRA and the vitamin E may be administered in either one single dosage, two dosages, or in more than two dosages per day.
  • the LTRA is administered simultaneous to administration of the vitamin E, e.g M as a single fixed dosage pharmaceutical composition or as separate compositions administered at the same time.
  • the LTRA is administered apart from the administration of the vitamin E, but in a concomitant treatment regime.
  • the LTRA may be administered at one time of the day, orally or topically, and the vitamin E may be administered later or earlier the same day, orally or topically. Or, in one embodiment, the LTRA may be administered daily, while the vitamin E is administered every few days, or vice versa.
  • the precise dosage and schedule for the administration of the LTRA and the vitamin E will vary depending on numerous factors, such as, for example, the route of administration and the seriousness of the condition.
  • the method of preventing scarring and/or capsular contracture and/or hyperpigmentation comprises administering at least one LTRA, and optionally vitamin E, to a patient prior to the formation of a scar and/or a capsular contracture and/or hyperpigmentation.
  • the administration of the at least one LTRA, and optionally vitamin E, to a patient may begin up to one year or more prior to the potential scar and/or capsular contracture and/or hyperpigmentation causing event.
  • the administration of the at least one LTRA, and optionally vitamin E is begun prior to the insertion of the implant.
  • the administration of the at least one LTRA, and optionally vitamin E, to a patient may begin up to one year or more prior to the insertion of the implant.
  • the administration of the at least one LTRA, and optionally vitamin E begins at least 30 days prior to the insertion of the implant.
  • the patient may be administered the at least one LTRA and the vitamin E following the occurrence of the potential scar and/or capsular contracture and/or hyperpigmentation causing event for an indefinite period of time.
  • the administration of the at least one LTRA and vitamin E last no more than one year, preferably no more than six or three months.
  • the administration of the at least one LTRA and vitamin E does not need to be continuous.
  • a patient may be removed from LTRA and Vitamin E administration and later have the at least one LTRA and Vitamin E administered again at a future time.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne l'administration combinée d'un antagoniste du récepteur de leukotriène et de la vitamine E afin de prévenir ou de traiter la cicatrisation et/ou une contracture capsulaire et/ou une hyperpigmentation.
PCT/US2007/006854 2006-03-20 2007-03-20 Traitement ou prévention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du récepteur de leukotriène et de la vitamine e WO2007109248A2 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002646969A CA2646969A1 (fr) 2006-03-20 2007-03-20 Traitement ou prevention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du recepteur de leukotriene et de la vitamine e
AU2007227286A AU2007227286A1 (en) 2006-03-20 2007-03-20 Treatment or prevention of scarring, capsular contractures and/or hyperpigmentation using leukotriene receptor antagonist and vitamin E
EP07753480A EP1996185A2 (fr) 2006-03-20 2007-03-20 Traitement ou prévention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du récepteur de leukotriène et de la vitamine e

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US78339806P 2006-03-20 2006-03-20
US60/783,398 2006-03-20

Publications (2)

Publication Number Publication Date
WO2007109248A2 true WO2007109248A2 (fr) 2007-09-27
WO2007109248A3 WO2007109248A3 (fr) 2008-03-20

Family

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PCT/US2007/006854 WO2007109248A2 (fr) 2006-03-20 2007-03-20 Traitement ou prévention de la cicatrisation, de contractures capsulaires et/ou d'une hyperpigmentation au moyen d'un antagoniste du récepteur de leukotriène et de la vitamine e

Country Status (4)

Country Link
EP (1) EP1996185A2 (fr)
AU (1) AU2007227286A1 (fr)
CA (1) CA2646969A1 (fr)
WO (1) WO2007109248A2 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6337076B1 (en) * 1999-11-17 2002-01-08 Sg Licensing Corporation Method and composition for the treatment of scars
WO2003074019A1 (fr) * 2002-03-06 2003-09-12 Showa Denko K.K. Composition cosmetique blanchissante
WO2003094882A1 (fr) * 2002-05-09 2003-11-20 Showa Denko K.K. Preparation externe de blanchiment de la peau
US6951869B2 (en) * 2002-02-26 2005-10-04 Schlesinger Stephen L Use of leukotriene receptor antagonist for treatment of scarring

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6337076B1 (en) * 1999-11-17 2002-01-08 Sg Licensing Corporation Method and composition for the treatment of scars
US6951869B2 (en) * 2002-02-26 2005-10-04 Schlesinger Stephen L Use of leukotriene receptor antagonist for treatment of scarring
WO2003074019A1 (fr) * 2002-03-06 2003-09-12 Showa Denko K.K. Composition cosmetique blanchissante
WO2003094882A1 (fr) * 2002-05-09 2003-11-20 Showa Denko K.K. Preparation externe de blanchiment de la peau

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
BAKER J.L.: 'The Effectiveness of Alpha-Tocopherol (Vitamin E) in Reducing the Incidence of Spherical Contracture around Breast Implants' PLAST RECONSTR. SURG. vol. 68, no. 5, 1981, pages 696 - 699 *
FUNASAKA Y. ET AL.: 'Depigmenting Effect of alpha-Tocopheryl Ferulate on Normal Human Melanocytes' PIGMENT CELL RES. vol. 13, no. SUPPL. 8, 2000, pages 170 - 174 *
MORELLI J.G. ET AL.: 'Leukotriene B4-Induced Human Melanocyte Pigmentation and Leukotriene C4-Induced Human Melanocyte Growth Are Inhibited by Different Isoquinolinesulfonamides' J. INVEST. DERMATOL. vol. 98, no. 1, 1992, pages 55 - 58 *
REID R.R. ET AL.: 'The Effect of Zafirlukast (Accolate) on Early Capsular Contracture in the Primary Augmentation Patient: A Pilot Study' AESTHETIC SURGERY JOURNAL vol. 25, no. 1, 2005, pages 26 - 30 *
TOMITA Y. ET AL.: 'Melanocyte-Stimulating Properties of Arachidonic Acid Metabolites: Possible Role in Postinflammatory Pigmentation' PIGMENT CELL RES. vol. 5, no. 5, PART 2, 1992, pages 357 - 361 *

Also Published As

Publication number Publication date
AU2007227286A1 (en) 2007-09-27
CA2646969A1 (fr) 2007-09-27
EP1996185A2 (fr) 2008-12-03
WO2007109248A3 (fr) 2008-03-20

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