Title:
TOPICAL ANTIFUNGAL COMPOSITION FOR TREATING ONYCHOMYCOSIS
Document Type and Number:
WIPO Patent Application WO/2014/122024
Kind Code:
A1
Abstract:
The present invention is directed to a nail lacquer consisting essentially of terbinafine as an antimycotic agent, hydroxypropyl chitosan as film forming agent, water and a lower alkanol as solvents. The invention is also directed to a method for treating onychomycosis by topically administering such a nail lacquer to a patient in need of such a treatment.
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Inventors:
MAILLAND FEDERICO (CH)
LEGORA MICHELA (IT)
CERIANI DANIELA (IT)
IOB GIULIANA (CH)
LEGORA MICHELA (IT)
CERIANI DANIELA (IT)
IOB GIULIANA (CH)
Application Number:
PCT/EP2014/051288
Publication Date:
August 14, 2014
Filing Date:
January 23, 2014
Export Citation:
Assignee:
POLICHEM SA (LU)
International Classes:
A61K31/137; A61K9/08; A61K47/10; A61K47/36; A61P31/10
Domestic Patent References:
| WO2002007683A1 | 2002-01-31 | |||
| WO2002011764A2 | 2002-02-14 | |||
| WO2002007683A1 | 2002-01-31 |
Foreign References:
| US6319509B1 | 2001-11-20 | |||
| US6455592B1 | 2002-09-24 | |||
| US7462362B2 | 2008-12-09 | |||
| EP0515312A2 | 1992-11-25 | |||
| US20120128612A1 | 2012-05-24 | |||
| US5681849A | 1997-10-28 | |||
| US7462362B2 | 2008-12-09 | |||
| US20080261986A1 | 2008-10-23 |
Other References:
ELEWSKI B E ET AL: "Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild-to-moderate toenail onychomycosis: results from three randomized studies using double-blind vehicle-controlled and open-label active-controlled designs.", JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY : JEADV MAR 2013, vol. 27, no. 3, March 2013 (2013-03-01), pages 287 - 294, XP055114091, ISSN: 0926-9959, DOI: 10.1111/j.1468-3083.2011.04373.x
GUPTA A: "Terbinafine nail solution in onychomycosis patients: Terbinafine pharmacokinetic profile and initial clinical efficacy and safety", JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, MOSBY, INC, US, vol. 60, no. 3, March 2009 (2009-03-01), pages AB113, XP025964326, ISSN: 0190-9622, [retrieved on 20090224]
GHANNOUM MAHMOUD A. ET AL: "Determination of the efficacy of terbinafine hydrochloride nail solution in the topical treatment of dermatophytosis in a guinea pig model", MYCOSES, vol. 52, no. 1, January 2009 (2009-01-01), pages 35 - 43, XP055114111, ISSN: 0933-7407, DOI: 10.1111/j.1439-0507.2008.01540.x
SHEMER A: "Update: medical treatment of onychomycosis", DERMATOLOGIC THERAPY, vol. 25, no. 6, November 2012 (2012-11-01), pages 582 - 593, XP055114094, ISSN: 1396-0296, DOI: 10.1111/j.1529-8019.2012.01551.x
"Onychomycosis - the current approach to diagnosis and therapy", 1999, MARTIN DUNITZ, pages: 6 - 9
TOSTI A; HAY R; ARENAS-GUZMAN R: "Patients at risk of onychomycosis - risk factor identification and active prevention", J EUR ACAD DERMATOL VENEOROL, vol. 19, 2005, pages 13 - 16
AJIT C; SUVANNASANKHA A; ZAERI N; MUNOZ SJ: "Terbinafine-associated hepatotoxicity", AM J MED SCI., vol. 325, 2003, pages 292 - 5
SLORDAL L; SPIGSET 0: "Heart failure induced by non-cardiac drugs", DRUG SAF., vol. 29, 2006, pages 567 - 86
BARAN R; TOSTI A; HARTMANE I ET AL.: "An innovative water soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis", J EUR ACAD DERMATOL VENEOROL, vol. 23, 2009, pages 773 - 781, XP055113869, DOI: doi:10.1111/j.1468-3083.2009.03164.x
ELEWSKI B; GHANNOUM MA; MAYSER P ET AL.: "Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild-to-moderate toenail onychomycosis: results from three randomized studies using double-blind vehicle-controlled and open-label active- controlled designs", J EUR ACAD DERMATOL VENEOROL, 2011
GUPTA A: "Terbinafine nail solution in onychomycosis patients: Terbinafine pharmacokinetic profile and initial clinical efficacy and safety", JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, MOSBY, INC, US, vol. 60, no. 3, March 2009 (2009-03-01), pages AB113, XP025964326, ISSN: 0190-9622, [retrieved on 20090224]
GHANNOUM MAHMOUD A. ET AL: "Determination of the efficacy of terbinafine hydrochloride nail solution in the topical treatment of dermatophytosis in a guinea pig model", MYCOSES, vol. 52, no. 1, January 2009 (2009-01-01), pages 35 - 43, XP055114111, ISSN: 0933-7407, DOI: 10.1111/j.1439-0507.2008.01540.x
SHEMER A: "Update: medical treatment of onychomycosis", DERMATOLOGIC THERAPY, vol. 25, no. 6, November 2012 (2012-11-01), pages 582 - 593, XP055114094, ISSN: 1396-0296, DOI: 10.1111/j.1529-8019.2012.01551.x
"Onychomycosis - the current approach to diagnosis and therapy", 1999, MARTIN DUNITZ, pages: 6 - 9
TOSTI A; HAY R; ARENAS-GUZMAN R: "Patients at risk of onychomycosis - risk factor identification and active prevention", J EUR ACAD DERMATOL VENEOROL, vol. 19, 2005, pages 13 - 16
AJIT C; SUVANNASANKHA A; ZAERI N; MUNOZ SJ: "Terbinafine-associated hepatotoxicity", AM J MED SCI., vol. 325, 2003, pages 292 - 5
SLORDAL L; SPIGSET 0: "Heart failure induced by non-cardiac drugs", DRUG SAF., vol. 29, 2006, pages 567 - 86
BARAN R; TOSTI A; HARTMANE I ET AL.: "An innovative water soluble biopolymer improves efficacy of ciclopirox nail lacquer in the management of onychomycosis", J EUR ACAD DERMATOL VENEOROL, vol. 23, 2009, pages 773 - 781, XP055113869, DOI: doi:10.1111/j.1468-3083.2009.03164.x
ELEWSKI B; GHANNOUM MA; MAYSER P ET AL.: "Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild-to-moderate toenail onychomycosis: results from three randomized studies using double-blind vehicle-controlled and open-label active- controlled designs", J EUR ACAD DERMATOL VENEOROL, 2011
Attorney, Agent or Firm:
PISTOLESI, Roberto et al. (Via Nino Bixio 7, Milano, IT)
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