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1. (WO2010084505) STABLE TOPICAL FORMULATION COMPRISING VORICONAZOLE
Latest bibliographic data on file with the International Bureau

Pub. No.: WO/2010/084505 International Application No.: PCT/IN2009/000316
Publication Date: 29.07.2010 International Filing Date: 03.06.2009
IPC:
A61K 31/4196 (2006.01) ,A61K 31/506 (2006.01) ,A61K 47/44 (2006.01) ,A61P 31/10 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
41
having five-membered rings with two or more ring hetero atoms, at least one of which is nitrogen, e.g. tetrazole
4196
1,2,4-Triazoles
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
495
having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
505
Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
506
not condensed and containing further heterocyclic rings
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
44
Oils, fats or waxes according to more than one of groups A61K47/02-A61K47/42109
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31
Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
10
Antimycotics
Applicants:
GLENMARK PHARMACEUTICALS LIMITED [IN/IN]; Glenmark House HDO - Corporate Bldg Wing -A, B.D Sawant Marg Chakala, Andheri (East) Mumbai 400 099 Maharashtra, IN (AllExceptUS)
DHUPPAD, Ulhas, Rameshchandra [IN/IN]; IN (UsOnly)
KHACHANE, Vasant, Sitaram [IN/IN]; IN (UsOnly)
BHAMRE, Nitin, Babulal [IN/IN]; IN (UsOnly)
SATPUTE, Ravindra, Moreshwar [IN/IN]; IN (UsOnly)
MAHAJAN, Narayan, Tukaram [IN/IN]; IN (UsOnly)
BASA, Shradhanjali [IN/IN]; IN (UsOnly)
KOTWAL, Rupesh, Subhashchandra [IN/IN]; IN (UsOnly)
SOMNATHE, Nitin, Dashrathrao [IN/IN]; IN (UsOnly)
Inventors:
DHUPPAD, Ulhas, Rameshchandra; IN
KHACHANE, Vasant, Sitaram; IN
BHAMRE, Nitin, Babulal; IN
SATPUTE, Ravindra, Moreshwar; IN
MAHAJAN, Narayan, Tukaram; IN
BASA, Shradhanjali; IN
KOTWAL, Rupesh, Subhashchandra; IN
SOMNATHE, Nitin, Dashrathrao; IN
Priority Data:
1204/MUM/200806.06.2008IN
1587/MUM/200824.07.2008IN
1967/MUM/200816.09.2008IN
61/103,31507.10.2008US
Title (EN) STABLE TOPICAL FORMULATION COMPRISING VORICONAZOLE
(FR) FORMULATION TOPIQUE STABLE COMPRENANT DU VORICONAZOLE
Abstract:
(EN) The present invention refers to a topical, preferably anhydrous pharmaceutical formulation comprising voriconazole or its pharmaceutically acceptable salt and a carrier. The formulation is prepared by dispersing voriconazole in a solvent, separately melting the excipients, mixing the dispersion with the molten excipients, homogenizing said mixture and then cooling it.
(FR) La présente invention porte sur une formulation topique stable comprenant une quantité efficace de voriconazole ou son sel pharmaceutiquement acceptable, et au moins un support pharmaceutique, sur un procédé de préparation de celle-ci et sur l'utilisation d'une telle formulation pour le traitement d'infections fongiques locales ou non systémiques chez un sujet. En particulier, la présente invention porte sur une formulation topique stable présentant une stabilité au stockage à une température d'environ 40°C et une humidité relative d'environ 75 % pendant une période d'au moins 3 mois, et qui ne contient pas plus de 9 % p/p d'impuretés totales (sur la base du poids total de la formulation) formées lors du stockage.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)
Also published as:
EP2303265MXMX/a/2010/013363US20110105448RU2010150406RU0002472510BRPI0914863
IN5/MUMNP/2011