EP 1663231 A4 20090429 - ORAL ITRACONAZOLE COMPOSITION WHICH IS NOT AFFECTED BY INGESTED FOOD AND PROCESS FOR PREPARING SAME
Title (en)
ORAL ITRACONAZOLE COMPOSITION WHICH IS NOT AFFECTED BY INGESTED FOOD AND PROCESS FOR PREPARING SAME
Title (de)
ORALE ITRACONAZOL-ZUSAMMENSETZUNG, DIE NICHT VON NAHRUNGSAUFNAHME BEEINFLUSST WIRD, UND HERSTELLUNGSVERFAHREN DAFÜR
Title (fr)
COMPOSITION ORALE D'ITRACONAZOLE NON AFFECTEE PAR LA NOURRITURE INGERE ET SON PROCEDE DE PREPARATION
Publication
Application
Priority
- KR 2004002264 W 20040907
- KR 20030063147 A 20030909
Abstract (en)
[origin: KR20050026169A] An oral itraconazole composition which is not affected by ingested food and a preparation method thereof are provided, which itraconazole composition forms stable emulsified microparticles when it is orally administered to enhance bioavailability of itraconazole, and is not affected by pH and ingested food, so that the difference of absorption in individuals can be reduced. The oral high viscosity glassy composition which is not affected by ingested food comprises itraconazole, acidifying agent, amphiphilic additives, volatile additives, surfactant and oil, wherein the bioavailability ratio of itraconazole before to after digestion is 0.8 or more; the viscosity of the composition is 10,000cps at 25 deg. C; the composition has self-microemulsifying capability; the acidifying agent is selected from phosphoric acid, hydrochloric acid and a solution thereof; the amphiphilic additive is selected from transcutol, dimethyl isosorbide, glycofurol, propylene glycol, propylene carbonate, solutol and a mixture thereof; the surfactant is selected from a reaction product of natural or hydrogenated vegetable oil and ethylene glycol, polyoxyethylene-sorbitan-fatty acid ester, polyoxyethylene fatty acid ester and a mixture thereof; and the oil is tocopherol, its derivatives and a mixture thereof. The method for preparing the oral itraconazole composition which is not affected by ingested food comprises the steps of: (a) dissolving itraconazole in a mixed solution of acidifying agent, amphiphilic additives and volatile additives; (b) adding surfactant and oil into the mixture and dissolving them; and (c) removing the volatile additives from the mixed solution, wherein the volatile additive is C2-C3 alcohol.
IPC 8 full level
A61K 31/496 (2006.01)
CPC (source: EP KR)
A61K 9/1075 (2013.01 - EP); A61K 9/485 (2013.01 - EP); A61K 9/4858 (2013.01 - EP); A61K 31/496 (2013.01 - EP KR)
Citation (search report)
- [Y] WO 0000179 A1 20000106 - WON JIN BIOPHARMA CO LTD [KR], et al
- [Y] WO 0059475 A1 20001012 - LIPOCINE INC [US]
- [DXY] KR 20020054573 A 20020708 - HAN MI PHARM IND CO LTD [KR]
- [DXY] KR 20030000799 A 20030106 - HAN MI PHARM IND CO LTD [KR]
- See references of WO 2005023262A1
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LI LU MC NL PL PT RO SE SI SK TR
DOCDB simple family (publication)
AU 2004270069 A1 20050317; AU 2004270069 B2 20080313; BR PI0414192 A 20061031; CA 2538019 A1 20050317; CA 2538019 C 20090901; CN 100475211 C 20090408; CN 1849123 A 20061018; EP 1663231 A1 20060607; EP 1663231 A4 20090429; IL 173743 A0 20060705; IL 173743 A 20120830; JP 2007505103 A 20070308; KR 100529766 B1 20051117; KR 20050026169 A 20050315; MX PA06002239 A 20060620; RU 2006111477 A 20060827
DOCDB simple family (application)
AU 2004270069 A 20040907; BR PI0414192 A 20040907; CA 2538019 A 20040907; CN 200480025851 A 20040907; EP 04774524 A 20040907; IL 17374306 A 20060215; JP 2006526025 A 20040907; KR 20030063147 A 20030909; MX PA06002239 A 20040907; RU 2006111477 A 20040907