EP 1180022 A4 20040107 - PROCESS FOR PREPARING PHARMACEUTICAL BULK MATERIAL HAVING UNIFORM DISSOLUTION
Title (en)
PROCESS FOR PREPARING PHARMACEUTICAL BULK MATERIAL HAVING UNIFORM DISSOLUTION
Title (de)
PROZESS ZUR MASSENHERSTELLUNG VON PHARMAZEUTISCHEM MATERIAL MIT EINHEITLICHER LÖSLICHKEIT
Title (fr)
ELABORATION D'UN PRODUIT PHARMACEUTIQUE EN VRAC UNIFORMEMENT DISSOUT
Publication
Application
Priority
- US 9913481 W 19990615
- US 13421599 P 19990514
Abstract (en)
[origin: WO0069417A1] The present invention provides a process for producing cefaclor crystalline bulk material having a dissolution rate in a capsule of >/= 80% in water in 30 minutes. One process route includes reducing the water content of cefaclor dihydrates or bulk material containing cefaclor dihydrate to produce a cefaclor form having a water content </= 2%. The cefaclor having the lower water content can then be rehydrated to a water content from 3.0 to 6.5% without adversely affecting the dissolution rate. An alternative process includes the addition of at least 0.05% of cefaclor related substances to inhibit conversion of the monohydrate to the dihydrate form.
IPC 1-7
IPC 8 full level
A61K 9/16 (2006.01); A61K 31/545 (2006.01)
CPC (source: EP)
A61K 9/1688 (2013.01); A61K 31/545 (2013.01)
Citation (search report)
- [X] US 5837292 A 19981117 - DIJKGRAAF BERNARDUS LEONARDUS [NL], et al
- [X] US 5516531 A 19960514 - MAKINO TADASHI [JP], et al
- [X] US 4713247 A 19871215 - SAKAMOTO TERUO [JP], et al
- [A] US 4968508 A 19901106 - OREN PETER L [US], et al
- [X] CHOW ALBERT H L ET AL: "Parameters affecting in-liquid drying microencapsulation and release rate of cefaclor.", INTERNATIONAL JOURNAL OF PHARMACEUTICS (AMSTERDAM), vol. 172, no. 1-2, 15 October 1998 (1998-10-15), pages 113 - 125, XP001147521, ISSN: 0378-5173
- See references of WO 0069417A1
Designated contracting state (EPC)
AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE
DOCDB simple family (publication)
WO 0069417 A1 20001123; AU 4441899 A 20001205; EP 1180022 A1 20020220; EP 1180022 A4 20040107
DOCDB simple family (application)
US 9913481 W 19990615; AU 4441899 A 19990615; EP 99927538 A 19990615