EP 3764989 A1 20210120 - STABLE LIQUID SUSPENSION COMPOSITION OF FLUDROCORTISONE
Title (en)
STABLE LIQUID SUSPENSION COMPOSITION OF FLUDROCORTISONE
Title (de)
STABILE FLÜSSIGE SUSPENSIONSZUSAMMENSETZUNG FÜR FLUDROCORTISON
Title (fr)
COMPOSITION DE SUSPENSION LIQUIDE STABLE DE FLUDROCORTISONE
Publication
Application
Priority
- GB 201803893 A 20180312
- IB 2019051696 W 20190303
Abstract (en)
[origin: GB2571937A] A stable liquid suspension comprising fludrocortisone or a salt thereof is provided, wherein the fludrocortisone is present in the range from about 0.001mg/ml to 1mg/ml, and wherein the liquid suspension further comprises a vehicle for fludrocortisone or salts thereof, a suspending agent, an antifoaming agent, at least one preservative and one or more inactive excipients. Preferably the vehicle for fludrocortisone is selected from polyethylene glycol, glycerol and propylene glycol. Preferably the suspending agent is selected from xanthan gum, guar gum, tragacanth gum, veegum, hydroxypropyl methylcellulose, Avicel® RC-591 (microcrystalline cellulose/sodium carboxymethyl cellulose), Carbopol® (carboxyvinyl polymer) and polyvinyl pyrrolidone. The antifoaming agent is preferably selected from polydimethylsiloxane, simethicone, other silicones, stearates, alcohols and glycols. The preservative is preferably selected from methyl parahydroxybenzoate (methyl paraben), ethyl parahydroxybenzoate (ethyl paraben) propyl parahydroxybenzoate (propyl paraben), butyl parahydroxybenzoate (butyl paraben), isobutyl parahydroxybenzoate (isobutyl paraben), isopropyl parahydroxybenzoate (isopropyl paraben) benzyl parahydroxybenzoate (benzyl paraben), sodium benzoate, benzoic acid, potassium sorbate and combinations thereof. Preferably the liquid suspension comprises (a) 0.001mg/ml to 1mg/ml fludrocortisone, (b) 0.01 to 5% w/v glycerol, (c) 0.1 to 10% w/v hydroxypropyl methylcellulose, (d) 0.005 to 1% w/v simethicone, (e) methyl paraben and ethyl paraben, (f) one or more inactive excipients.
IPC 8 full level
A61K 9/10 (2006.01); A61K 31/573 (2006.01); A61K 47/38 (2006.01)
CPC (source: EP GB)
A61K 9/0095 (2013.01 - GB); A61K 9/10 (2013.01 - EP GB); A61K 31/573 (2013.01 - EP GB); A61K 47/10 (2013.01 - GB); A61K 47/14 (2013.01 - GB); A61K 47/24 (2013.01 - GB); A61K 47/38 (2013.01 - EP GB); A61P 5/38 (2017.12 - GB); A61P 5/40 (2017.12 - EP)
Citation (search report)
See references of WO 2019175703A1
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
GB 201803893 D0 20180425; GB 2571937 A 20190918; GB 2571937 B 20210714; EP 3764989 A1 20210120; WO 2019175703 A1 20190919
DOCDB simple family (application)
GB 201803893 A 20180312; EP 19713218 A 20190303; IB 2019051696 W 20190303