EP 4281043 A1 20231129 - MICROEMULSION PRECONCENTRATE CONTAINING CLADRIBINE PARTICULARLY FOR ORAL ADMINISTRATION AND METHOD OF PREPARATION
Title (en)
MICROEMULSION PRECONCENTRATE CONTAINING CLADRIBINE PARTICULARLY FOR ORAL ADMINISTRATION AND METHOD OF PREPARATION
Title (de)
MIKROEMULSIONSVORKONZENTRAT MIT CLADRIBIN, INSBESONDERE ZUR ORALEN VERABREICHUNG UND HERSTELLUNGSVERFAHREN
Title (fr)
PRÉCONCENTRÉ DE MICROÉMULSION CONTENANT DE LA CLADRIBINE, EN PARTICULIER POUR UNE ADMINISTRATION ORALE ET SON PROCÉDÉ DE PRÉPARATION
Publication
Application
Priority
- CZ 202125 A 20210122
- CZ 2022050005 W 20220121
Abstract (en)
[origin: WO2022156836A1] The invention relates to an anhydrous microemulsion preconcentrate containing cladribine, comprising: cladribine dissolved in at least one aprotic polar solvent and in at least one auxiliary organic solvent having an acceptable affinity for water, a mixture of a non-ionogenic surfactant having a hydrophilic-lipophilic equilibrium > 10 with a non-ionogenic water-insoluble surfactant having a hydrophilic-lipophilic equilibrium < 10 and/or with lipophilic vehicles containing a high proportion of long-chain fatty acids, such as, e.g. Glycerol mono-oleate or glycerol mono-linoleate. The hydrophilic and hydrophobic components are mixed to form a homogeneous mixture. This homogeneous mixture is then mixed with a cladribine solution to produce a formulation which, when introduced into the gastrointestinal tract, spontaneously forms a dispersion of non-ionogenic surfactant nanoparticles containing dissolved cladribine molecules.
IPC 8 full level
A61K 9/107 (2006.01); A61K 31/7076 (2006.01); A61K 47/10 (2017.01); A61K 47/14 (2017.01); A61K 47/20 (2006.01); A61K 47/44 (2017.01)
CPC (source: CZ EP)
A61K 9/107 (2013.01 - EP); A61K 9/1075 (2013.01 - CZ EP); A61K 31/7076 (2013.01 - CZ EP); A61K 47/10 (2013.01 - CZ); A61K 47/14 (2013.01 - CZ); A61K 47/20 (2013.01 - CZ); A61K 47/44 (2013.01 - CZ); A61K 47/10 (2013.01 - EP); A61K 47/14 (2013.01 - EP); A61K 47/20 (2013.01 - EP); A61K 47/44 (2013.01 - EP)
Citation (search report)
See references of WO 2022156836A1
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
Designated validation state (EPC)
KH MA MD TN
DOCDB simple family (publication)
WO 2022156836 A1 20220728; CZ 202125 A3 20220803; CZ 309587 B6 20230503; EP 4281043 A1 20231129
DOCDB simple family (application)
CZ 2022050005 W 20220121; CZ 202125 A 20210122; EP 22708285 A 20220121