INJECTABLE WATER-IN-OIL EMULSIONS

摘要

The present invention provides adjuvants, for use in vaccine formulation, comprising a water-in-oil emulsion, characterised in that said emulsion comprises a polymeric emulsifier which is a block copolymer having a general formula A-COO-B-OOC-A, in which B is the divalent residue of a water-soluble polyalkylene glycol and A is the residue of a oil-soluble complex monocarboxylic acid. Such polymeric emulsifier, as well as the preparation thereof, has been disclosed in GB 2002400 and WO9607689. Preferably in the blockcopolymers of formula A-COO-B-OOC-A, component B is derived from polyethylene glycol and components A are derived from polyhydroxystearic acid, preferably from poly(12-hydroxy-stearic acid). Most preferred emulsifiers used in the adjuvants according to the invention are Arlacel P135, a PEG 30 Dipolyhydroxystearate. Another, similar, emulsifier for use with the invention is ATLOX®4912. Both Arlacel P135 and ATLOX®4912 are block copolymers (A-B-A) of polyethylene glycol and hydroxystearic acid with a molweight of approximately 5000 commercially available from ICI. It has een found that with the use of these emulsifiers adjuvants based on w/o emulsions that are stable and have a low viscosity can be obtained that may be based on metabolisable oils. Said adjuvants have an excellent adjuvant activity, and are well tolerated.