Composition comprising oil drops

Abstract

A composition comprises a water-soluble polymer matrix in which are dispersed droplets of oil, the composition comprising an active principle. The invention includes embodiments in which the active principle is included in at least some of the oil droplets as well as embodiments in which the oil droplets are released as the matrix containing them dissolves in an aqueous medium. In one embodiment, the oil droplets are substantially immobilized in or by the matrix and the immobilizing feature is lost as the matrix dissolves in aqueous media. In certain embodiments, the oil drops may collectively be referred to as the oil phase of the composition of the invention. The product may be in the form of mini-beads. The oil phase and/or the polymer matrix may each include a surfactant.

1 - 46 . (canceled) 
     
     
         47 . A vaccine or immune-modulating composition for oral administration comprising a water-soluble polymer matrix material in which are dispersed droplets of oil, the composition comprising an active principle. 
     
     
         48 . The composition according to  claim 47 , wherein the active principle comprises an adjuvant. 
     
     
         49 . The composition according to  claim 48 , wherein the adjuvant is α-galactosylceramide. 
     
     
         50 . The composition according to  claim 48  wherein the active principle comprises the adjuvant and an immunomodulator. 
     
     
         51 . The composition according to  claim 50 , wherein the immunomodulator is selected from a vaccine, an antigen, or an immunotherapeutic agent. 
     
     
         52 . The composition according to  claim 51 , wherein the active principle is a vaccine. 
     
     
         53 . The composition according to  claim 52 , wherein the vaccine is to prevent or treat a viral or bacterial infection. 
     
     
         54 . The composition according to  claim 53 , wherein the vaccine is for the treatment or prevention of a gastro-intestinal infection, a respiratory infection or a sexually transmitted genital infection. 
     
     
         55 . The composition according to  claim 53 , wherein the vaccine is for the treatment or prevention of a gastro-intestinal infection selected from those caused by  Helicobacter pylori, Vibrio cholerae , enterotoxigenic  Escherichia coli  (ETEC),  Shigella  spp.,  Clostridium difficile , rotaviruses or calici viruses; or a respiratory infection selected from those caused by  Mycoplasma pneumoniae , influenza virus, and respiratory syncytial virus; or a sexually transmitted genital infection selected from those caused by HIV,  Chlamydia trachomatis, Neisseria gonorrhoeae  or herpes simplex virus. 
     
     
         56 . The composition according to  claim 47  wherein the oil droplets comprise:
 i) polyglycol mono- and di-esters of 12-hydroxystearic acid and about 30% free polyethylene glycol; or 
 ii) linoleoyl macrogolglycerides (polyoxylglycerides). 
 
     
     
         57 . The composition according to  claim 56 , wherein part of the 12-hydroxy group of the 12-hydroxystearic acid is etherified with polyethylene glycol 
     
     
         58 . The composition according to  claim 47  wherein the active principle is included in at least some of the oil droplets. 
     
     
         59 . The composition according to  claim 48 , wherein the at least some of oil droplets comprise droplets of water-in-oil-emulsion. 
     
     
         60 . The composition according to  claim 47 , wherein the water-soluble polymer matrix material is selected from: one or more of gelatin, agar, a polyethylene glycol, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phthalated gelatin, succinated gelatin, cellulosephthalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters and polyvinylacetate-phthalate; and pectin. 
     
     
         61 . The composition according to  claim 60 , wherein the water-soluble polymer matrix material is gelatin. 
     
     
         62 . The composition according to  claim 61 , wherein the water-soluble polymer matrix further comprises a plasticizer. 
     
     
         63 . The composition according to  claim 62  wherein the plasticizer is a low molecular weight polyol. 
     
     
         64 . The composition according to  claim 47 , which is in the form of a mini-bead. 
     
     
         65 . The composition according to  claim 64 , wherein the mini-bead has a diameter of from 0.5 mm to 5 mm. 
     
     
         66 . The composition according to  claim 65 , wherein the mini-bead has a coat. 
     
     
         67 . The composition according to  claim 66 , wherein the coat comprises:
 (i) ethylcellulose; or   (ii) a polymeric coating material which material may comprise methacrylic acid co-polymers, ammonio methacrylate co-polymers, or mixtures thereof.   
     
     
         68 . The composition according to  claim 67 , wherein the coat comprises ethylcellulose in association with an emulsification agent. 
     
     
         69 . The composition of  claim 67 , wherein the emulsification agent is ammonium oleate 
     
     
         70 . The composition according to  claim 66 , wherein the coat comprises ethylcellulose in association with a plasticizer. 
     
     
         71 . The composition of  claim 70 , wherein the plasticizer is selected from dibutyl sebacate or medium chain triglycerides. 
     
     
         72 . The composition according to  claim 65  wherein the minibead has a coat which coat comprises i) a combination of ethylcellulose and a polysaccharide selected from chondroitin sulphate, pectin, dextran, guar gum and amylose and chitosan; or ii) a polymeric coating material. 
     
     
         73 . The composition according to  claim 72  wherein the coat comprises a polymeric coating material comprising a methacrylic acid co-polymer, an ammonio methacrylate co-polymer, or a mixture thereof. 
     
     
         74 . The composition according to  claim 72 , wherein the coat is outside a first coat which first coat comprises a cellulosic film-forming polymer. 
     
     
         75 . The composition according to  claim 74 , wherein the cellulosic film-forming polymer comprises hydroxypropylmethyl cellulose, hydroxypropyl cellulose, or a combination thereof. 
     
     
         76 . The composition according to  claim 47 , which is a dried oil-in-water emulsion. 
     
     
         77 . The composition according to  claim 47 , which is in the form of a plurality of minibeads in a single format. 
     
     
         78 . The composition according to  claim 77 , wherein the single format is a plurality of minibeads contained in a hard gel capsule, a sachet or container, or a plurality of minibeads in a tablet 
     
     
         79 . A method of making a composition, the method comprising:
 i) mixing an oil phase with an aqueous phase comprising a water-soluble polymer matrix material to form an emulsion, at least one of the oil phase and the aqueous phase comprising an active principle, wherein the active principle comprises an adjuvant which is α-galactosylceramide; and then   ii) causing the emulsion to solidify by exposing droplets of the emulsion to a solidification medium to form mini-beads.   
     
     
         80 . The method of  claim 79 , further comprising coating the mini-beads. 
     
     
         81 . The method of  claim 79 , wherein the mini-beads comprise the water-soluble polymer matrix material in which are dispersed droplets of oil.