Multi-phase emulsions based on amphiphilic block copolymers

1. A method of enhancing a body's response to an immunogen, comprising:

immunizing a subject in need thereof with a vaccine composition in a W/O/W emulsion wherein the emulsion does not contain poloxamers comprising:

(a) an antigen; and

(b) an adjuvant composition in a W/O/W emulsion, comprising:

(i) a continuous aqueous phase comprising H 2 O;

(ii) an oil phase dispersed in the continuous aqueous phase, comprising:

(1) oil;

(1) an internal aqueous phase comprising H 2 O, being dispersed in the oil; and

(2) a physiologically acceptable lipophilic emulsifier selected from the group consisting of mannide monooleate and sorbitan esters, stabilizing the interface between the inner aqueous phase and the oil to form a water-in-oil (W/O) emulsion; and

(iii) poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone), stabilizing the interface between the oil phase and the continuous aqueous phase.

2. The method of claim 1 , wherein the antigen is an influenza antigen.

3. The method of claim 2 , wherein the influenza antigen is an inactivated H5N1 virus.

4. The method of claim 1 , prior to the immunizing step further comprising:

preparing the adjuvant composition in the W/O/W emulsion, comprising:

(a) dissolving the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) in a buffered saline;

(b) providing a mixture comprising the oil and the physiologically acceptable lipophilic emulsifier; and

(c) emulsifying the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) in the buffered saline with the oil mixture to form the adjuvant composition in the W/O/W emulsion; and

admixing the adjuvant composition with the antigen to form the vaccine composition.

5. The method of claim 4 , further comprising:

placing the adjuvant composition in storage until ready for the immunizing step.

6. The method of claim 1 , wherein the antigen is dispersed in the continuous aqueous phase.

7. The method of claim 4 , wherein the adjuvant composition remains the W/O/W emulsion for at least 6 months when stored at 4° C.

8. The method of claim 4 , wherein the adjuvant composition remains the W/O/W emulsion for at least 2 months when stored at 37° C.

9. A method of enhancing a body's response to an immunogen, comprising:

immunizing a subject in need thereof a vaccine composition in an oil-in-water (O/W) emulsion comprising:

(a) an antigen; and

(b) an adjuvant composition in an O/W emulsion, comprising:

(i) a continuous aqueous phase comprising H 2 O;

(ii) an oil phase comprising oil dispersed in the continuous aqueous phase, and

(iii) poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone), stabilizing the interface between the oil phase and the continuous aqueous phase and wherein the adjuvant composition is without a lipophilic emulsifier.

10. The method of claim 9 , prior to the immunizing step further comprising:

preparing the adjuvant composition in the O/W emulsion, comprising:

dissolving the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) in a buffered saline;

providing the oil;

admixing the dissolved poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) in the buffered saline with the oil to form a mixture; and

homogenizing the mixture to obtain the adjuvant composition in the O/W emulsion; and

admixing the adjuvant composition with the antigen to form the vaccine composition.

11. The method of claim 1 , prior to the immunizing step further comprising:

preparing the vaccine composition, comprising:

(a) dissolving the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) and the antigen in a buffered saline;

(b) providing a mixture comprising the oil and the physiologically acceptable lipophilic emulsifier; and

(c) emulsifying the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) and the antigen in the buffered saline with the oil mixture to form the vaccine composition in the W/O/W emulsion.

12. A composition in a W/O/W emulsion wherein the emulsion does not contain poloxamers, comprising:

(a) a continuous aqueous phase comprising H 2 O;

(b) an oil phase, dispersed in the continuous aqueous phase, the oil phase comprising:

(i) oil;

(ii) an internal aqueous phase, being dispersed in the oil; and

(iii) a physiologically acceptable lipophilic emulsifier selected from the group consisting of mannide monooleate and sorbitan esters, stabilizing the interface between the inner aqueous phase and the oil to form a water-in-oil (W/O) emulsion; and

(c) poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone), stabilizing the interface between the oil phase and the continuous aqueous phase.

13. The composition of claim 12 , which is characterized by staving stable as a W/O/W emulsion for at least 6 months when stored at 4° C.

14. The composition of claim 12 , which is characterized by staying stable as a W/O/W emulsion for at least 2 months when stored at 37° C.

15. The composition of claim 12 , further comprising an antigen.

16. The composition of claim 15 , wherein the antigen is in the continuous aqueous phase.

17. The composition of claim 15 , wherein the antigen is dissolved in the internal aqueous phase of the oil phase.

18. A method for preparing the composition of claim 12 , comprising:

(a) dissolving the poly(ethylene glycol)-block-poly(lactide-co-ε-caprolactone) in a buffered saline;

(b) providing an oil mixture comprising the oil and the physiologically acceptable lipophilic emulsifier; and

(c) emulsifying the poly(ethylene glycol)-b lock-poly(lactide-co-εcaprolactone) in the buffered saline with the oil mixture to form the composition in the W/O/W emulsion.