Methods for preparing squalene
An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T 1 ; (b) a denaturing distillation carried out at a temperature T 2 ; wherein steps (a) and (b) may be performed in either order; T 1 and T 2 are sufficient to cause squalene to boil; T 2 >T 1 ; and T 2 >200° C.
1. A method for manufacturing squalene suitable for pharmaceutical use in a vaccine which comprises subjecting fish oil comprising squalene to:
(i) a purification distillation carried out at near vacuum; and
(ii) a denaturing distillation carried out at a temperature greater than or equal to 210° C. at a pressure of 0.8 to 5.0 mmHg, wherein the temperature in the denaturing distillation exceeds the temperature in the purification distillation; and
wherein the conditions for both the purification distillation and the denaturing distillation are sufficient to cause the squalene to boil; and
wherein the denaturing distillation denatures and/or removes potential contaminant proteins and viruses, thereby rendering the squalene safer for human use as compared with non-denatured squalene.
2. The method of claim 1 , wherein the purification distillation occurs at a temperature of less than 140° C.
3. The method of claim 1 , wherein the fish oil comprises one or more contaminant proteins.
4. The method of claim 3 , wherein the contaminant protein comprises parvalbumin.
5. The method of claim 1 , wherein the purification distillation is carried out at a temperature of from 70 to 100° C.
6. The method of claim 1 , wherein the purification distillation is carried out at a pressure of from 0.5 μm Hg to 5 μm Hg.
7. The method of claim 1 , wherein the purification distillation is carried out prior to the denaturing distillation.
8. The method of claim 1 , which further comprises a step of subjecting the fish oil to saponification prior to conducting the purification distillation and denaturing distillation steps.
9. The method of claim 1 , which further comprises a step of subjecting the fish oil to saponification before conducting the denaturing distillation step.
10. The method of claim 8 , wherein saponification comprises the addition of NaOH or KOH to the fish oil.
11. The method of claim 9 , wherein saponification comprises the addition of NaOH or KOH to the fish oil.
12. The method of claim 1 , wherein the purification distillation results in a composition comprising 99% squalene or more.
13. The method of claim 1 , wherein the fish oil is shark liver oil.