Methods for preparing squalene
AssigneeNovartis AG
InventorManinder Hora
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Abstract
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 T1 (b) a denaturing distillation carried out at a temperature T2; wherein steps (a) and (b) may be performed in either order; T1 and T2 are sufficient to cause squalene to boil; T2>T1; and T2>200° C.
Claims16
A method for the manufacture of an oil-in-water emulsion comprising an aqueous component, squalene, and 0.01 to 2% by weight polysorbate 80, the method comprising:
- (i) preparing squalene from a composition comprising squalene from an animal source by a process comprising steps of:
- (a) a purification distillation carried out at a temperature T1;
- and (b) a denaturing distillation carried out at a temperature T2;
- wherein steps (a) and (b) may be performed in either order;
- T1 and T2 are sufficient to cause squalene to boil;
- T2≥200° C.;
- T2>T1;
- and T2−T1 is from 10° C. to 300° C.;
- and
- (ii) preparing an emulsion using the squalene prepared in step (i).
A method for the manufacture of a pharmaceutically acceptable composition comprising an oil-in-water emulsion, comprising:
- (i) preparing squalene from a composition comprising squalene from an animal source by a process comprising steps of:
- (a) a purification distillation carried out at a temperature T1;
- and (b) a denaturing distillation carried out at a temperature T2;
- wherein steps (a) and (b) may be performed in either order;
- T1 and T2 are sufficient to cause squalene to boil;
- a T2≥200° C.;
- T2>T1;
- and T2−T1 is from 10° C. to 300° C.;
- and
- (ii) preparing an emulsion using the squalene prepared in step (i);
- and
- (iii) preparing a pharmaceutically acceptable composition using the emulsion prepared in step (ii).
Dependencies are inferred from the claim text.