Adjuvant and vaccine compositions containing monophosphoryl lipid A
AssigneeWyeth Holdings Corporation
InventorsVincent James LaPosta, John Hayward Eldridge
Life of this patent
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Abstract
The invention pertains to adjuvant and vaccine compositions of monophosphoryl lipid A, sugar and optionally an amine based surfactant, which when frozen and thawed or lyophilized and reconstituted reform a colloidal suspension having a light transmission of greater than or equal to 88% as measured spectrophotometrically.
Claims18
A method for the preparation of an aqueous colloidal suspension containing 3-O-desacyl-4′-monophosphoryl lipid A capable of being frozen and thawed comprising:
- a. suspending 3-O-desacyl-4′-monophosphoryl lipid A in an amount from 0.5 mg/ml up to 5 mg/ml and, an amine based surfactant in an amount from 0 to about 6 mg/ml in an aqueous diluent;
- b. forming an aqueous colloidal suspension having a light transmission of greater than or equal to 88%, as measured spectrophotometrically;
- c. adding sugar at about 10 to 200 mg/ml either before or after forming the aqueous colloidal suspension;
- d. freezing the sugar containing aqueous colloidal suspension;
- and
- e. thawing and recovering the aqueous colloidal suspension without sonication to prepare an aqueous colloidal suspension.
A method for the preparation of an aqueous colloidal suspension containing 3-O-desacyl-4′-monophosphoryl lipid A capable of being lyophilized and resuspended comprising:
- a. suspending 3-O-desacyl-4′-monophosphoryl lipid A in an amount from 0.5 mg/ml up to 5 mg/ml and, an amine based surfactant in an amount from 0 to about 6 mg/ml in an aqueous diluent;
- b. forming an aqueous colloidal suspension having a light transmission of greater than or equal to 88%, as measured spectrophotometrically;
- c. adding sugar at about 10 to 200 mg/ml either before or after forming the aqueous colloidal suspension;
- d. lyophilizing the sugar containing aqueous colloidal suspension to obtain a lyophilized composition;
- e. reconstituting the lyophilized composition without sonication with an aqueous diluent at an amount from 10 to 210 mg of the lyophilized composition per ml of aqueous diluent, and
- f. obtaining an aqueous composition in the form of an aqueous colloidal suspension having a light transmission of greater than or equal to 88% as measured spectrophotometrically without sonication.
Dependencies are inferred from the claim text.