Adjuvant and vaccine compositions containing monophosphoryl lipid A
AssigneeAmerican Cyanamid Company
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.
Claims44
A lyophilized composition comprising 0.2% up to 5% by weight 3-O-desacyl-4′-monophosphoryl lipid A, at least 70% by weight of sugar and 0% to about 30% by weight of an optionally added amine based surfactant wherein when 10 to 210 mg of said lyophilized composition is reconstituted per ml of an aqueous diluent, an aqueous colloidal suspension having a light transmission of greater than or equal to 88% as measured spectrophotometrically is formed without sonication
An aqueous composition which comprises a lyophilized composition comprising 0.2% up to 5% by weight 3-O-desacyl-4′-monophosphoryl lipid A, at least 70% by weight of sugar and 0% to about 30% by weight of an optionally added amine based surfactant reconstituted with an aqueous diluent at an amount from 10 to 210 mg of the lyophilized composition per ml of aqueous diluent, said 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.
An aqueous composition which comprises a lyophilized composition comprising 0.5 mg up to 2.5 mg of 3-O-desacyl-4′-monophosphoryl lipid A from about 10 to about 200 mg of sugar and 0 to about 6 mg of an added amine based surfactant reconstituted with an aqueous diluent at an amount from 10 to 210 mg of the lyophilized composition per ml of aqueous diluent, said 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.
A lyophilized composition prepared according to the method 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;
- and
- e. recovering a lyophilized composition wherein when 10-210 mg of said lyophilized composition is reconstituted per ml of an aqueous diluent, an aqueous colloidal suspension having light transmission of greater than or equal to 88% as measured spectrophotometrically is formed without sonication.
Dependencies are inferred from the claim text.