Emulsion formulation
AssigneeAstra Aktiebolag
InventorStefan Lundquist
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Abstract
The present invention is related to a pharmaceutical formulation which is an oil-in-water emulsion for parenteral and oral use which comprises (i) an emulsion-stabilizing surface active drug in high concentration; (ii) optionally a pharmacologically inert oil; (iii) optionally a surfactant; (iv) water or a buffer; and (v) an agent giving isotonicity to the final formulation; the use of and a process for preparation of the formulation.
Claims14
A sterile pharmaceutical formulation of an oil-in-water emulsion for parenteral and oral administration which comprises:
- (i) an emulsion-stabilizing surface active drug in a concentration ranging from 0.01 g to 5.0 g per 100 ml of the final formulation;
- (ii) a pharmacologically inert oil when the drug is not an internal oil;
- (iii) a surfactant when the drug is an internal oil;
- (iv) water or a buffer;
- and
- (v) an agent giving isotonicity to the final formulation;
- the formulated emulsion having a major fraction of stable droplets having a size below 200 nm so as to be suitable for sterile filtering before use.
A sterile pharmaceutical emulsion preparation for parenteral or oral administration comprising an emulsion-stabilizing surface active drug in base form which is dispersed and equilibrated in a two-phase, oil-water-system which further comprises a pharmacologically inert oil or surfactant;
- a sufficient amount of an agent for isotonicity;
- the preparation being homogenized under high pressure so as to obtain an emulsion which has a droplet size distribution where the main fraction is below 200 nm;
- and sterile filtered through a 0.2 micron particle cut-off membrane filter.
Dependencies are inferred from the claim text.