Emulsion vehicle for poorly soluble drugs
AssigneeSonus Pharmaceuticals, Inc.
InventorsKarel J. Lambert, Panayiotis P. Constantinides, Steven C. Quay
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Abstract
An emulsion of α-tocopherol, stabilized by biocompatible surfactants, as a vehicle or carrier for therapeutic drugs, which is substantially ethanol free and which can be administered to animals or humans various routes is disclosed. Also included in the emulsion is PEGylated vitamin E. PEGylated α-tocopherol includes polyethylene glycol subunits attached by a succinic acid diester at the ring hydroxyl of vitamin E and serves as a primary surfactant, stabilizer and a secondary solvent in emulsions of α-tocopherol.
Claims24
A pharmaceutical composition, comprising:
- α-tocopherol,
- one or more surfactants,
- an aqueous phase, and
- a therapeutic agent
- wherein said composition is in the form of an emulsion or micellar solution.
A pharmaceutical composition, comprising:
- α-tocopherol,
- one or more surfactants, and
- a therapeutic agent
- wherein said composition is in the form of a self-emulsifying drug delivery system and wherein said composition is substantially ethanol free.
A method of making an emulsion, comprising:
- a) dissolving a therapeutic agent in ethanol, to form a therapeutic agent solution;
- b) adding α-tocopherol to said therapeutic agent solution to form an α-tocopherol therapeutic agent solution;
- c) removing said ethanol from said α-tocopherol therapeutic agent solution to reduce the ethanol concentration to less than 0.3% therein;
- d) blending said substantially ethanol-free therapeutic agent solution with a surfactant to form a pre-emulsion;
- and
- e) homogenizing said pre-emulsion to form an emulsion.
Dependencies are inferred from the claim text.