| abstract |
A process for preparing an oil-in-water emulsion of a drug which is poorly soluble in water wherein the drug (e.g. amphotericin B) is dissolved in a solution of high or low pH prior to the formation of the drug emulsion. The solution of high pH is preferably a 0.5 M solution of sodium hydroxide and/or potassium hydroxide and the solution of low pH is preferably a 0.5 M solution of hydrochloric acid. The process comprises the steps of (a) dissolving the drug in a solution of high or low pH, (b) adding the resuting solution to a pre-formed emulsion, (c) adding to the emulsion an amount of an acid, base or buffer appropriate to neutralise at least substantially the product of step (b), and (d) where an acid or base is added in step (c), optionally adding sufficient buffer to adjust the pH of the product of step (c) to a desired value. A drug emulsion made by the process is also provided, in which the drug is primarily associated with the oil droplets. |