Liposomal-polyene preliposomal powder and method for its preparation
AssigneesUniversity of Texas System Board of Regents, Aronex Pharmaceuticals, Inc.
InventorsRobert P. Link, Reeta Mehta, Gabriel Lopez-Berestein
Life of this patent
Estimating the term…
Abstract
A method is disclosed for preparing a stable preliposomal powder which, when reconstituted with water or saline solution, forms a suspension of liposomes containing a polyene drug, such as nystatin. The method involves the steps of combining at least one phospholipid with a first organic solvent to form a first solution, adding a clarifying amount of water to the first solution, combining a polyene with a second organic solvent to form a second solution, combining the first and second solutions to produce a substantially clear combined solution, and then removing the organic solvents, leaving a powder.
Claims3
A lyophilized nystatin preliposomal powder, comprising nystatin, dimyristoyl phosphatidyl choline, and dimyristoyl glycerol, where the weight ratio of dimyristoyl phosphatidyl choline to dimyristoyl phosphatidyl glycerol is about 7:3, and where the powder is free of halogenated solvents.
A method of preparing a parenterally-administrable polyene preparation, comprising the steps of:
- a. combining at least one phospholipid with t-butyl alcohol to form a first solution;
- b. combining a first solution with an amount of water effective to clarify the first solution, forming a clarified first solution;
- c. combining polyene with an organic solvent selected from the group consisting of dimethyl sulfoxide and dimethyl formamide to form a second solution;
- d. combining the clarified first solution and the second solution to produce a substantially clear combined solution;
- e. removing substantially all the solvent from the solution by lyophilization, thereby forming a preliposomal powder;
- and
- f. adding the pharmaceutically acceptable solvent water to the preliposomal powder.
A method of preparing a parenterally-administrable polyene preparation, comprising the steps of:
- a. combining at least one phospholipid with t-butyl alcohol to form a first solution;
- b. combining a first solution with an amount of water effective to clarify the first solution, forming a clarified first solution;
- c. combining polyene with an organic solvent selected from the group consisting of dimethyl sulfoxide and dimethyl formamide to form a second solution;
- d. combining the clarified first solution and the second solution to produce a substantially clear combined solution;
- e. removing substantially all the solvent from the solution by lyophilization, thereby forming a preliposomal powder;
- and
- f. adding the pharmaceutically acceptable solvent saline to the preliposomal powder.
Dependencies are inferred from the claim text.