Reduction of flake-like aggregation in nanoparticulate active agent compositions
First Claim
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1. A method of reducing flake-like aggregates in an injectable nanoparticulate meloxicam composition, comprising:
- (a) preparing a dispersion of nanoparticulate meloxicam and at least one surface stabilizer, wherein the dispersion comprises meloxicam particles having an effective average particle size of less than about 2000 nm, at least one surface stabilizer, and a liquid in which the meloxicam particles are poorly soluble; and
(b) adding a flake-like aggregation reducing agent selected from (i) a buffer selected from the group consisting of a phosphate buffer, an acetate buffer, a citrate buffer, a sodium phosphate buffer a potassium phosphate buffer, and a sodium acetate buffer resulting in the composition having a pH above about 7.0, and (ii) a sugar selected from the group consisting of sucrose, mannitol and dextrose to the nanoparticulate meloxicam dispersion of step (a), wherein the resultant composition is suitable for injectable administration.
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Abstract
This invention is directed to reduction of flake-like aggregation in nanoparticulate compositions. Also encompassed by the invention are compositions comprising a nanoparticulate active agent, at least one surface stabilizer and a flake-like aggregation reducing agent, such as a buffer and a sugar. The nanoparticulate active agent compositions comprise particles of the active agent having an effective average particle size of less than about 2000 nm.
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15 Claims
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1. A method of reducing flake-like aggregates in an injectable nanoparticulate meloxicam composition, comprising:
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(a) preparing a dispersion of nanoparticulate meloxicam and at least one surface stabilizer, wherein the dispersion comprises meloxicam particles having an effective average particle size of less than about 2000 nm, at least one surface stabilizer, and a liquid in which the meloxicam particles are poorly soluble; and (b) adding a flake-like aggregation reducing agent selected from (i) a buffer selected from the group consisting of a phosphate buffer, an acetate buffer, a citrate buffer, a sodium phosphate buffer a potassium phosphate buffer, and a sodium acetate buffer resulting in the composition having a pH above about 7.0, and (ii) a sugar selected from the group consisting of sucrose, mannitol and dextrose to the nanoparticulate meloxicam dispersion of step (a), wherein the resultant composition is suitable for injectable administration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification