US 6,582,728 B1 · Spray drying of macromolecules to produce inhaleable dry powders

Abstract

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 μm mass median diameter (MMD), usually 1.0-4.0 μm MMD, and preferably 1.0-3.0 μm MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 μm mass median aerodynamic diameter (MMAD), usually 1.5-4.5 μm MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Claims27

Dependent claims

A method for preparing a dry powder composition for pulmonary administration, said method comprising the following steps performed sequentially:

(a) providing an aqueous solution comprising a pharmaceutically active macromolecule and a pharmaceutically acceptable carrier selected from the group consisting of human serum albumin, carbohydrates, amino acids, polypeptides, buffers, and salts;
and
(b) spray drying said aqueous solution from step (a) at a temperature in the range from 50° C. to 200° C. to produce a non-liposomal dry powder composition suitable for pulmonary administration comprising a therapeutically effective amount of said pharmaceutically active macromolecule and said pharmaceutically acceptable carrier and having a moisture content below 10% by weight,
wherein said pharmaceutically active macromolecule retains its activity upon spray drying.

1 more element

Dependencies are inferred from the claim text.

Spray drying of macromolecules to produce inhaleable dry powders

Life of this patent

Spray drying of macromolecules to produce inhaleable dry powders

Life of this patent

Abstract

Claims27