Dispersible macromolecule compositions and methods for their preparation and use
First Claim
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1. A method for preparing dispersible dry powders of biological macromolecules, said method comprising:
- providing an evaporable liquid medium containing a macromolecule selected from the group consisting of proteins, polypetides, oligopeptides, nucleic acids, and polysaccharides, wherein the concentration of total solids in the liquid medium is less than 10% by weight;
atomizing the liquid medium consisiting of said marcomolecule to form droplets by flowing the liquid medium and an atomization gas stream at a gas;
liquid mass flow ratio above 5 under conditions selected to form droplets having an average size of between 5 μ
m and 11 μ
m; and
drying the droplets in a single drying step, in a heated gas stream, wherein the heated gas stream has an outlet temperature of at least 70°
C., to produce particles having a rugosity of at least 2.0 as measured by air permeametry, wherein 90% of the mass of the powder comprises particles having a diameter in the range of between about 0.1 microns and about 7 microns, and wherein the particles have a final moisture content of below 5% by weight.
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Abstract
A process for preparing ultrafine powders of biological macromolecules comprises atomizing liquid solutions of the macromolecules, drying the droplets formed in the atomization step, and collecting the particles which result from drying. By properly controlling each of the atomization, drying, and collection steps, ultrafine dry powder compositions having characteristics particularly suitable for pulmonary delivery for therapeutic and other purposes may be prepared.
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Citations
18 Claims
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1. A method for preparing dispersible dry powders of biological macromolecules, said method comprising:
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providing an evaporable liquid medium containing a macromolecule selected from the group consisting of proteins, polypetides, oligopeptides, nucleic acids, and polysaccharides, wherein the concentration of total solids in the liquid medium is less than 10% by weight; atomizing the liquid medium consisiting of said marcomolecule to form droplets by flowing the liquid medium and an atomization gas stream at a gas;
liquid mass flow ratio above 5 under conditions selected to form droplets having an average size of between 5 μ
m and 11 μ
m; anddrying the droplets in a single drying step, in a heated gas stream, wherein the heated gas stream has an outlet temperature of at least 70°
C., to produce particles having a rugosity of at least 2.0 as measured by air permeametry, wherein 90% of the mass of the powder comprises particles having a diameter in the range of between about 0.1 microns and about 7 microns, and wherein the particles have a final moisture content of below 5% by weight. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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Specification