Spray freeze dry of compositions for pulmonary administration
AssigneeMedImmune, LLC
InventorsVu Truong-Le, Binh V. Pham, John F. Carpenter, Robert Seid, Theodore W. Randolph
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Abstract
This invention provides methods and compositions to preserve bioactive materials, such as viruses, bacteria, cells, or liposomes, in freeze dried particles suitable for pulmonary administration. Methods provide spray freeze drying of formulations to form stable freeze dried particles.
Claims40
A composition having improved stability and shelf-life comprising a bioactive material for pulmonary administration wherein the composition is prepared by the process comprising:
- spraying a liquid formulation comprising a polyol and the bioactive material to form droplets;
- freezing the droplets by immersion into a cold fluid;
- drying said droplets to form powder particles characterized by a particle density of 0.4 g/cm3 or less and comprising the bioactive material in a glassy matrix of the polyol;
- and,
- recovering said particles;
- wherein the bioactive material comprises a virus, bacteria, a non-living cell, or liposomes, and wherein the powder particles comprise an average physical diameter ranging from about 0.5 um to about 20 um.
A composition of dried particles comprising improved stability of bioactive materials, the composition comprising:
- particles comprising a bioactive material in a porous polyol glassy matrix;
- an average aerodynamic particle diameter ranging from about 0.5 um to about 10 um;
- and,
- an average physical particle diameter ranging from about 1 um to about 20 um;
- and,
- a particle density of 0.4 g/cm3 or less;
- wherein the bioactive materials comprise viruses, bacteria, non-living cells, or liposomes.
A composition comprising a bioactive material for pulmonary administration wherein the composition is prepared by a process comprising:
- spraying a liquid formulation comprising a polyol and the bioactive material to form droplets;
- freezing the droplets by immersion into a cold fluid;
- drying said droplets to form powder particles comprising the bioactive material in a glassy matrix of the polyol;
- and,
- recovering said particles;
- wherein the bioactive material comprises a liposome, and wherein the powder particles comprise average aerodynamic particle diameter ranging from about 0.5 um to about 10 um.
A composition comprising a bioactive material for pulmonary administration wherein the composition is prepared by a process comprising:
- spraying a liquid formulation comprising a polyol and the bioactive material to form droplets;
- freezing the droplets by immersion into a cold fluid;
- drying said droplets to form powder particles comprising the bioactive material in a glassy matrix of the polyol;
- and,
- recovering said particles;
- wherein the bioactive material comprises a non-living eukaryotic cell and wherein the powder particles comprise average aerodynamic particle diameter ranging from about 0.5 um to about 10 um.
A composition comprising a bioactive material for pulmonary administration wherein the composition is prepared by a process comprising:
- spraying a liquid formulation comprising a polyol and the bioactive material to form droplets;
- freezing the droplets by immersion into a cold fluid;
- drying said droplets to form powder particles comprising the bioactive material in a porous glassy matrix of the polyol;
- and,
- recovering said particles;
- wherein the bioactive material comprises a virus and wherein the powder particles comprise average aerodynamic particle diameter ranging from about 0.5 um to about 10 um.
A composition comprising a bioactive material for pulmonary administration wherein the composition is prepared by a process comprising:
- spraying a liquid formulation comprising a polyol and the bioactive material to form droplets;
- freezing the droplets by immersion into a cold fluid;
- drying said droplets to form powder particles comprising the bioactive material in a glassy matrix of the polyol;
- and,
- recovering said particles;
- wherein the bioactive material comprises a bacterium and wherein the powder particles comprise average aerodynamic particle diameter ranging from about 0.5 um to about 10 um.
Dependencies are inferred from the claim text.