Methods and apparatus for making particles using spray dryer and in-line jet mill
View Patent ↗Methods and apparatus are provided for making particles comprising: (a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material (e.g., a pharmaceutical agent), through an atomizer and into a primary drying chamber, having a drying gas flowing therethrough, to form droplets comprising the solvent and bulk material dispersed in the drying gas; (b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in drying gas; and (c) flowing the particles and at least a portion of the drying gas through a jet mill to deagglomerate or grind the particles. By coupling spray drying with “in-line” jet milling, a single step process is created from two separate unit operations, and an additional collection step is advantageously eliminated. The one-step, in-line process has further advantages in time and cost of processing.
1. A method for making a dry powder blend comprising:
(a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material, through an atomizer and into a primary drying chamber having a drying gas inlet, a discharge outlet, and a drying gas flowing therethrough, to form droplets comprising the solvent and the bulk material, wherein the droplets are dispersed in the drying gas;
(b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in the drying gas, the particles dispersed in the drying gas being a feedstream;
(c) adding a dry powder material to the feedstream to form a combined feedstream; and
(d) flowing the combined feedstream through an inline jet mill to deagglomerate or grind the particles and dry powder material of the combined feedstream, wherein the jet mill comprises a spiral jet mill or other fluid energy impact mill.
2. The method of claim 1 , wherein after step (b) and before step (c) the feedstream is directed through a particle concentration means to separate and remove at least a portion of the drying gas from the feedstream.
3. The method of claim 2 , wherein the particle concentration means comprises at least one cyclone separator.
4. The method of claim 3 , wherein the at least one cyclone separator separates between about 50 and 100 vol. % of the drying gas from the particles.
5. The method of claim 1 , wherein the combined feedstream after step (c) and before step (d) is directed through a particle concentration means to separate and remove at least a portion of the drying gas from the combined feedstream.
6. The method of claim 5 , wherein the particle concentration means comprises at least one cyclone separator.
7. The method of claim 1 , wherein step (d) deagglomerates at least a portion of agglomerated particles, if any, while substantially maintaining the size and morphology of the individual particles.
8. The method of claim 1 , wherein the particles comprise a pharmaceutical agent and the dry powder material is selected from the group consisting of an excipient material, a second pharmaceutical agent, and combinations thereof.
9. The method of claim 1 , wherein the particles are microparticles comprising a pharmaceutical agent and the dry powder material is in the form of microparticles having a size that is larger than the size of the microparticles which comprise the pharmaceutical agent.
10. The method of claim 1 , further comprising after step (b) and before step (c) flowing the feedstream through a jet mill to deagglomerate or grind the particles.
11. A method for making a dry powder pharmaceutical blend comprising:
(a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material which comprises a pharmaceutical agent, through an atomizer and into a primary drying chamber having a drying gas inlet, a discharge outlet, and a drying gas flowing therethrough, to form droplets comprising the solvent and the bulk material, wherein the droplets are dispersed in the drying gas;
(b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form microparticles dispersed in the drying gas, the microparticles dispersed in the drying gas together forming a feedstream;
(c) adding a dry powder material to the feedstream to form a combined feedstream, the dry powder material being selected from the group consisting of an excipient material, a second pharmaceutical agent, and combinations thereof; and
(d) flowing the combined feedstream through an inline jet mill to deagglomerate or grind the microparticles and dry powder material of the combined feedstream, wherein the jet mill comprises a spiral jet mill or other fluid energy impact mill.
12. The method of claim 11 , wherein step (d) deagglomerates at least a portion of agglomerated microparticles, if any, while substantially maintaining the size and morphology of the individual particles.
13. The method of claim 11 , wherein the dry powder material is in the form of microparticles having a size that is larger than the size of the microparticles which comprise the pharmaceutical agent.
14. An in-line process for making a dry powder blend comprising:
(a) spraying an emulsion, solution, or suspension, which comprises a solvent and a bulk material, through an atomizer and into a primary drying chamber having a drying gas inlet, a discharge outlet, and a drying gas flowing therethrough, to form droplets comprising the solvent and the bulk material, wherein the droplets are dispersed in the drying gas;
(b) evaporating, in the primary drying chamber, at least a portion of the solvent into the drying gas to solidify the droplets and form particles dispersed in the drying gas, the particles dispersed in the drying gas being a feedstream;
(c) flowing the feedstream through a first inline jet mill to deagglomerate or grind the particles, wherein the first jet mill comprises a spiral jet mill or other fluid energy impact mill;
(d) adding a dry powder material to the feedstream to form a combined feedstream; and
(e) optionally flowing the combined feedstream through a second inline jet mill to deagglomerate or grind the particles and dry powder material of the combined feedstream.
15. The process of claim 14 , wherein the feedstream after step (b) and before step (c) is directed through a particle concentration means to separate and remove at least a portion of the drying gas from the feedstream.
16. The process of claim 15 , wherein the particle concentration means comprises at least one cyclone separator.
17. The process of claim 14 , wherein the combined feedstream after step (d) and before step (e) is directed through a particle concentration means to separate and remove at least a portion of the drying gas from the combined feedstream.
18. The process of claim 17 , wherein the particle concentration means comprises at least one cyclone separator.
19. The process of claim 14 , wherein step (c) or step (e) deagglomerate at least a portion of agglomerated particles, if any, while substantially maintaining the size and morphology of the individual particles.
20. The process of claim 14 , wherein the particles comprise a pharmaceutical agent and the dry powder material is selected from the group consisting of an excipient material, a second pharmaceutical agent, and combinations thereof.
21. The process of claim 14 , wherein the particles are microparticles comprising a pharmaceutical agent and the dry powder material is in the form of microparticles having a size that is larger than the size of the microparticles which comprise the pharmaceutical agent.
22. A pharmaceutical composition comprising a dry powder blend made the method of claim 1 .
23. A pharmaceutical blend made by claim 11 .
24. A pharmaceutical composition comprising a dry powder blend made the process of claim 14 .