# US 10,369,537 B2 · Multi-nozzle spray dryer, method for scale-up of spray dried inhalation powders, multi-nozzle apparatus and use of multiple nozzles in a spray dryer > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,537 B2 - Document ID: US10369537B2 - Status: Granted - Kind: B2 - Application number: 15/280,433 - Filed: 2016-09-29 - Published: 2017-01-19 - Granted: 2019-08-06 - Earliest claimed: 2014-03-31 - Assignees: Hovione Holding Limited - Applicants: Hovione International Ltd - Inventors: José Luis Santos; Luis Olival; Maria Palha; Filipa Maia; Filipe Neves - Web page: https://patentgrep.com/patent/US10369537B2 ## CPC - B01J 2/04: in a gaseous medium {(if combined with suspending the material in a gas, e.g. fluidised beds B01J2/16)} - A61K 9/1682: {Processes} - B01D 1/18: to obtain dry solids (B01D1/24 takes precedence) - B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28) ## Abstract This present invention provides a spray dryer for use in preparing particles for inhalation, the spray dryer comprising a multi-nozzle apparatus comprising multiple single nozzles suitable for use in preparing inhalation powders and with a drying gas flow rate greater than about 80 kg/h. Also provided is a method for scaling-up a spray drying process for preparing particles for inhalation from a smaller scale spray dryer to a larger scale spray dryer, relative in size to each other, the method comprising the use in the larger scale spray dryer of a multi-nozzle apparatus comprising single nozzles suitable for use in preparing inhalation powders, wherein the number of nozzles in the larger spray dryer is determined by the ratio of the drying gas flow rate of the larger scale spray dryer to the drying gas flow rate of the smaller scale spray dryer. Also provided is a multi-nozzle apparatus produced from the method of the present invention, the multi-nozzle apparatus comprising multiple single nozzles suitable for use in preparing inhalation powders. Also provided is the use of multiple single nozzles suitable for use in preparing inhalation powders in a spray dryer with a drying gas flow rate greater than about 80 kg/h. The nozzles used in the present invention preferably prepare particles with a mean particle size less than about 5 microns. ## Claims ### Claim 1 A method for scaling-up a spray drying process for preparing particles for inhalation from a smaller scale spray dryer to a larger scale spray dryer, relative in size to each other, said method comprising the use in the larger scale spray dryer of a multi-nozzle apparatus comprising single nozzles suitable for use in preparing inhalation powders, wherein the smaller scale spray dryer comprises a number m of nozzles and the larger scale spray dryer comprises a number n of nozzles, and wherein n is determined by scaling m by a ratio, which may be rounded up or down to a whole number, of the drying gas flow rate of the larger scale spray dryer to the drying gas flow rate of the smaller scale spray dryer. ### Claim 2 (depends on 1) The method according to claim 1, wherein n is equal to the ratio of the drying gas flow rate of the larger scale spray dryer to the drying gas flow rate of the smaller scale spray dryer rounded up or down to a whole number. ### Claim 3 (depends on 2) The method according to claim 2, wherein the drying gas flow rate of the smaller scale spray dryer is from about 20 kg/h to about 120 kg/h. ### Claim 4 (depends on 3) The method according to claim 3, wherein the drying gas flow rate of the larger spray dryer is greater than about 80 kg/h. ### Claim 5 (depends on 3) The method according to claim 3, wherein the drying gas flow rate of the larger spray dryer is about 360 kg/h, about 650 kg/h, or about 1250 kg/h. ### Claim 6 (depends on 1) The method according to claim 1, wherein m is between 1 and 4. ### Claim 7 (depends on 6) The method according to claim 6, wherein n is between 2 and 16. ### Claim 8 (depends on 1) The method according to claim 1, wherein the drying gas flow rate of the smaller scale spray dryer is about 80 kg/h and the drying gas flow rate of the larger spray dryer is about 360 kg/h and m=1 and n=4 or the drying gas flow rate of the larger spray dryer is about 650 kg/h and m=1 and n=8. ### Claim 9 (depends on 1) The method according to claim 1, wherein the particles for inhalation comprise active pharmaceutical ingredients, drug product intermediates or drug products, optionally organic active pharmaceutical ingredients, drug product intermediates or drug products. ### Claim 10 (depends on 1) The method according to claim 1, wherein the particles have a mean particle size less than about 5 microns. ### Claim 11 (depends on 1) The method according to claim 1, wherein the single nozzles are two-fluid external or internal mixture nozzles. ### Claim 12 (depends on 1) The method according to claim 1, wherein the liquid feed flow and atomization gas flow are homogeneously distributed amongst the single nozzles. ### Claim 13 (depends on 1) The method according to claim 1, wherein all the single nozzles are of the same type. ### Claim 14 (depends on 2) The method according to claim 2, wherein the drying gas flow rate of the smaller scale spray dryer is from about 40 kg/h to about 80 kg/h. ### Claim 15 (depends on 2) The method according to claim 2, wherein the drying gas flow rate of the smaller scale spray dryer is about 40 kg/h. ### Claim 16 (depends on 15) The method according to claim 15, wherein the drying gas flow rate of the larger spray dryer is greater than about 120 kg/h. ### Claim 17 (depends on 16) The method according to claim 16, wherein the drying gas flow rate of the larger spray dryer is greater than 150 kg/h. ### Claim 18 (depends on 15) The method according to claim 15, wherein the drying gas flow rate of the larger spray dryer is about 360 kg/h, about 650 kg/h, or about 1250 kg/h. ### Claim 19 (depends on 16) The method according to claim 16, wherein the drying gas flow rate of the larger spray dryer is about 360 kg/h, about 650 kg/h, or about 1250 kg/h. ### Claim 20 (depends on 1) The method according to claim 1, wherein m=1 or 2 or 3 and n=2 or 3 or 4 or 5 or 8 or 10 or 16.