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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

一种喷雾干燥器、多喷嘴的技术，应用在喷雾蒸发、块状输送、液体分成珠滴颗粒化等方向，能够解决没有公开关键性能标准等问题

Inactive Publication Date: 2017-02-22
HOVIONE INTERNAT LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 1) The ability to generate particles in the respirable range (i.e., characterized by a volume distribution with a mean geometric size of less than 5 microns), regardless of the throughput required; high throughput multi-nozzle systems currently available in the art do not disclose such key performance criteria, and

Method used

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  • 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
  • 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
  • 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

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0048] This example considers a scaled-down version of the invention (eg Figure 6 shown) to demonstrate a proof-of-concept.

[0049] A feed mixture was prepared by dissolving 1.2 g of lysine and 4.8 g of trehalose in 234 g of water (total solids concentration approximately 2.5% w / w). Such excipient systems are known to produce amorphous powders in which the particle size is sensitive to changes in nebulization conditions. Therefore, this excipient system is ideal for the current proof-of-concept.

[0050] A laboratory scale spray dryer (BUCHI model B-290 Advanced) was used to process the above feed solution. In trial #1, the BUCHI unit was equipped with a single two-fluid nozzle with a nozzle cap and diameter of 1.4 and 0.7 mm, respectively. In trial #2, the BUCHI unit was equipped with a pair of two-fluid nozzles ( Figure 6 ), each with a nozzle cap and diameter of 1.4 and 0.7 mm (ie, the same as the nozzle for Test #1).

[0051] During the first test, the flow rate of...

example 2

[0059] This example considers the inventive multi-nozzle atomizer utilized in the SD1 unit ( figure 1 shown in ) demonstrates a proof-of-concept.

[0060] A feed mixture was prepared by dissolving 1.225 kg leucine and 4.9 kg trehalose in 33.8 kg ethanol and 135.1 kg water (total solids concentration approximately 3.5% w / w).

[0061] An SD1 operating at a nominal drying gas flow rate of about 110 kg / h was used to treat the above feed solution. In trial #1, the SD1 unit was equipped with a multi-nozzle atomizer operating with 2NIRO ETFN (hole = 0.5 mm) and a special housing for uniform liquid and gas distribution. In trial #2, the SD1 unit was equipped with a multi-nozzle atomizer operating with 1 NIRO ETFN (hole = 0.5 mm).

[0062] During the first test, the flow rate of the solution supplied to the two nozzles of the multi-nozzle atomizer was about 2 kg / h, and the flow rate of the atomizing gas supplied to the device was about 20 kg / h.

[0063] During the second test, the f...

example 3

[0069] This example considers the multi-nozzle atomizer of the present invention utilized in a commercial scale spray dryer unit ( figure 1 shown) demonstrates a proof-of-concept.

[0070] A feed mixture was prepared by dissolving 1.225 kg leucine and 4.9 kg trehalose in 33.8 kg ethanol and 135.1 kg water (total solids concentration approximately 3.5% w / w).

[0071] The above feed solution was treated using an SD2 operating at a nominal dry gas flow rate of about 360 kg / h. The SD2 unit is equipped with a multi-nozzle atomizer special housing operated with 4NIRO ETFN (hole = 0.5mm) for uniform liquid and gas distribution.

[0072] During the test, the flow rate of the solution supplied to the multi-nozzle atomizer was about 8 kg / h, and the flow rate of the atomizing gas supplied to the device was about 20 g / h.

[0073]

[0074] as from Figure 11 (Multi-nozzle atomizer operated with 4 nozzles) It can be seen that the particle size distribution and morphology are identical...

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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.

Description

technical field [0001] The present invention belongs to the technical field of drying methods. More specifically, the invention belongs to the technical field of spray-drying of active pharmaceutical ingredients (APIs), intermediates of pharmaceutical products and pharmaceutical products intended for administration by inhalation, with particular but not exclusive application. Active pharmaceutical ingredients (APIs), pharmaceutical product intermediates and pharmaceutical products can be organic compounds. Background technique [0002] The development of a manufacturing process for spray-dried inhalation powders involves two challenging constraints: i) a very small particle size is required (where the mean diameter is below 5 μm, typically below 3 μm); and ii) the particle size should not Increase during scale-up is allowed (despite the fact that most powders that are spray-dried for oral formulation administration will tend to increase in particle size during scale-up). T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01J2/04
CPCB01J2/04B01D1/18A61K9/1682
Inventor J·L·桑托斯L·奥利瓦尔M·帕利亚F·迈厄F·尼夫斯
Owner HOVIONE INTERNAT LTD
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