Freeze-dried preparation moisture control method and application thereof

A control method and technology of freeze-dried preparations, which can be used in freeze-dried transportation, drying, and pharmaceutical formulations. It can solve problems such as large quality changes, high product moisture, and short expiration dates, and achieve high purity, improved sublimation drying speed, and expiration dates. long effect

Active Publication Date: 2021-02-12
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most freeze-dried preparations on the market have a large quality change during storage, are easily degraded during storage, and have a short validity period. The reason is that the product has a high moisture content.

Method used

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  • Freeze-dried preparation moisture control method and application thereof
  • Freeze-dried preparation moisture control method and application thereof
  • Freeze-dried preparation moisture control method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 tedizolid phosphate for injection (200mg) freeze-drying process:

[0035] Pre-freezing strategy with slow cooling

[0036] (1) Preparation stage: put the tedizolid phosphate sample filled and half-stoppered into the freeze dryer;

[0037] (2) Pre-freezing: set the cooling rate of the freeze dryer to 10°C / h, and keep the temperature for 3 hours when the product temperature drops to -40°C;

[0038] (3) Sublimation drying: turn on the vacuum pump, and when the vacuum degree reaches 20Pa, set the partition to raise the temperature to -20°C at a rate of 5°C / h, and keep it warm for 12h;

[0039] (4) Analytical drying: set the partition to heat up to 40°C at a rate of 20°C / h, keep it warm for 5h after the partition temperature reaches 40°C, and close the aeration valve in the last 2h to keep the freeze-drying box at the ultimate vacuum;

[0040] (5) Plugging: after the freeze-drying finishes, fill the freeze-drying box with nitrogen to 50MPa, and plugging;

[0...

Embodiment 2

[0042] Embodiment 2 tedizolid phosphate for injection (200mg) freeze-drying process:

[0043] Pre-freezing strategy with 2 annealing

[0044] (1) Preparation stage: put the tedizolid phosphate sample filled and half-stoppered into the freeze dryer;

[0045] (2) Pre-freezing: set the cooling rate of the freeze dryer to 10°C / h, keep the product temperature down to -40°C for 1 hour, then raise the temperature to -23°C at a rate of 20°C / h, hold it for 1 hour, and then heat it at 10°C. The cooling rate of ℃ / h is -40℃, keep warm for 2h, after repeated annealing for 2 times, keep warm at -40℃ for 3h;

[0046](3) Sublimation drying: turn on the vacuum pump, and when the vacuum degree reaches 20Pa, set the partition to raise the temperature to -20°C at a rate of 5°C / h, and keep the temperature for 8h;

[0047] (4) Analytical drying: set the partition to heat up to 40°C at a rate of 20°C / h, keep it warm for 5h after the partition temperature reaches 40°C, and close the aeration valve ...

Embodiment 3

[0060] Embodiment 3 Azacitidine for injection (100mg) lyophilization process:

[0061] Pre-freezing strategy with slow cooling

[0062] (1) Preparation stage: put the half-filled azacitidine sample into the freeze dryer;

[0063] (2) Pre-freezing: set the cooling rate of the freeze dryer to 10°C / h, and keep the temperature for 3 hours when the product temperature drops to -45°C;

[0064] (3) Sublimation drying: turn on the vacuum pump, and when the vacuum degree reaches 20Pa, set the separator to raise the temperature to -17°C at a rate of 5°C / h, and keep it warm for 10h;

[0065] (4) Analytical drying: set the partition to heat up to 35°C at a rate of 20°C / h, keep warm for 5 hours after the temperature of the partition reaches 35°C, and close the aeration valve in the last 2 hours to maintain the ultimate vacuum in the freeze-drying box;

[0066] (5) Plugging: after the freeze-drying finishes, fill the freeze-drying box with nitrogen to normal pressure, and plugging;

[00...

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PUM

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Abstract

The invention relates to a freeze-dried preparation moisture control method and application thereof, and belongs to the technical field of preparation of freeze-dried preparations. The freeze-dried preparation with low impurity content and low moisture content is obtained by controlling various operation parameters of the cooling speed, the annealing temperature, the annealing frequency, the sublimation drying temperature and the sublimation drying vacuum degree in the pre-freezing process of the preparation, and the method solves the problems of high moisture content, poor stability in the storage period, short expiration date and the like of the final product of the freeze-dried preparation.

Description

technical field [0001] The invention relates to the technical field of preparation of freeze-dried preparations, in particular to a moisture control method for freeze-dried preparations and an application thereof. Background technique [0002] Freeze-drying technology is to pre-cool and freeze the substance containing a lot of water into a solid, and then directly sublimate the solid ice crystal under vacuum conditions, so that the substance itself retains the original skeleton structure, so that the material maintains the original shape, and the finished product Excellent rehydration properties. [0003] Freeze-drying technology has many different uses, and it is indispensable in many biochemical and pharmaceutical applications. Through freeze-drying, products such as pharmaceutical preparations are dried under vacuum, and the products are always in a state of high hypoxia, so that Drugs that are easily oxidized are protected from oxidation, and biological materials that c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F26B5/06F26B25/22A61K9/19A61K31/675A61K31/706A61K38/58
CPCF26B5/06F26B25/22A61K9/19A61K31/675A61K31/706A61K38/58
Inventor 李磊朱海潮宁长松王洪伟王娟
Owner NKD PHARMA CO LTD
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