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Freeze-drying method of GLP-1 analogue

A technology of GLP-1 and analogues, which is applied in the field of freeze-drying of GLP-1 analogues, can solve the problems of non-lyophilization process research and explanation, and achieve the effects of low moisture content, shortened time, and good solubility

Pending Publication Date: 2022-03-29
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are few studies on the freeze-drying process of GLP-1 analogues, and most of them only mention freeze-drying, but the freeze-drying process is not studied and explained

Method used

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  • Freeze-drying method of GLP-1 analogue
  • Freeze-drying method of GLP-1 analogue

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Freeze-drying of semaglutide

[0030] 1) Sample preparation: After the crude semaglutide peptide (synthesized by the company) is purified by ion exchange, reverse-phase purification and ultrafiltration desalination, the semaglutide fine peptide solution with a purity ≥ 99.0% and a single heterogeneity ≤ 0.15% is obtained (Purified and desalted by the company itself). The above-mentioned refined peptide solution was used as a sample to be freeze-dried, wherein: the concentration of the refined peptide solution was 10 mg / mL, and the volume was 1.2 L.

[0031] 2) Pre-freezing: Pre-freeze at -35°C for 2.0 hours, and the thickness of the sample is 1.0 cm.

[0032] 3) Pre-freezing until primary drying and heating: from -35°C to -20°C in 1.0h.

[0033] 4) Primary drying: from -20°C to -10°C at a rate of 0.5°C / h for a total of 20.0 hours; after rising to -10°C, continue to freeze-dry for 6.0 hours.

[0034] 5) Temperature rise from primary drying to secondary dryi...

Embodiment 2

[0036] Embodiment 2: Freeze-drying of semaglutide

[0037] 1) Sample preparation: After the crude semaglutide peptide (synthesized by the company) is purified by ion exchange, reverse-phase purification and ultrafiltration desalination, the semaglutide fine peptide solution with a purity ≥ 99.0% and a single heterogeneity ≤ 0.15% is obtained (Purified and desalted by the company itself). The above-mentioned refined peptide solution was used as a sample to be freeze-dried, wherein: the concentration of the refined peptide solution was 15 mg / mL, and the volume was 1.0 L.

[0038] 2) Pre-freezing: pre-freeze at -30°C for 3.0 hours, and the thickness of the sample is 1.2 cm.

[0039] 3) Pre-freezing until first drying and heating: from -30°C to -18°C in 1.5 hours.

[0040] 4) Primary drying: from -18°C to -8°C at a rate of 0.4°C / h for a total of 25.0 hours; after heating to -8°C, continue to freeze-dry for 4.0 hours.

[0041] 5) Temperature rise from primary drying to secondary...

Embodiment 3

[0043] Embodiment 3: Freeze-drying of semaglutide

[0044] 1) Sample preparation: After the crude semaglutide peptide (synthesized by the company) is purified by ion exchange, reverse-phase purification and ultrafiltration desalination, the semaglutide fine peptide solution with a purity ≥ 99.0% and a single heterogeneity ≤ 0.15% is obtained (Purified and desalted by the company itself). The above-mentioned refined peptide solution was used as a sample to be freeze-dried, wherein: the concentration of the refined peptide solution was 20 mg / mL, and the volume was 0.8 L.

[0045] 2) Pre-freezing: pre-freeze at -25°C for 4.0 hours, and the thickness of the sample is 0.8 cm.

[0046] 3) Pre-freezing until primary drying and heating: from -25°C to -15°C in 2.0 hours.

[0047] 4) Primary drying: from -15°C to -5°C at a rate of 0.6°C / h for a total of 16.7 hours; after rising to -5°C, continue to freeze-dry for 8.0 hours.

[0048] 5) Temperature rise from primary drying to secondar...

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Abstract

The invention discloses a freeze-drying method of a GLP-1 analogue. The freeze-drying method comprises the following steps: 1) pre-freezing: directly pre-freezing at-35 to-25 DEG C; (2) primary drying: carrying out primary drying in a linear heating manner, heating the primary drying temperature from-20 DEG C to-15 DEG C to-10 DEG C to-5 DEG C, and continuing freeze-drying for a period of time after the heating is finished; and 3) secondary drying: carrying out secondary drying at 25-35 DEG C. Wherein quick freezing is adopted in the pre-freezing process, and the solubility of the raw material medicine obtained through freeze-drying is better; linear heating is adopted in primary drying, and the time of primary drying can be shortened while related substances of the obtained raw material medicine are qualified; the temperature range of the secondary drying is 25-35 DEG C, and the moisture content is low while the related substances of the obtained raw material medicine are qualified.

Description

technical field [0001] The invention belongs to the technical field of GLP-1 analog processing, and relates to a freeze-drying method of GLP-1 analog. Background technique [0002] Glucagon-like peptide-1 (GLP-1) analogs, which belong to an incretin drug, can stimulate pancreatic β cells to secrete insulin in a glucose-dependent manner and inhibit the secretion of glucagon, thereby reducing blood sugar levels. The advantage of this type of drug is that in addition to hypoglycemic effects, it can also delay gastrointestinal emptying, improve satiety, and suppress appetite, thereby achieving the effect of reducing body weight. GLP-1 analogues can be obtained through chemical synthesis or biological fermentation, or combined with certain chemical modifications to prolong the half-life of such drugs, such as liraglutide, semaglutide, etc. [0003] For GLP-1 analogs, usually after purification and salt conversion, a pure peptide solution with a purity ≥ 99.0% and a single heter...

Claims

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Application Information

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IPC IPC(8): C07K14/605C07K1/14
CPCC07K14/605
Inventor 黄嘉成尹传龙唐洋明余品香
Owner HYBIO PHARMA