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Freeze-dried azacitidine preparation for injection

A technology for azacitidine and freeze-dried preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of reducing the stability of this product, increasing production costs, and being unable to inhibit decomposition, etc., to shorten the preparation time, shorten the freeze-drying cycle, and shorten the freeze-drying time. cycle effect

Inactive Publication Date: 2017-09-08
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main related substances of azacitidine for injection come from the hydrolyzate, and vitamin C, as a reduction protective agent, cannot inhibit the decomposition of this product in water, and the introduction of new components may bring unnecessary safety problems
[0008] The above-mentioned patents CN103251564A and CN101632643A have main drug concentrations of 4mg / ml and 3.3mg / ml respectively, which are equivalent to 25ml and 30ml per bottle, which makes freeze-drying difficult, prolongs the cycle, increases production costs, and indirectly reduces the stability of this product

Method used

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  • Freeze-dried azacitidine preparation for injection
  • Freeze-dried azacitidine preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] 1) Prescription

[0029] Azacitidine 50g

[0030] Mannitol 50g

[0031] Water for injection to 3L

[0032] 2) Preparation of azacitidine freeze-dried powder for injection:

[0033] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of azacitidine (with a particle size of 100 μm) and mannitol, put them in a sterile bag, mix for 10 minutes, slowly add to the water for injection, and stir to dissolve. Sampling and detection of the content of intermediate products; according to the results of intermediate detection, the liquid medicine was filled into vials and half stoppered; the freeze dryer was cooled to -40°C in advance, and the filled samples were sent to the freeze-drying box for 2.5 hours; The temperature of the shelf is raised to -10°C at 10°C / h and kept for 8h; raised to 40°C at 10°C / h and kept for 14h; then the limit vacuum is 2 hours, and the pressure rise test is carried out. The test should meet <0.1pa / min, Fin...

Embodiment 2

[0035] 1) Prescription

[0036] Azacitidine 50g

[0037] Mannitol 50g

[0038] Water for injection to 3L

[0039] 2) Preparation of azacitidine freeze-dried powder for injection:

[0040] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of azacitidine (with a particle size of 150 μm) and mannitol, put them in a sterile bag, mix for 10 minutes, slowly add to the water for injection, and stir to dissolve. Sampling and detection of the content of intermediate products; according to the results of intermediate detection, the liquid medicine was filled into vials and half stoppered; the freeze dryer was cooled to -40°C in advance, and the filled samples were sent to the freeze-drying box for 2.5 hours; The temperature of the shelf is raised to -10°C at 10°C / h and kept for 8h; raised to 40°C at 10°C / h and kept for 14h; then the limit vacuum is 2 hours, and the pressure rise test is carried out. The test should meet <0.1pa / min, Fin...

Embodiment 3

[0042] 1) Prescription

[0043] Azacitidine 50g

[0044] Mannitol 50g

[0045] Water for injection to 3L

[0046] 2) Preparation of azacitidine freeze-dried powder for injection:

[0047] Accurately weigh 90% of the prescribed amount of water for injection; weigh the prescribed amount of azacitidine (with a particle size of 200 μm) and mannitol, put them in a sterile bag, mix for 10 minutes, slowly add to the water for injection, and stir to dissolve. Sampling and detection of the content of intermediate products; according to the results of intermediate detection, the liquid medicine was filled into vials and half stoppered; the freeze dryer was cooled to -40°C in advance, and the filled samples were sent to the freeze-drying box for 2.5 hours; The temperature of the shelf is raised to -10°C at 10°C / h and kept for 8h; raised to 40°C at 10°C / h and kept for 14h; then the limit vacuum is 2 hours, and the pressure rise test is carried out. The test should meet <0.1pa / min, Fin...

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Abstract

The invention belongs to the technical field of medicinal preparations, and particularly provides a freeze-dried azacitidine preparation for injection and a preparation method thereof. The freeze-dried azacitidine preparation for injection comprises azacitidine and a proper amount of filler, wherein the filler is preferably mannitol. The preparation method comprises the following steps: weighing the azacitidine (the particle size is controlled to be 100-200 microns) according to a prescription dosage, mixing the azacitidine with the mannitol, adding a mixture into water for injection, stirring till the mixture is completely dissolved, filtering, subpackaging, performing freeze drying, pressing a cork, rolling a cover, and packaging. The preparation method is simple in process, low in production cost and high in efficiency; visible foreign matters and related substances are qualified; the freeze-dried azacitidine preparation for injection is good in redissolution and stable in product quality.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of azacitidine for injection. Background technique [0002] Myelodysplastic syndrome (MDS) is a group of diseases characterized by clonal abnormalities of hematopoietic stem cells, which can lead to hematopoietic failure and a high risk of progression to acute myeloid leukemia (AML). The disease is divided into 5 types, namely refractory anemia (RA), ring sideroblastic anemia, refractory anemia with increased blasts (REAB), refractory anemia with increased blasts-transition (RAEB) -T) and chronic myelomonocytic leukemia (CMML). [0003] Azacitidine (Azacitidine) is a DNA methyltransferase inhibitor, which can cause DNA hypomethylation and has direct cytotoxicity. It was developed by Pharmion Pharmaceutical Company of the United States. In May 2004, the FDA approved the drug Vidaza for the treatment of all subtypes of my...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K31/706A61P7/00A61P7/06A61P35/02
CPCA61K9/0019A61K9/19A61K31/706A61P35/02A61K47/10A61P7/06
Inventor 张贵民贾俊伟冯中
Owner LUNAN PHARMA GROUP CORPORATION
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