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Ganciclovir composition for injection and freeze drying process of ganciclovir composition

A technology of ganciclovir and drying process, applied in the field of ganciclovir composition for injection and its freeze-drying process, can solve the problems such as difficult removal of water, easy collapse and shrinkage of structure, prolonged freeze-drying cycle, etc. It is not easy to remove, the prescription is simple and reasonable, and the effect of prolonging the freeze-drying cycle

Inactive Publication Date: 2020-11-24
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the above-mentioned technical problems, the inventors have conducted a lot of research and developed a ganciclovir composition for injection and its freeze-drying process, which can effectively improve the reconstitution performance of the product, improve the stability, and at the same time without greatly prolonging the freeze-drying cycle. Under the premise, it solves the problems that the water is not easy to remove and the structure is easy to collapse and shrink due to the high solid content.

Method used

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  • Ganciclovir composition for injection and freeze drying process of ganciclovir composition
  • Ganciclovir composition for injection and freeze drying process of ganciclovir composition
  • Ganciclovir composition for injection and freeze drying process of ganciclovir composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] (1) Prepare 80% water for injection in the container; add 40.3g sodium hydroxide and stir to dissolve; add 250g (166.7mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.2, and then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).

[0029] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 1.5 hours, with a cooling rate of 75°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 9 hours. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and kept for 4 hours. in...

Embodiment 2

[0031] (1) Prepare 80% water for injection in the container; add 37.1g sodium hydroxide and stir to dissolve; add 230g (153.3mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.3, then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).

[0032] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 1 hour, with a cooling rate of 70°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 10 hours. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and kept for 3 hours. in progr...

Embodiment 3

[0034] (1) Prepare 80% water for injection in the container; add 41.9g sodium hydroxide and stir to dissolve; add 260g (173.3mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.5, then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).

[0035] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 2 hours, with a cooling rate of 80°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 8 hours. The heating rate was 5°C / h. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and...

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Abstract

The invention discloses a ganciclovir composition for injection and a freeze drying process of the ganciclovir composition. The ganciclovir composition for injection comprises ganciclovir and sodium hydroxide, and is prepared by freeze drying of a liquid medicine containing 150-180 mg / mL of ganciclovir. The freeze drying process comprises the following steps: sequentially pre-freezing, sublimationdrying and desorption drying of the ganciclovir liquid medicine to obtain a ganciclovir powder injection. The prescription is simple and reasonable, the process is simple and easy to operate, the obtained product has excellent stability and redissolution performance, the problems that moisture is not easy to remove in the freeze drying process and the freeze-dried product structure is easy to collapse and shrink due to high solid content are solved on the premise of not greatly prolonging the freeze drying period, and the quality stability of the product and the safety of clinical medicationare fundamentally ensured.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a ganciclovir composition for injection and a freeze-drying process thereof. Background technique [0002] Human cytomegalovirus (HCMV) belongs to the herpesviridae family and is one of the most common viruses that cause infectious diseases in humans, and it is also the most common virus that causes congenital infections worldwide. Ganciclovir can selectively inhibit the replication of herpes virus. It is the first drug approved by the US FDA for the treatment and prevention of CMV infection. It is recognized as one of the most broad-spectrum anti-DNA virus drugs. [0003] At present, the ganciclovir injection preparations on the market include injection solution and freeze-dried powder injection. The preparation of ganciclovir into ganciclovir freeze-dried powder for injection can significantly increase the stability of the finished product. However, in the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/02A61K31/522A61P31/22F26B5/06F26B25/22
CPCA61K9/0019A61K9/19A61K47/02A61K31/522A61P31/22F26B5/06F26B25/22
Inventor 林喜清吴健德吉家玉童庆国刘争光黄浩喜
Owner HAINAN LEVTEC PHARMA
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