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Stable cabazitaxel and albumin composition, and preparation method thereof

A technology of cabazitaxel and albumin, which is applied in the field of stable cabazitaxel albumin aseptic freeze-dried composition and its preparation, can solve problems such as safety, and achieve the goal of reducing production cost, lowering the concentration of use, and excellent stability Effect

Active Publication Date: 2017-06-16
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When using cabazitaxel injection clinically, it must be dissolved in Tween-80, and then diluted with ethanol, glucose or normal saline for injection. cause a series of security problems

Method used

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  • Stable cabazitaxel and albumin composition, and preparation method thereof
  • Stable cabazitaxel and albumin composition, and preparation method thereof
  • Stable cabazitaxel and albumin composition, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Dissolve 300mg of Cabazitaxel in 30ml of ethanol to form an organic phase, use 400ml of human serum albumin aqueous solution (15mg / ml) as the water phase, mix the water phase with the organic phase, place in a high-speed shearing machine at 10000rpm After shearing at a certain speed, transfer it to a high-pressure homogenizer, homogenize under a pressure of 35,000 psi, and circulate for 5 times to prepare a suspension with an average particle size of 119.8nm and a pH of 6.7. Pass the suspension through Filter and sterilize with a 0.22 μm sterile filter head, and directly freeze-dry for 60 hours to obtain a freeze-dried composition. After the freeze-drying is completed, the composition is reconstituted with physiological saline, and the measured zeta potential is -5.7mv. Particle size analysis was carried out using a Malvern particle size analyzer, and the measured average particle size was 120.3nm. After standing at room temperature, it was detected by high-performance l...

Embodiment 2

[0072] Dissolve 300mg of Cabazitaxel in 15ml of ethanol to form an organic phase, use 500ml of human serum albumin aqueous solution (6mg / ml) as the water phase, mix the water phase with the organic phase, place in a high-speed shearing machine at 7000rpm After shearing at a certain speed, transfer it to a high-pressure homogenizer, perform homogenization under a pressure of 30,000 psi, and circulate for 5 times to prepare a suspension with an average particle size of 134.4nm and a pH of 6.5. Pass the suspension through Filter and sterilize with a 0.22 μm sterile filter head, and directly freeze-dry for 60 hours to obtain a freeze-dried composition. After the freeze-drying is completed, the composition is reconstituted with physiological saline, and the measured zeta potential is -3.4mv. Particle size analysis was carried out using a Malvern particle size analyzer, and the measured average particle size was 135.4nm. After being placed at room temperature, it was detected by HPLC...

Embodiment 3

[0074] Dissolve 300 mg of Cabazitaxel in 10 ml of ethanol to form an organic phase, use 180 ml of human serum albumin aqueous solution (20 mg / ml) as the water phase, mix the water phase with the organic phase, and place in a high-speed shearing machine at 15000 rpm After shearing at a certain speed, transfer it to a high-pressure homogenizer, homogenize under a pressure of 40,000 psi, and circulate 6 times to prepare a suspension with an average particle size of 164.4nm and a pH of 7.0. Pass the suspension through Filter and sterilize with a 0.22 μm sterile filter head, and directly freeze-dry for 60 hours to obtain a freeze-dried composition. After the freeze-drying is completed, the composition is reconstituted with physiological saline, and the measured zeta potential is -7.5mv. Particle size analysis was carried out using a Malvern particle size analyzer, and the measured average particle size was 165.7nm. After being placed at room temperature, it was detected by HPLC that...

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Abstract

The invention provides a stable aseptic lyophilized cabazitaxel composition, and a preparation method thereof. The prescription and the preparation technology of the above preparation are screened, so the cabazitaxel and albumin composition prepared from a low concentration of an albumin solution has the characteristics of good stability and good safety, and also has the advantages of no use of water-insoluble chloroform / dichloromethane or other highly toxic organic solvents in the preparation process, no addition of a lyophilization protection agent or a protein stabilizer in a lyophilizing step, reduction of the medicine production cost, and guaranteeing of the safety of clinic medication.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations. More specifically, the present invention relates to a stable aseptic freeze-dried composition of cabazitaxel albumin and a preparation method thereof. Background technique [0002] Prostate cancer is the most common malignant tumor of the male reproductive system. The incidence increases with age, and its incidence has obvious regional differences. The incidence is higher in Europe and the United States, and lower in Asia. The morbidity and mortality of prostate cancer are second only to lung cancer, ranking second in cancer death. Prostate cancer, which develops slowly in older men in most cases, is less common in Asia than in Western countries but has been rising rapidly in recent years. [0003] According to statistics from the American Cancer Society, prostate cancer accounts for a quarter of newly diagnosed cancer cases in the United States each year. In 2010, there were about 22...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/337A61K47/42A61P35/00
CPCA61K9/0019A61K9/19A61K31/337A61K47/42B82Y5/00
Inventor 苏正兴杨立开赵栋周晶王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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