A freeze-dried composition of ixabepilone albumin and its preparation method

A technology of albumin and composition, which is applied in the direction of drug combination, freeze-dried delivery, non-active ingredients of polymer compounds, etc. Problems such as poor reproducibility, achieve good redispersibility, good uniformity, and easy operation

Active Publication Date: 2018-09-21
BRIGHTGENE BIO MEDICAL TECH (SUZHOU) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above method has significantly improved the dissolution rate of anticancer drugs, but the high-pressure homogenization process is complicated, the preparation cost is high, and it is not easy to scale up production; the preparation of nanocomposite powder or nanosuspension by precipitation method has a large particle size, and there are Uniformity is not easy to control, and the problem of poor reproducibility between batches; and ixabepilone / albumin nanoparticles have not been reported so far

Method used

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  • A freeze-dried composition of ixabepilone albumin and its preparation method
  • A freeze-dried composition of ixabepilone albumin and its preparation method
  • A freeze-dried composition of ixabepilone albumin and its preparation method

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Embodiment 1

[0041] Weigh 0.20g of Ixabepilone crude drug and dissolve it in 20.0ml of a mixed solvent of absolute ethanol and chloroform (1:5) to obtain a solution with a concentration of 10mg / mL, and pour it into the storage tank of the dispersed phase container; Then weigh 2.0 g of human serum albumin and dissolve it in 100 ml of water for injection (the pH is adjusted to 5.5 by citric acid) as the continuous phase, add the continuous phase to the continuous phase vessel, turn on the plunger pump to circulate the continuous phase, and keep the continuous phase flow rate at 20mL / min, open the valve to make the dispersed phase slowly pass through the membrane (pore size 0.1um) under a constant pressure of 50KPa and press it into the continuous phase until the pressure indicator drops, collect, centrifuge the resulting suspension, collect the precipitate, and pre-freeze to- The ixabepilone freeze-dried composition is obtained by freeze-drying at a temperature of below 40°C for 24 hours, whil...

Embodiment 2

[0043] Weigh 0.20g of Ixabepilone crude drug and dissolve it in 20.0ml of a mixed solvent of absolute ethanol and chloroform (1:5) to obtain a solution with a concentration of 10mg / mL, and pour it into the storage tank of the dispersed phase container; Then weigh 2.0 g of human serum albumin and dissolve it in 100 ml of water for injection (the pH is adjusted to 5.5 by citric acid) as the continuous phase, add the continuous phase to the continuous phase vessel, turn on the plunger pump to circulate the continuous phase, and keep the continuous phase flow rate at 50mL / min, open the valve to make the dispersed phase slowly pass through the membrane (pore size 0.1um) under a constant pressure of 200KPa and press into the continuous phase until the pressure indicator drops, collect, centrifuge the resulting suspension, collect the precipitate, and pre-frozen until- The ixabepilone freeze-dried composition is obtained by freeze-drying at a temperature of below 40°C for 24 hours, whi...

Embodiment 3

[0045] Weigh 0.20g of Ixabepilone crude drug and dissolve it in 20.0ml of a mixed solvent of absolute ethanol and chloroform (1:5) to obtain a solution with a concentration of 10mg / mL, and pour it into the storage tank of the dispersed phase container; Then weigh 2.0 g of human serum albumin and dissolve it in 100 ml of water for injection (the pH is adjusted to 5.5 by citric acid) as the continuous phase, add the continuous phase to the continuous phase vessel, turn on the plunger pump to circulate the continuous phase, and keep the continuous phase flow rate at 50mL / min, open the valve to make the dispersed phase slowly pass through the membrane (pore size 0.4um) under a constant pressure of 200KPa and press into the continuous phase until the pressure indicator drops, collect, centrifuge the resulting suspension, collect the precipitate, and pre-freeze to- The ixabepilone freeze-dried composition is obtained by freeze-drying at a temperature of below 40°C for 24 hours, while ...

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Abstract

The invention relates to an ixabepilone albumin freeze-dried composition, and a method for preparing the freeze-dried composition through a simple process. The method for preparing the ixabepilone albumin freeze-dried composition allows the particle size of the freeze-dried composition to be in uniform distribution and completely meet clinical medication required standards, and is simple in process and suitable for industrialized amplification.

Description

Technical field [0001] The invention relates to the field of pharmacy, in particular to nano-preparation technology, and more particularly to a freeze-dried ixabepilone composition and a preparation method thereof. Background technique [0002] Ixabepilone (ixabepilone) is a semi-synthetic epothilone B derivative with the following chemical structure: [0003] [0004] Ixabepilone can directly bind to the β subunit of tubulin to inhibit the depolymerization of microtubules, thereby promoting the stability of microtubules in tumor cells and exerting anti-tumor effects. [0005] Although ixabepilone has significant curative effect, it is difficult to prepare with water-based medium due to its poor water solubility, making it difficult to study its formulation. [0006] The US Food and Drug Administration (FDA) approved the marketing of ixabepilone injection on October 16, 2007, using 52.8% (w / v) polyoxyethylated castor oil (trade name Cremophor-EL) and The mixture of 39.8% (w / v) absolu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/427A61K47/42A61P35/00
Inventor 袁建栋马万顺吴洪升郑芳芳
Owner BRIGHTGENE BIO MEDICAL TECH (SUZHOU) CO LTD
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