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Freeze-dried isavuconazonium sulfate powder injection and preparation method

A technology of isavuconazolium and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations, can solve the problems of nephrotoxicity risk, cumbersome preparation process, and complex composition, and achieve plump appearance, improved curative effect, and convenient transportation and storage Effect

Inactive Publication Date: 2018-05-04
JIANGSU CHIA TAI FENGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The liquid preparation is administered orally, and its application to critically ill patients who are difficult to swallow is limited. In addition, the composition of the self-microemulsifying system is complex and the preparation process is cumbersome. Very few drugs on the market have been successfully formulated as self-microemulsifying system, and the composition contains surfactants, there is a potential risk of nephrotoxicity

Method used

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  • Freeze-dried isavuconazonium sulfate powder injection and preparation method
  • Freeze-dried isavuconazonium sulfate powder injection and preparation method
  • Freeze-dried isavuconazonium sulfate powder injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 8～9

[0045] Table 3. Embodiment 8~9 prescription

[0046] project

Example 8

Example 9

Example 10

Isavuconazolium sulfate / g

4

4

4

Mannitol / g

0.8

1

1

concentrated sulfuric acid

/

/

/

Water for injection / ml

30

40

30

Preparation amount

10 bottles

10 bottles

10 bottles

[0047] Preparation method: preparation method: take 50-90% of the water for injection to dissolve the excipient (one or more in mannitol, lactose, sodium chloride, sorbitol), and after all dissolve, reduce the temperature to 0-15 ℃, add isavuconazolium sulfate, stir to dissolve into a clear solution, adjust the pH to 1.2-1.8 with sulfuric acid, add water for injection to constant volume, then sterile filter and pack. After half-press stoppering, cool to -40°C, keep warm for 3 hours, heat up to -15°C~0°C for sublimation and drying for 5 hours, then raise the temperature to 20~40°C, analyze and dry for 8~20 hours, t...

Embodiment 11

[0050] Example 11 Preparation of isavuconazolium sulfate freeze-dried powder for injection, 100 bottles in total

[0051] prescription:

Embodiment 11

[0052] Table 5. Embodiment 11 prescription

[0053] project

Example 11

Isavuconazolium sulfate / g

40

Mannitol / g

10

concentrated sulfuric acid

/

Water for injection / ml

300

Preparation amount

100 bottles

[0054]Preparation method: preparation method: take 50-90% of the water for injection to dissolve the excipient (one or more in mannitol, lactose, sodium chloride, sorbitol), and after all the dissolution, reduce the temperature to 0-15 ℃, add isavuconazolium sulfate, stir to dissolve into a clear solution, adjust the pH to 1.5 with sulfuric acid, add water for injection to make up the volume, then sterile filter and pack. After half-press stoppering, cool to -40°C, keep warm for 3 hours, heat up to -15°C~0°C for sublimation and drying for 5 hours, then heat up to 20~40°C, analyze and dry for 8~20 hours, then cool down to 5-10°C, keep warm After 1 hour, stoppering and coming out of the cabinet, the freeze-dryi...

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Abstract

The invention provides a freeze-dried isavuconazonium sulfate powder injection and a preparation method. The powder injection is prepared from isavuconazonium sulfate as an effective component for therapy as well as an excipient and pH regulator dilute sulfuric acid. The prepared freeze-dried isavuconazonium sulfate powder injection is rapid and complete to redissolve, good in stability and convenient to store and transport, and application of isavuconazonium sulfate to the field of preparations is enriched.

Description

technical field [0001] The invention relates to an antifungal freeze-dried powder injection of isavuconazolium sulfate and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The Chinese chemical name of isavuconazolium sulfate: [0003] Glycine, N-methyl-[2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2, 5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridyl]methyl ester, Sulfate; [0004] English chemical name: [0005] Glycine,N-methyl-,[2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl) -2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methylester,sulfate; [0006] Molecular weight: 814.853; [0007] CAS registration number: 946075-13-4 [0008] Molecular formula: C 35 h 36 f 2 N 8 o 5 S·SO 4 [0009] Structural formula: [0010] [0011] Isavuconazonium sulfate (isavuconazonium sulf...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/02A61K31/4439A61P31/10
CPCA61K9/19A61K9/0019A61K31/4439A61K47/02A61K47/26
Inventor 朱永强唐云袁晓远刘双
Owner JIANGSU CHIA TAI FENGHAI PHARMA
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