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Etoposide lyophilized powder for injection

A technology of freeze-dried powder injection and etoposide, which is applied in freeze-dried delivery, powder delivery, medical preparations of inactive ingredients, etc., can solve the problems of low bioavailability and poor water solubility of oral preparations

Active Publication Date: 2014-07-23
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The poor water solubility of etoposide and its decomposition into inactive products in acidic medium are the main reasons for the low bioavailability of its oral preparations

Method used

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  • Etoposide lyophilized powder for injection
  • Etoposide lyophilized powder for injection
  • Etoposide lyophilized powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Etoposide 80g

[0022] The composition of sorbitol, dextran and lactose (the weight ratio of the three is 1:3:1) 200g

[0023] Composition of arginine and cysteine ​​hydrochloride (the weight ratio of the two is 1:4) 5g

[0024] Disodium edetate 10g

[0025] Hydrochloric acid solution (0.1mol / l) to adjust the pH to 6.5

[0026] Add water for injection to 1000ml

[0027] Preparation:

[0028] Weigh respectively the prescribed amount of etoposide, sorbitol, dextran, lactose, arginine, cysteine ​​hydrochloride and disodium edetate, add to water for injection, fully stir to dissolve, add activated carbon, absorb, Decarburization filter. The hydrochloric acid solution adjusted the pH to 6.5. After filtering with a 0.22μm filter membrane, fill it into washed, dried and sterilized vials, each containing 3mL, half-press the cap, turn on the freeze dryer, cool down to -40°C, freeze-dry, crimp the cap, and check ,Package.

Embodiment 2

[0030] Etoposide 90g

[0031] Composition of sorbitol, dextran and lactose (the weight ratio of the three is 1:3:1) 300g

[0032] Composition of arginine and cysteine ​​hydrochloride (the weight ratio of the two is 1:4) 5g

[0033] Disodium EDTA 5g

[0034] Adjust pH to 5.5 with citric acid (0.1mol / l)

[0035] Add water for injection to 1000ml

[0036] Preparation method is the same as embodiment 1

Embodiment 3

[0038]

[0039]

[0040] Adjust pH to 6.0 with citric acid (0.1mol / l)

[0041] Add water for injection to 1000ml

[0042] Preparation method is the same as embodiment 1

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Abstract

The invention relates to an etoposide lyophilized powder for injection. The powder can overcome the defects of etoposide, improve the bioavailability of etoposide, is convenient to use, can be absorbed fast, and can come into play rapidly. By screening the prescription of the etoposide lyophilized powder for injection, the invention finds that the combined use of a specific excipient with an antioxidant and a chelating agent at the same time can generate a finished product of etoposide lyophilized powder for injection with the advantages of high stability, fewer impurities, little side effect, high safety, convenient storage and use, low production cost, and the like.

Description

technical field [0001] The application relates to a kind of etoposide freeze-dried powder injection. Background technique [0002] Etoposide (etoposide) is a semi-synthetic podophyllotoxin derivative, which has broad-spectrum antitumor activity and is clinically used in the treatment of acute leukemia, testicular cancer and small cell lung cancer. However, the absolute bioavailability of oral preparations of etoposide is only 25% to 75%. The poor water solubility of etoposide and its decomposition into inactive products in acidic medium are the main reasons for the low bioavailability of its oral preparations. Contents of the invention [0003] The purpose of this application is to provide a novel etoposide freeze-dried powder injection, which can overcome the above-mentioned defects of etoposide, improve the bioavailability of etoposide, and is convenient to use, fast to absorb and play a role quickly. [0004] Through the screening of the etoposide freeze-dried powder ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/26A61K9/19A61K31/7048A61P35/00
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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