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Degarelix-containing pharmaceutical composition for injection and preparation method and application thereof

A degarelix and injection technology, applied in the field of pharmaceutical preparations, can solve problems such as sudden cardiac death, and achieve the effects of reducing swelling, increasing clinical safety, and reducing swelling

Active Publication Date: 2022-01-21
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the pharmacological characteristics of degarelix itself, clinical data show that the use of the original drug degarelix acetate for injection can cause QTc interval prolongation (QTc interval is the QT interval corrected according to heart rate, indicating ventricular depolarization and recovery). The total polarization time, the currently internationally recognized standard for QTc prolongation is: male QTc interval>450ms, female QTc interval>470ms), which will cause torsades de pointes, causing palpitation, fainting, and severe heart failure in patients. Sudden death

Method used

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  • Degarelix-containing pharmaceutical composition for injection and preparation method and application thereof
  • Degarelix-containing pharmaceutical composition for injection and preparation method and application thereof
  • Degarelix-containing pharmaceutical composition for injection and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037]

[0038] The preparation method is as follows:

[0039] 1) Stir and dissolve 0.90g of potassium acetate in 250ml of water for injection, then add 15g of mannitol and stir to dissolve;

[0040] 2) Dissolving 6g of degarelix in 1);

[0041] 3) Add 2.4g of glycerin to 2), control the temperature to 40°C, stir to dissolve, add water for injection to 90% of the total volume;

[0042] 4) Add an appropriate amount of glacial acetic acid to adjust the pH to 4.8, and add water for injection to make the volume to 300ml;

[0043] 5) Sterilize and filter with a 0.22 μm filter; the sterilized medicinal solution is divided into 100 bottles of vials for injection (3ml each bottle), half-tightened and placed in a lyophilizer to freeze-dry to obtain final product.

Embodiment 2

[0045]

[0046] The preparation method is as follows:

[0047] 1) Stir and dissolve 1.20 g of potassium dihydrogen phosphate in 250 ml of water for injection, then add 15 g of mannitol and stir to dissolve;

[0048] 2) Dissolving 6g of degarelix in 1);

[0049] 3) Add 2.4g of glycerin to 2), control the temperature to 40°C, stir to dissolve, add water for injection to 90% of the total volume;

[0050] 4) Add an appropriate amount of glacial acetic acid to adjust the pH to 4.8, and add water for injection to make the volume to 300ml;

[0051] 5) Sterilize and filter with a 0.22 μm filter; the sterilized medicinal solution is divided into 100 bottles of vials for injection (3ml each bottle), half-tightened and placed in a lyophilizer to freeze-dry to obtain final product.

Embodiment 3

[0053]

[0054] The preparation method is as follows:

[0055] 1) Stir and dissolve 1.80 g of dipotassium hydrogen phosphate in 250 ml of water for injection, then add 15 g of mannitol and stir to dissolve;

[0056] 2) Dissolving 6g of degarelix in 1);

[0057] 3) Add 2.4g of glycerin to 2), control the temperature to 40°C, stir to dissolve, add water for injection to 90% of the total volume;

[0058] 4) Add an appropriate amount of glacial acetic acid to adjust the pH to 4.8, and add water for injection to make the volume to 300ml;

[0059] 5) Sterilize and filter with a 0.22 μm filter; the sterilized medicinal solution is divided into 100 bottles of vials for injection (3ml each bottle), half-tightened and placed in a lyophilizer to freeze-dry to obtain final product.

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Abstract

The invention discloses a degarelix-containing pharmaceutical composition for injection and a preparation method and application thereof, the pharmaceutical composition comprises degarelix, mannitol and a pH regulator; the pH regulator comprises acetic acid and a pH buffer agent; the pH buffer agent is selected from one of potassium acetate, dipotassium phosphate, monopotassium phosphate and potassium citrate. The degarelix-containing pharmaceutical composition for injection disclosed by the invention is used for treating advanced prostatic cancer, and compared with an original medicine, the degarelix-containing pharmaceutical composition for injection can be used for remarkably improving the symptom of ventricular tachycardia caused by degarelix.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing degarelix for injection, a preparation method and application thereof. Background technique [0002] Prostate cancer is the leading health killer of adult men in industrialized countries. With the continuous improvement of living standards, the incidence of prostate cancer is high in our country, and the morbidity and mortality have increased significantly. The incidence of prostate cancer in 2019 is about 10 / 100,000. Therefore, the development of drugs for the prevention and treatment of prostate cancer has extensive market demand and social significance. [0003] In 2008, the FDA approved Degarelix Acetate for Injection developed by Ferring Pharmaceutical Company of Denmark Drugs used to treat advanced prostate cancer. In September 2018, Degarelix acetate for injection was approved by the CFDA to enter the Chine...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K9/19A61K47/26A61K47/12A61K47/02A61K47/10A61K38/09A61P35/00
CPCA61K9/0019A61K9/10A61K9/19A61K47/26A61K47/12A61K47/02A61K47/10A61K38/09A61P35/00
Inventor 宋乾博范忠实张伟明唐洋明余品香
Owner HYBIO PHARMA
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