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Freeze-drying preparation as well as preparation method and application thereof

A technology of freeze-dried preparations and freeze-dried excipients, applied in the field of medicine, can solve the problems of poor storage stability of finished products, inability to ensure complete reconstitution, long reconstitution time, etc., and achieve good storage stability, short reconstitution time, The effect of simple preparation process

Active Publication Date: 2022-06-17
ZHUHAI BEIHAI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Aiming at the deficiencies in the prior art, the present invention provides a freeze-dried formulation (composition) containing fosaprepitant or a pharmaceutically acceptable salt thereof and human serum albumin, a preparation method thereof and a clinical application method thereof. The reconstitution time of the dry preparation is short, the storage stability is good, safe and effective, and the preparation process is simple, which is suitable for industrial production. A series of problems such as poor storage stability of finished products

Method used

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  • Freeze-drying preparation as well as preparation method and application thereof
  • Freeze-drying preparation as well as preparation method and application thereof
  • Freeze-drying preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0231] 1.1 Prescribing Information

[0232] Raw materials Prescription 1-1 Prescription 1-2 Prescription 1-3 Prescription 1-4 Prescription 1-5 Fosaprepitant dimeglumine 1.545g 1.545g 1.545g 1.545g 1.545g human serum albumin 240mg 360mg 600mg 1200mg 2400mg Freeze-dried excipients 0mg 0mg 0mg 0mg 0mg 0.5mol / L sodium hydroxide Moderate Moderate Moderate Moderate Moderate purified water to 36mL to 36mL to 36mL to 36mL to 36mL

[0233] 1.2 Preparation process

[0234] In a 100mL beaker (including a rotor), add an appropriate amount of water (10°C to 30°C) and the prescribed amount of human serum albumin, and start stirring. The total solution of this step is 88.33% of the prepared amount.

[0235] Weigh the prescribed amount of fosaprepitant dimeglumine and add it to the above 100mL beaker to dissolve it.

[0236] Slowly add 0.5mol / L sodium hydroxide solution dropwise to adjust the pH of ...

Embodiment 2

[0247] 2.1 Prescribing Information

[0248] Raw materials Prescription 2-1 Prescription 2-2 Prescription 2-3 Fosaprepitant dimeglumine 1.0303g 1.0303g 1.0303g human serum albumin 1600mg 2400mg 3200mg Freeze-dried excipients 0mg 0mg 0mg 0.5mol / L sodium hydroxide Moderate Moderate Moderate purified water to 24mL to 24mL to 24mL

[0249] 2.2 Preparation process

[0250] In a 50mL beaker (including a rotor), add an appropriate amount of water (10°C to 30°C) and the prescribed amount of human serum albumin, and start stirring. The total solution of this step is 88.33% of the prepared amount.

[0251] Weigh the prescribed amount of fosaprepitant dimeglumine and add it to the above-mentioned 50 mL beaker to dissolve it.

[0252] Slowly add 0.5mol / L sodium hydroxide solution dropwise to adjust the pH of the medicinal solution to 8.50-9.00.

[0253] Add water to make up the total amount, stir evenly, filter the l...

Embodiment 3

[0264] 3.1 Prescribing Information

[0265] Raw materials Prescription 3-1 Prescription 3-2 Prescription 3-3 Prescription 3-4 Prescription 3-5 Fosaprepitant dimeglumine 1.545g 1.545g 1.545g 1.545g 1.545g Palonosetron Hydrochloride 1.764mg 1.764mg 1.764mg 1.764mg 1.764mg human serum albumin 360mg 480mg 600mg 1200mg 2400mg Freeze-dried excipients 0mg 0mg 0mg 0mg 0mg 0.5mol / L sodium hydroxide Moderate Moderate Moderate Moderate Moderate purified water to 36mL to 36mL to 36mL to 36mL to 36mL

[0266] 3.2 Preparation process

[0267] In a 100mL beaker (including a rotor), add an appropriate amount of water (10°C to 30°C), the prescribed amount of human serum albumin, and the prescribed amount of palonosetron hydrochloride, and start stirring. The total solution in this step is 88.33% of the preparation amount.

[0268] Weigh the prescribed amount of fosaprepitant dimeglumine...

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PUM

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Abstract

The invention relates to a freeze-dried preparation and a preparation method and application thereof, the freeze-dried preparation comprises fosaprepitant or pharmaceutically acceptable salt thereof and human serum albumin, and the weight ratio of fosaprepitant or pharmaceutically acceptable salt thereof to human serum albumin is 1: 0.2-1: 2. The freeze-dried preparation can further comprise palonosetron or a pharmaceutically acceptable salt of the palonosetron, a freeze-dried excipient and a pH value regulator. The freeze-drying preparation is short in redissolution time, good in storage stability, remarkable in curative effect and few in toxic and side effects, and the preparation method and the use method of the freeze-drying preparation are simple.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a freeze-dried preparation for treating and preventing nausea and vomiting caused by tumor chemotherapy, and more particularly to a lyophilized preparation comprising fosaprepitant or a pharmaceutically acceptable salt thereof and, if necessary, a A lyophilized formulation of palonosetron or a pharmaceutically acceptable salt thereof. Background technique [0002] Tumor is a disease that seriously threatens human life and quality of life, and chemotherapy is one of the main methods for the treatment of malignant tumors. The most common side effect of chemotherapy is nausea and vomiting (CINV), which is generally considered one of the most painful adverse reactions by cancer patients. If not controlled well, it will affect the patient's functional status and quality of life, and patients may be delayed due to CINV. Scheduled chemotherapy and sometimes even refusal of potentially...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61K47/42A61K31/473A61P35/00
CPCA61K9/19A61K31/675A61K47/42A61K31/473A61P35/00A61K2300/00
Inventor 孙群胡波波
Owner ZHUHAI BEIHAI BIOTECH CO LTD
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