A kind of icatibant injection composition and its preparation method and preparation

A technology for icatibant and injection, applied in the field of medicine, can solve the problems of high production cost, complex production line, high product price, etc., and achieve the effect of maintaining stability and excipient safety

Inactive Publication Date: 2016-04-20
ADLAI NORTYE BIOPHARMA CO LTD
View PDF3 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During the preparation of the existing icatibant injection for long-term storage, particle precipitation and discoloration will occur, which is more likely to cause the degradation of icatibant, resulting in an excessively high impurity content; in addition, the commercially available injection products use prepackaged Syringe, this kind of filling production line is relatively complicated, the production cost is high, and the product price is expensive

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of icatibant injection composition and its preparation method and preparation
  • A kind of icatibant injection composition and its preparation method and preparation
  • A kind of icatibant injection composition and its preparation method and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The preparation of embodiment 1 icatibant injection composition

[0042] Weigh 30.0mg of icatibant, 60.0mg of lyoprotectant (mannitol) and 60.0mg of solubilizer and stabilizer (glucose) in a sterile container, stir and dissolve the mixture with 1mL of water for injection, after stirring and dissolving, wash with acetic acid Adjust the pH to 5.5, continue to dilute to 3 mL with water for injection, filter with a 0.22 μm microporous membrane under sterile conditions, freeze-dry, and obtain the product.

[0043] The freeze-drying process is as follows: ① In the pre-freezing stage, the sample reaches the set temperature of -25°C within half an hour and maintains it for 2 hours, and then the sample reaches the pre-freezing temperature of -55°C within half an hour and maintains it for 2 hours; ② Freeze sublimation In the primary drying stage, the sample reaches the set temperature of -10°C within 1 minute and maintains it for 25 hours; ③ in the freeze-sublimation secondary dr...

Embodiment 2

[0044] The preparation of embodiment 2 icatibant injection composition

[0045] Weigh 30.0mg of icatibant, 60.0mg of lyoprotectant (glucose) and 60.0mg of solubilizer and stabilizer (sucrose) into a sterile container, stir and dissolve the mixture with 1mL of water for injection, after stirring and dissolving, adjust with acetic acid The pH value is 5.5, continue to dilute to 3 mL with water for injection, filter with a 0.22 μm microporous membrane under sterile conditions, and freeze-dry to obtain the obtained product.

[0046] The freeze-drying process is as follows: ① In the pre-freezing stage, the sample reaches the set temperature of -25°C within half an hour and maintains it for 2 hours, and then the sample reaches the pre-freezing temperature of -55°C within half an hour and maintains it for 2 hours; ② Freeze sublimation In the primary drying stage, the sample reaches the set temperature of -10°C within 1 minute and maintains it for 25 hours; ③ in the freeze-sublimation...

Embodiment 3

[0047] The preparation of embodiment 3 icatibant injection composition

[0048] Weigh 30.0mg of icatibant, 60.0mg of lyoprotectant (sucrose) and 60.0mg of solubilizer and stabilizer (glycerin) into a sterile container, stir and dissolve the mixture with 1mL of water for injection, after stirring and dissolving, adjust with acetic acid The pH value is 5.5, continue to dilute to 3 mL with water for injection, filter with a 0.22 μm microporous membrane under sterile conditions, and freeze-dry to obtain the obtained product.

[0049] The freeze-drying process is as follows: ① In the pre-freezing stage, the sample reaches the set temperature of -25°C within half an hour and maintains it for 2 hours, and then the sample reaches the pre-freezing temperature of -55°C within half an hour and maintains it for 2 hours; ② Freeze sublimation In the primary drying stage, the sample reaches the set temperature of -10°C within 1 minute and maintains it for 25 hours; ③ in the freeze-sublimatio...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention relates to the technical field of medicine, and in particular relates to an Icatibant composition for injection and a preparation method and a preparation thereof. Icatibant composition for injection includes Icatibant, a freeze-drying protective agent, a cosolvent and stabilizer, and a pH regulator, wherein the mass ratio of Icatibant, the freeze-drying protective agent and the cosolvent and stabilizer is 1:(1-100):(1-100). The freeze-drying protective agent ensures that Icatibant does not degrade in the preparation and preservation processes; the cosolvent and stabilizer not only solves the problem of easy precipitation of Icatibant in solution state, but also plays the role of accelerating the re-dissolution of the freeze-dried injection powder preparation; the pH regulator can regulate the pH value of the Icatibant composition for injection after re-dissolution, and further maintains the stability of Icatibant. The Icatibant composition for injection provided by the invention has good stability, simple and reasonable formula and good re-dissolution performance, and can be prepared into the freeze-dried injection powder without being prepared into a pre-filled syringe; and the production process is simple.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a composition for injection of icatibant and a preparation method and preparation thereof. Background technique [0002] Icatibant, English name: Icatibant, is a decapeptide containing 5 non-protein source amino acids, the structural formula is as follows: [0003] [0004] The peptide sequence is: H-D-Arg-Arg-Pro-Hyp-Gly-Thi-Ser-D-Tic-Oic-Arg-OH. [0005] Hereditary angioedema (HAE), also known as C1 inhibitor deficiency, is a rare autosomal dominant genetic disease caused by genetic defects, with an incidence of 1 / 50000~1 / 10000. HAE is characterized by unpredictable episodic edema and swelling of the hands, feet, face, larynx, and abdomen, resulting in disfigurement, disability, or death. Patients usually have a family history of the disease. Patients with HAE may develop rapid edema of the hands, feet, extremities, face, intestines, larynx, or trachea, which ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/08A61K9/19A61K47/26A61K47/10A61K47/42A61K47/36A61K47/34A61K47/02A61K47/18A61K47/22A61K47/12
Inventor 叶晓峰何南海林晓峰杨东晖路杨
Owner ADLAI NORTYE BIOPHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap