Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Parenteral glucagon formulations

一种胰高血糖素、肠胃外的技术，应用在可注射液体组合物领域，能够解决胰高血糖素降解困难、未曾报道等问题

Active Publication Date: 2017-08-29
LATITUDE PHARMA
View PDF9 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Preventing the degradation of glucagon in aqueous solution is very difficult, and no effective method to effectively inhibit the gelation and degradation of glucagon has been reported

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
  • Parenteral glucagon formulations
  • Parenteral glucagon formulations
  • Parenteral glucagon formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0138] The purpose of this study was to determine the effect of high sugar concentrations (>10% w / v) on glucagon gelation. For each test composition, a lyophilized cake containing 1 mg glucagon and 100 mg lactose was prepared to have the same The same lyophilized cake composition in the Hypokit, except that the glucagon in these lyophilized cakes was produced synthetically rather than by recombinant DNA methods. Each lyophilized cake was dissolved in about 1 mL of sugar solution to obtain the final liquid composition as shown in Table 1. For comparison, F12 was prepared to have the same Mixing of the 2 vials supplied by Hypokit produces a final solution of the same composition.

[0139] Each solution was filled into an insulin pump reservoir cartridge (Medtronic, Inc. example reservoir #MMT-332A), placed on a shaker platform in a 37°C incubator and subjected to continuous agitation at 100 RPM. After 0, 3.5, and 7 days, a portion of the solution was removed and tested for ...

Embodiment 2

[0143] The purpose of this study was to compare the rates of gelation and chemical degradation of glucagon in solutions prepared by diluting the glucagon from Lyophilized cakes of Hypokit (Novo Nordisk) were dissolved to prepare. These reconstituted solutions were tested using the same procedure as in Example 1. The final solution composition and test results are shown in Table 2. Manufactured using recombinant DNA methods Glucagon in Hypokit freeze-dried cakes.

[0144] Table 2

[0145]

[0146] The results of the present study demonstrate that high concentrations (≥20%) of sugars or combinations of sugars significantly improve the stability of glucagon at body temperature by inhibiting gelation and chemical degradation in solutions containing Hypokit recombinant DNA produced glucagon.

Embodiment 3

[0148] The purpose of this study was to compare the rate of chemical degradation of glucagon between solutions obtained from commercially available The lyophilized cake of the Glucagon kit was prepared by dissolving. The lyophilized cake from the Glucagon for Injection (rDNA Origin) kit from Eli Lilly and Company ("Glucagon Emergency Kit for Hypoglycemia") was tested using the same procedure as Example 1 shape. The final solution composition and test results are shown in Table 3. Lyophilized cakes of the glucagon in the Glucagon Emergency Kit for Hypoglycemia were manufactured using recombinant DNA methods.

[0149] table 3

[0150]

[0151] These results indicate that high concentrations (>20% w / v) of sugar or combination of sugars significantly improved glucagon solution stability at body temperature by inhibiting chemical degradation.

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

This invention relates to compositions of glucagon suitable for administration by manual injection or by an insulin pump or other injection device to treat hypoglycemia. Said compositions comprise glucagon and a sugar, have a final pH between about 1.5 and 3, and are gel-free, chemically-stable at body temperature and pump-able.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 62 / 069,097, filed October 27, 2014, the teachings of which are hereby incorporated by reference in their entirety for all purposes. field of invention [0003] The present invention relates to an injectable liquid composition comprising glucagon and sugar for the treatment and prevention of hypoglycemia. Background of the invention [0004] Glucagon, a hormone secreted by the pancreas, is a polypeptide consisting of a single chain of 29 amino acids with a molecular weight of 3,485 Da. Glucagon stimulates the liver to convert stored glycogen into glucose, which is released into the blood. In medicine, glucagon is mainly used to treat hypoglycemia (a condition in which blood sugar concentration is lower than normal) due to excess insulin. Glucagon is also used during radiographic studies of the stomach, duodenum, small bowel, and colon when reduced bowe...

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 Applications(China)
IPC IPC(8): A61K38/26C07K14/605A61P3/08
CPCC07K14/605A61K38/26A61K9/0019A61K9/08A61K47/26A61P3/08A61K47/02A61K47/10
Inventor 陈献
Owner LATITUDE PHARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

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

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com