Preparation method of pharmaceutical composition for delayed release of somatostatin analogs

A technology for delayed release and composition, applied in the field of preparation of the pharmaceutical composition of the delayed release somatostatin analogue lanreotide, and the preparation of the pharmaceutical composition, which can solve the problems of not adding acid publicly and achieve the effect of improving convenience

Active Publication Date: 2018-12-14
益普生制药股份有限公司
View PDF12 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method of making this composition involves two freeze-drying steps, but there is no disclosure of the addition of acid to adjust the final pH

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
  • Preparation method of pharmaceutical composition for delayed release of somatostatin analogs
  • Preparation method of pharmaceutical composition for delayed release of somatostatin analogs
  • Preparation method of pharmaceutical composition for delayed release of somatostatin analogs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 10

[0120] Example 10: Preferred method of preparing compositions of the invention

[0121] Pre-lyophilized cells were prepared by dissolving 25 g / l of pure lanreotide [BIM-23014] in 15% aqueous acetic acid. The cells were placed in empty metal trays, cooled from room temperature to 2°C over 10 minutes and then held at this temperature for 3 hours. The cooled mixture was then frozen to -40°C within 10 minutes and then held at this temperature for 2.75 hours. A vacuum of 20 μbar was applied and this vacuum was maintained while the mixture was heated from -40°C to 25°C over 20 hours, then heated to 35°C and held for 16.75 hours.

[0122] The water for injection is acidified with glacial acetic acid in an amount sufficient to provide anhydrous acetate with a final content of 9.6%-10%. The acidified water and lanreotide acetate were then mixed as follows to obtain a concentration of 24.6% pure lanreotide and 9.6%-10% anhydrous acetate: weigh lanreotide acetate and water, place In t...

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

PropertyMeasurementUnit
depthaaaaaaaaaa
Login to view more

Abstract

The present invention relates to a preparation method of a pharmaceutical composition for delayed release of somatostatin analogues, and to a pharmaceutical composition prepared according to the method. In a preferred aspect, the method comprises the steps of mixing lanreotide acetate with acetic acid, lyophilizing the resulting mixture once, and hydrating the lyophilizate. In the last step of the process, acetic acid can be added to adjust the pH to the desired value.

Description

[0001] This application is a divisional application of PCT application PCT / EP2011 / 000069 filed on January 11, 2011, with the title of the invention "Preparation method for pharmaceutical composition of somatostatin analogs for delayed release", said PCT application The date of entering the Chinese national phase is July 10, 2012, and the application number is 201180005703.8. technical field [0002] The present invention relates to the pharmaceutical field, in particular, the present invention relates to a preparation method of a pharmaceutical composition for delayed release of somatostatin analogues and a pharmaceutical composition prepared according to the method. [0003] The present invention also relates to a pharmaceutical composition for delayed release of the somatostatin analog lanreotide. Background technique [0004] Many peptide therapeutic regimens require continuous or repeated administration to a patient over an extended period of time. Repeated injections a...

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): A61K9/19A61K38/12A61K47/12A61P5/08A61K38/08
CPCA61K9/0019A61K9/19A61K38/12A61K47/12A61K38/08A61K38/31A61P43/00A61P5/02A61P5/08A61K9/08A61K38/04C07K7/06
Inventor M·蒙特T·C·拉夫曼C·鲁姆R·谢里夫-谢赫
Owner 益普生制药股份有限公司
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