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Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

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

Active Publication Date: 2016-04-06
BEAUFOUR IPSEN TIANJIN PHARMACEUTICAL CO LTD
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  • 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

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  • Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs
  • Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs
  • Process for the preparation of pharmaceutical compositions for the sustained release of somatostatin analogs

Examples

Experimental program
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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...

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Abstract

The invention relates to a process for the preparation of injectable pharmaceutical compositions for the sustained release of somatostatin analogues and to pharmaceutical compositions prepared according to the process. In a preferred aspect the process comprises the steps of combining lanreotide acetate and acetic acid, lyophilizing the resulting mixture only once, and hydrating the lyophilizate. Acetic acid may be added to a desired pH during the final step of the process.

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

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Application Information

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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 BEAUFOUR IPSEN TIANJIN PHARMACEUTICAL CO LTD
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