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Growth hormone composition

A dry composition, growth hormone technology, applied in the directions of drug delivery, freeze-dried delivery, medical preparations of inactive ingredients, etc., can solve the problems of increasing the concentration of immediately available drugs, not meeting medical needs, overdosing, etc.

Inactive Publication Date: 2015-12-09
ASCENDIS PHARMA ENDOCRINOLOGY DIV AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the reversible linkage between the PEG moiety and the drug degrades during storage, then the immediately available drug concentration is increased which leads to the risk of overdose
Furthermore, any drug released during storage undergoes rapid renal clearance after administration to the patient, thus reducing the time for the long-acting composition to provide therapeutically relevant amounts of the drug
This creates a risk of unmet medical needs
[0011] In addition, rhGH is known to undergo decomposition reactions under storage conditions, which can produce impurities of the corresponding components

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0397] Example 1: Synthesis of hGH polymer prodrugs

[0398]

[0399] hGH polymer prodrug (1) with c~500 was synthesized as described in WO-A2009 / 133137.

Embodiment 2

[0400] Example 2: Stability Test of Compositions Containing hGH Polymer Prodrugs

[0401] Five different lyophilized compositions (Cl, C2, C3, C4 and C5) of the hGH polymer prodrug were prepared. Each composition contained an amount of hGH polymer prodrug 1 to yield a concentration of 5 mg / ml after reconstitution. Formulations were placed upright in an incubator set at 40°C / 75%RH. After 17 days, one vial of each formulation was removed from each incubator, reconstituted with sterile water for injection, and used for analysis.

[0402]

[0403]

[0404]

Embodiment 3

[0405] Example 3: Stability Test of Compositions Containing hGH Polymer Prodrugs

[0406] Three different lyophilized compositions (C6, C7 and C8) of the hGH polymer prodrug were prepared. Each composition contained an amount of hGH polymer prodrug 1 to yield a concentration of 30 mg / ml after reconstitution. Formulations were placed upright in an incubator set at 40°C / 75%RH and an incubator set at 2-8°C. At each time point, one vial of each formulation was removed from each incubator, reconstituted with sterile water for injection and analyzed.

[0407]

[0408]

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PUM

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Abstract

The present invention relates to dry compositions of rhGH polymer prodrug containing a lyoprotectant and, optionally, one or more than one excipient. Such compositions are stable for at least 1 year, when stored at 2-8° C. The invention further relates to methods of manufacturing said compositions, containers comprising such composition as well as a kit of parts.

Description

[0001] This application is a divisional application of the Chinese patent application 201080057256.6 with the filing date of December 15, 2010 and the title of the invention is "dry growth hormone composition transiently linked to a polymer carrier". technical field [0002] The present invention relates to dry compositions of rhGH polymeric prodrugs, methods for their preparation, and containers and kits comprising said compositions. Background technique [0003] Growth hormone (GH) is a hormone that stimulates growth and cell reproduction in humans and other animals. It is a single chain polypeptide hormone of 191 amino acids synthesized, stored and secreted by somatotroph cells within the flanks of the anterior pituitary gland. When referring to human growth hormone (hGH) produced by recombinant DNA technology, this hormone is also commonly known as somatotropin and is abbreviated as "rhGH". [0004] Growth hormone has several functions in the body, most notably increasi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/48A61K47/36A61K38/27
CPCA61K38/27A61K9/0019A61K9/19A61K47/48215A61K47/60A61K9/08A61K45/06A61K47/10A61K47/12A61K47/18A61K47/26A61M5/19
Inventor G·N·拉斯姆森S·金德曼H·拉乌T·韦格
Owner ASCENDIS PHARMA ENDOCRINOLOGY DIV AS
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