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Stable human growth hormone liquid preparation

A technology of human growth hormone and liquid preparation, applied in the field of stable liquid preparation

Pending Publication Date: 2016-03-23
DAEWOONG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, as mentioned above, although various attempts have been made to provide liquid formulations of somatotropin, there is still a need for more stable liquid formulations of somatotropin

Method used

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  • Stable human growth hormone liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1: Preparation and Analysis of Human Growth Hormone Liquid Preparation

[0032] The liquid formulations of the present invention are prepared as follows. 4.0 mg / ml of natural human growth hormone (Daewoong, Korea, which was supplied as a bulk solution before being lyophilized) was mixed with sodium acetate (Sigma), sodium citrate as a buffer to adjust the pH to the range of 6.0-6.2 (Sigma) or a 10 mM aqueous solution of sodium dihydrogen phosphate (Sigma). After the solution was adjusted to the final concentration, it was mixed with excipient (D-mannitol, Sigma), surfactant {polyethylene glycol-15 polyhydroxystearate (SolutolHS15, BASF), poloxamer 188 (Lutrol F68, BASF), Poloxamer 407 (Lutrol F127, BASF), polyoxyethylene ether castor oil ELP (BASF), Tween20 (CRILLET1HP, Croda) or Tween80 (CRILLET4HP, Croda)}, stabilizer (polyethylene glycol Alcohol 300 (PEG300, BASF), polyethylene glycol 400 (PEG400, BASF), PVPK-12 (Kollidon12PF, BASF), PVPK-15 (Kollidon15PF, ...

Embodiment 2

[0034] Example 2: Evaluation of the Effect of Surfactants on the Stability of Human Growth Hormone

[0035] In order to study the influence of pharmaceutically acceptable surfactants on the stability of human growth hormone, human growth hormone liquid preparations were prepared using the components listed in Table 1, and then analyzed according to the same method as in Example 1.

[0036] Table 1

[0037]

[0038] The thus-prepared liquid preparations were evaluated for deamidation and aggregation of human growth hormone according to the type of surfactant, and the results are given in Table 2 below.

[0039] In Table 2, deamidation (%) indicates the calibrated remaining proportion (%) of undeamidated active human growth hormone according to the time at 40°C, and aggregation indicates activity that does not form dimers or aggregates Calibrated remaining proportion (%) of human growth hormone.

[0040] Table 2

[0041]

[0042]

[0043] Preparation of formulations ...

Embodiment 3

[0044] Example 3: Evaluation of the Effect of Stabilizers on the Stability of Human Growth Hormone

[0045] In order to study the influence of different stabilizers on the stability of human growth hormone, liquid preparations of human growth hormone were prepared using the components listed in Table 3, and then analyzed according to the same method as in Example 1.

[0046] table 3

[0047]

[0048] The deamidation and aggregation of the liquid formulations thus prepared were evaluated according to the type of stabilizer, and the results are given in Table 4 below.

[0049] Table 4

[0050]

[0051]

[0052] As shown in Table 4, among the stabilizers used, PEG300 (polyethylene glycol 300) and two amino acids (L-Lys·HCl and L-Arg·HCl) were found to stabilize human growth hormone. In particular, when L-lysine and L-arginine were used, aggregation in the formulation was inhibited to a higher degree.

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Abstract

The invention discloses a stable liquid preparation, which consists of human growth hormone, and L-lysine, L-arginine or polyethylene glycol 300, as well as a poly (ethylene oxide)-poly (propylene oxide) copolymer, polyethylene glycol-15 poly-hydroxy stearate or polyethylene glycol-35 castor oil.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 200680055699.5 (PCT / KR2006 / 002640) with an application date of July 6, 2006, and the title of the invention is "Stable Human Growth Hormone Liquid Preparation". technical field [0002] The present invention relates to a stable liquid formulation comprising human growth hormone; L-lysine, L-arginine or polyethylene glycol 300; and poly(ethylene oxide) poly(propylene oxide) copolymer, polyethylene glycol -15 polyhydroxystearate or macrogol-35 castor oil. Background technique [0003] Human growth hormone, produced in the human pituitary gland, is a single-chain polypeptide of 191 amino acids with a molecular weight of approximately 22,000 Daltons. Human growth hormone is mainly used in the treatment of pituitary dwarfism in children (Endocrinol. Rev. 4, 155, 1983). [0004] Human growth hormone tends to be unstable in pharmaceutical formulations. Somatotropin degradation products including...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/27A61K47/34A61K47/18A61P5/06A61K47/14A61K47/44
CPCA61K9/08A61K38/27A61K47/10A61K47/183A61K47/34
Inventor 金仙姬郑尧景张裁荣李相吉李玟锡朴胜国
Owner DAEWOONG CO LTD
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