RU98117135A - COMPOSITION OF STABILIZED HORMONE GROWTH AND METHOD FOR PREPARING IT - Google Patents

COMPOSITION OF STABILIZED HORMONE GROWTH AND METHOD FOR PREPARING IT

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Publication number
RU98117135A
RU98117135A RU98117135/14A RU98117135A RU98117135A RU 98117135 A RU98117135 A RU 98117135A RU 98117135/14 A RU98117135/14 A RU 98117135/14A RU 98117135 A RU98117135 A RU 98117135A RU 98117135 A RU98117135 A RU 98117135A
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RU
Russia
Prior art keywords
growth hormone
composition
stabilizing agent
buffer
weight
Prior art date
Application number
RU98117135/14A
Other languages
Russian (ru)
Other versions
RU2191029C2 (en
Inventor
Майкл Керин МакНамара
Уильям Неил Чарман
Сюзн Энн Чарман
Original Assignee
Си Эс Эл ЛИМИТЕД
Монаш Юниверсити
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AUPN8012A external-priority patent/AUPN801296A0/en
Application filed by Си Эс Эл ЛИМИТЕД, Монаш Юниверсити filed Critical Си Эс Эл ЛИМИТЕД
Publication of RU98117135A publication Critical patent/RU98117135A/en
Application granted granted Critical
Publication of RU2191029C2 publication Critical patent/RU2191029C2/en

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Claims (11)

1. Способ приготовления стабильный жидкой композиции гормона роста, отличающийся тем, что содержит гормон роста, буфер и эффективное для стабилизации количество по меньшей мере одного стабилизирующего агента, выбранного из группы, состоящей из: (i) неионных поверхностно-активных веществ из полиоксиэтилен-полиоксипропиленового блок-сополимера, (ii) таурохолевой кислоты или ее солей, или производных, и (iii) производных метилцеллюлозы, где способ включает смешивание гормона роста с буфером и стабилизирующим агентом (агентами) в таких условиях, что гормон роста не подвергается контакту с концентрациями буфера или стабилизирующего агента (агентов), большими чем 2х от конечных концентраций буфера или стабилизирующего агента (агентов) в композиции.1. A method of preparing a stable liquid growth hormone composition, characterized in that it contains growth hormone, a buffer and an effective stabilization amount of at least one stabilizing agent selected from the group consisting of: (i) non-ionic surfactants from polyoxyethylene-polyoxypropylene a block copolymer, (ii) taurocholic acid or its salts or derivatives, and (iii) methyl cellulose derivatives, wherein the method comprises mixing growth hormone with a buffer and a stabilizing agent (s) under such conditions, that growth hormone is not exposed to concentrations of the buffer or stabilizing agent (s) greater than 2 times the final concentrations of the buffer or stabilizing agent (s) in the composition. 2. Способ по п.1, отличающийся тем, что гормон роста является гормоном роста человека. 2. The method according to claim 1, characterized in that the growth hormone is a human growth hormone. 3. Способ по пп. 1 и 2, отличающийся тем, что композиция содержит 0,1-5,0 вес. /об. %, предпочтительно 0,05-2,0 вес/об.%, более предпочтительно 0,08-1,0 вес/об.% стабилизирующего агента (агентов). 3. The method according to PP. 1 and 2, characterized in that the composition contains 0.1-5.0 weight. /about. %, preferably 0.05-2.0 weight / vol.%, more preferably 0.08-1.0 weight / vol.% stabilizing agent (s). 4. Способ по пп. 1-3, отличающийся тем, что стабилизирующий агент (агенты) выбираются из Pluronic (товарное наименование) полиспиртов, таурохолевой кислоты и ее солей и гидроксипропилметилцеллюлозы. 4. The method according to PP. 1-3, characterized in that the stabilizing agent (s) are selected from Pluronic (trade name) polyalcohols, taurocholic acid and its salts and hydroxypropyl methylcellulose. 5. Способ по пп. 1-4, отличающийся тем, что композиция содержит 0,08 вес/об. % Pluronic (TH) полиспирта в качестве стабилизирующего агента (агентов). 5. The method according to PP. 1-4, characterized in that the composition contains 0.08 weight / vol. % Pluronic (TH) polyalcohol as a stabilizing agent (s). 6. Способ по пп. 1-5, отличающийся тем, что композиция содержит фармакологически приемлемый буфер, предпочтительно фосфатный или нитратный буфер, с концентрацией 2,5 - 50 мМ, предпочтительно 10-20 мМ. 6. The method according to PP. 1-5, characterized in that the composition contains a pharmacologically acceptable buffer, preferably phosphate or nitrate buffer, with a concentration of 2.5 to 50 mm, preferably 10-20 mm. 7. Способ по пп. 1-6, отличающийся тем, что pH композиции составляет 5,0 - 7,5, предпочтительно 5,0 - 6,8, более предпочтительно 5,2 - 6,5 и наиболее предпочтительно 5,4 - 5,8. 7. The method according to PP. 1-6, characterized in that the pH of the composition is 5.0 to 7.5, preferably 5.0 to 6.8, more preferably 5.2 to 6.5 and most preferably 5.4 to 5.8. 8. Способ по пп. 1-7, отличающийся тем, что стабилизирующий агент (агенты) вводят в композицию непосредственно перед окончательным определением объема. 8. The method according to PP. 1-7, characterized in that the stabilizing agent (agents) are introduced into the composition immediately before the final determination of volume. 9. Стабильная жидкая композиция гормона роста, приготовленная по способу в соответствии с любым из пп. 1-8. 9. A stable liquid growth hormone composition prepared by the method in accordance with any one of paragraphs. 1-8. 10. Стабильная жидкая композиция гормона роста, содержащая гормон роста, буфер и эффективное для стабилизации количество по меньшей мере одного стабилизирующего агента, выбранного из таурохолевой кислоты или ее солей, или производных и производных метилцеллюлозы. 10. A stable liquid growth hormone composition containing growth hormone, a buffer and an effective stabilization amount of at least one stabilizing agent selected from taurocholic acid or its salts, or methyl cellulose derivatives and derivatives. 11. Способ лечения больного человека или животного, нуждающегося в гормоне роста, включающий введение указанному пациенту фармацевтически эффективного количества композиции по пп. 9-10. 11. A method of treating a sick person or animal in need of growth hormone, comprising administering to said patient a pharmaceutically effective amount of a composition according to claims. 9-10.
RU98117135/14A 1996-02-12 1997-02-12 Composition of stabilized growth hormone and method of its preparing RU2191029C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPN8012 1996-02-12
AUPN8012A AUPN801296A0 (en) 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof

Publications (2)

Publication Number Publication Date
RU98117135A true RU98117135A (en) 2000-06-27
RU2191029C2 RU2191029C2 (en) 2002-10-20

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU98117135/14A RU2191029C2 (en) 1996-02-12 1997-02-12 Composition of stabilized growth hormone and method of its preparing

Country Status (13)

Country Link
US (1) US6593296B1 (en)
EP (1) EP0889733B1 (en)
JP (1) JP4255515B2 (en)
CN (1) CN1132626C (en)
AT (1) ATE340587T1 (en)
AU (1) AUPN801296A0 (en)
CA (1) CA2246501C (en)
DE (1) DE69736739T2 (en)
DK (1) DK0889733T3 (en)
HK (1) HK1017851A1 (en)
RU (1) RU2191029C2 (en)
TR (1) TR199801558T2 (en)
WO (1) WO1997029767A1 (en)

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