RU2009143016A - Способ лечения диабета ii типа, суспензионный состав, осмотическое устройство для доставки и способ его изготовления - Google Patents

Способ лечения диабета ii типа, суспензионный состав, осмотическое устройство для доставки и способ его изготовления Download PDF

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RU2009143016A
RU2009143016A RU2009143016/15A RU2009143016A RU2009143016A RU 2009143016 A RU2009143016 A RU 2009143016A RU 2009143016/15 A RU2009143016/15 A RU 2009143016/15A RU 2009143016 A RU2009143016 A RU 2009143016A RU 2009143016 A RU2009143016 A RU 2009143016A
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glp
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Томас Р. АЛЕССИ (US)
Томас Р. АЛЕССИ
Райан Д. МЕРСЕР (US)
Райан Д. МЕРСЕР
Катрин М. РОЛОФФ (US)
Катрин М. РОЛОФФ
Бин ЯН (US)
Бин Ян
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Интарсия Терапьютикс, Инк. (US)
Интарсия Терапьютикс, Инк.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
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    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • C07K7/067—Hemoregulatory peptides based on sequence Glp-Glu-Asp-Cys-Lys
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
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Abstract

1. Суспензионный состав, включающий состав частиц, содержащий инсулинотропный пептид, дисахарид, метионин и буферное вещество, и носитель неводной однофазной суспензии, содержащий по меньшей мере один полимер типа пирролидона и по меньшей мере один растворитель, выбранный из группы, включающей лауриллактат, лауриловый спирт, бензилбензоат и их смеси, при этом носитель суспензии проявляет характеристики вязкой жидкости, а состав частиц диспергирован в носителе. ! 2. Состав по п.1, в котором инсулитропным пептидом является глюкагоноподобный пептид-1 (GLP-1), производное GLP-1 или аналог GLP-1. ! 3. Состав по п.2, в котором инсулитропным пептидом является амид GLP (7-36). ! 4. Состав по п.1, в котором инсулитропным пептидом является эксенатид, производное эксенатида или аналог эксенатида. ! 5. Состав по п.4, в котором инсулитропным пептидом является синтетический пептид, эксенатид. !6. Состав по п.1, в котором буферное вещество выбрано из группы, включающей цитрат, гистидин, сукцинат и их смеси. ! 7. Состав по п.6, в котором буферным веществом является цитрат. ! 8. Состав по п.1, в котором дисахарид выбран из группы, включающей лактозу, сахарозу, трегалозу, целлобиозу и их смеси. ! 9. Состав по п.1, в котором состав частиц получен при высушивании с распылением препарата частиц. ! 10. Состав п.1, в котором растворитель выбран из группы, включающей лауриллактат, бензилбензоат и их смеси. ! 11. Состав по п.10, в котором растворитель в основном содержит бензилбензоат. ! 12. Состав по п.1, в котором полимер в основном содержит поливинилпирролидон. ! 13. Состав по п.1, в котором носитель в основном содержит пирролидон и бензилбензоат. ! 14. Состав по п.13, в котором носит

Claims (20)

1. Суспензионный состав, включающий состав частиц, содержащий инсулинотропный пептид, дисахарид, метионин и буферное вещество, и носитель неводной однофазной суспензии, содержащий по меньшей мере один полимер типа пирролидона и по меньшей мере один растворитель, выбранный из группы, включающей лауриллактат, лауриловый спирт, бензилбензоат и их смеси, при этом носитель суспензии проявляет характеристики вязкой жидкости, а состав частиц диспергирован в носителе.
2. Состав по п.1, в котором инсулитропным пептидом является глюкагоноподобный пептид-1 (GLP-1), производное GLP-1 или аналог GLP-1.
3. Состав по п.2, в котором инсулитропным пептидом является амид GLP (7-36).
4. Состав по п.1, в котором инсулитропным пептидом является эксенатид, производное эксенатида или аналог эксенатида.
5. Состав по п.4, в котором инсулитропным пептидом является синтетический пептид, эксенатид.
6. Состав по п.1, в котором буферное вещество выбрано из группы, включающей цитрат, гистидин, сукцинат и их смеси.
7. Состав по п.6, в котором буферным веществом является цитрат.
8. Состав по п.1, в котором дисахарид выбран из группы, включающей лактозу, сахарозу, трегалозу, целлобиозу и их смеси.
9. Состав по п.1, в котором состав частиц получен при высушивании с распылением препарата частиц.
10. Состав п.1, в котором растворитель выбран из группы, включающей лауриллактат, бензилбензоат и их смеси.
11. Состав по п.10, в котором растворитель в основном содержит бензилбензоат.
12. Состав по п.1, в котором полимер в основном содержит поливинилпирролидон.
13. Состав по п.1, в котором носитель в основном содержит пирролидон и бензилбензоат.
14. Состав по п.13, в котором носитель содержит приблизительно 50% растворителя и приблизительно 50% полимера.
15. Состав по любому из пп.1-14, в котором общее содержание воды в суспензионном составе равно или менее приблизительно 10 мас.%.
16. Осмотическое устройство для доставки, включающее суспензионный состав по пп.1-15.
17. Способ лечения диабета II типа у субъекта, нуждающегося в указанном лечении, включающий доставку суспензионного состава по пп.1-15 из осмотического устройства для доставки при постоянной скорости в течение периода приблизительно от одного месяца до приблизительно одного года.
18. Способ по п.17, в котором инсулинотропным пептидом является амид GLP-1 (7-36) и доставку суспензионного состава осуществляют при практически постоянной скорости в диапазоне от приблизительно 100 мкг/сут до приблизительно 160 мкг/сут.
19. Способ по п.17, в котором инсулинотропным пептидом является эксенатид и доставку суспензионного состава осуществляли при практически постоянной скорости в диапазоне от приблизительно 5 мкг/сут до приблизительно 160 мкг/сут.
20. Способ изготовления осмотического устройства для доставки, включающий наличие в качестве средства резервуара и заполнение суспензионным составом по пп.1-15 этого резервуара.
RU2009143016/15A 2007-04-23 2008-04-22 Способ лечения диабета ii типа и ожирения, осмотическое устройство для доставки и способ его изготовления RU2440097C2 (ru)

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