RU2005113999A - Твердый препарат - Google Patents

Твердый препарат Download PDF

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Publication number
RU2005113999A
RU2005113999A RU2005113999/15A RU2005113999A RU2005113999A RU 2005113999 A RU2005113999 A RU 2005113999A RU 2005113999/15 A RU2005113999/15 A RU 2005113999/15A RU 2005113999 A RU2005113999 A RU 2005113999A RU 2005113999 A RU2005113999 A RU 2005113999A
Authority
RU
Russia
Prior art keywords
solid preparation
active ingredient
biguanide
insulin
phase
Prior art date
Application number
RU2005113999/15A
Other languages
English (en)
Other versions
RU2357757C2 (ru
Inventor
Масахико КОИКЕ (JP)
Масахико КОИКЕ
Хиройоси КОЯМА (JP)
Хиройоси Кояма
Наору ХАМАГУТИ (JP)
Наору ХАМАГУТИ
Original Assignee
Такеда Фармасьютикал Компани Лимитед (Jp)
Такеда Фармасьютикал Компани Лимитед
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32064024&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RU2005113999(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Такеда Фармасьютикал Компани Лимитед (Jp), Такеда Фармасьютикал Компани Лимитед filed Critical Такеда Фармасьютикал Компани Лимитед (Jp)
Publication of RU2005113999A publication Critical patent/RU2005113999A/ru
Application granted granted Critical
Publication of RU2357757C2 publication Critical patent/RU2357757C2/ru

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/427Thiazoles not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. Твердый препарат, имеющий фазу, в которой однородно диспергированы сенсибилизатор инсулина и активный ингредиент, за исключением сенсибилизаторов инсулина, и характеризующийся твердостью, равной 100-400 Н.
2. Твердый препарат по п.1, в котором активный ингредиент является бигуанидом.
3. Твердый препарат по п.2, в котором бигуанид является гидрохлоридом метформина.
4. Твердый препарат, имеющий фазу, в которой однородно диспергированы сенсибилизатор инсулина и активный ингредиент, за исключением сенсибилизаторов инсулина, и характеризующийся соотношением среднего размера частиц активного ингредиента и сенсибилизатора инсулина, равным 0,5:15.
5. Твердый препарат по п.4, в котором активный ингредиент является бигуанидом.
6. Твердый препарат по п.5, в котором бигуанид является гидрохлоридом метформина.
7. Твердый препарат, имеющий фазу, в которой однородно диспергированы сенсибилизатор инсулина и активный ингредиент, за исключением сенсибилизаторов инсулина, и характеризующийся коэффициентом вариации содержания сенсибилизатора инсулина, не превышающим 6%.
8. Твердый препарат по п.7, в котором активный ингредиент является бигуанидом.
9. Твердый препарат по п.8, в котором бигуанид является гидрохлоридом метформина.
10. Твердый препарат, имеющий фазу, в которой однородно диспергированы сенсибилизатор инсулина и активный ингредиент, за иключением сенсибилизаторов инсулина, и характеризующийся элюированием не менее 70% сенсибилизатора инсулина через 30 мин при выполнении испытания на растворимость лопастным методом при 37°С со скоростью вращения 50 об/мин с использованием буфера, содержащего хлористоводородную кислоту и хлорид калия при рН 2,0, в качестве испытуемого раствора.
11. Твердый препарат по п.10, в котором активный ингредиент является бигуанидом.
12. Твердый препарат по п.11, в котором бигуанид является гидрохлоридом метформина.
13. Твердый препарат, имеющий фазу, в которой однородно диспергированы гидрохлорид пиоглитазона и гидрохлорид метформина, и характеризующийся соотношением среднего размера частиц гидрохлорида метформина и гидрохлорида пиоглитазона, равным 0,5:15.
14. Твердый препарат по п.13, который имеет пленочное покрытие.
RU2005113999/15A 2002-10-07 2003-10-06 Твердый препарат RU2357757C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2002-294045 2002-10-07
JP2002294045 2002-10-07

Publications (2)

Publication Number Publication Date
RU2005113999A true RU2005113999A (ru) 2005-12-10
RU2357757C2 RU2357757C2 (ru) 2009-06-10

Family

ID=32064024

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2005113999/15A RU2357757C2 (ru) 2002-10-07 2003-10-06 Твердый препарат

Country Status (26)

Country Link
US (1) US9101660B2 (ru)
EP (1) EP1561472B2 (ru)
JP (2) JP4236553B2 (ru)
KR (2) KR20070119095A (ru)
CN (1) CN100427143C (ru)
AU (1) AU2003271103B2 (ru)
BR (1) BR0315082A (ru)
CA (1) CA2501587C (ru)
CO (1) CO5700740A2 (ru)
CR (1) CR7797A (ru)
CY (1) CY1114863T1 (ru)
DK (1) DK1561472T3 (ru)
ES (1) ES2437072T5 (ru)
HK (1) HK1080385A1 (ru)
IL (1) IL167835A (ru)
MA (1) MA27487A1 (ru)
MX (1) MXPA05003668A (ru)
NO (1) NO332993B1 (ru)
NZ (2) NZ552559A (ru)
PL (1) PL219608B1 (ru)
PT (1) PT1561472E (ru)
RU (1) RU2357757C2 (ru)
SI (1) SI1561472T1 (ru)
UA (1) UA80991C2 (ru)
WO (1) WO2004030700A1 (ru)
ZA (1) ZA200503507B (ru)

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EP1738754B1 (en) 2004-04-14 2015-07-15 Takeda Pharmaceutical Company Limited Solid pharmaceutical preparation
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ES2576258T3 (es) * 2005-12-22 2016-07-06 Takeda Pharmaceutical Company Limited Preparación sólida que contiene un sensibilizador de insulina
KR101220643B1 (ko) * 2006-08-16 2013-01-14 알리코제약(주) 사포그릴레이트 함유 경구투여 형태의 약제
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WO2009030257A1 (en) * 2007-09-05 2009-03-12 Deutsches Krebsforschungszentrum Stiftung des öffentlichen Rechts Methods and compounds for treating diseases caused by reactive oxygen species
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Also Published As

Publication number Publication date
MA27487A1 (fr) 2005-08-01
PL376176A1 (en) 2005-12-27
ZA200503507B (en) 2006-08-30
AU2003271103B2 (en) 2008-02-28
NZ552559A (en) 2008-04-30
CA2501587C (en) 2008-06-03
UA80991C2 (en) 2007-11-26
KR100820609B1 (ko) 2008-04-10
JP2008208141A (ja) 2008-09-11
NO20052239L (no) 2005-06-29
BR0315082A (pt) 2005-08-16
EP1561472B2 (en) 2021-01-20
IL167835A (en) 2010-11-30
NO332993B1 (no) 2013-02-11
DK1561472T3 (da) 2013-11-11
EP1561472A1 (en) 2005-08-10
PL219608B1 (pl) 2015-06-30
ES2437072T5 (es) 2021-10-13
NO20052239D0 (no) 2005-05-06
SI1561472T1 (sl) 2014-01-31
CO5700740A2 (es) 2006-11-30
JP2004149521A (ja) 2004-05-27
RU2357757C2 (ru) 2009-06-10
CN100427143C (zh) 2008-10-22
CR7797A (es) 2005-11-15
PT1561472E (pt) 2013-12-09
JP4236553B2 (ja) 2009-03-11
AU2003271103A1 (en) 2004-04-23
EP1561472B1 (en) 2013-10-02
EP1561472A4 (en) 2009-07-08
US9101660B2 (en) 2015-08-11
CA2501587A1 (en) 2004-04-15
KR20070119095A (ko) 2007-12-18
NZ539711A (en) 2007-09-28
MXPA05003668A (es) 2005-06-08
WO2004030700A1 (ja) 2004-04-15
US20050287207A1 (en) 2005-12-29
CN1717253A (zh) 2006-01-04
CY1114863T1 (el) 2016-12-14
KR20050070039A (ko) 2005-07-05
HK1080385A1 (en) 2006-04-28
ES2437072T3 (es) 2014-01-08

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