RU2016144695A - Комплекс танната ситаглиптина - Google Patents

Комплекс танната ситаглиптина Download PDF

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Publication number
RU2016144695A
RU2016144695A RU2016144695A RU2016144695A RU2016144695A RU 2016144695 A RU2016144695 A RU 2016144695A RU 2016144695 A RU2016144695 A RU 2016144695A RU 2016144695 A RU2016144695 A RU 2016144695A RU 2016144695 A RU2016144695 A RU 2016144695A
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RU
Russia
Prior art keywords
sitagliptin
complex according
dosage form
oral dosage
effective amount
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RU2016144695A
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English (en)
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RU2696588C2 (ru
RU2016144695A3 (ru
Inventor
Виклифф ОМВАНЧА
Руби БЕРЛЕЙДЖ
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Мерк Шарп И Доум Корп.
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Publication of RU2016144695A publication Critical patent/RU2016144695A/ru
Publication of RU2016144695A3 publication Critical patent/RU2016144695A3/ru
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7032Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/235Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D487/00Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04Ortho-condensed systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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

Claims (15)

1. Комплекс танната ситаглиптина.
2. Комплекс танната ситаглиптина по п. 1, где содержание ситаглиптина составляет приблизительно от 25% до приблизительно 75% по массе.
3. Комплекс танната ситаглиптина по п. 2, где содержание ситаглиптина составляет приблизительно от 29% до приблизительно 33% по массе.
4. Комплекс танната ситаглиптина по п. 1, где отношение ситаглиптина к дубильной кислоте составляет приблизительно от 3:1 до приблизительно 1:4 по массе.
5. Комплекс танната ситаглиптина по п. 4, где отношение составляет приблизительно 2:1 по массе.
6. Фармацевтическая композиция, содержащая терапевтически эффективное количество комплекса танната ситаглиптина по п. 1 и инертный носитель.
7. Фармацевтическая композиция по п. 6, которая дополнительно содержит терапевтически эффективное количество дополнительного фармацевтически активного ингредиента.
8. Фармацевтический промежуточный продукт, который содержит терапевтически эффективное количество комплекса танната ситаглиптина по п. 1, фармацевтически приемлемый полимер и, необязательно, один или несколько полиолов, высокоинтенсивных подсластителей, ароматизаторов.
9. Пероральная дозированная форма, которая содержит фармацевтический промежуточный продукт по п. 8.
10. Пероральная дозированная форма по п. 9, которая находится в форме таблетки, капсулы, гранулы или порошка.
11. Пероральная дозированная форма по п. 9, которая находится в форме мягкой жвачки, медицинской жевательной резинки, жевательной таблетки, дезинтегрирующей таблетки, сиропа, саше, пероральной пленки, геля или лиосферы.
12. Пероральная дозированная форма по п. 9 с незначительным высвобождением в ротовой полости и немедленным высвобождение в желудке.
13. Пероральная дозированная форма по п. 12, которая представляет собой мягкую жвачку, медицинскую жевательную резинку, пероральную пленку, дезинтегрирующую таблетку или сироп.
14. Способ лечения, контроля или профилактики одного или нескольких заболеваний, при которых показан ингибитор DPP-IV, где способ включает введение терапевтически эффективного количества комплекса танната ситаглиптина по п. 1 нуждающемуся в этом пациенту.
15. Способ по п. 14, где заболевание представляет собой диабет 2 типа, ожирение или высокое артериальное давление.
RU2016144695A 2014-04-17 2015-04-13 Комплекс танната ситаглиптина RU2696588C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461980641P 2014-04-17 2014-04-17
US61/980,641 2014-04-17
PCT/US2015/025504 WO2015160678A1 (en) 2014-04-17 2015-04-13 Sitagliptin tannate complex

Publications (3)

Publication Number Publication Date
RU2016144695A true RU2016144695A (ru) 2018-05-21
RU2016144695A3 RU2016144695A3 (ru) 2018-10-11
RU2696588C2 RU2696588C2 (ru) 2019-08-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU2016144695A RU2696588C2 (ru) 2014-04-17 2015-04-13 Комплекс танната ситаглиптина

Country Status (12)

Country Link
US (1) US9833463B2 (ru)
EP (1) EP3131631B1 (ru)
JP (1) JP6523328B2 (ru)
KR (1) KR102351813B1 (ru)
CN (1) CN106456998B (ru)
AU (1) AU2015247921B2 (ru)
BR (1) BR112016023839A8 (ru)
CA (1) CA2945681A1 (ru)
ES (1) ES2932383T3 (ru)
MX (1) MX2016013588A (ru)
RU (1) RU2696588C2 (ru)
WO (1) WO2015160678A1 (ru)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201818969A (zh) * 2016-10-19 2018-06-01 日商帝化製藥股份有限公司 在生體內之藥物溶出控制用組成物
US11096890B2 (en) 2017-09-29 2021-08-24 Merck Sharp & Dohme Corp. Chewable dosage forms containing sitagliptin and metformin
WO2021199118A1 (ja) 2020-03-30 2021-10-07 三菱電機株式会社 エレベーター

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Also Published As

Publication number Publication date
AU2015247921A1 (en) 2016-10-13
JP2017511350A (ja) 2017-04-20
KR20160145008A (ko) 2016-12-19
MX2016013588A (es) 2017-01-26
CN106456998B (zh) 2020-07-28
ES2932383T3 (es) 2023-01-18
WO2015160678A1 (en) 2015-10-22
BR112016023839A2 (pt) 2017-08-15
US9833463B2 (en) 2017-12-05
EP3131631B1 (en) 2022-11-16
RU2696588C2 (ru) 2019-08-05
AU2015247921B2 (en) 2019-07-11
RU2016144695A3 (ru) 2018-10-11
US20170042922A1 (en) 2017-02-16
KR102351813B1 (ko) 2022-01-18
BR112016023839A8 (pt) 2023-04-11
CN106456998A (zh) 2017-02-22
JP6523328B2 (ja) 2019-05-29
EP3131631A4 (en) 2017-11-29
CA2945681A1 (en) 2015-10-22
EP3131631A1 (en) 2017-02-22

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