BRPI0814299A2 - Preparação sólida, e, métodos para estabilizar um composto em uma preparação sólida, e para produzir uma preparação sólida - Google Patents

Preparação sólida, e, métodos para estabilizar um composto em uma preparação sólida, e para produzir uma preparação sólida

Info

Publication number
BRPI0814299A2
BRPI0814299A2 BRPI0814299-8A2A BRPI0814299A BRPI0814299A2 BR PI0814299 A2 BRPI0814299 A2 BR PI0814299A2 BR PI0814299 A BRPI0814299 A BR PI0814299A BR PI0814299 A2 BRPI0814299 A2 BR PI0814299A2
Authority
BR
Brazil
Prior art keywords
solid preparation
stabilizing
compound
methods
producing
Prior art date
Application number
BRPI0814299-8A2A
Other languages
English (en)
Inventor
Kazumichi Yamamoto
Hiroyoshi Koyama
Original Assignee
Takeda Pharmaceutical
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39930391&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0814299(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical filed Critical Takeda Pharmaceutical
Publication of BRPI0814299A2 publication Critical patent/BRPI0814299A2/pt
Publication of BRPI0814299B1 publication Critical patent/BRPI0814299B1/pt
Publication of BRPI0814299B8 publication Critical patent/BRPI0814299B8/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BRPI0814299A 2007-07-19 2008-07-16 preparação sólida compreendendo alogliptina e cloridreto de metformina, uso de uma preparação sólida, e, métodos para estabilizar um composto em uma preparação sólida, e para produzir uma preparação sólida BRPI0814299B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007188574 2007-07-19
PCT/JP2008/063228 WO2009011451A1 (en) 2007-07-19 2008-07-16 Solid preparation comprising alogliptin and metformin hydrochloride

Publications (3)

Publication Number Publication Date
BRPI0814299A2 true BRPI0814299A2 (pt) 2015-02-03
BRPI0814299B1 BRPI0814299B1 (pt) 2018-12-18
BRPI0814299B8 BRPI0814299B8 (pt) 2021-05-25

Family

ID=39930391

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0814299A BRPI0814299B8 (pt) 2007-07-19 2008-07-16 preparação sólida compreendendo alogliptina e cloridreto de metformina, uso de uma preparação sólida, e, métodos para estabilizar um composto em uma preparação sólida, e para produzir uma preparação sólida

Country Status (27)

Country Link
US (1) US8900638B2 (pt)
EP (1) EP2185138B1 (pt)
JP (2) JP5479318B2 (pt)
KR (1) KR101536786B1 (pt)
CN (1) CN101801351B (pt)
AR (1) AR067557A1 (pt)
AU (1) AU2008276842C9 (pt)
BR (1) BRPI0814299B8 (pt)
CA (1) CA2694620C (pt)
CO (1) CO6160301A2 (pt)
CR (1) CR11267A (pt)
DO (1) DOP2010000028A (pt)
EA (1) EA020870B1 (pt)
EC (1) ECSP109979A (pt)
ES (1) ES2603879T3 (pt)
GE (1) GEP20125672B (pt)
IL (1) IL203171A (pt)
JO (1) JO3272B1 (pt)
MA (1) MA31592B1 (pt)
MY (1) MY159203A (pt)
NZ (1) NZ583346A (pt)
PE (2) PE20140923A1 (pt)
TN (1) TN2010000019A1 (pt)
TW (1) TWI421102B (pt)
UA (1) UA98799C2 (pt)
WO (1) WO2009011451A1 (pt)
ZA (1) ZA201000831B (pt)

Families Citing this family (61)

* Cited by examiner, † Cited by third party
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JP5689458B2 (ja) * 2009-05-13 2015-03-25 ワイス・エルエルシー グルコサミンを包含する栄養補助食品を安定化させる方法
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RS57926B1 (sr) 2009-11-13 2019-01-31 Astrazeneca Ab Formulacije tablete sa trenutnim oslobađanjem
KR20210033559A (ko) 2009-11-27 2021-03-26 베링거 인겔하임 인터내셔날 게엠베하 리나글립틴과 같은 ｄｐｐ－ｉｖ 억제제를 사용한 유전자형 검사된 당뇨병 환자의 치료
JP2013522279A (ja) 2010-03-18 2013-06-13 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 糖尿病及び関連状態の治療で用いるｇｐｒ１１９作動薬とｄｄｐ−ｉｖ阻害薬リナグリプチンの組合せ
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JP2012051832A (ja) * 2010-08-31 2012-03-15 Fancl Corp 顆粒組成物及びそれを含有する食品又は医薬品
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US9750705B2 (en) 2012-08-31 2017-09-05 The Regents Of The University Of California Agents useful for treating obesity, diabetes and related disorders
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CN103353491B (zh) * 2013-06-29 2018-11-16 北京万全德众医药生物技术有限公司 一种用液相色谱法分离测定苯甲酸阿格列汀原料及其制剂的方法
JP5922310B2 (ja) * 2013-07-25 2016-05-24 株式会社三和化学研究所 医薬製剤
CN104749269B (zh) * 2013-12-31 2018-12-28 中美华世通生物医药科技（武汉）有限公司 一种利用hplc测定阿格列汀原料药及制剂中对映异构体杂质的方法
JP6615109B2 (ja) 2014-02-28 2019-12-04 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Ｄｐｐ−４阻害薬の医学的使用
CN105527348B (zh) * 2014-09-28 2018-07-24 中美华世通生物医药科技（武汉）有限公司 分离分析苯甲酸阿格列汀制剂及其有关物质的方法
CN104569172A (zh) * 2014-11-05 2015-04-29 广东东阳光药业有限公司 一种用液相色谱检测苯甲酸阿格列汀片溶出度的方法
CN105675733B (zh) * 2014-11-17 2020-01-31 重庆医药工业研究院有限责任公司 一种用液相色谱法分离测定琥珀酸曲格列汀及其光学异构体的方法
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EP3784672A4 (en) 2018-04-27 2022-03-30 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi TABLET FORMULATIONS INCLUDING METFORMIN AND SITAGLIPTIN
CN108743611A (zh) * 2018-06-20 2018-11-06 常州制药厂有限公司 一种复方利血平片的制备方法
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