JP2015533134A - 錠剤の機械的安定性に適切な少なくとも1種の水和物形成活性物質及び/又はアジュバントを含有する機械的に安定な錠剤、特にアルギニン含有錠剤の製造における選択的に水分調整された打錠材料の使用 - Google Patents

錠剤の機械的安定性に適切な少なくとも1種の水和物形成活性物質及び/又はアジュバントを含有する機械的に安定な錠剤、特にアルギニン含有錠剤の製造における選択的に水分調整された打錠材料の使用 Download PDF

Info

Publication number
JP2015533134A
JP2015533134A JP2015536105A JP2015536105A JP2015533134A JP 2015533134 A JP2015533134 A JP 2015533134A JP 2015536105 A JP2015536105 A JP 2015536105A JP 2015536105 A JP2015536105 A JP 2015536105A JP 2015533134 A JP2015533134 A JP 2015533134A
Authority
JP
Japan
Prior art keywords
arginine
hydrate
formulation
composition
adjuvants
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2015536105A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015533134A5 (cg-RX-API-DMAC7.html
Inventor
マリア ブスル
マリア ブスル
エドゥアルド バルテス
エドゥアルド バルテス
Original Assignee
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
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
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
Application filed by 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, 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 filed Critical 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
Publication of JP2015533134A publication Critical patent/JP2015533134A/ja
Publication of JP2015533134A5 publication Critical patent/JP2015533134A5/ja
Pending legal-status Critical Current

Links

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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/435Heterocyclic 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
    • 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K9/20Pills, 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
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
JP2015536105A 2012-10-09 2013-10-08 錠剤の機械的安定性に適切な少なくとも1種の水和物形成活性物質及び/又はアジュバントを含有する機械的に安定な錠剤、特にアルギニン含有錠剤の製造における選択的に水分調整された打錠材料の使用 Pending JP2015533134A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12187796 2012-10-09
EP12187796.3 2012-10-09
PCT/EP2013/070979 WO2014056942A1 (en) 2012-10-09 2013-10-08 Use of selectively moisture-adjusted tabletting material in the production of mechanically stable tablets which contain at least one hydrate-forming active substance and/or adjuvant relevant to the mechanical stability of the tablets, particularly arginine-containing tablets

Publications (2)

Publication Number Publication Date
JP2015533134A true JP2015533134A (ja) 2015-11-19
JP2015533134A5 JP2015533134A5 (cg-RX-API-DMAC7.html) 2016-12-01

Family

ID=47010364

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015536105A Pending JP2015533134A (ja) 2012-10-09 2013-10-08 錠剤の機械的安定性に適切な少なくとも1種の水和物形成活性物質及び/又はアジュバントを含有する機械的に安定な錠剤、特にアルギニン含有錠剤の製造における選択的に水分調整された打錠材料の使用

Country Status (4)

Country Link
US (2) US20140100236A1 (cg-RX-API-DMAC7.html)
EP (1) EP2908806A1 (cg-RX-API-DMAC7.html)
JP (1) JP2015533134A (cg-RX-API-DMAC7.html)
WO (1) WO2014056942A1 (cg-RX-API-DMAC7.html)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7407955B2 (en) 2002-08-21 2008-08-05 Boehringer Ingelheim Pharma Gmbh & Co., Kg 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
DE102004054054A1 (de) 2004-11-05 2006-05-11 Boehringer Ingelheim Pharma Gmbh & Co. Kg Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine
NZ600394A (en) 2006-05-04 2014-04-30 Boehringer Ingelheim Int Polymorphs of a dpp-iv enzyme inhibitor
EP1852108A1 (en) 2006-05-04 2007-11-07 Boehringer Ingelheim Pharma GmbH & Co.KG DPP IV inhibitor formulations
PE20080251A1 (es) 2006-05-04 2008-04-25 Boehringer Ingelheim Int Usos de inhibidores de dpp iv
AR071175A1 (es) 2008-04-03 2010-06-02 Boehringer Ingelheim Int Composicion farmaceutica que comprende un inhibidor de la dipeptidil-peptidasa-4 (dpp4) y un farmaco acompanante
KR20190016601A (ko) 2008-08-06 2019-02-18 베링거 인겔하임 인터내셔날 게엠베하 메트포르민 요법이 부적합한 환자에서의 당뇨병 치료
US20200155558A1 (en) 2018-11-20 2020-05-21 Boehringer Ingelheim International Gmbh Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug
CN102753161A (zh) 2009-11-27 2012-10-24 贝林格尔.英格海姆国际有限公司 基因型糖尿病患者利用dpp-iv抑制剂例如利拉利汀的治疗
CN107961377B (zh) 2010-05-05 2022-11-22 勃林格殷格翰国际有限公司 组合疗法
AR083878A1 (es) 2010-11-15 2013-03-27 Boehringer Ingelheim Int Terapia antidiabetica vasoprotectora y cardioprotectora, linagliptina, metodo de tratamiento
US20130303462A1 (en) 2012-05-14 2013-11-14 Boehringer Ingelheim International Gmbh Use of a dpp-4 inhibitor in podocytes related disorders and/or nephrotic syndrome
US20130303554A1 (en) 2012-05-14 2013-11-14 Boehringer Ingelheim International Gmbh Use of a dpp-4 inhibitor in sirs and/or sepsis
WO2013174767A1 (en) 2012-05-24 2013-11-28 Boehringer Ingelheim International Gmbh A xanthine derivative as dpp -4 inhibitor for use in modifying food intake and regulating food preference
PE20151727A1 (es) 2013-03-14 2015-12-17 Boehringer Ingelheim Int Acido 2-aza-biciclo[2.2.1]heptano-3-carboxilico (bencil-ciano-metil)-amidas sustituidas inhibidores de catepsina c
WO2015128453A1 (en) 2014-02-28 2015-09-03 Boehringer Ingelheim International Gmbh Medical use of a dpp-4 inhibitor
EA031376B1 (ru) 2014-09-12 2018-12-28 Бёрингер Ингельхайм Интернациональ Гмбх Спироциклические ингибиторы катепсина с
CA3022202A1 (en) 2016-06-10 2017-12-14 Boehringer Ingelheim International Gmbh Combinations of linagliptin and metformin
TR201720515A2 (tr) * 2017-12-15 2019-07-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Li̇nagli̇pti̇n i̇çeren bi̇r kati oral dozaj formu
EP3801539A4 (en) * 2018-06-01 2022-02-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi SOLID ORAL PHARMACEUTICAL COMPOSITIONS OF LINAGLIPTIN

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514100A (ja) * 2002-10-24 2006-04-27 イーノス・ファーマシューティカルス・インコーポレーテッド 徐放性l−アルギニン製剤並びに製造方法および使用方法
WO2007138997A1 (ja) * 2006-05-26 2007-12-06 Toyama Chemical Co., Ltd. 3-{5-[4-(シクロペンチルオキシ)-2-ヒドロキシベンゾイル]-2-[(3-ヒドロキシ-1,2-ベンズイソオキサゾール-6-イル)メトキシ]フェニル}プロピオン酸またはその塩を含有する経口用組成物
JP2010254580A (ja) * 2009-04-21 2010-11-11 Taisho Pharmaceutical Co Ltd アルギニン含有錠剤の製造方法
JP2011088838A (ja) * 2009-10-21 2011-05-06 Taisho Pharmaceutical Co Ltd アルギニン及びカルニチン含有錠剤の製造方法
JP2011516456A (ja) * 2008-04-03 2011-05-26 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 新規製剤、該製剤を含む錠剤、それらの使用及びそれらの調製方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2003231252A1 (en) * 2002-05-09 2003-11-11 Enos Pharmaceuticals, Inc. Methods and compositions for the treatment and prevention of intermittent claudication or alzheimer's disease
US20080145424A1 (en) 2002-10-24 2008-06-19 Enos Phramaceuticals, Inc. Sustained release L-arginine formulations and methods of manufacture and use
JP2005298373A (ja) 2004-04-08 2005-10-27 Kyowa Hakko Kogyo Co Ltd 吸水性アミノ酸含有糖衣錠剤
JP2010027011A (ja) 2008-07-17 2010-02-04 Alios:Kk ネイルサロンスペース貸しシステム及びネイルサロン運営システム
UY32427A (es) * 2009-02-13 2010-09-30 Boheringer Ingelheim Internat Gmbh Composicion farmaceutica, forma farmaceutica, procedimiento para su preparacion, metodos de tratamiento y usos de la misma
UY33937A (es) 2011-03-07 2012-09-28 Boehringer Ingelheim Int Composiciones farmacéuticas que contienen inhibidores de dpp-4 y/o sglt-2 y metformina
US9555001B2 (en) 2012-03-07 2017-01-31 Boehringer Ingelheim International Gmbh Pharmaceutical composition and uses thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006514100A (ja) * 2002-10-24 2006-04-27 イーノス・ファーマシューティカルス・インコーポレーテッド 徐放性l−アルギニン製剤並びに製造方法および使用方法
WO2007138997A1 (ja) * 2006-05-26 2007-12-06 Toyama Chemical Co., Ltd. 3-{5-[4-(シクロペンチルオキシ)-2-ヒドロキシベンゾイル]-2-[(3-ヒドロキシ-1,2-ベンズイソオキサゾール-6-イル)メトキシ]フェニル}プロピオン酸またはその塩を含有する経口用組成物
JP2011516456A (ja) * 2008-04-03 2011-05-26 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 新規製剤、該製剤を含む錠剤、それらの使用及びそれらの調製方法
JP2010254580A (ja) * 2009-04-21 2010-11-11 Taisho Pharmaceutical Co Ltd アルギニン含有錠剤の製造方法
JP2011088838A (ja) * 2009-10-21 2011-05-06 Taisho Pharmaceutical Co Ltd アルギニン及びカルニチン含有錠剤の製造方法

Also Published As

Publication number Publication date
WO2014056942A1 (en) 2014-04-17
EP2908806A1 (en) 2015-08-26
US20170095423A1 (en) 2017-04-06
US20140100236A1 (en) 2014-04-10

Similar Documents

Publication Publication Date Title
JP2015533134A (ja) 錠剤の機械的安定性に適切な少なくとも1種の水和物形成活性物質及び/又はアジュバントを含有する機械的に安定な錠剤、特にアルギニン含有錠剤の製造における選択的に水分調整された打錠材料の使用
JP2015533134A5 (cg-RX-API-DMAC7.html)
JP5047156B2 (ja) 医薬パッケージ
MXPA05006802A (es) Formulacion no higroscopica que comprende un farmaco higroscopico.
JP6533317B2 (ja) アナグリプチン含有固形製剤
KR20100107044A (ko) 부프로피온 히드로클로라이드의 안정화된 지연 방출 조성물 및 상기 조성물의 제조 방법
WO2017012600A1 (en) A pharmaceutical composition containing valsartan and sacubitril and methods for preparation and stabilization thereof
US10603280B2 (en) Active ingredient containing stabilised solid medicinal forms and methods for the production thereof
JP6653116B2 (ja) オルメサルタンのプロドラッグ製剤
ES2732711T3 (es) Composición farmacéutica estable sólida de citisina y proceso para la preparación de la misma
EP2934488B1 (en) A pharmaceutical composition containing candesartan cilexetil and amlodipine
JP5635491B2 (ja) 固形医薬組成物
ES2239707T3 (es) Procedimiento de granulacion por via humeda para la preparacion de tabletas farmaceuticas que contienen anhidrato de hidrocloruro de paroxetina.
EP2117534B1 (en) A pharmaceutical composition with atorvastatin active ingredient
ES2584059T3 (es) Composiciones farmacéuticas estabilizadas que comprenden sales de rasagilina
JP2020121776A (ja) エソメプラゾール製剤の乾燥剤包装体
WO2014112531A1 (ja) 5-ヒドロキシ-1h-イミダゾール-4-カルボキサミドもしくはその塩またはその水和物を含む固形製剤の包装体
RU2642934C2 (ru) Капсульный состав
WO2015188794A1 (en) A stabilized formulation of fesoterodine
JPWO2004047822A1 (ja) テプレノンを充填したヒドロキシプロピルメチルセルロースカプセル製剤
KR20190031660A (ko) 안정성이 개선된 습식과립 정제 및 이의 제조방법
JP2024023047A (ja) ビルダグリプチン含有医薬品
CZ29404U1 (cs) Stabilizovaný léčivý přípravek obsahující kanagliflozin
HK1213808B (en) A pharmaceutical composition containing candesartan cilexetil and amlodipine
PL231174B1 (pl) Sposób zabezpieczenia stałych postaci leku zawierającego 4-[(4-metylopiperazyn-1-ylo) metylo]-N-[4-metylo-3-[(4-pirydyn-3- ylopirymidyn-2-ylo)amino]fenylo]benzamid w formie krystalicznej odmiany alfa soli addycyjnej z kwasem metanosulfonowym

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20161011

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20161011

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20170727

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170807

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20171107

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180105

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20180314

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180613

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20181003