DK2898886T3 - Farmaceutisk sammensætning til oral administration med forbedret eluering og/eller absorptionsevne - Google Patents
Farmaceutisk sammensætning til oral administration med forbedret eluering og/eller absorptionsevne Download PDFInfo
- Publication number
- DK2898886T3 DK2898886T3 DK13839200.6T DK13839200T DK2898886T3 DK 2898886 T3 DK2898886 T3 DK 2898886T3 DK 13839200 T DK13839200 T DK 13839200T DK 2898886 T3 DK2898886 T3 DK 2898886T3
- Authority
- DK
- Denmark
- Prior art keywords
- acid
- pharmaceutical composition
- carbonyl
- methylpyrrol
- morpholin
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Pulmonology (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
Claims (14)
1. Farmaceutisk sammensætning til oral administration omfattende: 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf, som en aktiv farmaceutisk ingrediens; og mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre.
2. Den farmaceutiske sammensætning til oral administration ifølge krav 1, hvor syreadditivet er indeholdt i en mængde på 0,25 til 5 massedele per massedel af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid.
3. Den farmaceutiske sammensætning til oral administration ifølge krav 1, hvor syreadditivet er indeholdt i en mængde på 0,5 til 2 massedele per massedel af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid.
4. Den farmaceutiske sammensætning til oral administration ifølge krav 1, hvor sammensætningen yderligere omfatter et fortyndingsmiddel, og syreadditivet er indeholdt i en mængde på 0,15 til 6 massedele per massedel af fortynderen.
5. Den farmaceutiske sammensætning til oral administration ifølge et hvilket som helst af kravene 1 til 4, hvor syreadditivet er fumarsyre.
6. Den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 1 til 5, hvor en forskel i opløsningshastighed mellem en aktiv farmaceutisk ingrediens af et farmaceutisk præparat indeholdende et syreadditiv og en aktiv farmaceutisk ingrediens af et farmaceutisk præparat ikke indeholdende syreadditiv er over 10%, hvor de farmaceutiske præparater opnås 15 minutter efter en opløsningstest ifølge en opløsningstestfremgangsmåde beskrevet i den japanske farmakopé, 16. udgave.
7. Den farmaceutiske sammensætning til oral administration ifølge et hvilket som helst af kravene 1 til 5, hvor AUC og Cmax af den aktive farmaceutiske ingrediens opnået efter oral administration af den farmaceutiske sammensætning er 1,5 eller flere gange større end AUC og Cmax af den farmaceutiske sammensætning ikke indeholdende syreadditiv.
8. Fremgangsmåde til at stabilisere 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning, hvilken fremgangsmåde omfatter at tilsætte mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til den farmaceutiske sammensætning.
9. Fremgangsmåde til at forbedre opløsning af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning, hvilken fremgangsmåde omfatter at tilsætte mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til den farmaceutiske sammensætning.
10. Fremgangsmåde til at forbedre absorption af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning, hvilken fremgangsmåde omfatter at tilsætte mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til den farmaceutiske sammensætning.
11. Anvendelse af mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til at stabilisere 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning.
12. Anvendelse af mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til at forbedre opløsning af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning.
13. Anvendelse af mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til at forbedre absorption af 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf indeholdt i en farmaceutisk sammensætning.
14. Anvendelse af mindst et syreadditiv valgt fra gruppen bestående af adipinsyre, succinsyre, fumarsyre, L-asparaginsyre, og L-glutaminsyre til at frembringe en farmaceutisk sammensætning til oral administration omfattende 4-((l-methylpyrrol-2-yl)-carbonyl)-N-(4-(4-morpholin-l-yl-carbonylpiperidin-l-yl)-phenyl)-l-piperazincarboxamid, et salt deraf, eller et solvat deraf.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2012205681 | 2012-09-19 | ||
| PCT/JP2013/075157 WO2014046129A1 (ja) | 2012-09-19 | 2013-09-18 | 溶出性及び／又は吸収性が改善された経口投与用医薬組成物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2898886T3 true DK2898886T3 (da) | 2017-03-27 |
Family
ID=50341439
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK13839200.6T DK2898886T3 (da) | 2012-09-19 | 2013-09-18 | Farmaceutisk sammensætning til oral administration med forbedret eluering og/eller absorptionsevne |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US9555115B2 (da) |
| EP (1) | EP2898886B1 (da) |
| JP (1) | JP5791817B2 (da) |
| KR (1) | KR101609105B1 (da) |
| CN (1) | CN104640547B (da) |
| AU (1) | AU2013319118B2 (da) |
| BR (1) | BR112015005489B1 (da) |
| CA (1) | CA2884731C (da) |
| DK (1) | DK2898886T3 (da) |
| ES (1) | ES2622585T3 (da) |
| HK (1) | HK1207969A1 (da) |
| HU (1) | HUE032635T2 (da) |
| MX (1) | MX345435B (da) |
| MY (1) | MY183976A (da) |
| PL (1) | PL2898886T3 (da) |
| PT (1) | PT2898886T (da) |
| RU (1) | RU2589701C1 (da) |
| SG (1) | SG11201501043TA (da) |
| TW (1) | TWI536992B (da) |
| WO (1) | WO2014046129A1 (da) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI707851B (zh) * | 2015-09-17 | 2020-10-21 | 日商大鵬藥品工業股份有限公司 | 哌嗪化合物的新穎結晶 |
Family Cites Families (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3237575A1 (de) * | 1982-10-09 | 1984-04-12 | Dr. Karl Thomae Gmbh, 7950 Biberach | Neue orale mopidamolformen |
| JP4292588B2 (ja) * | 1997-01-31 | 2009-07-08 | 日産化学工業株式会社 | ピリダジノン化合物類の経口製剤 |
| TW482675B (en) * | 1997-01-31 | 2002-04-11 | Green Cross Corp | Compositions for oral administration containing pyridazinone compounds technical field of the invention |
| JP3797764B2 (ja) * | 1997-10-01 | 2006-07-19 | エーザイ株式会社 | 光安定化組成物 |
| CN100436452C (zh) * | 2000-12-21 | 2008-11-26 | 沃泰克斯药物股份有限公司 | 可用作蛋白激酶抑制剂的吡唑化合物 |
| EP1397160A1 (en) * | 2001-04-30 | 2004-03-17 | Shire Laboratories Inc. | Pharmaceutical composition including ace/nep inhibitors and bioavailability enhancers |
| WO2003055525A1 (fr) | 2001-12-25 | 2003-07-10 | Takeda Chemical Industries, Ltd. | Preparations contenant un acide |
| JP2003252762A (ja) * | 2001-12-25 | 2003-09-10 | Takeda Chem Ind Ltd | 酸配合製剤 |
| DE10209982A1 (de) | 2002-03-07 | 2003-09-25 | Boehringer Ingelheim Pharma | Oral zu applizierende Darreichungsform für schwerlösliche basische Wirkstoffe |
| DE10337697A1 (de) * | 2003-08-16 | 2005-03-24 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Tablette enthaltend 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenyl-amino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester oder dessen Salze |
| JP4572293B2 (ja) | 2004-07-21 | 2010-11-04 | トーアエイヨー株式会社 | ピモベンダン経口投与製剤 |
| EP2056792B1 (en) * | 2006-08-31 | 2023-06-07 | Adare Pharmaceuticals, Inc. | Drug delivery systems comprising solid solutions of weakly basic drugs |
| AU2008235790B2 (en) | 2007-03-28 | 2013-06-06 | Takeda Pharmaceutical Company Limited | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent |
| JP5343845B2 (ja) | 2007-05-21 | 2013-11-13 | 東レ株式会社 | 特定の有機酸を含有する経口製剤並びに経口製剤の溶出性及び化学的安定性の改善方法 |
| WO2009147211A1 (en) | 2008-06-04 | 2009-12-10 | Biovitrum Ab (Publ) | New compounds v |
| EP2564833B1 (en) | 2008-07-28 | 2017-12-20 | Takeda Pharmaceutical Company Limited | Photostabilized pharmaceutical composition |
| DE112009005027B4 (de) | 2009-03-06 | 2018-07-19 | Toyota Jidosha Kabushiki Kaisha | Fahrzeugantriebsunterstützungsvorrichtung |
| JP5111657B2 (ja) * | 2009-03-09 | 2013-01-09 | 大鵬薬品工業株式会社 | プロスタグランジンｄ合成酵素を阻害するピペラジン化合物 |
-
2013
- 2013-09-18 HU HUE13839200A patent/HUE032635T2/en unknown
- 2013-09-18 MX MX2015003410A patent/MX345435B/es active IP Right Grant
- 2013-09-18 PT PT138392006T patent/PT2898886T/pt unknown
- 2013-09-18 DK DK13839200.6T patent/DK2898886T3/da active
- 2013-09-18 AU AU2013319118A patent/AU2013319118B2/en active Active
- 2013-09-18 US US14/423,750 patent/US9555115B2/en active Active
- 2013-09-18 WO PCT/JP2013/075157 patent/WO2014046129A1/ja active Application Filing
- 2013-09-18 BR BR112015005489-7A patent/BR112015005489B1/pt active IP Right Grant
- 2013-09-18 JP JP2014536878A patent/JP5791817B2/ja active Active
- 2013-09-18 ES ES13839200.6T patent/ES2622585T3/es active Active
- 2013-09-18 TW TW102133892A patent/TWI536992B/zh active
- 2013-09-18 CA CA2884731A patent/CA2884731C/en active Active
- 2013-09-18 MY MYPI2015700813A patent/MY183976A/en unknown
- 2013-09-18 RU RU2015114567/15A patent/RU2589701C1/ru active
- 2013-09-18 CN CN201380048719.6A patent/CN104640547B/zh active Active
- 2013-09-18 PL PL13839200T patent/PL2898886T3/pl unknown
- 2013-09-18 KR KR1020157009713A patent/KR101609105B1/ko active IP Right Grant
- 2013-09-18 EP EP13839200.6A patent/EP2898886B1/en active Active
- 2013-09-18 SG SG11201501043TA patent/SG11201501043TA/en unknown
-
2015
- 2015-09-02 HK HK15108589.3A patent/HK1207969A1/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| TWI536992B (zh) | 2016-06-11 |
| MX2015003410A (es) | 2015-06-04 |
| BR112015005489B1 (pt) | 2022-07-12 |
| KR101609105B1 (ko) | 2016-04-04 |
| ES2622585T3 (es) | 2017-07-06 |
| KR20150056827A (ko) | 2015-05-27 |
| CA2884731C (en) | 2016-11-01 |
| JP5791817B2 (ja) | 2015-10-07 |
| WO2014046129A1 (ja) | 2014-03-27 |
| MY183976A (en) | 2021-03-17 |
| BR112015005489A2 (pt) | 2017-07-04 |
| MX345435B (es) | 2017-01-30 |
| AU2013319118A1 (en) | 2015-03-12 |
| HK1207969A1 (en) | 2016-02-19 |
| EP2898886A1 (en) | 2015-07-29 |
| RU2589701C1 (ru) | 2016-07-10 |
| US20150297722A1 (en) | 2015-10-22 |
| JPWO2014046129A1 (ja) | 2016-08-18 |
| CN104640547A (zh) | 2015-05-20 |
| CA2884731A1 (en) | 2014-03-27 |
| PL2898886T3 (pl) | 2017-06-30 |
| TW201414476A (zh) | 2014-04-16 |
| EP2898886B1 (en) | 2017-02-15 |
| HUE032635T2 (en) | 2017-10-30 |
| AU2013319118B2 (en) | 2016-03-03 |
| EP2898886A4 (en) | 2016-04-27 |
| CN104640547B (zh) | 2017-07-11 |
| SG11201501043TA (en) | 2015-04-29 |
| US9555115B2 (en) | 2017-01-31 |
| PT2898886T (pt) | 2017-03-23 |
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