DK2394648T3 - Farmaceutisk sammensætning til oral indgivelse - Google Patents
Farmaceutisk sammensætning til oral indgivelse Download PDFInfo
- Publication number
- DK2394648T3 DK2394648T3 DK10738504.9T DK10738504T DK2394648T3 DK 2394648 T3 DK2394648 T3 DK 2394648T3 DK 10738504 T DK10738504 T DK 10738504T DK 2394648 T3 DK2394648 T3 DK 2394648T3
- Authority
- DK
- Denmark
- Prior art keywords
- oral administration
- tablet
- formulation
- release portion
- solifenacin
- Prior art date
Links
Classifications
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/439—Heterocyclic 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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (19)
1. Tablet til oral indgivelse omfattende (1) et lag omfattende en del med modificeret frigivelse omfattende tamsulosin eller et farmaceutisk acceptabelt salt deraf, og en polymer som danner en hydrogel, og (2) et lag omfattende en del med øjeblikkelig frigivelse omfattende solifenacin eller et farmaceutisk acceptabelt salt deraf og mindst et hydrofilt stof fra gruppen bestående af D-mannitol, maltose, polyethylenglycol, og polyvinyl pyrrol idon.
2. Tablet til oral indgivelse ifølge krav 1, hvor delen til øjeblikkelig frigivelse er disintegreret og/eller opløst inden delen med modificeret frigivelse danner en gel.
3. Tablet til oral indgivelse ifølge krav 1 eller 2, hvor 70% eller mere solifenacin er opløst efter 15 minutter i overensstemmelse med en opløsningstest, metode 1 (kurvemetode; 100 rpm) beskrevet i den japanske farmakopé.
4. Tablet til oral indgivelse ifølge krav 1 eller 2, hvor 85% eller mere solifenacin er opløst efter 15 minutter.
5. Tablet til oral indgivelse ifølge krav 3, hvor 90% eller mere solifenacin er opløst efter 60 minutter.
6. Tablet til oral indgivelse ifølge krav 3, hvor 85% eller mere solifenacin er opløst efter 30 minutter og 90% eller mere solifenacin er opløst efter 60 minutter.
7. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 6, hvor det hydrofile stof udgør 5 vægtprocent til 99 vægtprocent.
8. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 7, hvor et hydrofilt stof eller to eller flere hydrofile stoffer valgt fra gruppen bestående af polyethylenglycol, maltose, og polyvinylpyrrolidon anvendes som et bindemiddel.
9. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 8, hvor mannitol som det hydrofile stof anvendes som et fyldstof.
10. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 9, hvor den hydrogel-dannende polymer har en viskositet på 4000 mPa*s eller mere i en 1% vandig opløsning (25°C).
11. Tablet til oral indgivelse ifølge krav 10, hvor den hydrogel-dannende polymer er en polymer eller to eller flere polymerer valgt from gruppen bestående af polyethylenoxid, hydroxypropylmethylcellulose, carboxymethylcellulosenatrium, og en carboxyvinylpolymer.
12. Tablet til oral indgivelse ifølge krav 11, hvor den hydrogel-dannende polymer er polyethylenoxid.
13. Tablet til oral indgivelse ifølge krav 12, hvor polyethylenoxid har en viskositetsgennemsnitlig molekylevægt på 5.000.000 eller mere.
14. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 13, hvor den hydrogel-dannende polymer udgør 5 vægtprocent til 95 vægtprocent.
15. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 14, hvor delen med modificeret frigivelse endvidere omfatter et tilsætningsstof der muliggør at vand trænger ind i formuleringen.
16. Tablet til oral indgivelse ifølge krav 15, hvor tilsætningsstoffet som muliggør at vand trænger ind i formuleringen har en opløselighed således at mængden af vand der er påkrævet for at opløse 1 g af tilsætningsstoffet er 5 mL eller mindre.
17. Tablet til oral indgivelse ifølge krav 16, hvor tilsætningsstoffet som muliggør at vand trænger ind i formuleringen udgør 3 vægtprocent til 80 vægtprocent.
18. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 17, som er en tablet til behandling af nedre urinvejssymptomer forbundet med godartet prostatahyperplasi.
19. Tablet til oral indgivelse ifølge et hvilket som helst af krav 1 til 18, som er en flerlags-tablet.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14985409P | 2009-02-04 | 2009-02-04 | |
PCT/JP2010/051393 WO2010090172A1 (ja) | 2009-02-04 | 2010-02-02 | 経口投与用医薬組成物 |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2394648T3 true DK2394648T3 (da) | 2016-09-26 |
Family
ID=42542065
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10738504.9T DK2394648T3 (da) | 2009-02-04 | 2010-02-02 | Farmaceutisk sammensætning til oral indgivelse |
Country Status (27)
Country | Link |
---|---|
US (1) | US9198904B2 (da) |
EP (1) | EP2394648B1 (da) |
JP (1) | JP5553026B2 (da) |
KR (1) | KR20110126650A (da) |
CN (1) | CN102307579B (da) |
AU (1) | AU2010211725C1 (da) |
BR (1) | BRPI1007484B1 (da) |
CA (1) | CA2751039C (da) |
CY (1) | CY1118057T1 (da) |
DK (1) | DK2394648T3 (da) |
ES (1) | ES2603747T3 (da) |
HR (1) | HRP20161138T1 (da) |
HU (1) | HUE029638T2 (da) |
IL (1) | IL214420A (da) |
LT (1) | LT2394648T (da) |
MX (1) | MX342062B (da) |
MY (1) | MY160652A (da) |
NZ (1) | NZ594311A (da) |
PL (1) | PL2394648T3 (da) |
PT (1) | PT2394648T (da) |
RS (1) | RS55151B1 (da) |
RU (1) | RU2580652C2 (da) |
SG (1) | SG173528A1 (da) |
SI (1) | SI2394648T1 (da) |
UA (1) | UA102885C2 (da) |
WO (1) | WO2010090172A1 (da) |
ZA (1) | ZA201105572B (da) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP5028893B2 (ja) | 2006-07-18 | 2012-09-19 | 日産自動車株式会社 | アンダーカバー |
TWI519322B (zh) * | 2008-04-15 | 2016-02-01 | 愛戴爾製藥股份有限公司 | 包含弱鹼性藥物及控制釋放劑型之組合物 |
EP2500013B1 (en) * | 2011-03-15 | 2019-10-02 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pharmaceutical composition comprising solifenacin |
CN102743757A (zh) * | 2012-07-09 | 2012-10-24 | 张家华 | 治疗膀胱流出道梗阻所致膀胱活动过度的药物 |
CN104602693A (zh) | 2012-08-31 | 2015-05-06 | 安斯泰来制药株式会社 | 口服给药用药物组合物 |
KR101639692B1 (ko) * | 2013-12-13 | 2016-07-14 | 제일약품주식회사 | 2 이상의 유효성분을 포함하는 구강 내 속붕해 다중유닛 약제학적 조성물 |
JP2017078023A (ja) * | 2014-02-28 | 2017-04-27 | アステラス製薬株式会社 | 経口投与用医薬組成物 |
JP6915258B2 (ja) * | 2016-10-21 | 2021-08-04 | ニプロ株式会社 | 医薬組成物粒子とそれを含む口腔内崩壊製剤、医薬組成物粒子の製造方法 |
PL3697392T3 (pl) | 2017-10-17 | 2024-03-25 | Synthon B.V. | Tabletki zawierające tamsulosynę i solifenacynę |
BR112022021336A2 (pt) * | 2020-04-27 | 2022-12-13 | Zim Laboratories Ltd | Nova composição farmacêutica multiparticulada de tansulosina e solifenacina |
WO2022117594A1 (en) | 2020-12-01 | 2022-06-09 | Adamed Pharma S.A. | Orally-administered preparation containing solifenacin and tamsulosin |
Family Cites Families (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS56110665A (en) | 1980-02-08 | 1981-09-01 | Yamanouchi Pharmaceut Co Ltd | Sulfamoyl-substituted phenetylamine derivative and its preparation |
US5391825A (en) | 1980-02-08 | 1995-02-21 | Yamanouchi Pharmaceutical Co., Ltd. | Sulfamoyl substituted phenethylamine intermediates |
US4558156A (en) | 1980-02-08 | 1985-12-10 | Yamanouchi Pharmaceutical Co., Ltd. | Sulfamoyl-substituted phenethylamine derivatives |
EP0185117A1 (de) | 1984-12-21 | 1986-06-25 | IPEX Getränke-Herstellungs- und Vertriebsgesellschaft mbH | Getränk |
JPS62114952A (ja) | 1985-11-13 | 1987-05-26 | Yamanouchi Pharmaceut Co Ltd | 置換フエネチルアミン誘導体の製造法 |
KR100355130B1 (ko) | 1992-09-18 | 2003-01-30 | 야마노우치세이야쿠 가부시키가이샤 | 하이드로겔서방성정제 |
NO2005012I1 (no) | 1994-12-28 | 2005-06-06 | Debio Rech Pharma Sa | Triptorelin og farmasoytisk akseptable salter derav |
US6878386B1 (en) * | 1999-04-13 | 2005-04-12 | Beecham Pharmaceuticals (Pte) Limited | Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate |
GB0129962D0 (en) * | 2001-12-14 | 2002-02-06 | Pfizer Ltd | Method of treatment |
WO2003088952A1 (en) | 2002-04-15 | 2003-10-30 | Adams Laboratories, Inc. | Sustained release of guaifenesin combination drugs |
CA2487899A1 (en) * | 2002-06-07 | 2003-12-18 | Yamanouchi Pharmaceutical Co., Ltd. | Overactive bladder treating drug |
JP4523265B2 (ja) * | 2002-11-13 | 2010-08-11 | 旭化成ファーマ株式会社 | 排尿障害治療用口腔内崩壊製剤 |
US7442387B2 (en) | 2003-03-06 | 2008-10-28 | Astellas Pharma Inc. | Pharmaceutical composition for controlled release of active substances and manufacturing method thereof |
US8128958B2 (en) | 2003-11-10 | 2012-03-06 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
US8197846B2 (en) | 2003-11-10 | 2012-06-12 | Astellas Pharma Inc. | Sustained release pharmaceutical composition |
WO2005062898A2 (en) * | 2003-12-24 | 2005-07-14 | Advancis Pharmaceutical Corporation | Enhanced absorption of modified release dosage forms |
WO2006070735A1 (ja) * | 2004-12-27 | 2006-07-06 | Astellas Pharma Inc. | ソリフェナシンまたはその塩の安定な粒子状医薬組成物 |
JPWO2006090759A1 (ja) * | 2005-02-25 | 2008-07-24 | アステラス製薬株式会社 | ソリフェナシン含有医薬 |
US7815939B2 (en) * | 2005-07-20 | 2010-10-19 | Astellas Pharma Inc. | Coated fine particles containing drug for intrabuccally fast disintegrating dosage forms |
CA2697137A1 (en) | 2007-07-20 | 2009-01-29 | Astellas Pharma Inc. | Pharmaceutical composition for amelioration of lower urinary tract symptoms associated with prostatomegaly |
EP2018850A1 (en) | 2007-07-24 | 2009-01-28 | Ratiopharm GmbH | Pharmaceutical composition comprising solifenacin or a pharmaceutically acceptable salt thereof |
-
2010
- 2010-02-02 LT LTEP10738504.9T patent/LT2394648T/lt unknown
- 2010-02-02 CA CA2751039A patent/CA2751039C/en not_active Expired - Fee Related
- 2010-02-02 CN CN2010800066920A patent/CN102307579B/zh not_active Expired - Fee Related
- 2010-02-02 UA UAA201110643A patent/UA102885C2/ru unknown
- 2010-02-02 ES ES10738504.9T patent/ES2603747T3/es active Active
- 2010-02-02 MY MYPI2011003445A patent/MY160652A/en unknown
- 2010-02-02 WO PCT/JP2010/051393 patent/WO2010090172A1/ja active Application Filing
- 2010-02-02 RS RS20160788A patent/RS55151B1/sr unknown
- 2010-02-02 HU HUE10738504A patent/HUE029638T2/en unknown
- 2010-02-02 DK DK10738504.9T patent/DK2394648T3/da active
- 2010-02-02 BR BRPI1007484-8A patent/BRPI1007484B1/pt active IP Right Grant
- 2010-02-02 SI SI201031282T patent/SI2394648T1/sl unknown
- 2010-02-02 AU AU2010211725A patent/AU2010211725C1/en active Active
- 2010-02-02 NZ NZ594311A patent/NZ594311A/xx unknown
- 2010-02-02 KR KR1020117020464A patent/KR20110126650A/ko active IP Right Grant
- 2010-02-02 PL PL10738504.9T patent/PL2394648T3/pl unknown
- 2010-02-02 MX MX2011008188A patent/MX342062B/es active IP Right Grant
- 2010-02-02 PT PT107385049T patent/PT2394648T/pt unknown
- 2010-02-02 EP EP10738504.9A patent/EP2394648B1/en active Active
- 2010-02-02 SG SG2011056033A patent/SG173528A1/en unknown
- 2010-02-02 JP JP2010549466A patent/JP5553026B2/ja active Active
- 2010-02-02 US US12/698,566 patent/US9198904B2/en not_active Expired - Fee Related
- 2010-02-02 RU RU2011136636/15A patent/RU2580652C2/ru active
-
2011
- 2011-07-28 ZA ZA2011/05572A patent/ZA201105572B/en unknown
- 2011-08-02 IL IL214420A patent/IL214420A/en active IP Right Grant
-
2016
- 2016-09-06 HR HRP20161138TT patent/HRP20161138T1/hr unknown
- 2016-09-27 CY CY20161100958T patent/CY1118057T1/el unknown
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