[go: up one dir, main page]

HUE029400T2 - Solifenacint tartalmazó gyógyászati készítmény - Google Patents

Solifenacint tartalmazó gyógyászati készítmény Download PDF

Info

Publication number
HUE029400T2
HUE029400T2 HUE11783576A HUE11783576A HUE029400T2 HU E029400 T2 HUE029400 T2 HU E029400T2 HU E11783576 A HUE11783576 A HU E11783576A HU E11783576 A HUE11783576 A HU E11783576A HU E029400 T2 HUE029400 T2 HU E029400T2
Authority
HU
Hungary
Prior art keywords
pharmaceutical composition
suspension
solifenacin
acid
drug
Prior art date
Application number
HUE11783576A
Other languages
English (en)
Inventor
Tatsunobu Yoshioka
Makoto Murai
Hiroaki Tasaki
Original Assignee
Astellas Pharma Inc
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 Astellas Pharma Inc filed Critical Astellas Pharma Inc
Publication of HUE029400T2 publication Critical patent/HUE029400T2/hu

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
    • A61K31/33—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
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • 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
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/58—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
    • A61K47/585—Ion exchange resins, e.g. polystyrene sulfonic acid resin
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • 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
    • A61P13/06—Anti-spasmodics
    • 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
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (6)

  1. Solifenacít tartalmazó gyógyászati készítmény Szabadalmi Igénypontok !.. Orális adagolásra szolgáló gyógyászati .készítmény, mely soiífenacin vagy gyógyászatílag elfogadható sója és poiacrilin kálium között alkotott komplexet, és Carbomer Homopolymer Type 8-t: tartalmaz, ahol a gyógyászati készítmény egy szuszpenzió, a pH-érték 5 vagy magasabb és § vagy alacsonyabb, a soiífenacin - polacrilin kálium keverési tömegaránya 1:1 és 1;S' közötti, és a szuszpenzíó viszkozitása löö cPs vagy nagyobb és 3ÖQÖ cPs vagy kisebb, aboi a viszkozitás megállapítása 25°C hőmérsékleten, löörpm fordulatszámú forgó viszkoziméter alkalmazásával történik,
  2. 2, Az i< igénypont szerinti gyógyászati készítmény, ahoi a soiífenacin vagy gyógyászatllag elfogadható sója soiífenacin szukclnát,
  3. 3, Az 1:, vagy 2. igénypont szerinti gyógyászati készítmény, ahol a pH-érték ó vagy magasabb és 7 vagy alacsonyabb,
  4. 4, Az 1-3, Igénypontok bármelyike szerinti gyógyászati készítmény, ahol a Carborner Homopölymer Type 8 keverési mennyisége 1,5 mg/ml vagy nagyobb és 3 mg/mL vagy kisebb,
  5. 5, Az 1-4, igénypontok bármelyike szerinti gyógyászati készítmény, ahoi a solifenoein 8S%-a vagy annál nagyobb mennyisége 15 perc alatt leadásra: kerül az United States Pharmacopeia oldás! vizsgálatban, az oldást vizsgálat során folyadékként 0,1 N sósavat alkalmazva,
  6. 6, Az 5, igénypont szerinti gyógyászati készítmény, ahol a soiífenacin 85%-a vagy annál nagyobb mennyisége 1$ perc alatt leadásra kerül az 50 rpm lapát-sebességű lapát-módszerrel végzett United States Pharmacopeia -oldást vizsgálatban, az oldás! vizsgalat során folyadékként 900 ml 0.1 H sósavat és 5 ml, az 1-4, igénypontok bármelyike szerinti szuszpenziót alkalmazva.
HUE11783576A 2010-05-19 2011-05-18 Solifenacint tartalmazó gyógyászati készítmény HUE029400T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US34631110P 2010-05-19 2010-05-19

Publications (1)

Publication Number Publication Date
HUE029400T2 true HUE029400T2 (hu) 2017-03-28

Family

ID=44972988

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE11783576A HUE029400T2 (hu) 2010-05-19 2011-05-18 Solifenacint tartalmazó gyógyászati készítmény

Country Status (24)

Country Link
US (1) US9918970B2 (hu)
EP (1) EP2572717B1 (hu)
JP (1) JP5831449B2 (hu)
KR (1) KR20130093010A (hu)
CN (1) CN102905706A (hu)
AU (1) AU2011255951C1 (hu)
BR (1) BR112012029461A2 (hu)
CA (1) CA2799942C (hu)
CY (1) CY1117816T1 (hu)
EA (1) EA023294B1 (hu)
ES (1) ES2588008T3 (hu)
HR (1) HRP20160901T1 (hu)
HU (1) HUE029400T2 (hu)
IL (1) IL223113A0 (hu)
LT (1) LT2572717T (hu)
MX (1) MX2012013328A (hu)
PH (1) PH12012502132A1 (hu)
PL (1) PL2572717T3 (hu)
PT (1) PT2572717T (hu)
RS (1) RS55044B1 (hu)
SI (1) SI2572717T1 (hu)
TW (1) TW201208684A (hu)
WO (1) WO2011145642A1 (hu)
ZA (1) ZA201208762B (hu)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2942063A1 (en) 2014-05-06 2015-11-11 S.I.I.T. S.r.L. - Unipersonale Composition for fluidizing mucus comprising chitosan and copolymers
CN104133011A (zh) * 2014-07-01 2014-11-05 北京万全德众医药生物技术有限公司 液相色谱法分离分析琥珀酸索利那新中间体及其有关物质
WO2018154495A1 (en) 2017-02-24 2018-08-30 Ftf Pharma Private Limited Pharmaceutical composition of oral solution of muscarinic antagonist
UY38137A (es) * 2018-03-08 2019-07-31 Intas Third Party Sales 2005 S L Una forma de dosificación oral sólida farmacéutica de solifenacina
KR20210114271A (ko) 2020-03-10 2021-09-23 주식회사 종근당 솔리페나신 또는 이의 약제학적으로 허용가능한 염을 함유하는 약제학적 조성물

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5554367A (en) * 1984-10-31 1996-09-10 Alcon Laboratories, Inc. Compositions for treatment of glaucoma
JP3207494B2 (ja) * 1992-04-02 2001-09-10 ロート製薬株式会社 水性懸濁製剤
JPH075604A (ja) * 1993-06-18 1995-01-10 Konica Corp ハロゲン化銀写真感光材料
GB9402029D0 (en) 1994-02-03 1994-03-30 Smithkline Beecham Plc Novel formulation
NO2005012I1 (no) 1994-12-28 2005-06-06 Debio Rech Pharma Sa Triptorelin og farmasoytisk akseptable salter derav
WO2008128028A2 (en) * 2007-04-11 2008-10-23 Dr. Reddy's Laboratories Ltd. Solifenacin compositions
ATE411047T1 (de) * 1999-07-14 2008-10-15 Schering Plough Ltd Maskieren des geschmacks der oralen flüssigen chinolon-zubereitungen mit ionenaustauscherharzen
US7001615B1 (en) * 2001-12-07 2006-02-21 Alcon, Inc. Sustained release ophthalmic, otic and nasal suspension
DE10224086A1 (de) 2002-05-31 2003-12-11 Bayer Ag Pharmazeutische Zubereitungen zur oralen Anwendung enthaltend wirkstoffbeladene Ionentauscherharze sowie strukturviskose Gelbildner als Verdicker
KR101270908B1 (ko) 2004-03-25 2013-06-03 아스텔라스세이야쿠 가부시키가이샤 솔리페나신 또는 그의 염의 고형 제제용 조성물
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

Also Published As

Publication number Publication date
US20110288118A1 (en) 2011-11-24
MX2012013328A (es) 2013-02-01
EA201291276A1 (ru) 2013-05-30
PT2572717T (pt) 2016-07-19
CN102905706A (zh) 2013-01-30
PH12012502132A1 (en) 2013-02-04
TW201208684A (en) 2012-03-01
ES2588008T3 (es) 2016-10-28
AU2011255951A1 (en) 2012-12-20
SI2572717T1 (sl) 2016-11-30
US9918970B2 (en) 2018-03-20
EP2572717A1 (en) 2013-03-27
KR20130093010A (ko) 2013-08-21
CA2799942C (en) 2018-07-17
EP2572717A4 (en) 2013-11-20
EA023294B1 (ru) 2016-05-31
IL223113A0 (en) 2013-02-03
CY1117816T1 (el) 2017-05-17
AU2011255951C1 (en) 2015-02-19
LT2572717T (lt) 2016-09-26
EP2572717B1 (en) 2016-06-15
ZA201208762B (en) 2014-02-26
HRP20160901T1 (hr) 2016-10-07
BR112012029461A2 (pt) 2017-03-01
WO2011145642A1 (ja) 2011-11-24
CA2799942A1 (en) 2011-11-24
RS55044B1 (sr) 2016-12-30
JP5831449B2 (ja) 2015-12-09
AU2011255951B2 (en) 2014-08-14
PL2572717T3 (pl) 2016-12-30
JPWO2011145642A1 (ja) 2013-07-22

Similar Documents

Publication Publication Date Title
US7094429B2 (en) Process for preparing tannate liquid and semi-solid dosage forms
CA2567075C (en) Pharmaceutical suspension composition
ES2760673T3 (es) Composición farmacéutica que contiene mirabegrón
US8765150B2 (en) Riluzole aqueous suspensions
HUE029400T2 (hu) Solifenacint tartalmazó gyógyászati készítmény
US6239141B1 (en) Trovafloxacin oral suspensions
EP3668508A1 (en) An oral pharmaceutical composition comprising zonisamide and process of preparation thereof
US10596263B2 (en) Pazopanib formulation
US20050203115A1 (en) Narcotic-NSAID ion pairs
TW202313007A (zh) 包括胺基甲酸酯化合物的口服水性懸浮製劑