WO2010097243A3 - Procédé de fabrication de formes posologiques orales de solifénacine et de ses sels pharmaceutiquement acceptables - Google Patents

Procédé de fabrication de formes posologiques orales de solifénacine et de ses sels pharmaceutiquement acceptables Download PDF

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Publication number
WO2010097243A3
WO2010097243A3 PCT/EP2010/001262 EP2010001262W WO2010097243A3 WO 2010097243 A3 WO2010097243 A3 WO 2010097243A3 EP 2010001262 W EP2010001262 W EP 2010001262W WO 2010097243 A3 WO2010097243 A3 WO 2010097243A3
Authority
WO
WIPO (PCT)
Prior art keywords
solifenacin
pharmaceutically acceptable
acceptable salts
dosage forms
oral dosage
Prior art date
Application number
PCT/EP2010/001262
Other languages
English (en)
Other versions
WO2010097243A2 (fr
Inventor
Miha Vrbinc
Franc Vrecer
Urska Turk
Urska Jursic
Original Assignee
Krka, D. D., Novo Mesto
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=42041747&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2010097243(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Krka, D. D., Novo Mesto filed Critical Krka, D. D., Novo Mesto
Priority to ES10705984.2T priority Critical patent/ES2609061T3/es
Priority to EP10705984.2A priority patent/EP2400954B1/fr
Priority to DK10705984.2T priority patent/DK2400954T3/en
Priority to EA201190161A priority patent/EA023529B1/ru
Priority to SI201031356A priority patent/SI2400954T1/sl
Publication of WO2010097243A2 publication Critical patent/WO2010097243A2/fr
Publication of WO2010097243A3 publication Critical patent/WO2010097243A3/fr
Priority to HRP20161730TT priority patent/HRP20161730T1/hr

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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
    • A61K31/439—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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting 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
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/28—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
    • 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
    • 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

Abstract

La présente invention concerne des compositions pharmaceutiques qui comprennent de la solifénacine ou ses sels pharmaceutiquement acceptables en tant que principe actif et qui sont préparées par des procédés technologiques par voie sèche, de préférence par le procédé de compression directe ou de compactage par cylindres, en d'autres termes par le procédé en l'absence d'un solvant liquide, et leur procédé de préparation.
PCT/EP2010/001262 2009-02-27 2010-03-01 Procédé de fabrication de formes posologiques orales de solifénacine et de ses sels pharmaceutiquement acceptables WO2010097243A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
ES10705984.2T ES2609061T3 (es) 2009-02-27 2010-03-01 Procedimiento para formar unas formas farmacéuticas orales sólidas de solifenacina y sus sales farmacéuticamente aceptables
EP10705984.2A EP2400954B1 (fr) 2009-02-27 2010-03-01 Procédé de fabrication de formes posologiques orales de solifénacine et de ses sels pharmaceutiquement acceptables
DK10705984.2T DK2400954T3 (en) 2009-02-27 2010-03-01 Process for forming solid oral dosage forms of solifenacin and its pharmaceutically acceptable salts
EA201190161A EA023529B1 (ru) 2009-02-27 2010-03-01 Способ получения твердых лекарственных форм солифенацина и его фармацевтически приемлемых солей для перорального введения
SI201031356A SI2400954T1 (sl) 2009-02-27 2010-03-01 Postopek za pripravo trdne oralne dozirne oblike solifenacina in njegovih farmacevtsko sprejemljivih soli
HRP20161730TT HRP20161730T1 (hr) 2009-02-27 2016-12-15 Postupak proizvodnje čvrstih oralnih doznih oblika solifenacina i njegovih farmaceutski prikladnih soli

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SIP-200900056 2009-02-27
SI200900056 2009-02-27
SIP-200900159 2009-06-08
SI200900159 2009-06-08

Publications (2)

Publication Number Publication Date
WO2010097243A2 WO2010097243A2 (fr) 2010-09-02
WO2010097243A3 true WO2010097243A3 (fr) 2011-06-16

Family

ID=42041747

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/001262 WO2010097243A2 (fr) 2009-02-27 2010-03-01 Procédé de fabrication de formes posologiques orales de solifénacine et de ses sels pharmaceutiquement acceptables

Country Status (9)

Country Link
EP (1) EP2400954B1 (fr)
DK (1) DK2400954T3 (fr)
EA (1) EA023529B1 (fr)
ES (1) ES2609061T3 (fr)
HR (1) HRP20161730T1 (fr)
HU (1) HUE030376T2 (fr)
PL (1) PL2400954T3 (fr)
SI (1) SI2400954T1 (fr)
WO (1) WO2010097243A2 (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201291189A1 (ru) * 2010-05-07 2013-05-30 Зентива К.С. Фармацевтическая композиция, содержащая солифенацин, и способ его получения
EP2500013B1 (fr) 2011-03-15 2019-10-02 Alfred E. Tiefenbacher (GmbH & Co. KG) Composition pharmaceutique comprenant de la solifénacine
EP2778167A1 (fr) 2013-03-11 2014-09-17 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Composition pharmaceutique comprenant solifenacin ou l'un de ses sels pharmaceutiquement acceptable
KR20150092385A (ko) * 2014-02-03 2015-08-13 씨제이헬스케어 주식회사 솔리페나신을 포함하는 안정한 제제 및 이의 제조방법
CN104940152B (zh) * 2014-03-31 2017-12-29 成都国为生物医药有限公司 一种含有琥珀酸索利那新的药物组合物
CN105012961B (zh) * 2014-04-17 2020-07-21 燃点(南京)生物医药科技有限公司 稳定的药物组合物及其制备方法
WO2015170237A1 (fr) * 2014-05-05 2015-11-12 Torrent Pharmaceuticals Limited Composition de solifénacine stable
CN105362245A (zh) * 2014-08-30 2016-03-02 山东中泰药业有限公司 含有索利那新的片剂组合物及其制备方法
CN104523628B (zh) * 2014-12-24 2017-08-25 乐普药业股份有限公司 一种可粉末直接压片的琥珀酸索利那新片剂及其制备方法
US20180214453A1 (en) * 2015-08-05 2018-08-02 Interquim, S.A. Rivaroxaban pharmaceutical compositions
CN105395494A (zh) * 2015-11-27 2016-03-16 浙江华义医药有限公司 一种含琥珀酸索利那新的药物组合物及其制备方法
EP3666261A4 (fr) * 2017-08-08 2020-08-05 Mitsubishi Chemical Corporation Comprimé pharmaceutique et son procédé de production
KR101977890B1 (ko) * 2018-05-08 2019-05-13 씨제이헬스케어 주식회사 솔리페나신을 포함하는 안정한 제제 및 이의 제조방법

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007072169A2 (fr) * 2005-12-20 2007-06-28 Pfizer Products Inc. Combinaison pharmaceutique utilisee pour traiter des troubles urinaires du bas appareil (tuba)
US20080114028A1 (en) * 2006-07-24 2008-05-15 Tamas Koltai Process for preparing polymorphic forms of solifenacin succinate
WO2008128028A2 (fr) * 2007-04-11 2008-10-23 Dr. Reddy's Laboratories Ltd. Compositions à base de solifénacine
WO2010012459A2 (fr) * 2008-07-29 2010-02-04 Krka, D.D., Novo Mesto Procédé de préparation de sels de solifénacine et inclusion de ces derniers dans des formes pharmaceutiques

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU508480B2 (en) 1977-04-13 1980-03-20 Asahi Kasei Kogyo Kabushiki Kaisha Microcrystalline cellulose excipient and pharmaceutical composition containing thesame
EP0876814A1 (fr) 1997-05-07 1998-11-11 "PHARLYSE", Société Anonyme Exipient pour inhalateur à poudre sèche, procédé de sa préparation et compositions pharmaceutiques la contenant
KR101156406B1 (ko) 2004-03-25 2012-06-13 아스텔라스세이야쿠 가부시키가이샤 솔리페나신 또는 그의 염의 고형 제제용 조성물
EP2018850A1 (fr) 2007-07-24 2009-01-28 Ratiopharm GmbH Composition pharmaceutique comportant de la solifénacine ou sel acceptable pharmaceutiquement

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007072169A2 (fr) * 2005-12-20 2007-06-28 Pfizer Products Inc. Combinaison pharmaceutique utilisee pour traiter des troubles urinaires du bas appareil (tuba)
US20080114028A1 (en) * 2006-07-24 2008-05-15 Tamas Koltai Process for preparing polymorphic forms of solifenacin succinate
WO2008128028A2 (fr) * 2007-04-11 2008-10-23 Dr. Reddy's Laboratories Ltd. Compositions à base de solifénacine
WO2010012459A2 (fr) * 2008-07-29 2010-02-04 Krka, D.D., Novo Mesto Procédé de préparation de sels de solifénacine et inclusion de ces derniers dans des formes pharmaceutiques

Also Published As

Publication number Publication date
HUE030376T2 (en) 2017-05-29
EA023529B1 (ru) 2016-06-30
EA201190161A1 (ru) 2012-02-28
WO2010097243A2 (fr) 2010-09-02
HRP20161730T1 (hr) 2017-02-24
PL2400954T3 (pl) 2017-04-28
EP2400954A2 (fr) 2012-01-04
DK2400954T3 (en) 2017-01-16
SI2400954T1 (sl) 2017-02-28
EP2400954B1 (fr) 2016-09-28
ES2609061T3 (es) 2017-04-18

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