WO2012010669A3 - Arzneimittel zur oralen verabreichung umfassend ein gemisch aus silodosin und einem basischen copolymer - Google Patents

Arzneimittel zur oralen verabreichung umfassend ein gemisch aus silodosin und einem basischen copolymer Download PDF

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Publication number
WO2012010669A3
WO2012010669A3 PCT/EP2011/062566 EP2011062566W WO2012010669A3 WO 2012010669 A3 WO2012010669 A3 WO 2012010669A3 EP 2011062566 W EP2011062566 W EP 2011062566W WO 2012010669 A3 WO2012010669 A3 WO 2012010669A3
Authority
WO
WIPO (PCT)
Prior art keywords
silodosin
mixture
oral administration
medicinal drug
basic copolymer
Prior art date
Application number
PCT/EP2011/062566
Other languages
English (en)
French (fr)
Other versions
WO2012010669A2 (de
Inventor
Katrin Rimkus
Sandra Brueck
Original Assignee
Ratiopharm Gmbh
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 Ratiopharm Gmbh filed Critical Ratiopharm Gmbh
Priority to EP11735435.7A priority Critical patent/EP2595607A2/de
Priority to JP2013520157A priority patent/JP2013532651A/ja
Publication of WO2012010669A2 publication Critical patent/WO2012010669A2/de
Publication of WO2012010669A3 publication Critical patent/WO2012010669A3/de

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Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • 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

Abstract

Die Erfindung betrifft ein Arzneimittel zur oralen Verabreichung umfassend ein Gemisch aus Silodosin bzw. einem pharmazeutisch verträglichen Salz davon und einem basischen Copolymer. Des Weiteren betrifft die vorliegende Erfindung ein Verfahren zur Herstellung dieses Arzneimittels.
PCT/EP2011/062566 2010-07-23 2011-07-21 Arzneimittel zur oralen verabreichung umfassend ein gemisch aus silodosin und einem basischen copolymer WO2012010669A2 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP11735435.7A EP2595607A2 (de) 2010-07-23 2011-07-21 Arzneimittel zur oralen verabreichung umfassend ein gemisch aus silodosin und einem basischen copolymer
JP2013520157A JP2013532651A (ja) 2010-07-23 2011-07-21 シロドシンと塩基性コポリマーとの混合物を含む経口投与用医薬品

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10170649.7 2010-07-23
EP10170649 2010-07-23

Publications (2)

Publication Number Publication Date
WO2012010669A2 WO2012010669A2 (de) 2012-01-26
WO2012010669A3 true WO2012010669A3 (de) 2012-07-26

Family

ID=44628851

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/062566 WO2012010669A2 (de) 2010-07-23 2011-07-21 Arzneimittel zur oralen verabreichung umfassend ein gemisch aus silodosin und einem basischen copolymer

Country Status (3)

Country Link
EP (1) EP2595607A2 (de)
JP (1) JP2013532651A (de)
WO (1) WO2012010669A2 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013061338A1 (en) * 2011-08-24 2013-05-02 Cadila Healthcare Limited Pharmaceutical compositions of silodosin
WO2014006635A2 (en) * 2012-07-02 2014-01-09 Hetero Research Foundation Solid oral compositions of silodosin
CN105142633A (zh) * 2013-03-26 2015-12-09 橘生药品工业株式会社 西洛多辛苦味被掩蔽的口服给药制剂
KR102206104B1 (ko) * 2014-04-03 2021-01-22 한미약품 주식회사 실로도신을 포함하는 과립물, 및 이를 포함하는 약학적 조성물 및 제형
WO2016051782A1 (ja) * 2014-09-30 2016-04-07 キッセイ薬品工業株式会社 苦味を有する薬剤の苦味をマスキングした経口投与製剤
JP2016138073A (ja) * 2015-01-29 2016-08-04 大原薬品工業株式会社 安定性を改善した、シロドシンを含有する錠剤
JP2017014119A (ja) * 2015-06-26 2017-01-19 東和薬品株式会社 経口医薬組成物
JP7023600B2 (ja) * 2016-10-17 2022-02-22 東和薬品株式会社 シロドシン含有医薬組成物とその製造方法
EP3354283B1 (de) 2017-06-20 2019-08-07 Alfred E. Tiefenbacher (GmbH & Co. KG) Pharmazeutische kapselzusammensetzung mit silodosin
JP2019070045A (ja) * 2019-02-06 2019-05-09 大原薬品工業株式会社 安定性を改善した、シロドシンを含有する錠剤
CN112933084A (zh) * 2019-12-10 2021-06-11 广东东阳光药业有限公司 一种赛洛多辛组合物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1574215A1 (de) * 2002-12-16 2005-09-14 Kissei Pharmaceutical Co., Ltd. Feste arznei zur oralen verabreichung
WO2006020111A1 (en) * 2004-07-19 2006-02-23 Par Pharmaceutical, Inc. Formulation stabilizer for proton pump inhibitors
JP4324266B2 (ja) * 1999-02-26 2009-09-02 キッセイ薬品工業株式会社 α１Ａアドレナリン受容体の変異体、当該変異体を用いた測定方法及び前立腺肥大に伴う排尿困難症治療剤

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69319551T2 (de) 1992-12-02 1998-10-29 Kissei Pharmaceutical Indolin Verbindungen zur Behandlung von Dysurien
DE19653605C2 (de) 1996-12-20 2002-11-28 Roehm Gmbh Haft- und Bindemittel für dermale oder transdermale Therapiesysteme und dessen Verwendung zur Herstellung eines transdermalen Therapiesystems
UA78854C2 (en) 2002-09-06 2007-04-25 Kissei Pharmaceutical Crystal for an oral solid drug and oral solid drug for dysuria treatment containing the same
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4324266B2 (ja) * 1999-02-26 2009-09-02 キッセイ薬品工業株式会社 α１Ａアドレナリン受容体の変異体、当該変異体を用いた測定方法及び前立腺肥大に伴う排尿困難症治療剤
EP1574215A1 (de) * 2002-12-16 2005-09-14 Kissei Pharmaceutical Co., Ltd. Feste arznei zur oralen verabreichung
WO2006020111A1 (en) * 2004-07-19 2006-02-23 Par Pharmaceutical, Inc. Formulation stabilizer for proton pump inhibitors

Also Published As

Publication number Publication date
JP2013532651A (ja) 2013-08-19
EP2595607A2 (de) 2013-05-29
WO2012010669A2 (de) 2012-01-26

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