WO2009008487A1 - 被覆製剤 - Google Patents

被覆製剤 Download PDF

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Publication number
WO2009008487A1
WO2009008487A1 PCT/JP2008/062523 JP2008062523W WO2009008487A1 WO 2009008487 A1 WO2009008487 A1 WO 2009008487A1 JP 2008062523 W JP2008062523 W JP 2008062523W WO 2009008487 A1 WO2009008487 A1 WO 2009008487A1
Authority
WO
WIPO (PCT)
Prior art keywords
pioglytazone
preparation
salt
individual
coating layer
Prior art date
Application number
PCT/JP2008/062523
Other languages
English (en)
French (fr)
Inventor
Hiroto Bando
Yoshihiro Omachi
Kenichiro Kiyoshima
Original Assignee
Takeda Pharmaceutical Company Limited
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 Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Priority to EP08791071.7A priority Critical patent/EP2172200B1/en
Priority to US12/452,587 priority patent/US9427434B2/en
Priority to JP2009522677A priority patent/JP5350240B2/ja
Publication of WO2009008487A1 publication Critical patent/WO2009008487A1/ja

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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

　本発明は、ピオグリタゾン又はその塩を活性成分とする製剤であって、ピオグリタゾンのバイオアベイラビリティーが高く、かつ薬物血中濃度の個体間バラツキが少ない製剤を提供する。また、本発明は、保存時の着色変化が抑制された製剤を提供する。該製剤は、２０°Cにおける水に対する溶解度が１０ｍｇ／ｍＬ以上であり、かつ２５°Cにおける第一酸解離定数Ｋａ１の負の常用対数ｐＫａ１が５以下である、製薬上許容される有機酸を含む核と、ピオグリタゾン又はその塩を含む被覆層とを含む。該被覆層はマンニトール又はトレハロースをさらに含み得る。
PCT/JP2008/062523 2007-07-12 2008-07-10 被覆製剤 WO2009008487A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP08791071.7A EP2172200B1 (en) 2007-07-12 2008-07-10 Coated preparation
US12/452,587 US9427434B2 (en) 2007-07-12 2008-07-10 Coated preparation
JP2009522677A JP5350240B2 (ja) 2007-07-12 2008-07-10 被覆製剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007-183749 2007-07-12
JP2007183749 2007-07-12

Publications (1)

Publication Number Publication Date
WO2009008487A1 true WO2009008487A1 (ja) 2009-01-15

Family

ID=40228658

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/062523 WO2009008487A1 (ja) 2007-07-12 2008-07-10 被覆製剤

Country Status (6)

Country Link
US (1) US9427434B2 (ja)
EP (1) EP2172200B1 (ja)
JP (1) JP5350240B2 (ja)
AR (1) AR067491A1 (ja)
TW (1) TW200914006A (ja)
WO (1) WO2009008487A1 (ja)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013503876A (ja) * 2009-09-02 2013-02-04 ジオファーム オンコロジー インク インジブリンに関する薬学的組成物
JP2013506648A (ja) * 2009-09-30 2013-02-28 メルク シャープ エンド ドーム リミテッド ｃ−ＭＥＴキナーゼ阻害剤の製剤
JP2013521332A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド パルス状薬剤放出
JP2014530802A (ja) * 2011-10-21 2014-11-20 武田薬品工業株式会社 徐放性製剤

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8846315B2 (en) 2008-08-12 2014-09-30 Zinfandel Pharmaceuticals, Inc. Disease risk factors and methods of use
SI2324126T1 (sl) 2008-08-12 2014-07-31 Zinfandel Pharmaceuticals, Inc. Postopek identifikacije dejavnikov tveganja za Alzheimerjevo bolezen
GEP201706786B (en) 2011-01-10 2017-12-11 Takeda Pharmaceuticals Co Methods and drug products for treating alzheimer's disease
EP2765855A4 (en) * 2011-10-12 2015-03-25 Merck Sharp & Dohme PHARMACEUTICAL COMPOSITIONS FOR DISPERSION INHIBITION
WO2013106526A1 (en) * 2012-01-10 2013-07-18 Teva Pharmaceutical Industries Ltd. Saxagliptin parmaceutical formulations
BR112015030617B1 (pt) * 2013-06-17 2020-12-22 Nippon Soda Co., Ltd formulação sólida

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WO1987006130A1 (fr) * 1986-04-16 1987-10-22 Laboratoires Delagrange Comprimes a matrice
WO1993009781A1 (en) * 1991-11-14 1993-05-27 Ss Pharmaceutical Co., Ltd. Sustained-release trapidil tablet
JPH05262767A (ja) * 1992-03-19 1993-10-12 Takeda Chem Ind Ltd 持続性製剤
WO1997010224A1 (en) 1995-09-13 1997-03-20 Takeda Chemical Industries, Ltd. Benzoxazepine compounds, their production and use as lipid lowering agents
WO1998045285A1 (en) 1997-04-04 1998-10-15 Merck & Co., Inc. Somatostatin agonists
WO1998044921A1 (en) 1997-04-04 1998-10-15 Merck & Co., Inc. Somatostatin agonists
WO1999022735A1 (en) 1997-10-30 1999-05-14 Merck & Co., Inc. Somatostatin agonists
WO2001014372A2 (en) 1999-08-25 2001-03-01 Takeda Chemical Industries, Ltd. Oxazole and thiazole derivatives as neurotrophin production/secretion promoting agent
WO2001025228A1 (fr) 1999-10-07 2001-04-12 Tadeka Chemical Industries, Ltd. Derives d'amines
WO2001082925A1 (fr) 2000-04-28 2001-11-08 Takeda Chemical Industries, Ltd. Antagonistes de l'hormone concentrant la melanine
WO2001087834A1 (fr) 2000-05-16 2001-11-22 Takeda Chemical Industries, Ltd. Antagoniste de l'hormone de concentration de la melanine
WO2003042204A1 (fr) 2001-10-19 2003-05-22 Takeda Chemical Industries, Ltd. Derive d'amine
WO2003055525A1 (fr) * 2001-12-25 2003-07-10 Takeda Chemical Industries, Ltd. Preparations contenant un acide
WO2003074032A1 (de) * 2002-03-07 2003-09-12 Boehringer Ingelheim Pharma Gmbh & Co. Kg Oral zu applizierende darreichungsform für schwerlösliche basische wirkstoffe
WO2004006921A1 (ja) * 2002-07-11 2004-01-22 Takeda Pharmaceutical Company Limited 被覆製剤の製造法
WO2004067001A1 (ja) * 2003-01-29 2004-08-12 Takeda Pharmaceutical Company Limited 被覆製剤の製造法

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US5026560A (en) 1987-01-29 1991-06-25 Takeda Chemical Industries, Ltd. Spherical granules having core and their production
JPH0832625B2 (ja) * 1987-01-29 1996-03-29 武田薬品工業株式会社 有核顆粒およびその製造法
US5952509A (en) 1996-06-27 1999-09-14 Takeda Chemical Industries, Ltd. Production of benzaldehyde compounds
US20010056177A1 (en) * 1997-12-20 2001-12-27 Becker Nathaniel T. Matrix granule
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JP4284017B2 (ja) 2000-10-06 2009-06-24 武田薬品工業株式会社 固形製剤
CA2454778A1 (en) * 2001-07-06 2003-01-16 Computer Associates Think, Inc. System and method for managing object based clusters
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US20050074494A1 (en) * 2003-10-06 2005-04-07 Xiu-Xiu Cheng Itraconazole immediate release formulation
US20060089387A1 (en) * 2004-10-26 2006-04-27 Le Huang Stabilized pharmaceutical composition comprising antidiabetic agent
CL2007001194A1 (es) * 2006-04-27 2008-01-04 Takeda Pharmaceutical Preparacion farmaceutica solida que comprende particulas que comprenden (i) particulas de nucleo con excipiente y (ii) pioglitazona o una sal de la misma y un polimero soluble en acido, como copolimero de aminoalquil metacrilato e o dietilaminoacetato de polivinilacetal, ambos recubriendo el nucleo

Patent Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987006130A1 (fr) * 1986-04-16 1987-10-22 Laboratoires Delagrange Comprimes a matrice
WO1993009781A1 (en) * 1991-11-14 1993-05-27 Ss Pharmaceutical Co., Ltd. Sustained-release trapidil tablet
JPH05262767A (ja) * 1992-03-19 1993-10-12 Takeda Chem Ind Ltd 持続性製剤
WO1997010224A1 (en) 1995-09-13 1997-03-20 Takeda Chemical Industries, Ltd. Benzoxazepine compounds, their production and use as lipid lowering agents
WO1998045285A1 (en) 1997-04-04 1998-10-15 Merck & Co., Inc. Somatostatin agonists
WO1998044921A1 (en) 1997-04-04 1998-10-15 Merck & Co., Inc. Somatostatin agonists
WO1999022735A1 (en) 1997-10-30 1999-05-14 Merck & Co., Inc. Somatostatin agonists
WO2001014372A2 (en) 1999-08-25 2001-03-01 Takeda Chemical Industries, Ltd. Oxazole and thiazole derivatives as neurotrophin production/secretion promoting agent
WO2001025228A1 (fr) 1999-10-07 2001-04-12 Tadeka Chemical Industries, Ltd. Derives d'amines
WO2001082925A1 (fr) 2000-04-28 2001-11-08 Takeda Chemical Industries, Ltd. Antagonistes de l'hormone concentrant la melanine
WO2001087834A1 (fr) 2000-05-16 2001-11-22 Takeda Chemical Industries, Ltd. Antagoniste de l'hormone de concentration de la melanine
WO2003042204A1 (fr) 2001-10-19 2003-05-22 Takeda Chemical Industries, Ltd. Derive d'amine
WO2003055525A1 (fr) * 2001-12-25 2003-07-10 Takeda Chemical Industries, Ltd. Preparations contenant un acide
WO2003074032A1 (de) * 2002-03-07 2003-09-12 Boehringer Ingelheim Pharma Gmbh & Co. Kg Oral zu applizierende darreichungsform für schwerlösliche basische wirkstoffe
JP2005526738A (ja) 2002-03-07 2005-09-08 ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト 低溶解度の薬物を経口投与するための投与剤形
WO2004006921A1 (ja) * 2002-07-11 2004-01-22 Takeda Pharmaceutical Company Limited 被覆製剤の製造法
WO2004067001A1 (ja) * 2003-01-29 2004-08-12 Takeda Pharmaceutical Company Limited 被覆製剤の製造法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
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See also references of EP2172200A4 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013503876A (ja) * 2009-09-02 2013-02-04 ジオファーム オンコロジー インク インジブリンに関する薬学的組成物
JP2013506648A (ja) * 2009-09-30 2013-02-28 メルク シャープ エンド ドーム リミテッド ｃ−ＭＥＴキナーゼ阻害剤の製剤
JP2013521332A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド パルス状薬剤放出
JP2016040309A (ja) * 2010-03-05 2016-03-24 ユニヴァーシティー オヴ ストラスクライド パルス状薬剤放出
JP2014530802A (ja) * 2011-10-21 2014-11-20 武田薬品工業株式会社 徐放性製剤

Also Published As

Publication number Publication date
TW200914006A (en) 2009-04-01
JP5350240B2 (ja) 2013-11-27
EP2172200A1 (en) 2010-04-07
EP2172200A4 (en) 2010-07-28
US9427434B2 (en) 2016-08-30
US20100166853A1 (en) 2010-07-01
JPWO2009008487A1 (ja) 2010-09-09
EP2172200B1 (en) 2015-09-16
AR067491A1 (es) 2009-10-14

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