WO2008117814A1 - 大腸送達用経口製剤 - Google Patents

大腸送達用経口製剤 Download PDF

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Publication number
WO2008117814A1
WO2008117814A1 PCT/JP2008/055652 JP2008055652W WO2008117814A1 WO 2008117814 A1 WO2008117814 A1 WO 2008117814A1 JP 2008055652 W JP2008055652 W JP 2008055652W WO 2008117814 A1 WO2008117814 A1 WO 2008117814A1
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Prior art keywords
pharmaceutical preparation
oral pharmaceutical
colon
drug
specific delivery
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PCT/JP2008/055652
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English (en)
French (fr)
Inventor
Hiroyuki Kubo
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Teikoku Seiyaku Co., Ltd.
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.)
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Publication date
Application filed by Teikoku Seiyaku Co., Ltd. filed Critical Teikoku Seiyaku Co., Ltd.
Priority to AU2008230364A priority Critical patent/AU2008230364A1/en
Priority to EP08738876.5A priority patent/EP2143424A4/en
Priority to CA002684655A priority patent/CA2684655A1/en
Priority to CN200880017544A priority patent/CN101677958A/zh
Priority to JP2009506354A priority patent/JPWO2008117814A1/ja
Priority to US12/450,438 priority patent/US20100209520A1/en
Publication of WO2008117814A1 publication Critical patent/WO2008117814A1/ja

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/04Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/06Antiabortive agents; Labour repressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/38Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/12Antidiuretics, e.g. drugs for diabetes insipidus

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hematology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Obesity (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Immunology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

 本発明は、優れた大腸への薬物送達能を有する経口製剤に関し、より詳しくは、本発明は、薬物を大腸に送達するための経口製剤であって、薬学的に許容可能な賦形剤から少なくともなる核と、該核を被覆する、薬物を含む内層と、該内層を被覆する、pH6.6以下で溶解または膨潤しうる陽イオン性ポリマーを含む中間層と、該中間層を被覆する、pH7.0以上で溶解しうる陰イオン性ポリマーを含む外層とを含んでなる、経口製剤に関する。
PCT/JP2008/055652 2007-03-26 2008-03-26 大腸送達用経口製剤 WO2008117814A1 (ja)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AU2008230364A AU2008230364A1 (en) 2007-03-26 2008-03-26 Oral pharmaceutical preparation for colon-specific delivery
EP08738876.5A EP2143424A4 (en) 2007-03-26 2008-03-26 ORAL PHARMACEUTICAL PREPARATION FOR SPECIFIC DELIVERY TO THE COLON
CA002684655A CA2684655A1 (en) 2007-03-26 2008-03-26 Oral pharmaceutical preparation for colon-specific delivery
CN200880017544A CN101677958A (zh) 2007-03-26 2008-03-26 用于结肠-特异性递送的口服药物制剂
JP2009506354A JPWO2008117814A1 (ja) 2007-03-26 2008-03-26 大腸送達用経口製剤
US12/450,438 US20100209520A1 (en) 2007-03-26 2008-03-26 Oral pharmaceutical preparation for colon-specific delivery

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US90723007P 2007-03-26 2007-03-26
US60/907,230 2007-03-26

Publications (1)

Publication Number Publication Date
WO2008117814A1 true WO2008117814A1 (ja) 2008-10-02

Family

ID=39788547

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/055652 WO2008117814A1 (ja) 2007-03-26 2008-03-26 大腸送達用経口製剤

Country Status (8)

Country Link
US (1) US20100209520A1 (ja)
EP (1) EP2143424A4 (ja)
JP (1) JPWO2008117814A1 (ja)
KR (1) KR20090122489A (ja)
CN (1) CN101677958A (ja)
AU (1) AU2008230364A1 (ja)
CA (1) CA2684655A1 (ja)
WO (1) WO2008117814A1 (ja)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014529630A (ja) * 2011-09-07 2014-11-13 ザウラー−ブロシュ、ローラント 哺乳類の消化管における一つあるいは複数の物質の放出制御製剤
JP2016517425A (ja) * 2013-03-14 2016-06-16 セラバイオーム,エルエルシー プロバイオティクス生物及び/又は治療剤の標的化胃腸管デリバリー
JP2020534290A (ja) * 2017-09-20 2020-11-26 ティロッツ ファーマ アーゲーTillotts Pharma Ag 溶液/懸濁液層状化による抗体を含む固形剤形の調製
JP2022503581A (ja) * 2018-08-24 2022-01-12 ドクトル ファルク ファルマ ゲーエムベーハー 有効成分を遠位結腸で遅延放出する多層構造ペレット剤

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10653631B2 (en) 2011-09-07 2020-05-19 Roland SAUR-BROSCH Optimal colon targeting technology
GB201202433D0 (en) 2012-02-13 2012-03-28 Diurnal Ltd Controlled drug release
EP2830599B1 (en) * 2012-03-29 2018-08-15 Therabiome, Llc Gastrointestinal site-specific oral vaccination formulations active on the ileum and appendix
EP2659881B1 (en) * 2012-04-30 2017-11-29 Tillotts Pharma Ag A delayed release drug formulation
MA38847B2 (fr) 2013-10-29 2021-02-26 Tillotts Pharma Ag Formulation médicamenteuse à libération retardée
US10182993B2 (en) 2015-04-06 2019-01-22 Patheon Softgels Inc. Compositions for colonic delivery of drugs
EP3346996A4 (en) 2015-09-11 2019-04-17 Sun Pharmaceutical Industries Limited ORAL PHARMACEUTICAL PHARMACEUTICAL FORM OF BUDESONID
WO2017173068A1 (en) * 2016-03-30 2017-10-05 University Of Maryland, Baltimore Microparticulate system for colonic drug delivery
US20180272042A1 (en) * 2017-03-22 2018-09-27 Brown University Drug-polymer film for controlled local delivery at tissue-device interface
KR102336720B1 (ko) * 2017-08-03 2021-12-08 주식회사 씨티씨바이오 유산균을 함유하는 장용성 과립 및 이의 제조방법
EP3703515A1 (en) * 2017-11-03 2020-09-09 DSM IP Assets B.V. New delivery system

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JPS6327424A (ja) * 1986-07-17 1988-02-05 Shionogi & Co Ltd 徐放性製剤およびその製造法
JPS63301816A (ja) * 1987-01-29 1988-12-08 Takeda Chem Ind Ltd 有核顆粒およびその製造法
WO1994010983A1 (en) * 1992-11-06 1994-05-26 Hisamitsu Pharmaceutical Co., Inc. Peroral pharmaceutical preparation releasable in lower digestive tract
JPH0710745A (ja) * 1993-06-22 1995-01-13 Tanabe Seiyaku Co Ltd 放出開始時間制御型腸デリバリー経口製剤
JP2821952B2 (ja) 1992-11-06 1998-11-05 久光製薬株式会社 下部消化管放出性の経口医薬製剤
JP2967492B2 (ja) 1989-05-11 1999-10-25 中外製薬株式会社 腸内適所放出経口製剤
JP3185206B2 (ja) 1995-07-20 2001-07-09 田辺製薬株式会社 消化管下部放出型被覆カプセル製剤
JP2002080398A (ja) * 2000-07-14 2002-03-19 Roberto Valducci pHに依存する多相的な放出を伴う経口用の固体の薬学的組成物

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Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6327424A (ja) * 1986-07-17 1988-02-05 Shionogi & Co Ltd 徐放性製剤およびその製造法
JPS63301816A (ja) * 1987-01-29 1988-12-08 Takeda Chem Ind Ltd 有核顆粒およびその製造法
JP2967492B2 (ja) 1989-05-11 1999-10-25 中外製薬株式会社 腸内適所放出経口製剤
WO1994010983A1 (en) * 1992-11-06 1994-05-26 Hisamitsu Pharmaceutical Co., Inc. Peroral pharmaceutical preparation releasable in lower digestive tract
JP2821952B2 (ja) 1992-11-06 1998-11-05 久光製薬株式会社 下部消化管放出性の経口医薬製剤
JPH0710745A (ja) * 1993-06-22 1995-01-13 Tanabe Seiyaku Co Ltd 放出開始時間制御型腸デリバリー経口製剤
JP3185206B2 (ja) 1995-07-20 2001-07-09 田辺製薬株式会社 消化管下部放出型被覆カプセル製剤
JP2002080398A (ja) * 2000-07-14 2002-03-19 Roberto Valducci pHに依存する多相的な放出を伴う経口用の固体の薬学的組成物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2143424A4

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014529630A (ja) * 2011-09-07 2014-11-13 ザウラー−ブロシュ、ローラント 哺乳類の消化管における一つあるいは複数の物質の放出制御製剤
JP2018065846A (ja) * 2011-09-07 2018-04-26 ザウラー−ブロシュ、ローラント 哺乳類の消化管における一つあるいは複数の物質の放出制御製剤
JP2016517425A (ja) * 2013-03-14 2016-06-16 セラバイオーム,エルエルシー プロバイオティクス生物及び/又は治療剤の標的化胃腸管デリバリー
JP2019077705A (ja) * 2013-03-14 2019-05-23 セラバイオーム,エルエルシー プロバイオティクス生物及び/又は治療剤の標的化胃腸管デリバリー
JP2020534290A (ja) * 2017-09-20 2020-11-26 ティロッツ ファーマ アーゲーTillotts Pharma Ag 溶液/懸濁液層状化による抗体を含む固形剤形の調製
JP7204743B2 (ja) 2017-09-20 2023-01-16 ティロッツ ファーマ アーゲー 溶液/懸濁液層状化による抗体を含む固形剤形の調製
JP2022503581A (ja) * 2018-08-24 2022-01-12 ドクトル ファルク ファルマ ゲーエムベーハー 有効成分を遠位結腸で遅延放出する多層構造ペレット剤
JP7374992B2 (ja) 2018-08-24 2023-11-07 ドクトル ファルク ファルマ ゲーエムベーハー 有効成分を遠位結腸で遅延放出する多層構造ペレット剤

Also Published As

Publication number Publication date
JPWO2008117814A1 (ja) 2010-07-15
EP2143424A1 (en) 2010-01-13
EP2143424A4 (en) 2013-07-31
US20100209520A1 (en) 2010-08-19
KR20090122489A (ko) 2009-11-30
CA2684655A1 (en) 2008-10-02
CN101677958A (zh) 2010-03-24
AU2008230364A1 (en) 2008-10-02

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