KR101367814B1 - 위장체류 제제 및 이의 제조 방법 - Google Patents

위장체류 제제 및 이의 제조 방법 Download PDF

Info

Publication number
KR101367814B1
KR101367814B1 KR1020087003902A KR20087003902A KR101367814B1 KR 101367814 B1 KR101367814 B1 KR 101367814B1 KR 1020087003902 A KR1020087003902 A KR 1020087003902A KR 20087003902 A KR20087003902 A KR 20087003902A KR 101367814 B1 KR101367814 B1 KR 101367814B1
Authority
KR
South Korea
Prior art keywords
weight
gelling agent
agent
weak
gastroretentive
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
KR1020087003902A
Other languages
English (en)
Korean (ko)
Other versions
KR20080048461A (ko
Inventor
마헨드라 차우다리
옴프라카쉬 디 찬드와니
라자쉬리 에스 옐레가온카
Original Assignee
에씨팜
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 에씨팜 filed Critical 에씨팜
Publication of KR20080048461A publication Critical patent/KR20080048461A/ko
Application granted granted Critical
Publication of KR101367814B1 publication Critical patent/KR101367814B1/ko
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Communicable Diseases (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Cosmetics (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
KR1020087003902A 2005-07-19 2006-07-19 위장체류 제제 및 이의 제조 방법 Expired - Fee Related KR101367814B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05291542.8 2005-07-19
EP05291542A EP1745775B1 (en) 2005-07-19 2005-07-19 Gastroretentive formulations and manufacturing process thereof.
PCT/IB2006/002636 WO2007010400A2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof

Publications (2)

Publication Number Publication Date
KR20080048461A KR20080048461A (ko) 2008-06-02
KR101367814B1 true KR101367814B1 (ko) 2014-02-27

Family

ID=35517256

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020087003902A Expired - Fee Related KR101367814B1 (ko) 2005-07-19 2006-07-19 위장체류 제제 및 이의 제조 방법

Country Status (12)

Country Link
US (1) US9629800B2 (enExample)
EP (2) EP1745775B1 (enExample)
JP (1) JP5199084B2 (enExample)
KR (1) KR101367814B1 (enExample)
CN (1) CN101237858B (enExample)
AT (1) ATE396710T1 (enExample)
AU (1) AU2006271314B2 (enExample)
BR (1) BRPI0612901B8 (enExample)
CA (1) CA2616081C (enExample)
DE (1) DE602005007205D1 (enExample)
RU (1) RU2376983C2 (enExample)
WO (1) WO2007010400A2 (enExample)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20080076382A (ko) * 2007-02-15 2008-08-20 (주)아모레퍼시픽 실로스타졸의 제어방출 제제 및 그 제조방법
CA2738114A1 (en) 2008-09-22 2010-04-08 Rubicon Research Private Limited Compositions exhibiting delayed transit through the gastrointestinal tract
FR2945947B1 (fr) 2009-05-29 2011-07-29 Flamel Tech Sa Compositions pharmaceutiques flottantes a liberation controlee
EP2457561A4 (en) 2009-07-06 2014-03-05 Kyorin Seiyaku Kk TABLET WITH HIGH STRUCTURE
EP2361615A1 (en) 2010-02-19 2011-08-31 Alfred E. Tiefenbacher GmbH & Co. KG Dipyridamole prolonged-release tablet
EP2544666A2 (en) 2010-03-09 2013-01-16 Council of Scientific and Industrial Research Gastroretentive, extended release composition of therapeutic agent
CN104258408B (zh) * 2010-03-31 2017-10-03 持田制药株式会社 易服用性固体制剂
CN101919817B (zh) * 2010-07-23 2012-05-30 山东齐都药业有限公司 一种拉呋替丁胃内滞留控制释放组合物
CA2847614C (en) 2011-09-30 2018-10-23 Mochida Pharmaceutical Co., Ltd. Easily dosable solid preparation
DE102012102414A1 (de) 2012-03-21 2013-10-10 Michael Dittgen Pharmazeutische Zusammensetzung für die einmal tägliche Anwendung antidiabetischer Arzneimittel wie Metformin mit Zwei-Puls-Freisetzung
WO2013168179A2 (en) * 2012-04-03 2013-11-14 Rubicon Research Private Limited Controlled release pharmaceutical formulations of antiviral agents
CN103110601B (zh) * 2013-02-04 2014-10-29 成都恒瑞制药有限公司 一种格列齐特胃漂浮片及其制备方法
FR3014692B1 (fr) * 2013-12-18 2016-01-29 Ethypharm Sa Compositions pharmaceutiques orales a retention gastrique.
TWI705814B (zh) * 2014-06-20 2020-10-01 美商梅琳塔有限責任公司 醫藥組成物及其用途
KR102414503B1 (ko) 2016-03-17 2022-06-29 티오제네시스 테라퓨틱스, 인크. 시스테아민의 조절 방출을 위한 조성물 및 시스테아민 민감성 장애의 전신 치료
CN107184560B (zh) * 2017-06-03 2021-02-02 寿光富康制药有限公司 二甲双胍胃滞留片及制备方法
US11612576B2 (en) 2017-09-20 2023-03-28 Thiogenesis Therapeutics, Inc. Methods for the treatment of cysteamine sensitive disorders
IL275312B2 (en) 2017-12-18 2024-09-01 Tris Pharma Inc Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
US11337919B2 (en) * 2017-12-18 2022-05-24 Tris Pharma, Inc. Modified release drug powder composition comprising gastro-retentive RAFT forming systems having trigger pulse drug release
US11337920B2 (en) 2017-12-18 2022-05-24 Tris Pharma, Inc. Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release
CN109602714B (zh) * 2018-12-29 2020-06-12 广东中润药物研发有限公司 一种利伐沙班胃滞留片及其制备方法
GB2599950A (en) * 2020-10-16 2022-04-20 Zentiva Ks Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same
CN117042629A (zh) * 2021-01-13 2023-11-10 杜邦营养美国公司 胃滞留药物递送系统

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4996222A (en) * 1986-08-01 1991-02-26 Smith Kline & French Laboratories Limited Pharmaceutical formulations
US6261601B1 (en) * 1997-09-19 2001-07-17 Ranbaxy Laboratories Limited Orally administered controlled drug delivery system providing temporal and spatial control

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61148115A (ja) * 1984-12-21 1986-07-05 Tooa Eiyoo Kk 難溶性薬物の徐放性製剤及びその製造法
FR2653337B1 (fr) * 1989-10-23 1992-02-07 Dow Corning Sa Element a liberation prolongee et procede pour le fabriquer.
US6635280B2 (en) 1997-06-06 2003-10-21 Depomed, Inc. Extending the duration of drug release within the stomach during the fed mode
ES2234139T3 (es) * 1997-08-11 2005-06-16 Alza Corporation Forma de dosificacion de un agente activo de liberacion prolongada adaptada para la retencion gastrica.
CA2320900C (en) * 1998-03-19 2009-10-27 Bristol-Myers Squibb Company Biphasic controlled release delivery system for high solubility pharmaceuticals and method
ID29843A (id) * 1998-09-14 2001-10-18 Ranbaxy Lab Ltd Sistem pemberian obat melalui mulut yang dikontrol secara teratur yang memberikan pengontrolan tempat dan bersifat sementara
US6797283B1 (en) 1998-12-23 2004-09-28 Alza Corporation Gastric retention dosage form having multiple layers
DE69927708T2 (de) * 1998-12-23 2006-07-06 Alza Corp., Mountain View Dosierungsformen, die poröse partikel enthalten
US6635281B2 (en) * 1998-12-23 2003-10-21 Alza Corporation Gastric retaining oral liquid dosage form
EA200200914A1 (ru) * 2000-03-03 2003-02-27 Рэнбакси Лабораториз Лимитед Система контроля дозирования для однократного ежедневного приема назначенного ципрофлоксацина
KR20040018394A (ko) * 2001-07-04 2004-03-03 썬 파마슈티컬 인더스트리스 리미티드 위 정체 제어되는 약물 전달 계
EP1509208A1 (en) * 2002-02-04 2005-03-02 Ranbaxy Laboratories Limited Hydrodynamically balancing oral drug delivery system with biphasic release
GB0205253D0 (en) * 2002-03-06 2002-04-17 Univ Gent Immediate release pharmaceutical granule compositions and a continuous process for making them
WO2003101431A1 (en) 2002-06-04 2003-12-11 J.B. Chemicals & Pharmaceuticals Ltd. Pharmaceutical composition for controlled drug delivery system
WO2005060942A1 (en) * 2003-12-19 2005-07-07 Aurobindo Pharma Ltd Extended release pharmaceutical composition of metformin

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4996222A (en) * 1986-08-01 1991-02-26 Smith Kline & French Laboratories Limited Pharmaceutical formulations
US6261601B1 (en) * 1997-09-19 2001-07-17 Ranbaxy Laboratories Limited Orally administered controlled drug delivery system providing temporal and spatial control

Also Published As

Publication number Publication date
US20080220060A1 (en) 2008-09-11
CA2616081C (en) 2013-09-10
WO2007010400A2 (en) 2007-01-25
RU2376983C2 (ru) 2009-12-27
KR20080048461A (ko) 2008-06-02
JP2009501777A (ja) 2009-01-22
AU2006271314B2 (en) 2011-07-07
CA2616081A1 (en) 2007-01-25
AU2006271314A1 (en) 2007-01-25
CN101237858A (zh) 2008-08-06
US9629800B2 (en) 2017-04-25
EP1904034A2 (en) 2008-04-02
BRPI0612901A2 (pt) 2010-12-07
BRPI0612901B8 (pt) 2021-05-25
CN101237858B (zh) 2012-07-04
DE602005007205D1 (de) 2008-07-10
EP1745775B1 (en) 2008-05-28
BRPI0612901B1 (pt) 2020-08-04
RU2008106220A (ru) 2009-08-27
HK1122729A1 (en) 2009-05-29
EP1745775A1 (en) 2007-01-24
WO2007010400A3 (en) 2007-04-05
JP5199084B2 (ja) 2013-05-15
ATE396710T1 (de) 2008-06-15

Similar Documents

Publication Publication Date Title
KR101367814B1 (ko) 위장체류 제제 및 이의 제조 방법
US20040052844A1 (en) Time-controlled, sustained release, pharmaceutical composition containing water-soluble resins
KR20090065524A (ko) 프로그래머블 부력전달기술
CZ20024216A3 (cs) Přípravky s chinolonovými antibiotiky s prodlouženým účinkem a způsob jejich výroby
CN106659794A (zh) 二甲双胍的缓释制剂及其制备方法
US20120034276A1 (en) Solid preparation
JP3110794B2 (ja) １，４−ジヒドロピリジン誘導体を含有する製剤
JP2024501051A (ja) 持続放出ウパダシチニブ配合物
MXPA06006677A (es) Formas de dosis de torasemida de liberacion sostenida.
AU2010228256A1 (en) Solid preparation
KR101925590B1 (ko) 개선된 생체이용률을 갖는 페노피브릭산 제제
JP2006507298A (ja) 経口持続放出型錠剤、ならびにその製造法および使用法
WO2020101586A1 (en) Controlled release propiverine formulations
JP3597823B2 (ja) 固形製剤
KR20050114921A (ko) 방출제어형 약제학적 조성물
CA2503380A1 (en) Pharmaceutical compositions containing venlafaxine
US20080206338A1 (en) Controlled release formulations of an alpha-adrenergic receptor antagonist
JP2003048828A (ja) 有効成分として塩酸ビュープロピオンを含む、改良型放出医薬品組成物
HK1122729B (en) Gastroretentive formulations and manufacturing process thereof
JP2008115083A (ja) 塩酸トラマドール含有コーティング顆粒
WO2006136927A1 (en) Extended release formulations comprising venlafaxine

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

R18-X000 Changes to party contact information recorded

St.27 status event code: A-3-3-R10-R18-oth-X000

A201 Request for examination
AMND Amendment
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

AMND Amendment
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E601 Decision to refuse application
PE0601 Decision on rejection of patent

St.27 status event code: N-2-6-B10-B15-exm-PE0601

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

AMND Amendment
J201 Request for trial against refusal decision
P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PJ0201 Trial against decision of rejection

St.27 status event code: A-3-3-V10-V11-apl-PJ0201

PB0901 Examination by re-examination before a trial

St.27 status event code: A-6-3-E10-E12-rex-PB0901

B701 Decision to grant
PB0701 Decision of registration after re-examination before a trial

St.27 status event code: A-3-4-F10-F13-rex-PB0701

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

FPAY Annual fee payment

Payment date: 20170213

Year of fee payment: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

FPAY Annual fee payment

Payment date: 20180212

Year of fee payment: 5

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

FPAY Annual fee payment

Payment date: 20190207

Year of fee payment: 6

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 6

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 7

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 8

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 9

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 10

PC1903 Unpaid annual fee

St.27 status event code: A-4-4-U10-U13-oth-PC1903

Not in force date: 20240221

Payment event data comment text: Termination Category : DEFAULT_OF_REGISTRATION_FEE

PC1903 Unpaid annual fee

St.27 status event code: N-4-6-H10-H13-oth-PC1903

Ip right cessation event data comment text: Termination Category : DEFAULT_OF_REGISTRATION_FEE

Not in force date: 20240221