JP5560268B2 - 胃保持型医薬剤形 - Google Patents

胃保持型医薬剤形 Download PDF

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Publication number
JP5560268B2
JP5560268B2 JP2011514137A JP2011514137A JP5560268B2 JP 5560268 B2 JP5560268 B2 JP 5560268B2 JP 2011514137 A JP2011514137 A JP 2011514137A JP 2011514137 A JP2011514137 A JP 2011514137A JP 5560268 B2 JP5560268 B2 JP 5560268B2
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Japan
Prior art keywords
polymer
dosage form
pharmaceutical dosage
unit
gastric
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JP2011514137A
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English (en)
Japanese (ja)
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JP2012504551A (ja
JP2012504551A5 (enExample
Inventor
ビネス・ピレイ
ヤヒャ・チョーナラ
カラー・マーフィー
サラシュニー・モーニサミ
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University of the Witwatersrand
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University of the Witwatersrand
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    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/525—Isoalloxazines, e.g. riboflavins, vitamin B2
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2011514137A 2008-06-19 2009-06-03 胃保持型医薬剤形 Expired - Fee Related JP5560268B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ZA200710997 2008-06-19
ZA2007/10997 2008-06-19
PCT/IB2009/005828 WO2009153632A1 (en) 2008-06-19 2009-06-03 A gastroretentive pharmaceutical dosage form

Publications (3)

Publication Number Publication Date
JP2012504551A JP2012504551A (ja) 2012-02-23
JP2012504551A5 JP2012504551A5 (enExample) 2012-09-06
JP5560268B2 true JP5560268B2 (ja) 2014-07-23

Family

ID=44309136

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011514137A Expired - Fee Related JP5560268B2 (ja) 2008-06-19 2009-06-03 胃保持型医薬剤形

Country Status (5)

Country Link
US (1) US8778396B2 (enExample)
EP (1) EP2306983A1 (enExample)
JP (1) JP5560268B2 (enExample)
WO (1) WO2009153632A1 (enExample)
ZA (1) ZA200903854B (enExample)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0914080A2 (pt) 2008-10-08 2015-10-27 Bioplus Life Sciences Pvt Ltda "sistema de liberação de dosagem controlada, método de administração e processo de preparação do mesmo"
US20110212189A1 (en) * 2009-11-01 2011-09-01 Adeona Pharmaceuticals, Inc. Gastroretentive oral high dose zinc preparations
EP2444064A1 (en) * 2010-10-22 2012-04-25 Meliatys Process for making multiparticulate gastroretentive dosage forms
US8589775B2 (en) * 2011-03-14 2013-11-19 Infineon Technologies Ag Error tolerant flip-flops
CN104666267B (zh) * 2015-03-27 2017-08-08 康普药业股份有限公司 一种阿昔洛韦药物组合物
CN113197851A (zh) 2015-05-06 2021-08-03 辛纳吉勒公司 包含药物粒子的药用悬浮液、用于其配给的装置、以及其使用方法
MX392606B (es) 2016-03-17 2025-03-24 Thiogenesis Therapeutics Inc Composiciones para la liberacion controlada de cisteamina y el tratamiento sistemico de trastornos sensibles a la cisteamina.
WO2019060634A1 (en) 2017-09-20 2019-03-28 Thiogenesis Therapeutics, Inc. METHODS OF TREATING CYSTEAMINE SENSITIVE DISORDERS
US12514818B2 (en) 2017-12-18 2026-01-06 Tris Pharma, Inc. Pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
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
AU2018388577B2 (en) * 2017-12-18 2024-06-06 Tris Pharma, Inc. Modified release drug powder composition comprising gastro-retentive raft forming systems having trigger pulse drug release
US11666546B2 (en) 2017-12-18 2023-06-06 Tris Pharma, Inc GHB pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
US10835489B2 (en) 2018-03-09 2020-11-17 University Of Saskatchewan Modified release formulations of mycophenolate mofetil
JP2021529158A (ja) * 2018-06-19 2021-10-28 ナショナル ユニバーシティー オブ シンガポールＮａｔｉｏｎａｌ Ｕｎｉｖｅｒｓｉｔｙ ｏｆ Ｓｉｎｇａｐｏｒｅ 様々な適応症についての生物学的利用能を向上させるための５−ヒドロキシトリプトファンの製剤
CN109925289B (zh) * 2019-04-11 2021-05-25 海南普利制药股份有限公司 地氯雷他定分散片
EP3968980A1 (en) 2019-05-14 2022-03-23 Clexio Biosciences Ltd. Treatment of nocturnal symptoms and morning akinesia in subjects with parkinson's disease
WO2022195476A1 (en) 2021-03-15 2022-09-22 Clexio Biosciences Ltd. Gastroretentive devices for assessment of intragastric conditions
AU2022320730A1 (en) 2021-07-30 2024-03-14 Evecxia Therapeutics, Inc. 5-hydroxytryptophan gastroretentive dosage forms
US12409163B2 (en) 2021-07-30 2025-09-09 Evecxia Therapeutics, Inc. Method of enhancing 5-hydroxytryptophan (5-HTP) exposure
US11779567B2 (en) 2021-10-14 2023-10-10 Evecxia Therapeutics, Inc. Method for optimizing 5-hydroxytryptamine function in the brain for therapeutic purposes

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE302597T1 (de) * 1997-06-06 2005-09-15 Depomed Inc Im magen verweilende orale dosierungsformen von wasserlöslichen arzneistoffen mit kontrollierter freisetzung
AP1659A (en) * 1998-09-14 2006-09-06 Ranbaxy Laboratories Ltd Orally administered controlled drug delivery system providing temporal and spatial control.
US6797283B1 (en) * 1998-12-23 2004-09-28 Alza Corporation Gastric retention dosage form having multiple layers
US7674480B2 (en) * 2000-06-23 2010-03-09 Teva Pharmaceutical Industries Ltd. Rapidly expanding composition for gastric retention and controlled release of therapeutic agents, and dosage forms including the composition
US20050064027A1 (en) * 2001-12-15 2005-03-24 Spherics, Inc. Bioadhesive drug delivery system with enhanced gastric retention
JP2004002320A (ja) * 2002-03-04 2004-01-08 Medorekkusu:Kk 生体内で相転移する液状マトリックスおよび液状経口製剤
WO2005079752A2 (en) * 2004-02-11 2005-09-01 Rubicon Research Private Limited Controlled release pharmaceutical compositions with improved bioavailability
US20050249799A1 (en) * 2004-03-03 2005-11-10 Spherics, Inc. Polymeric drug delivery system for hydrophobic drugs
AU2006263337A1 (en) * 2005-06-29 2007-01-04 Panacea Biotec Ltd. Modified release pharmaceutical compositions on the basis of two polymers and processes thereof
WO2007106957A1 (en) 2006-03-21 2007-09-27 Laboratoires Smb S.A. Multiple units controlled-release floating dosage forms
WO2008058288A2 (en) 2006-11-09 2008-05-15 Proprius Pharmaceuticals, Inc. Sustained release methotrexate formulations and methods of use thereof

Also Published As

Publication number Publication date
US8778396B2 (en) 2014-07-15
WO2009153632A1 (en) 2009-12-23
JP2012504551A (ja) 2012-02-23
EP2306983A1 (en) 2011-04-13
US20110182988A1 (en) 2011-07-28
ZA200903854B (en) 2011-02-23

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