JP2018517735A - フマル酸ジメチル粒子及びそれらの医薬組成物 - Google Patents

フマル酸ジメチル粒子及びそれらの医薬組成物 Download PDF

Info

Publication number
JP2018517735A
JP2018517735A JP2017565133A JP2017565133A JP2018517735A JP 2018517735 A JP2018517735 A JP 2018517735A JP 2017565133 A JP2017565133 A JP 2017565133A JP 2017565133 A JP2017565133 A JP 2017565133A JP 2018517735 A JP2018517735 A JP 2018517735A
Authority
JP
Japan
Prior art keywords
dmf
inner layer
dosage form
controlled release
polymer
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.)
Pending
Application number
JP2017565133A
Other languages
English (en)
Japanese (ja)
Other versions
JP2018517735A5 (enExample
Inventor
ボウラス，ピエール
イルダム，アーウィン
カルキ，シャム・ビー
キースマン，ウィリアム・エフ
レオン，チェク−ユイ
リン，イーチーン
トレメントッツィ，アンドレア
ザワネ，ピーター
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biogen MA Inc
Original Assignee
Biogen MA Inc
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 Biogen MA Inc filed Critical Biogen MA Inc
Publication of JP2018517735A publication Critical patent/JP2018517735A/ja
Publication of JP2018517735A5 publication Critical patent/JP2018517735A5/ja
Priority to JP2021184469A priority Critical patent/JP2022042512A/ja
Pending legal-status Critical Current

Links

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
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/16—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2017565133A 2015-06-17 2016-06-15 フマル酸ジメチル粒子及びそれらの医薬組成物 Pending JP2018517735A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021184469A JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562181061P 2015-06-17 2015-06-17
US62/181,061 2015-06-17
PCT/US2016/037486 WO2016205270A1 (en) 2015-06-17 2016-06-15 Dimethyl fumarate particles and pharmaceutical compositions thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2021184469A Division JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

Publications (2)

Publication Number Publication Date
JP2018517735A true JP2018517735A (ja) 2018-07-05
JP2018517735A5 JP2018517735A5 (enExample) 2019-07-18

Family

ID=56292916

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2017565133A Pending JP2018517735A (ja) 2015-06-17 2016-06-15 フマル酸ジメチル粒子及びそれらの医薬組成物
JP2021184469A Pending JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2021184469A Pending JP2022042512A (ja) 2015-06-17 2021-11-12 フマル酸ジメチル粒子及びそれらの医薬組成物

Country Status (13)

Country Link
US (2) US11291642B2 (enExample)
EP (1) EP3310341A1 (enExample)
JP (2) JP2018517735A (enExample)
KR (1) KR20180018711A (enExample)
CN (1) CN107920997A (enExample)
AU (2) AU2016279997B2 (enExample)
CA (1) CA2989581A1 (enExample)
EA (1) EA201890068A1 (enExample)
HK (1) HK1254054A1 (enExample)
IL (1) IL256296A (enExample)
MA (1) MA42196A (enExample)
MX (1) MX387092B (enExample)
WO (1) WO2016205270A1 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022523510A (ja) * 2019-01-31 2022-04-25 エレクトロフィ，インコーポレイテッド 粒子形成及び形態構造
JP2022525482A (ja) * 2019-03-20 2022-05-16 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
JP2022525926A (ja) * 2019-03-20 2022-05-20 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018005345A (es) * 2015-10-28 2018-08-14 Sun Pharmaceutical Ind Ltd Composiciones farmaceuticas de dimetil fumarato.
EP3413879A1 (en) 2016-02-11 2018-12-19 Biogen MA Inc. Pharmaceutical bead formulations comprising dimethyl fumarate
CA3075720A1 (en) * 2017-10-02 2019-04-11 Novartis Ag Method for preparing a pharmaceutical product
US11318682B2 (en) 2018-04-06 2022-05-03 Hewlett-Packard Development Company, L.P. Three-dimensional (3D) object printing based on build material permeability
EP3860849A4 (en) * 2018-10-05 2022-06-22 ISP Investments LLC SMOOTH HIGH SOLIDS FILM COATING COMPOSITION WITH WATER SOLUBLE CELLULOSE ETHER, PROCESS FOR ITS PRODUCTION
TR201818293A2 (tr) * 2018-11-30 2020-06-22 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Di̇meti̇l fumarat i̇çeren geci̇kmeli̇ salim sağlayan kapsül
CN116669715A (zh) * 2020-11-18 2023-08-29 Fb-Hrs有限责任公司 含有多非利特和美西律的组合物及其应用
WO2022120194A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
IL307454A (en) 2021-04-07 2023-12-01 Battelle Memorial Institute Technologies for rapid design, construction, testing, learning to identify and use non-viral vectors
WO2022254356A1 (en) 2021-06-04 2022-12-08 Zim Laboratories Limited Delayed release compositions of dimethyl fumarate
US11590071B2 (en) * 2021-07-06 2023-02-28 King Abdulaziz University Injectable drug delivery implant composition and method of use thereof
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025090498A1 (en) * 2023-10-23 2025-05-01 Isp Investments Llc Encapsulated medium chain fatty acid salts and oral solid dosage forms derived therefrom
WO2025122954A1 (en) 2023-12-08 2025-06-12 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009144558A1 (en) * 2008-04-18 2009-12-03 Intec Pharma Ltd. Carbidopa/lipodopa gastroretentive drug delivery
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
JP2014522413A (ja) * 2011-06-08 2014-09-04 バイオジェン・アイデック・エムエイ・インコーポレイテッド 高純度結晶性ジメチルフマラートの調製方法
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation of dimethyl fumarate

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2725623A1 (fr) 1994-10-18 1996-04-19 Flamel Tech Sa Microcapsules medicamenteuses et/ou nutritionnelles pour administration per os
US5972389A (en) 1996-09-19 1999-10-26 Depomed, Inc. Gastric-retentive, oral drug dosage forms for the controlled-release of sparingly soluble drugs and insoluble matter
DE19853487A1 (de) 1998-11-19 2000-05-25 Fumapharm Ag Muri Verwendung von Dialkylfumaraten
IL133196A0 (en) 1999-11-29 2001-03-19 Yissum Res Dev Co Gastroretentive controlled release pharmaceutical dosage forms
DE10101307A1 (de) * 2001-01-12 2002-08-01 Fumapharm Ag Muri Fumarsäurederivate als NF-kappaB-Inhibitor
US8101209B2 (en) 2001-10-09 2012-01-24 Flamel Technologies Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
US6723340B2 (en) 2001-10-25 2004-04-20 Depomed, Inc. Optimal polymer mixtures for gastric retentive tablets
PL2316430T3 (pl) 2004-10-08 2012-11-30 Forward Pharma As Kompozycje farmaceutyczne o kontrolowanym uwalnianiu, zawierające ester kwasu fumarowego
US8298574B2 (en) 2006-01-18 2012-10-30 Intec Pharma Ltd. Method and apparatus for forming delivery devices for oral intake of an agent
WO2010079222A1 (en) * 2009-01-09 2010-07-15 Forward Pharma A/S Pharmaceutical formulation comprising one or more fumaric acid esters in an erosion matrix
EP2379062A1 (en) * 2009-01-09 2011-10-26 Forward Pharma A/S Pharmaceutical composition comprising one or more fumaric acid esters
JP6189333B2 (ja) * 2012-02-07 2017-08-30 バイオジェン エムエー インコーポレーテッド フマル酸ジメチルを含有する医薬組成物
WO2015042294A1 (en) * 2013-09-18 2015-03-26 Xenoport, Inc. Nanoparticle compositions of dimethyl fumarate
WO2015089420A1 (en) * 2013-12-13 2015-06-18 Biogen Idec Ma Inc. Controlled release dosage form for once daily administration of dimethyl fumarate
ES2713157T3 (es) * 2014-02-28 2019-05-20 Banner Life Sciences Llc Cápsulas blandas entéricas de liberación controlada de ésteres de fumarato

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009144558A1 (en) * 2008-04-18 2009-12-03 Intec Pharma Ltd. Carbidopa/lipodopa gastroretentive drug delivery
JP2014522413A (ja) * 2011-06-08 2014-09-04 バイオジェン・アイデック・エムエイ・インコーポレイテッド 高純度結晶性ジメチルフマラートの調製方法
WO2013076216A1 (en) * 2011-11-24 2013-05-30 Synthon Bv Controlled release particles comprising dimethyl fumarate
WO2015044853A2 (en) * 2013-09-25 2015-04-02 Glenmark Pharmaceuticals Limited; Glenmark Generics Limited Process for preparation of dimethyl fumarate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
AICH PHARMA ET AL., AICH PHARMA FORUM 2015 OCCUPATIONAL TOXICOLOGY, IH AND CONTAINMENT CHALLENGES ASSOCIATED WITH AN API, JPN7020004074, 3 June 2015 (2015-06-03), ISSN: 0004548822 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022523510A (ja) * 2019-01-31 2022-04-25 エレクトロフィ，インコーポレイテッド 粒子形成及び形態構造
JP2022525482A (ja) * 2019-03-20 2022-05-16 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のコーティング
JP2022525926A (ja) * 2019-03-20 2022-05-20 リンドラ セラピューティクス， インコーポレイティド 胃内滞留剤形用のカプセル及びカプセルコーティング
US12447130B2 (en) 2019-03-20 2025-10-21 Lyndra Therapeutics, Inc. Capsules and capsule coatings for gastric residence dosage forms

Also Published As

Publication number Publication date
MX2017016509A (es) 2018-08-16
MX387092B (es) 2025-03-19
KR20180018711A (ko) 2018-02-21
EA201890068A1 (ru) 2018-09-28
AU2016279997B2 (en) 2021-10-21
WO2016205270A1 (en) 2016-12-22
IL256296A (en) 2018-02-28
WO2016205270A8 (en) 2017-01-19
HK1254054A1 (zh) 2019-07-12
MA42196A (fr) 2018-04-25
AU2016279997A1 (en) 2018-01-18
CN107920997A (zh) 2018-04-17
US11291642B2 (en) 2022-04-05
AU2022200155A1 (en) 2022-02-10
US20220362195A1 (en) 2022-11-17
US20190070143A1 (en) 2019-03-07
CA2989581A1 (en) 2016-12-22
EP3310341A1 (en) 2018-04-25
JP2022042512A (ja) 2022-03-14

Similar Documents

Publication Publication Date Title
US20220362195A1 (en) Dimethyl fumarate particles and pharmaceutical compositions thereof
CN101022788B (zh) 包含普拉克索或其可药用盐的延长释放小球制剂、其制备方法及其用途
JP5808670B2 (ja) 弱塩基性薬物を含む組成物及び徐放性剤形
CN101378736B (zh) 用于口服给药的多微粒药物剂型
US10172794B2 (en) Controlled release dosage form for once daily administration of dimethyl fumarate
EP1478350B1 (en) Pharmaceutical dosage forms comprising tablet core having a tensile strength below 38 n/sqcm and a coating to protect the soft core
JP2003514845A (ja) 胃内滞留性制御放出医薬剤形
KR101412401B1 (ko) 삼투 펌프 제어 방출 정제 및 이의 제조방법
JPH0759499B2 (ja) 拡散被覆された複合単位服用剤
TW201902459A (zh) 具有釋放速率調節膜之胃的滯留系統
JP2002526437A (ja) アジテーション非依存性薬学的マルチプル−ユニット持効性製剤およびその製法
JP5052051B2 (ja) 腸溶性顆粒剤及びその製造方法
CN106619520A (zh) 一种右兰索拉唑钠的干混悬剂及其制备方法
CN100475197C (zh) 口服的可持续释放的药用组合物
KR101739166B1 (ko) 다층형 약제
ES2683366T3 (es) Dispersión molecular sólida de fesoterodina
WO2003070223A1 (en) Sustained release preparations and process for producing the same
CN101287453A (zh) 包含头孢菌素的毫微粒和控制释放组合物
CN1568954A (zh) 美沙拉嗪结肠定位释药微丸制剂及其制备方法
JP5070618B2 (ja) 腸溶性顆粒剤及びその製造方法
JP2001501642A (ja) 弱酸性薬剤の結腸送達
CN108066304A (zh) 具有缓释性能的坦索罗辛口腔崩解片组合物
Gautam et al. A REVIEW ON MICROSPHERES: TYPES, METHODS AND EVALUATION.
CN114051407A (zh) 包含坦洛新或其盐酸盐的药物组合物和它的制备方法
Dahmash Modified drug release oral solid formulations of floating pellets, using extrusion and spheronisation method

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190614

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20190614

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20200513

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200812

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20201215

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210315

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20210713

RD01 Notification of change of attorney

Free format text: JAPANESE INTERMEDIATE CODE: A7426

Effective date: 20211111

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20211111