JP7323451B2 - フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤 - Google Patents

フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤 Download PDF

Info

Publication number
JP7323451B2
JP7323451B2 JP2019543833A JP2019543833A JP7323451B2 JP 7323451 B2 JP7323451 B2 JP 7323451B2 JP 2019543833 A JP2019543833 A JP 2019543833A JP 2019543833 A JP2019543833 A JP 2019543833A JP 7323451 B2 JP7323451 B2 JP 7323451B2
Authority
JP
Japan
Prior art keywords
release
phloroglucinol
dosage form
trimethylphloroglucinol
release formulation
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.)
Active
Application number
JP2019543833A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020510000A5 (enExample
JP2020510000A (ja
Inventor
パテル、ピユーシュ
ピアース、キャサリン
イサクソン、ジョナサン
Original Assignee
シンリックス ファーマ、エルエルシー
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 シンリックス ファーマ、エルエルシー filed Critical シンリックス ファーマ、エルエルシー
Publication of JP2020510000A publication Critical patent/JP2020510000A/ja
Publication of JP2020510000A5 publication Critical patent/JP2020510000A5/ja
Priority to JP2023085724A priority Critical patent/JP2023116518A/ja
Application granted granted Critical
Publication of JP7323451B2 publication Critical patent/JP7323451B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/167Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • 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
    • A61K9/4816Wall or shell material
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2019543833A 2017-03-08 2018-03-08 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤 Active JP7323451B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023085724A JP2023116518A (ja) 2017-03-08 2023-05-24 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762468501P 2017-03-08 2017-03-08
US62/468,501 2017-03-08
PCT/US2018/021505 WO2018165404A1 (en) 2017-03-08 2018-03-08 Pharmaceutical formualtions of phloroglucinol and trimethylphloroglucinol

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2023085724A Division JP2023116518A (ja) 2017-03-08 2023-05-24 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤

Publications (3)

Publication Number Publication Date
JP2020510000A JP2020510000A (ja) 2020-04-02
JP2020510000A5 JP2020510000A5 (enExample) 2021-04-15
JP7323451B2 true JP7323451B2 (ja) 2023-08-08

Family

ID=61768496

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2019543833A Active JP7323451B2 (ja) 2017-03-08 2018-03-08 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤
JP2023085724A Pending JP2023116518A (ja) 2017-03-08 2023-05-24 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023085724A Pending JP2023116518A (ja) 2017-03-08 2023-05-24 フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤

Country Status (11)

Country Link
US (2) US20200009076A1 (enExample)
EP (1) EP3592337B1 (enExample)
JP (2) JP7323451B2 (enExample)
KR (1) KR102636273B1 (enExample)
CN (1) CN110381925A (enExample)
AU (1) AU2018231044B2 (enExample)
CA (1) CA3053254C (enExample)
DK (1) DK3592337T3 (enExample)
EA (1) EA201992116A1 (enExample)
ES (1) ES2958616T3 (enExample)
WO (1) WO2018165404A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112535659B (zh) * 2019-09-20 2022-03-22 南京艾德凯腾生物医药有限责任公司 一种间苯三酚注射液的配制方法
CN115244028A (zh) 2019-12-20 2022-10-25 凯瑞康宁生物工程有限公司 4-缬氨酰氧基丁酸的合成方法
CN113750058B (zh) * 2020-06-01 2023-07-04 北京九能天远科技有限公司 一种间苯三酚冻干口崩片及其制备方法
AU2021293941B2 (en) 2020-06-18 2024-03-28 XWPharma Ltd. Pharmaceutical granulations of water-soluble active pharmaceutical ingredients
AU2021292406B2 (en) * 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
EP4171520A1 (en) * 2020-06-26 2023-05-03 Bausch Health Ireland Limited Targeted release rifaximin compositions
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
CN115666527B (zh) 2020-10-05 2025-03-07 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的修饰释放组合物
TW202300139A (zh) 2021-03-19 2023-01-01 凱瑞康寧生技股份有限公司 γ-羟基丁酸衍生物的聯合釋放製劑的藥代動力學
CN113304109A (zh) * 2021-06-08 2021-08-27 内蒙古大唐药业股份有限公司 一种醋柳黄酮固体脂质纳米粒分散液及其制备方法
CN115282132B (zh) * 2022-02-10 2024-01-30 郑州大学第一附属医院 用于缓解ercp胆道痉挛的复合物及其制备方法
AU2023292263A1 (en) * 2022-06-13 2024-12-12 Cinphloro Pharma, Llc Phloroglucinol formulations and methods of use

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002370968A (ja) 2001-06-12 2002-12-24 Towa Yakuhin Kk 薬物含有徐放性顆粒およびそれを含む錠剤
JP2009529524A (ja) 2006-03-10 2009-08-20 エイジーアイ・セラピューティクス・リサーチ・リミテッド 炎症性腸疾患を治療するための調節放出製剤と方法
JP2011525188A (ja) 2008-06-20 2011-09-15 ユーランド,インコーポレイテッド 徐放性骨格筋弛緩薬剤形の調製
WO2013087410A1 (fr) 2011-12-16 2013-06-20 Pharmeuro Traitement des crises de migraines, notamment d'algies vasculaires de la face
WO2014171542A1 (ja) 2013-04-19 2014-10-23 武田薬品工業株式会社 放出制御製剤
CN103494792B (zh) 2013-08-27 2015-03-04 寿光富康制药有限公司 一种复方间苯三酚冻干口腔崩解片及制备方法
JP2015143258A (ja) 2009-02-13 2015-08-06 ロマーク ラボラトリーズ エル.シー. ニタゾキサニドの制御放出医薬配合物

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5773031A (en) 1996-02-27 1998-06-30 L. Perrigo Company Acetaminophen sustained-release formulation
JP4563516B2 (ja) 1997-02-20 2010-10-13 マサチューセッツ インスティテュート オブ テクノロジー 迅速分散性を示す投与剤形、その使用法並びにその製造方法
SK180499A3 (en) * 1997-07-01 2001-08-06 Pfizer Sertraline salts and sustained-release dosage forms of sertraline
FR2772615B1 (fr) * 1997-12-23 2002-06-14 Lipha Comprime multicouche pour la liberation instantanee puis prolongee de substances actives
ITMI20020514A1 (it) 2002-03-12 2003-09-12 Jagotec Ag Sistema terapeutico per il rilascio controllato di uno o piu' principi attivi
DK1545475T3 (da) 2002-10-01 2014-07-28 Banner Pharmacaps Inc Enterisk sammensætning til fremstillingen af blød kapselvæg
US7387793B2 (en) 2003-11-14 2008-06-17 Eurand, Inc. Modified release dosage forms of skeletal muscle relaxants
US8846100B2 (en) 2006-05-12 2014-09-30 Shire Llc Controlled dose drug delivery system
JP5345620B2 (ja) 2007-08-15 2013-11-20 マクニール−ピーピーシー・インコーポレーテツド 即時放出及び徐放型イブプロフェンの投与法
CN102548544B (zh) * 2009-10-09 2015-01-21 永进药品工业株式会社 同时具有速效特性和长效特性的药物组合物
KR101320802B1 (ko) * 2010-02-16 2013-10-23 주식회사 드림파마 방출 제어형 사포그릴레이트 염산염 함유 다층 정제
GB201003731D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Immediate/delayed drug delivery
HK1216513A1 (zh) 2013-03-15 2016-11-18 阿普雷奇亚制药有限责任公司 包含左乙拉西坦的快速分散劑型
KR101587142B1 (ko) * 2013-12-26 2016-01-21 한국유나이티드제약 주식회사 속방층과 2개의 서방층으로 이루어진 위장관 질환 치료용 모사프리드 구연산염 삼층정 서방제제
HUE047477T2 (hu) * 2015-06-04 2020-04-28 Pfizer Palbociclib szilárd dózisformái
KR101758451B1 (ko) * 2015-06-10 2017-07-27 대화제약 주식회사 안정성이 개선된 플로로글루시놀 무수물 함유 속용성 정제의 제조방법

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002370968A (ja) 2001-06-12 2002-12-24 Towa Yakuhin Kk 薬物含有徐放性顆粒およびそれを含む錠剤
JP2009529524A (ja) 2006-03-10 2009-08-20 エイジーアイ・セラピューティクス・リサーチ・リミテッド 炎症性腸疾患を治療するための調節放出製剤と方法
JP2011525188A (ja) 2008-06-20 2011-09-15 ユーランド,インコーポレイテッド 徐放性骨格筋弛緩薬剤形の調製
JP2015143258A (ja) 2009-02-13 2015-08-06 ロマーク ラボラトリーズ エル.シー. ニタゾキサニドの制御放出医薬配合物
WO2013087410A1 (fr) 2011-12-16 2013-06-20 Pharmeuro Traitement des crises de migraines, notamment d'algies vasculaires de la face
WO2014171542A1 (ja) 2013-04-19 2014-10-23 武田薬品工業株式会社 放出制御製剤
CN103494792B (zh) 2013-08-27 2015-03-04 寿光富康制药有限公司 一种复方间苯三酚冻干口腔崩解片及制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Expert Opin Ther Patents,2009年,19(6),847-866
World J Gastroenterol,2014年,20(20),6031-6043

Also Published As

Publication number Publication date
AU2018231044A1 (en) 2019-08-08
WO2018165404A1 (en) 2018-09-13
CA3053254C (en) 2024-02-20
KR102636273B1 (ko) 2024-02-16
AU2018231044B2 (en) 2023-04-06
WO2018165404A8 (en) 2019-09-12
DK3592337T3 (da) 2023-09-18
US20200009076A1 (en) 2020-01-09
JP2023116518A (ja) 2023-08-22
BR112019016091A2 (pt) 2020-04-14
EP3592337B1 (en) 2023-07-05
KR20190122218A (ko) 2019-10-29
ES2958616T3 (es) 2024-02-12
AU2018231044A8 (en) 2019-10-03
EA201992116A1 (ru) 2020-01-29
US20250177320A1 (en) 2025-06-05
CA3053254A1 (en) 2018-09-13
JP2020510000A (ja) 2020-04-02
CN110381925A (zh) 2019-10-25
EP3592337A1 (en) 2020-01-15

Similar Documents

Publication Publication Date Title
JP7323451B2 (ja) フロルグルシノールおよびトリメチルフロログルシノールの医薬製剤
JP5253381B2 (ja) シグモイド放出プロファイルを有するオキサカルバゼピンの制御放出製剤
JP7602324B2 (ja) 重水素化ドンペリドン組成物、方法、及び調製
US20150164920A1 (en) Controlled release formulation comprising mesalamine
HK40012399A (en) Pharmaceutical formulations of phloroglucinol and trimethylphloroglucinol
HK40012399B (en) Pharmaceutical formulations of phloroglucinol and trimethylphloroglucinol
EA046180B1 (ru) Фармацевтический состав флороглюцинола и триметилфлороглюцинола
BR112019016091B1 (pt) Unidade de dosagem oral e uso de floroglucinol e trimetilfloroglucinol
HK40064919A (en) Deuterated domperidone compositions and methods for therapy of disorders
HK1259508B (zh) 氘代多潘立酮组合物和用於治疗病症的方法
HK1259508A1 (en) Deuterated domperidone compositions and methods for therapy of disorders

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200220

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210302

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20210302

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220412

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20220711

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20220909

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20221012

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20230124

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230524

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20230605

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20230704

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20230727

R150 Certificate of patent or registration of utility model

Ref document number: 7323451

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150