JP2021512869A - 経口製剤及びその使用 - Google Patents

経口製剤及びその使用 Download PDF

Info

Publication number
JP2021512869A
JP2021512869A JP2020541731A JP2020541731A JP2021512869A JP 2021512869 A JP2021512869 A JP 2021512869A JP 2020541731 A JP2020541731 A JP 2020541731A JP 2020541731 A JP2020541731 A JP 2020541731A JP 2021512869 A JP2021512869 A JP 2021512869A
Authority
JP
Japan
Prior art keywords
composition
total weight
sodium
amount
present
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
JP2020541731A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021512869A5 (enExample
Inventor
ヴァンカン，ピエール
ササーマン，アンドレーア
ブールスシャイト ウィルムブリンク，グラシエラ
ブールスシャイト ウィルムブリンク，グラシエラ
Original Assignee
ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ）
ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ）
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
Priority claimed from AU2018900324A external-priority patent/AU2018900324A0/en
Application filed by ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ）, ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） filed Critical ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ）
Publication of JP2021512869A publication Critical patent/JP2021512869A/ja
Publication of JP2021512869A5 publication Critical patent/JP2021512869A5/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
    • 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
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2020541731A 2018-02-02 2019-02-01 経口製剤及びその使用 Pending JP2021512869A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AU2018900324 2018-02-02
AU2018900324A AU2018900324A0 (en) 2018-02-02 Oral Formulations and Uses Thereof
PCT/AU2019/050076 WO2019148247A1 (en) 2018-02-02 2019-02-01 Oral formulations and uses thereof

Publications (2)

Publication Number Publication Date
JP2021512869A true JP2021512869A (ja) 2021-05-20
JP2021512869A5 JP2021512869A5 (enExample) 2022-01-11

Family

ID=67477795

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020541731A Pending JP2021512869A (ja) 2018-02-02 2019-02-01 経口製剤及びその使用

Country Status (9)

Country Link
US (1) US20200368166A1 (enExample)
EP (1) EP3746078A4 (enExample)
JP (1) JP2021512869A (enExample)
CN (1) CN111670035A (enExample)
AU (1) AU2019215802A1 (enExample)
CA (1) CA3089656A1 (enExample)
MX (1) MX2020008137A (enExample)
WO (1) WO2019148247A1 (enExample)
ZA (1) ZA202005143B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022514782A (ja) * 2018-12-24 2022-02-15 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 化合物の製造、その新しい塩形態および治療的使用

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3746077A4 (en) 2018-02-02 2021-10-27 Eustralis Pharmaceuticals Limited (Trading as Pressura Neuro) PARENTERAL FORMULATIONS AND THEIR USES
WO2021035289A1 (en) * 2019-08-23 2021-03-04 Eustralis Pharmaceuticals Limited (Trading As Pressura Neuro) Therapeutic methods and uses thereof
CN118217314A (zh) * 2020-09-30 2024-06-21 杭州远大生物制药有限公司 微生物制剂及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011504491A (ja) * 2007-11-23 2011-02-10 ルピン・リミテッド プレガバリンの制御放出医薬組成物
JP2016523262A (ja) * 2013-07-02 2016-08-08 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 慢性外傷性脳障害ｉｉを予防及び／又は治療する方法

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI367112B (en) * 2006-06-30 2012-07-01 Schering Corp Immediate-release tablet formulations of a thrombin receptor antagonist
US20100184819A1 (en) * 2007-07-19 2010-07-22 Robert Vink Method for reducing intracranial pressure
LT2722045T (lt) * 2009-11-18 2016-09-26 Helsinn Healthcare Sa Kompozicija skirta gydyti centralizuotai kontroliuojamą pykinimą ir vėmimą
IN2013MU02031A (enExample) * 2013-06-14 2015-06-05 Novoexcipients Pvt Ltd
RU2718044C2 (ru) * 2013-11-12 2020-03-30 Вертекс Фармасьютикалз Инкорпорейтед Способ получения фармацевтических композиций для лечения опосредованных cftr заболеваний
KR20160068975A (ko) * 2013-12-03 2016-06-15 에프. 호프만-라 로슈 아게 약학 조성물

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011504491A (ja) * 2007-11-23 2011-02-10 ルピン・リミテッド プレガバリンの制御放出医薬組成物
JP2016523262A (ja) * 2013-07-02 2016-08-08 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 慢性外傷性脳障害ｉｉを予防及び／又は治療する方法

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
PHARM TECH JAPAN, vol. 24, no. 8, JPN6022045429, 2008, pages 75 - 78, ISSN: 0005195660 *
ファルマシア, vol. 40, no. 9, JPN6022045428, 2004, pages 822 - 826, ISSN: 0005195659 *
ファルマシア, vol. 52, no. 5, JPN6022045430, 2016, pages 417 - 421, ISSN: 0005195661 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022514782A (ja) * 2018-12-24 2022-02-15 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 化合物の製造、その新しい塩形態および治療的使用
JP7587215B2 (ja) 2018-12-24 2024-11-20 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 化合物の製造、その新しい塩形態および治療的使用

Also Published As

Publication number Publication date
EP3746078A4 (en) 2021-11-17
US20200368166A1 (en) 2020-11-26
AU2019215802A1 (en) 2020-07-23
MX2020008137A (es) 2020-10-19
EP3746078A1 (en) 2020-12-09
CN111670035A (zh) 2020-09-15
CA3089656A1 (en) 2019-08-08
WO2019148247A1 (en) 2019-08-08
ZA202005143B (en) 2021-08-25

Similar Documents

Publication Publication Date Title
JP5289975B2 (ja) マンニトール又は乳糖を含有する固形製剤
TWI556819B (zh) 苯達莫司汀（ｂｅｎｄａｍｕｓｔｉｎｅ）之口服劑量型及其醫療用途
KR102512868B1 (ko) 올라파립의 용해도 및 생체이용율이 개선된 조성물
EP2540318A1 (en) Sustained-release solid preparation for oral use
JP2021512869A (ja) 経口製剤及びその使用
EP3620156A1 (en) Composition having improved water solubility and bioavailability
JP6093762B2 (ja) 徐放性製剤
US8987285B2 (en) Pharmaceutical compositions, dosage forms and new forms of the compound of formula (I), and methods of use thereof
US9861577B2 (en) Orally disintegrating tablet
WO2022208156A1 (en) Pharmaceutical composition of molnupiravir
JPWO2016175230A1 (ja) 経口投与用医薬組成物
CA2853117C (en) Sublingual pharmaceutical composition containing an antihistamine agent and method for the preparation thereof
US20100272800A1 (en) Orally disintegrating olanzapine tablet
US11260055B2 (en) Oral pharmaceutical composition of lurasidone and preparation thereof
EP3094315B1 (en) Pharmaceutical composition comprising aripiprazole or salt thereof
SA112330839B1 (ar) تركيب صيدلي وطريقة لتحضيره
KR102488167B1 (ko) 피롤카르복사미드의 고형 조성물
TR2022013352A2 (tr) Oral farmasöti̇k formülasyonlar
BR112019016802B1 (pt) Composição farmacêutica em comprimidos, e, comprimido

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20211130

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20211130

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20221101

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230123

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230418

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20231114