JP7826492B2 - フェキソフェナジン含有組成物 - Google Patents

フェキソフェナジン含有組成物

Info

Publication number
JP7826492B2
JP7826492B2 JP2024539614A JP2024539614A JP7826492B2 JP 7826492 B2 JP7826492 B2 JP 7826492B2 JP 2024539614 A JP2024539614 A JP 2024539614A JP 2024539614 A JP2024539614 A JP 2024539614A JP 7826492 B2 JP7826492 B2 JP 7826492B2
Authority
JP
Japan
Prior art keywords
sodium
spray
diluent
dried formulation
disintegrant
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
JP2024539614A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024546513A5 (https=
JP2024546513A (ja
Inventor
ダニエラ マルドナド カヴァラリ
マクシム リブロー
チャキブ ザグルール
Original Assignee
オペラ ヘルスケア グループ ソシエテ パル アクシオン サンプリフィエ
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 オペラ ヘルスケア グループ ソシエテ パル アクシオン サンプリフィエ filed Critical オペラ ヘルスケア グループ ソシエテ パル アクシオン サンプリフィエ
Publication of JP2024546513A publication Critical patent/JP2024546513A/ja
Publication of JP2024546513A5 publication Critical patent/JP2024546513A5/ja
Application granted granted Critical
Publication of JP7826492B2 publication Critical patent/JP7826492B2/ja
Active 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/14—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
    • 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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2024539614A 2021-12-29 2021-12-29 フェキソフェナジン含有組成物 Active JP7826492B2 (ja)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2021/000916 WO2023126637A1 (en) 2021-12-29 2021-12-29 Compositions containing fexofenadine

Publications (3)

Publication Number Publication Date
JP2024546513A JP2024546513A (ja) 2024-12-24
JP2024546513A5 JP2024546513A5 (https=) 2025-01-10
JP7826492B2 true JP7826492B2 (ja) 2026-03-09

Family

ID=80122351

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024539614A Active JP7826492B2 (ja) 2021-12-29 2021-12-29 フェキソフェナジン含有組成物

Country Status (12)

Country Link
US (1) US20250082623A1 (https=)
EP (1) EP4456880B1 (https=)
JP (1) JP7826492B2 (https=)
KR (1) KR20240136358A (https=)
CN (1) CN118715004A (https=)
AR (1) AR128113A1 (https=)
AU (1) AU2021480621A1 (https=)
CA (1) CA3242293A1 (https=)
CO (1) CO2024009774A2 (https=)
MX (1) MX2024008242A (https=)
PE (1) PE20242355A1 (https=)
WO (1) WO2023126637A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026074306A1 (en) 2024-10-03 2026-04-09 Opella Healthcare Group Sas Chewable fexofenadine tablets

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005513008A (ja) 2001-11-16 2005-05-12 エティファーム フェキソフェナジンを含む口内分散性タブレット
JP2009519935A (ja) 2005-12-14 2009-05-21 サノフィ−アベンティス・ユー・エス・エルエルシー フェキソフェナジン懸濁液製剤
CN102512389A (zh) 2011-12-27 2012-06-27 天津市嵩锐医药科技有限公司 非索非那定盐酸盐口腔崩解药物组合物
JP2013525340A (ja) 2010-04-21 2013-06-20 サノフイ フェキソフェナジンを主成分とする組成物及びその製造方法
JP2013231051A (ja) 2009-12-02 2013-11-14 Aptalis Pharma Ltd 味覚遮蔽・即放性フェキソフェナジン・マイクロカプセルを製造する方法
CN105997910A (zh) 2016-06-09 2016-10-12 北京化工大学 一种掩味制剂及其制备方法

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101761983B1 (ko) * 2014-08-25 2017-08-07 아주대학교산학협력단 구강내 속붕해 필름 조성물 및 그 제조방법

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005513008A (ja) 2001-11-16 2005-05-12 エティファーム フェキソフェナジンを含む口内分散性タブレット
JP2009519935A (ja) 2005-12-14 2009-05-21 サノフィ−アベンティス・ユー・エス・エルエルシー フェキソフェナジン懸濁液製剤
JP2013231051A (ja) 2009-12-02 2013-11-14 Aptalis Pharma Ltd 味覚遮蔽・即放性フェキソフェナジン・マイクロカプセルを製造する方法
JP2013525340A (ja) 2010-04-21 2013-06-20 サノフイ フェキソフェナジンを主成分とする組成物及びその製造方法
CN102512389A (zh) 2011-12-27 2012-06-27 天津市嵩锐医药科技有限公司 非索非那定盐酸盐口腔崩解药物组合物
CN105997910A (zh) 2016-06-09 2016-10-12 北京化工大学 一种掩味制剂及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
B. Rashmika et al.，"Formulation development and In Vivo evaluation of Fexofenadine HCl solid dispersions by spray drying technique"，Der Pharmacia Lettre，2013年，Vol.5, No.6，p.73-82

Also Published As

Publication number Publication date
CA3242293A1 (en) 2023-07-06
EP4456880B1 (en) 2026-03-18
AU2021480621A1 (en) 2024-07-18
CN118715004A (zh) 2024-09-27
WO2023126637A1 (en) 2023-07-06
PE20242355A1 (es) 2024-12-16
MX2024008242A (es) 2024-07-19
CO2024009774A2 (es) 2024-08-08
US20250082623A1 (en) 2025-03-13
AR128113A1 (es) 2024-03-27
EP4456880A1 (en) 2024-11-06
KR20240136358A (ko) 2024-09-13
JP2024546513A (ja) 2024-12-24

Similar Documents

Publication Publication Date Title
US8048449B2 (en) Mouth dissolving pharmaceutical composition and process for preparing the same
JP4740740B2 (ja) 薬物含有粒子および該粒子を含む固形製剤
JP4920798B2 (ja) ２種以上の粒子を含有する口腔内速崩壊錠
KR101551506B1 (ko) 레바미피드를 함유하는 의약 조성물
JP6054940B2 (ja) １−（３−（２−（１−ベンゾチオフェン−５−イル）エトキシ）プロピル）アゼチジン−３−オールまたはその塩を含有する固形医薬組成物
EP3013323A2 (en) Complex granule formulation having improved stability comprising levocetirizine and montelukast
KR20140030212A (ko) 구강내 속붕괴성정
WO2011136751A2 (en) Water soluble pharmaceutical composition
JP2010270110A (ja) ネオテームを含有する経口製剤
JP7826492B2 (ja) フェキソフェナジン含有組成物
US12064414B2 (en) Stable amorphous Eliglustat premix and process for the preparation thereof
KR100604034B1 (ko) 암로디핀 유리염기를 함유한 구강 속붕해정 및 그의 조성물
JPWO2019208540A1 (ja) 安定性に優れた固形製剤
KR100957731B1 (ko) 쓴맛이 저감된 프란루카스트 수화물을 함유하는 제제
JP3899522B2 (ja) 苦味が低減されたプランルカスト水和物を含有する製剤
JP2024546513A5 (https=)
JP7745371B2 (ja) ゾニサミド原薬粒子およびその用途
HK40111138A (zh) 含有非索非那定的组合物
EP3505164A1 (en) An effervescent composition comprising erdosteine
TR201617675A2 (tr) Ari̇pi̇prazole monohi̇drat formülasyonlarinin ağizda dağilan tablet formu
WO2019197939A1 (en) Taste masked mouth dissolving formulation of montelukast sodium and levocetirizine hydrochloride
JP2008094751A (ja) プランルカスト水和物含有医薬組成物
WO2026074306A1 (en) Chewable fexofenadine tablets
JP2010053048A (ja) 苦味が緩和されたイルベサルタン含有医薬組成物
WO2021123341A1 (en) Composition comprising diosmin

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241226

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20241226

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20251015

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20251016

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260116

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: 20260126

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20260225

R150 Certificate of patent or registration of utility model

Ref document number: 7826492

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150