JP7801996B2 - 小児懸濁液製剤 - Google Patents

小児懸濁液製剤

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Publication number
JP7801996B2
JP7801996B2 JP2022516686A JP2022516686A JP7801996B2 JP 7801996 B2 JP7801996 B2 JP 7801996B2 JP 2022516686 A JP2022516686 A JP 2022516686A JP 2022516686 A JP2022516686 A JP 2022516686A JP 7801996 B2 JP7801996 B2 JP 7801996B2
Authority
JP
Japan
Prior art keywords
omeprazole
storage
mixture
sodium
stable
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
JP2022516686A
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English (en)
Japanese (ja)
Other versions
JP2022550690A (ja
JP2022550690A5 (https=
Inventor
モーリス ジョゼフ アンソニー クランシー，
デニス マーク マクデイド，
ダミアン パトリック フリン，
Original Assignee
ジオーラス ファーマシューティカルズ リミテッド
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Publication of JP2022550690A publication Critical patent/JP2022550690A/ja
Priority to JP2025152489A priority Critical patent/JP2025170126A/ja
Publication of JP2022550690A5 publication Critical patent/JP2022550690A5/ja
Application granted granted Critical
Publication of JP7801996B2 publication Critical patent/JP7801996B2/ja
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Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2022516686A 2019-10-04 2020-10-02 小児懸濁液製剤 Active JP7801996B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025152489A JP2025170126A (ja) 2019-10-04 2025-09-12 小児懸濁液製剤

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201962911035P 2019-10-04 2019-10-04
US62/911,035 2019-10-04
US201962911689P 2019-10-07 2019-10-07
US62/911,689 2019-10-07
US202063062785P 2020-08-07 2020-08-07
US63/062,785 2020-08-07
PCT/IB2020/059280 WO2021064682A1 (en) 2019-10-04 2020-10-02 Pediatric suspension formulation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025152489A Division JP2025170126A (ja) 2019-10-04 2025-09-12 小児懸濁液製剤

Publications (3)

Publication Number Publication Date
JP2022550690A JP2022550690A (ja) 2022-12-05
JP2022550690A5 JP2022550690A5 (https=) 2025-10-30
JP7801996B2 true JP7801996B2 (ja) 2026-01-19

Family

ID=72744602

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022516686A Active JP7801996B2 (ja) 2019-10-04 2020-10-02 小児懸濁液製剤
JP2025152489A Pending JP2025170126A (ja) 2019-10-04 2025-09-12 小児懸濁液製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025152489A Pending JP2025170126A (ja) 2019-10-04 2025-09-12 小児懸濁液製剤

Country Status (15)

Country Link
US (2) US11826359B2 (https=)
EP (2) EP4331572A3 (https=)
JP (2) JP7801996B2 (https=)
KR (1) KR20220103711A (https=)
CN (1) CN114929222B (https=)
AU (1) AU2020358472B2 (https=)
CA (1) CA3153555A1 (https=)
ES (1) ES2974364T3 (https=)
IE (1) IE20200221A1 (https=)
IL (1) IL291778B2 (https=)
MX (1) MX2022003917A (https=)
PH (1) PH12022550798A1 (https=)
TW (1) TW202126301A (https=)
WO (1) WO2021064682A1 (https=)
ZA (1) ZA202203563B (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202126301A (zh) 2019-10-04 2021-07-16 愛爾蘭商席歐拉斯製藥有限公司 小兒懸浮調配物
GB2631129A (en) * 2023-06-23 2024-12-25 Orbit Pharma Ltd A powder composition for oral suspension of proton pump inhibitors and the method of preparing the same

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004521955A (ja) 2001-07-09 2004-07-22 キュレーターズ・オブ・ザ・ユニバーシティ・オブ・ミズーリ 新規置換ベンズイミダゾール製剤およびその使用方法

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
US5840737A (en) 1996-01-04 1998-11-24 The Curators Of The University Of Missouri Omeprazole solution and method for using same
US6489346B1 (en) * 1996-01-04 2002-12-03 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
US20020192299A1 (en) 2000-12-28 2002-12-19 Rajneesh Taneja Pharmaceutical compositions of a non-enteric coated proton pump inhibitor with a carbonate salt and bicarbonate salt combination
CA2448997A1 (en) * 2001-05-31 2002-12-05 Microdose Technologies, Inc. Metering and packaging of controlled release medication
US20050220870A1 (en) * 2003-02-20 2005-10-06 Bonnie Hepburn Novel formulation, omeprazole antacid complex-immediate release for rapid and sustained suppression of gastric acid
US20050098526A1 (en) * 2003-11-06 2005-05-12 Robertino Catalin Two bottles/containers in one
WO2005076987A2 (en) 2004-02-10 2005-08-25 Santarus, Inc. Combination of proton pump inhibitor, buffering agent, and nonsteroidal anti-inflammatory agent
ES2283172B1 (es) * 2005-01-21 2008-08-16 Universidad De Granada Suspension extemporanea de omeprazol para via oral.
AR056062A1 (es) * 2006-06-05 2007-09-19 Bago Sa Labor Composicion farmaceutica antiacida en forma de polvo, preparacion farmaceutica que la comprende y proceso para su preparacion
EP2068854A2 (en) 2006-07-29 2009-06-17 Graceway Pharmaceuticals, LLC Business method to treat and/or prevent a gastric acid disorder with a proton pump inhibitor (ppi) and a cholinergic agonist to induce rapid onset of ppi action with or without food
EP2068841B1 (en) 2006-10-05 2018-09-26 Santarus, Inc. Novel formulations of proton pump inhibitors and methods of using these formulations
JP2011512416A (ja) 2008-02-20 2011-04-21 ザ・キュレイターズ・オブ・ザ・ユニバーシティー・オブ・ミズーリ オメプラゾール及びランソプラゾールの組合せと緩衝剤を含んでなる組成物とそれを使用する方法
JP5248614B2 (ja) 2008-09-01 2013-07-31 株式会社フレッシュ キャップおよびキャップ付き容器
PL2827843T3 (pl) * 2012-03-20 2016-11-30 Sposób wytwarzania dojelitowych alginianowych mikrokapsułek poprzez żelowanie jonowe zawierających diklofenak lub jedną z jego soli oraz zawierającej je wielocząsteczkowej kompozycji farmaceutycznej
GB2513172A (en) 2013-04-18 2014-10-22 Nupharm Lab Ltd Liquid dosage form and delivery system
BR112017001968A2 (pt) 2014-07-30 2017-11-21 Sun Pharmaceutical Ind Ltd embalagem de duas câmaras para uma composição farmacêutica líquida oral de múltiplas doses
CA2984725A1 (en) * 2015-05-01 2016-11-10 Sun Pharmaceutical Industries Limited Dual-chamber pack for extended release suspension compositions
US10238803B2 (en) 2016-05-02 2019-03-26 Sun Pharmaceutical Industries Limited Drug delivery device for pharmaceutical compositions
US11207307B2 (en) 2016-06-16 2021-12-28 Azurity Pharmaceuticals, Inc. Composition and method for proton pump inhibitor suspension
US10137111B2 (en) * 2016-08-11 2018-11-27 Adamis Pharmaceuticals Corporation Drug compositions comprising an anti-parasitic and proton pump inhibitor
TW202126301A (zh) 2019-10-04 2021-07-16 愛爾蘭商席歐拉斯製藥有限公司 小兒懸浮調配物

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004521955A (ja) 2001-07-09 2004-07-22 キュレーターズ・オブ・ザ・ユニバーシティ・オブ・ミズーリ 新規置換ベンズイミダゾール製剤およびその使用方法

Also Published As

Publication number Publication date
US11826359B2 (en) 2023-11-28
AU2020358472B2 (en) 2026-01-15
US20230390266A1 (en) 2023-12-07
WO2021064682A1 (en) 2021-04-08
IE20200221A1 (en) 2022-08-17
EP4331572A3 (en) 2024-06-05
KR20220103711A (ko) 2022-07-22
CA3153555A1 (en) 2021-04-08
AU2020358472A1 (en) 2022-04-07
CN114929222A (zh) 2022-08-19
JP2025170126A (ja) 2025-11-14
ZA202203563B (en) 2025-07-30
EP4331572A2 (en) 2024-03-06
IL291778A (en) 2022-06-01
ES2974364T3 (es) 2024-06-27
EP3799861A1 (en) 2021-04-07
IL291778B2 (en) 2024-09-01
MX2022003917A (es) 2022-06-14
IL291778B1 (en) 2024-05-01
EP3799861B1 (en) 2023-11-22
US12465600B2 (en) 2025-11-11
US20210100784A1 (en) 2021-04-08
PH12022550798A1 (en) 2023-09-18
JP2022550690A (ja) 2022-12-05
TW202126301A (zh) 2021-07-16
CN114929222B (zh) 2025-10-28

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