ES2974364T3 - Formulación de suspensión pediátrica - Google Patents

Formulación de suspensión pediátrica Download PDF

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Publication number
ES2974364T3
ES2974364T3 ES20199781T ES20199781T ES2974364T3 ES 2974364 T3 ES2974364 T3 ES 2974364T3 ES 20199781 T ES20199781 T ES 20199781T ES 20199781 T ES20199781 T ES 20199781T ES 2974364 T3 ES2974364 T3 ES 2974364T3
Authority
ES
Spain
Prior art keywords
omeprazole
mixture
pharmaceutically acceptable
acceptable salt
sodium
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
ES20199781T
Other languages
English (en)
Spanish (es)
Inventor
Maurice Joseph Anthony Clancy
Dennis Mark Mcdaid
Damien Patrick Flynn
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.)
Xeolas Pharmaceuticals Ltd
Original Assignee
Xeolas Pharmaceuticals Ltd
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 Xeolas Pharmaceuticals Ltd filed Critical Xeolas Pharmaceuticals Ltd
Application granted granted Critical
Publication of ES2974364T3 publication Critical patent/ES2974364T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1412Containers with closing means, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K9/1611Inorganic compounds
    • 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
    • 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

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)
ES20199781T 2019-10-04 2020-10-02 Formulación de suspensión pediátrica Active ES2974364T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962911035P 2019-10-04 2019-10-04
US201962911689P 2019-10-07 2019-10-07
US202063062785P 2020-08-07 2020-08-07

Publications (1)

Publication Number Publication Date
ES2974364T3 true ES2974364T3 (es) 2024-06-27

Family

ID=72744602

Family Applications (1)

Application Number Title Priority Date Filing Date
ES20199781T Active ES2974364T3 (es) 2019-10-04 2020-10-02 Formulación de suspensión pediátrica

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

Family Cites Families (23)

* 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
US6645988B2 (en) 1996-01-04 2003-11-11 Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
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

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
JP7801996B2 (ja) 2026-01-19
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
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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