AU2020358472B2 - Pediatric suspension formulation - Google Patents

Pediatric suspension formulation

Info

Publication number
AU2020358472B2
AU2020358472B2 AU2020358472A AU2020358472A AU2020358472B2 AU 2020358472 B2 AU2020358472 B2 AU 2020358472B2 AU 2020358472 A AU2020358472 A AU 2020358472A AU 2020358472 A AU2020358472 A AU 2020358472A AU 2020358472 B2 AU2020358472 B2 AU 2020358472B2
Authority
AU
Australia
Prior art keywords
omeprazole
mixture
sodium
storage
pharmaceutically acceptable
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
AU2020358472A
Other languages
English (en)
Other versions
AU2020358472A1 (en
Inventor
Maurice Joseph Anthony Clancy
Damien Patrick Flynn
Dennis Mark McDaid
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
Publication of AU2020358472A1 publication Critical patent/AU2020358472A1/en
Application granted granted Critical
Publication of AU2020358472B2 publication Critical patent/AU2020358472B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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)
AU2020358472A 2019-10-04 2020-10-02 Pediatric suspension formulation Active AU2020358472B2 (en)

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

Publications (2)

Publication Number Publication Date
AU2020358472A1 AU2020358472A1 (en) 2022-04-07
AU2020358472B2 true AU2020358472B2 (en) 2026-01-15

Family

ID=72744602

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020358472A Active AU2020358472B2 (en) 2019-10-04 2020-10-02 Pediatric suspension formulation

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 (6)

* 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
WO2001051050A1 (en) * 2000-01-11 2001-07-19 The Curators Of The University Of Missouri Novel substituted benzimidazole dosage forms and method of using same
US8093271B2 (en) * 2006-06-05 2012-01-10 Laboratorios Bago S.A. Anti-acid pharmaceutical composition in powder form and process for making it
WO2013139377A1 (en) * 2012-03-20 2013-09-26 Laboratorios Bagó S.A. Method for producing enteric alginate microcapsules via ionic gelation containing diclofenac or one of the salts thereof and multiparticled pharmaceutical composition containing them
US9051100B2 (en) * 2008-09-01 2015-06-09 Fresh Co., Ltd. Cap and container with cap
US20180042901A1 (en) * 2016-08-11 2018-02-15 Adamis Pharmaceuticals Corporation Drug compositions comprising an anti-parasitic and proton pump inhibitor

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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.
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
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
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 (6)

* 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
WO2001051050A1 (en) * 2000-01-11 2001-07-19 The Curators Of The University Of Missouri Novel substituted benzimidazole dosage forms and method of using same
US8093271B2 (en) * 2006-06-05 2012-01-10 Laboratorios Bago S.A. Anti-acid pharmaceutical composition in powder form and process for making it
US9051100B2 (en) * 2008-09-01 2015-06-09 Fresh Co., Ltd. Cap and container with cap
WO2013139377A1 (en) * 2012-03-20 2013-09-26 Laboratorios Bagó S.A. Method for producing enteric alginate microcapsules via ionic gelation containing diclofenac or one of the salts thereof and multiparticled pharmaceutical composition containing them
US20180042901A1 (en) * 2016-08-11 2018-02-15 Adamis Pharmaceuticals Corporation Drug compositions comprising an anti-parasitic and proton pump inhibitor

Also Published As

Publication number Publication date
US11826359B2 (en) 2023-11-28
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
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

Similar Documents

Publication Publication Date Title
RU2241460C2 (ru) Фармацевтическая композиция цефуроксим аксетила с маскированным горьким вкусом
US12465600B2 (en) Pediatric suspension formulation
JPH08503482A (ja) 部分水素添加植物油で被覆されたシメチジン顆粒剤
JP2000516243A (ja) 治療薬耐性ストレプトコッカス・ニューモニエのための薬剤の製造におけるアモキシシリンおよびクラブラン酸塩の組み合せの使用
US20080274200A1 (en) Dose titratable liquid dosage forms of acid labile drugs
CZ294434B6 (cs) Léčivo pro léčení bakteriálních infekcí u pediatrických pacientů
US8093271B2 (en) Anti-acid pharmaceutical composition in powder form and process for making it
CN101272768A (zh) 双氯芬酸制剂和使用方法
EP2005945A9 (en) Oseltamivir phosphate granule and preparation mehtod thereof
JP2013028603A (ja) プロトンポンプ阻害剤の液体剤形
KR20250041170A (ko) 항경련제의 안정한 약제학적 경구용 액체 제형
US20020099044A1 (en) Composition comprising amoxycillin and clavulanic acid
EP2558079B1 (en) Ciprofloxacin dry syrup composition
CZ11407U1 (cs) Farmaceutický prostředek uzpůsobený pro pediatrické podávání