AU2011232408B2 - Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances - Google Patents

Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances Download PDF

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Publication number
AU2011232408B2
AU2011232408B2 AU2011232408A AU2011232408A AU2011232408B2 AU 2011232408 B2 AU2011232408 B2 AU 2011232408B2 AU 2011232408 A AU2011232408 A AU 2011232408A AU 2011232408 A AU2011232408 A AU 2011232408A AU 2011232408 B2 AU2011232408 B2 AU 2011232408B2
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AU
Australia
Prior art keywords
controlled release
dosage form
drug
administration
release dosage
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.)
Ceased
Application number
AU2011232408A
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English (en)
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AU2011232408A1 (en
Inventor
Clark Patrick Allphin
James Frederick Pfeiffer
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.)
Jazz Pharmaceuticals Inc
Original Assignee
Jazz Pharmaceuticals Inc
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44673619&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2011232408(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Jazz Pharmaceuticals Inc filed Critical Jazz Pharmaceuticals Inc
Publication of AU2011232408A1 publication Critical patent/AU2011232408A1/en
Application granted granted Critical
Publication of AU2011232408B2 publication Critical patent/AU2011232408B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61P25/20—Hypnotics; Sedatives

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2011232408A 2010-03-24 2011-03-24 Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances Ceased AU2011232408B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US31721210P 2010-03-24 2010-03-24
US61/317,212 2010-03-24
PCT/US2011/029802 WO2011119839A1 (en) 2010-03-24 2011-03-24 Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances

Publications (2)

Publication Number Publication Date
AU2011232408A1 AU2011232408A1 (en) 2012-10-11
AU2011232408B2 true AU2011232408B2 (en) 2015-07-30

Family

ID=44673619

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2011232408A Ceased AU2011232408B2 (en) 2010-03-24 2011-03-24 Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances

Country Status (10)

Country Link
US (9) US20120076865A1 (https=)
EP (1) EP2549987A4 (https=)
JP (1) JP5968300B2 (https=)
CN (1) CN102917697B (https=)
AU (1) AU2011232408B2 (https=)
BR (1) BR112012024019B1 (https=)
CA (1) CA2794171C (https=)
IL (1) IL222012A (https=)
MX (2) MX391660B (https=)
WO (1) WO2011119839A1 (https=)

Cited By (10)

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US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

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EP2309988B1 (en) 2008-07-21 2015-11-25 SI Group, Inc. High content sodium ibuprofen granules, their preparation and their use in preparing non-effervescent solid dosage forms
US8778398B2 (en) * 2008-11-04 2014-07-15 Jazz Pharmaceuticals, Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
US8771735B2 (en) * 2008-11-04 2014-07-08 Jazz Pharmaceuticals, Inc. Immediate release dosage forms of sodium oxybate
MX391660B (es) 2010-03-24 2025-03-21 Jazz Pharmaceuticals Inc Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas
US20160068463A1 (en) 2012-11-14 2016-03-10 Metabolix, Inc. Production of salts of 4-hydroxybutyrate using biobased raw materials
CN104884048B (zh) * 2012-12-14 2018-11-23 Si集团有限公司 高含量布洛芬钠颗粒、其制备及其在制备非泡腾固体剂型中的用途
WO2014127053A2 (en) 2013-02-13 2014-08-21 Metabolix, Inc. Process for ultra pure chemical production from biobased raw starting materials
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
US20150275167A1 (en) * 2014-03-28 2015-10-01 Corning Incorporated Composition and method for cell culture sustained release
ES2668379T3 (es) * 2014-07-09 2018-05-17 Pierre Fabre Médicament Método para el tratamiento de trastornos del movimiento con befiradol
CA2910865C (en) 2014-07-15 2016-11-29 Isa Odidi Compositions and methods for reducing overdose
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
FR3049463B1 (fr) * 2016-04-01 2019-07-05 Debregeas Et Associes Pharma Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique
US11000498B2 (en) 2016-07-22 2021-05-11 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
WO2019126216A1 (en) 2017-12-18 2019-06-27 Tris Phama, Inc. Pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
WO2019126214A1 (en) 2017-12-18 2019-06-27 Tris Pharma, Inc. Pharmaceutical composition comprising ghb gastro-retentive raft forming systems having trigger pulse drug release
US11337919B2 (en) 2017-12-18 2022-05-24 Tris Pharma, Inc. Modified release drug powder composition comprising gastro-retentive RAFT forming systems having trigger pulse drug release
EP3737353A1 (en) 2017-12-18 2020-11-18 Tris Pharma, Inc. Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
JP7349428B2 (ja) 2017-12-20 2023-09-22 フラメル アイルランド リミテッド 改善された安定性を有するパッケージされた修飾放出ガンマ－ヒドロキシブチラート製剤
BR112021006027A2 (pt) * 2018-11-19 2021-06-29 Jazz Pharmaceuticals Ireland Limited formulações de fármaco resistente a álcool
KR102881504B1 (ko) 2019-12-20 2025-11-06 엑스더블유파마 리미티드 4-발레릴옥시부티르산의 합성 방법
TW202139986A (zh) 2020-02-21 2021-11-01 愛爾蘭商爵士製藥愛爾蘭有限責任公司 治療原發性嗜睡症之方法
EP4153146A4 (en) * 2020-05-23 2024-07-10 Lyrus Life Sciences Pvt. LTD. PHARMACEUTICAL COMPOSITION OF A SUSTAINED RELEASE ORAL SUSPENSION AND METHOD FOR THE MANUFACTURE THEREOF
AU2021292406B2 (en) * 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
CN115803017A (zh) 2020-06-18 2023-03-14 凯瑞康宁生物工程有限公司 水溶性活性药物成分的药物造粒物
CN116261451A (zh) 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
KR20230058151A (ko) * 2020-10-05 2023-05-02 엑스더블유파마 리미티드 감마-하이드록시부티르산 유도체의 변형된 방출 조성물
US12582622B2 (en) 2020-10-08 2026-03-24 Jazz Pharmaceuticals Ireland Limited Sodium oxybate to treat idiopathic hypersomnia
WO2022082105A2 (en) 2020-10-16 2022-04-21 Jazz Pharmaceuticals Ireland Limited Treatment methods using ghb
EP4588471A3 (en) 2021-03-19 2025-09-24 XWPharma Ltd. Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
EP4415701A1 (en) 2021-10-11 2024-08-21 Jazz Pharmaceuticals Ireland Limited Method of administering oxybate
WO2023135150A1 (en) 2022-01-11 2023-07-20 Jazz Pharmaceuticals Ireland Limited Method of administering oxybate
WO2024163966A1 (en) 2023-02-03 2024-08-08 Tris Pharma, Inc. Low sodium oxybate once nightly composition

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