CN102300463B - 扎来普隆(zaleplon)胃滞留药物传递系统 - Google Patents

扎来普隆(zaleplon)胃滞留药物传递系统 Download PDF

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Publication number
CN102300463B
CN102300463B CN200980153943.5A CN200980153943A CN102300463B CN 102300463 B CN102300463 B CN 102300463B CN 200980153943 A CN200980153943 A CN 200980153943A CN 102300463 B CN102300463 B CN 102300463B
Authority
CN
China
Prior art keywords
zaleplon
dosage forms
gastric retentive
biodegradable
multilamellar
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.)
Expired - Fee Related
Application number
CN200980153943.5A
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English (en)
Chinese (zh)
Other versions
CN102300463A (zh
Inventor
苏赫尔·马斯里
埃坦·莫尔
戴维·基尔迈尔
埃琳娜·克吕夫
焦拉·卡尔尼
纳达夫·纳翁
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Indaptus Therapeutics Inc
Original Assignee
Intec Pharma 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
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Publication of CN102300463A publication Critical patent/CN102300463A/zh
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Publication of CN102300463B publication Critical patent/CN102300463B/zh
Expired - Fee Related 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
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets
    • 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
    • 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
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Anesthesiology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN200980153943.5A 2008-12-04 2009-10-19 扎来普隆(zaleplon)胃滞留药物传递系统 Expired - Fee Related CN102300463B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12005108P 2008-12-04 2008-12-04
US61/120,051 2008-12-04
PCT/IB2009/007731 WO2010064139A2 (en) 2008-12-04 2009-10-19 Zaleplon gastroretentive drug delivery system

Publications (2)

Publication Number Publication Date
CN102300463A CN102300463A (zh) 2011-12-28
CN102300463B true CN102300463B (zh) 2015-03-25

Family

ID=42232930

Family Applications (1)

Application Number Title Priority Date Filing Date
CN200980153943.5A Expired - Fee Related CN102300463B (zh) 2008-12-04 2009-10-19 扎来普隆(zaleplon)胃滞留药物传递系统

Country Status (11)

Country Link
US (2) US9693981B2 (enExample)
EP (1) EP2378883B1 (enExample)
JP (2) JP2012510987A (enExample)
KR (1) KR20110116004A (enExample)
CN (1) CN102300463B (enExample)
CA (1) CA2745741A1 (enExample)
ES (1) ES2562925T3 (enExample)
IL (1) IL213376A (enExample)
PL (1) PL2378883T3 (enExample)
WO (2) WO2010064139A2 (enExample)
ZA (1) ZA201104620B (enExample)

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US9248111B2 (en) 2011-03-01 2016-02-02 Pharnext Therapeutic approaches for treating parkinson's disease
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CA2874737A1 (en) 2012-06-01 2013-12-05 Lynn Health Science Institute, Inc. Use of baclofen to treat insomnia
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MX2016016406A (es) 2014-06-11 2017-10-12 Massachusetts Inst Technology Estructuras de permanencia, y métodos relacionados.
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US10987328B2 (en) 2015-02-20 2021-04-27 Osmotica Kereskedelmi Es Szolgaltato Kft Controlled release dosage form
US10300032B2 (en) 2015-02-20 2019-05-28 Osmotica Kereskedelmi Es Szolgaltato Kft Controlled release dosage form
WO2016132218A1 (en) 2015-02-20 2016-08-25 Osmotica Kereskedelmi Es Szolgaltato Kft Method of administering r-baclofen in an extended release dosage form
US10172800B2 (en) 2015-02-20 2019-01-08 Osmotica Kereskedelmi Es Szolgaltato Kft Controlled release dosage form with enhanced pharmacokinetics
AU2016342374B2 (en) 2015-10-23 2022-08-04 Nortiva Bio, Inc. Gastric residence systems for sustained release of therapeutic agents and methods of use thereof
US9849125B1 (en) 2015-11-03 2017-12-26 Banner Lifie Sciences LLC Anti-overingestion dosage forms
KR102796240B1 (ko) 2015-12-08 2025-04-16 린드라 테라퓨틱스 인코퍼레이티드 위 체류 시스템을 위한 기하 구성형태
US12109305B2 (en) 2016-05-27 2024-10-08 Lyndra Therapeutics, Inc. Materials architecture for gastric residence systems
RU2019103297A (ru) * 2016-07-11 2020-08-11 Интек Фарма Лтд. Гастроретентивные составы для перорального введения и пути их применения
EP3518902A4 (en) 2016-09-30 2020-07-08 Lyndra, Inc. GASTRIC RESIDENCE SYSTEMS FOR LONG-TERM ADMINISTRATION OF ADAMANTANE CLASS MEDICINES
CA3060026A1 (en) * 2017-04-18 2018-10-25 Jayant Jagannath Khandare Polymer based formulation for release of drugs and bioactives at specific git sites
US10335375B2 (en) 2017-05-30 2019-07-02 Patheon Softgels, Inc. Anti-overingestion abuse deterrent compositions
TWI811221B (zh) 2017-06-09 2023-08-11 美商萊恩卓治療公司 具有釋放速率調節膜之胃的滯留系統
EP3705118B1 (en) 2017-10-31 2024-02-14 Samyang Holdings Corporation Oral solid dosage form composition having improved disintegration and preparation method therefor
IL286512B2 (en) * 2019-03-20 2026-03-01 Lyndra Therapeutics Inc Capsules and capsule coatings for stomach-retaining dosage forms
CN113840596A (zh) * 2019-03-20 2021-12-24 林德拉治疗公司 用于胃滞留剂型的衣层
US11654124B2 (en) 2019-07-29 2023-05-23 Amneal Pharmaceuticals Llc Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
US10792262B1 (en) * 2019-07-29 2020-10-06 Saol International Limited Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
US20220409539A1 (en) * 2019-12-30 2022-12-29 Fraunhofer Usa Inc. Particles for multi-dose delivery
US11491125B1 (en) * 2021-09-29 2022-11-08 Amneal Pharmaceuticals Llc Baclofen formulations and methods of minimizing patient exposure to metabolite variations
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Also Published As

Publication number Publication date
WO2010064100A1 (en) 2010-06-10
CA2745741A1 (en) 2010-06-10
KR20110116004A (ko) 2011-10-24
EP2378883A2 (en) 2011-10-26
US9693981B2 (en) 2017-07-04
JP2015028094A (ja) 2015-02-12
EP2378883B1 (en) 2015-12-23
WO2010064139A3 (en) 2010-09-10
ZA201104620B (en) 2012-03-28
US20110091542A1 (en) 2011-04-21
JP2012510987A (ja) 2012-05-17
CN102300463A (zh) 2011-12-28
IL213376A (en) 2015-06-30
ES2562925T3 (es) 2016-03-09
WO2010064139A2 (en) 2010-06-10
EP2378883A4 (en) 2014-03-05
PL2378883T3 (pl) 2016-06-30
JP6104873B2 (ja) 2017-03-29
US20120021051A1 (en) 2012-01-26
IL213376A0 (en) 2011-07-31

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