DK2547324T3 - Fremgangsmåde til fremstilling af en frysetørret hurtigt opløselig, flerfaset doseringsform - Google Patents

Fremgangsmåde til fremstilling af en frysetørret hurtigt opløselig, flerfaset doseringsform Download PDF

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Publication number
DK2547324T3
DK2547324T3 DK11712090T DK11712090T DK2547324T3 DK 2547324 T3 DK2547324 T3 DK 2547324T3 DK 11712090 T DK11712090 T DK 11712090T DK 11712090 T DK11712090 T DK 11712090T DK 2547324 T3 DK2547324 T3 DK 2547324T3
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DK
Denmark
Prior art keywords
preparing
procedure
pharmaceutical form
phase pharmaceutical
quick soluble
Prior art date
Application number
DK11712090T
Other languages
English (en)
Inventor
Wei Tian
Original Assignee
Catalent Uk Swindon Zydis 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.)
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Publication of DK2547324T3 publication Critical patent/DK2547324T3/da

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    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2063Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Transplantation (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DK11712090T 2010-03-16 2011-03-15 Fremgangsmåde til fremstilling af en frysetørret hurtigt opløselig, flerfaset doseringsform DK2547324T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/724,601 US10548839B2 (en) 2010-03-16 2010-03-16 Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
PCT/US2011/028483 WO2011115969A2 (en) 2010-03-16 2011-03-15 Process of manufacturing a lyophilized fast dissolving, muti-phasic dosage form

Publications (1)

Publication Number Publication Date
DK2547324T3 true DK2547324T3 (da) 2019-10-28

Family

ID=44169183

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11712090T DK2547324T3 (da) 2010-03-16 2011-03-15 Fremgangsmåde til fremstilling af en frysetørret hurtigt opløselig, flerfaset doseringsform

Country Status (14)

Country Link
US (1) US10548839B2 (da)
EP (1) EP2547324B1 (da)
JP (1) JP5723965B2 (da)
KR (1) KR101573510B1 (da)
CN (1) CN103118662B (da)
AU (1) AU2011227446B2 (da)
BR (1) BR112012023324B8 (da)
CA (1) CA2793302C (da)
DK (1) DK2547324T3 (da)
ES (1) ES2751329T3 (da)
IL (1) IL221932A (da)
MX (1) MX363495B (da)
SG (1) SG184091A1 (da)
WO (1) WO2011115969A2 (da)

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US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
US20160136097A1 (en) 2013-07-06 2016-05-19 Daicel Corporation Ultrafast-disintegrating tablet and method for manufacturing same
EP3238712B1 (en) 2014-12-25 2023-11-01 Daicel Corporation Very rapidly disintegrating tablet, and method for producing same
MX384337B (es) * 2016-10-13 2025-03-14 Catalent Uk Swindon Zydis Ltd Composiciones farmacéuticas liofilizadas para suministro vaginal.
ES2947572T3 (es) 2016-10-25 2023-08-11 Catalent Uk Swindon Zydis Ltd Composiciones de diferentes densidades para comprimidos multicapa de desintegración rápida
IL267689B2 (en) 2016-12-31 2025-05-01 Bioxcel Therapeutics Inc Use of sublingual dexmedetomidine for the treatment of agitation
MX383146B (es) 2017-01-11 2025-03-13 Ferring Bv Composición farmacéutica de disgregación rápida.
EP3716953A1 (en) * 2017-11-27 2020-10-07 DSM IP Assets B.V. Freeze-dried multiparticulate solid dosage form
KR102232077B1 (ko) 2017-12-29 2021-03-25 주식회사 누베베 사상의학에 따라 처방가능한 한약 비만치료 타블릿 제제
ES2982045T3 (es) 2018-03-08 2024-10-14 Catalent Uk Swindon Zydis Ltd Proceso para reducir la endotoxina presente en la gelatina
BR112020026672A2 (pt) 2018-06-27 2021-03-30 Bioxcel Therapeutics, Inc. Formulações de filme contendo dexmedetomidina e métodos para produzi-las
KR20210129649A (ko) 2019-02-22 2021-10-28 카탈렌트 유.케이. 스윈던 지디스 리미티드 이부프로펜을 포함하는 약학적 조성물의 응집, 에어레이션 최소화 및 코팅 보존
AU2020225818B2 (en) 2019-02-22 2025-09-18 Catalent U.K. Swindon Zydis Limited Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
JP7543291B2 (ja) 2019-02-22 2024-09-02 キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド 医薬品の崩壊時間を安定させるための、保管中の薬物粒子コーティング材料の凝集を最小限に抑える
ES2961850T3 (es) 2019-02-22 2024-03-14 Catalent Uk Swindon Zydis Ltd Minimización de la aireación de suspensiones durante la mezcla en línea
BR112022000992A2 (pt) 2019-07-19 2022-06-14 Arx Llc Regimes de tratamento de dexmedetomidina não sedantes
US12208160B2 (en) 2020-07-31 2025-01-28 Catalent U.K. Swindon Zydis Limited Pharmaceutical compositions comprising coated API
US20240000705A1 (en) * 2020-09-17 2024-01-04 Catalent U.K. Swindon Zydis Limited Use of surfactant with high molecular weight fish gelatin based dosage formulations to improve flow characteristics
WO2022103639A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
EP4329759A4 (en) 2021-04-30 2025-07-16 Mind Medicine Inc CRYSTALLINE FORMS OF LSD SALTS
IL309143A (en) 2021-06-11 2024-02-01 Orphai Therapeutics Inc Stabilized apilimod compositions and uses thereof
JP7846211B2 (ja) * 2021-08-19 2026-04-14 デフィニウム セラピューティクス ユーエス, インコーポレイテッド 治療適用のためのd-リゼルグ酸ジエチルアミドの即時放出製剤
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Also Published As

Publication number Publication date
CN103118662B (zh) 2016-08-10
WO2011115969A2 (en) 2011-09-22
ES2751329T3 (es) 2020-03-31
KR20130060179A (ko) 2013-06-07
CN103118662A (zh) 2013-05-22
IL221932A (en) 2017-06-29
US10548839B2 (en) 2020-02-04
JP2013522308A (ja) 2013-06-13
US20110229573A1 (en) 2011-09-22
BR112012023324A2 (pt) 2016-05-24
MX363495B (es) 2019-03-26
CA2793302C (en) 2017-04-04
JP5723965B2 (ja) 2015-05-27
EP2547324A2 (en) 2013-01-23
AU2011227446A1 (en) 2012-10-04
MX2012010607A (es) 2013-03-21
SG184091A1 (en) 2012-10-30
EP2547324B1 (en) 2019-07-24
BR112012023324B1 (pt) 2021-04-27
CA2793302A1 (en) 2011-09-22
BR112012023324B8 (pt) 2021-05-25
KR101573510B1 (ko) 2015-12-01
AU2011227446B2 (en) 2016-06-30
WO2011115969A3 (en) 2012-04-26

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