BR112012023324A2 - processo de preparação de uma forma de dosagem multifásica liofilizada de dissolução rápida - Google Patents

processo de preparação de uma forma de dosagem multifásica liofilizada de dissolução rápida

Info

Publication number
BR112012023324A2
BR112012023324A2 BR112012023324A BR112012023324A BR112012023324A2 BR 112012023324 A2 BR112012023324 A2 BR 112012023324A2 BR 112012023324 A BR112012023324 A BR 112012023324A BR 112012023324 A BR112012023324 A BR 112012023324A BR 112012023324 A2 BR112012023324 A2 BR 112012023324A2
Authority
BR
Brazil
Prior art keywords
dosage form
fast dissolving
preparing
lyophilized
dissolving lyophilized
Prior art date
Application number
BR112012023324A
Other languages
English (en)
Other versions
BR112012023324B8 (pt
BR112012023324B1 (pt
Inventor
Wei Tian
Original Assignee
Catalent Pharma Solutions Llc
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 Catalent Pharma Solutions Llc filed Critical Catalent Pharma Solutions Llc
Publication of BR112012023324A2 publication Critical patent/BR112012023324A2/pt
Publication of BR112012023324B1 publication Critical patent/BR112012023324B1/pt
Publication of BR112012023324B8 publication Critical patent/BR112012023324B8/pt

Links

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth 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
    • 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
    • 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
    • A61K9/19—Particulate 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2063—Proteins, e.g. gelatin
    • 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
    • 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
    • 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Transplantation (AREA)
  • Psychiatry (AREA)
  • Communicable Diseases (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

processo de preparação de uma forma de dosagem liofilizada, de dissolução rápida, multi-fásica. uma forma de dosagem multi-fásica, liofilizada, de dissolução rápida (fddf) para a distribuição de um ingrediente farmaceuticamente ativo é preparada por dosagem seqüencial de uma formulação contendo um agente de formação de matriz de não gelificação e uma formulação contendo uma gelatina de gelificação.
BR112012023324A 2010-03-16 2011-03-15 processo de preparação de uma forma de dosagem multifásica liofilizada de dissolução rápida BR112012023324B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12/724,601 2010-03-16
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 (3)

Publication Number Publication Date
BR112012023324A2 true BR112012023324A2 (pt) 2016-05-24
BR112012023324B1 BR112012023324B1 (pt) 2021-04-27
BR112012023324B8 BR112012023324B8 (pt) 2021-05-25

Family

ID=44169183

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012023324A BR112012023324B8 (pt) 2010-03-16 2011-03-15 processo de preparação de uma forma de dosagem multifásica liofilizada de dissolução rápida

Country Status (14)

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

Families Citing this family (17)

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Publication number Priority date Publication date Assignee Title
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
WO2016103904A1 (ja) 2014-12-25 2016-06-30 株式会社ダイセル 超速崩壊錠剤及びその製造方法
JP7219712B2 (ja) * 2016-10-13 2023-02-08 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 膣送達のための凍結乾燥医薬組成物
US11517533B2 (en) * 2016-10-25 2022-12-06 Catalent U.K. Swindon Zydis Limited Compositions of different densities for fast disintegrating multi-layer tablet
BR112019013503A2 (pt) 2016-12-31 2020-01-07 Bioxcel Therapeutics, Inc. Uso de dexmedetomidina sublingual para o tratamento da agitação
CA3046725A1 (en) 2017-01-11 2018-07-19 Ferring B.V. A fast disintegrating pharmaceutical composition
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
WO2019171173A1 (en) 2018-03-08 2019-09-12 Catalent U.K. Swindon Zydis Limited Process to reduce endotoxin in gelatin
CN114983981A (zh) 2018-06-27 2022-09-02 比奥克斯塞尔医疗股份有限公司 含右美托咪定的膜制剂及其制造方法
JP2022521317A (ja) 2019-02-22 2022-04-06 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
ES2966816T3 (es) 2019-02-22 2024-04-24 Catalent Uk Swindon Zydis Ltd Minimización de la aglomeración, aireación y conservación del recubrimiento de composiciones farmacéuticas que comprenden ibuprofeno
MX2022000709A (es) 2019-07-19 2022-05-19 Bioxcel Therapeutics Inc Regimenes de tratamiento con dexmedetomidina no sedante.
JP2023535829A (ja) 2020-07-31 2023-08-21 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 コーティングされたａｐｉを含む医薬組成物
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CA3220152A1 (en) 2021-06-11 2022-12-15 Keith FANDRICK Stabilized apilimod compositions and uses thereof

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Also Published As

Publication number Publication date
KR20130060179A (ko) 2013-06-07
CN103118662B (zh) 2016-08-10
US10548839B2 (en) 2020-02-04
MX363495B (es) 2019-03-26
ES2751329T3 (es) 2020-03-31
CN103118662A (zh) 2013-05-22
IL221932A (en) 2017-06-29
KR101573510B1 (ko) 2015-12-01
AU2011227446B2 (en) 2016-06-30
JP2013522308A (ja) 2013-06-13
WO2011115969A2 (en) 2011-09-22
BR112012023324B8 (pt) 2021-05-25
EP2547324B1 (en) 2019-07-24
JP5723965B2 (ja) 2015-05-27
WO2011115969A3 (en) 2012-04-26
AU2011227446A1 (en) 2012-10-04
CA2793302C (en) 2017-04-04
EP2547324A2 (en) 2013-01-23
MX2012010607A (es) 2013-03-21
BR112012023324B1 (pt) 2021-04-27
CA2793302A1 (en) 2011-09-22
SG184091A1 (en) 2012-10-30
US20110229573A1 (en) 2011-09-22
DK2547324T3 (da) 2019-10-28

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Owner name: R.P. SCHERER TECHNOLOGIES, LLC (US)

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