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MX363495B - Proceso de manufacturacion de una forma de dosificacion multifasica de rapida disolucion liofilizada. - Google Patents

Proceso de manufacturacion de una forma de dosificacion multifasica de rapida disolucion liofilizada.

Info

Publication number
MX363495B
MX363495B MX2012010607A MX2012010607A MX363495B MX 363495 B MX363495 B MX 363495B MX 2012010607 A MX2012010607 A MX 2012010607A MX 2012010607 A MX2012010607 A MX 2012010607A MX 363495 B MX363495 B MX 363495B
Authority
MX
Mexico
Prior art keywords
dosage form
muti
manufacturing
fast dissolving
phasic
Prior art date
Application number
MX2012010607A
Other languages
English (en)
Other versions
MX2012010607A (es
Inventor
Tian Wei
Original Assignee
Scherer Technologies Llc R P
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 Scherer Technologies Llc R P filed Critical Scherer Technologies Llc R P
Publication of MX2012010607A publication Critical patent/MX2012010607A/es
Publication of MX363495B publication Critical patent/MX363495B/es

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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Communicable Diseases (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Psychiatry (AREA)
  • Virology (AREA)
  • Transplantation (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a la preparación de una forma de dosificación de rápida disolución, liofilizada, multifásica (FDDF) para el suministro de un ingrediente farmacéuticamente activo por dosificación secuencial de una formulación que contiene un agente que forma matriz no gelificante y una formulación que contiene una gelatina gelificante.
MX2012010607A 2010-03-16 2011-03-15 Proceso de manufacturacion de una forma de dosificacion multifasica de rapida disolucion liofilizada. MX363495B (es)

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 (2)

Publication Number Publication Date
MX2012010607A MX2012010607A (es) 2013-03-21
MX363495B true MX363495B (es) 2019-03-26

Family

ID=44169183

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2012010607A MX363495B (es) 2010-03-16 2011-03-15 Proceso de manufacturacion de una forma de dosificacion multifasica de rapida disolucion liofilizada.

Country Status (14)

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

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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
KR102191468B1 (ko) 2013-07-06 2020-12-15 주식회사 다이셀 초고속 붕괴 정제 및 그 제조 방법
PL3238712T3 (pl) 2014-12-25 2024-04-02 Daicel Corporation Tabletka ulegająca bardzo szybkiemu rozpadowi i sposób jej wytwarzania
US11026883B2 (en) * 2016-10-13 2021-06-08 Catalent U.K. Swindon Zydis Limited Lyophilized pharmaceutical compositions for vaginal delivery
JP6968184B2 (ja) * 2016-10-25 2021-11-17 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 速崩壊多層錠のための異なる密度の組成物
US11839604B2 (en) 2016-12-31 2023-12-12 Bioxcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
RU2751193C2 (ru) 2017-01-11 2021-07-12 Ферринг Б.В. Быстро распадающаяся фармацевтическая композиция
JP2021504327A (ja) * 2017-11-27 2021-02-15 ディーエスエム アイピー アセッツ ビー．ブイ．Ｄｓｍ Ｉｐ Ａｓｓｅｔｓ Ｂ．Ｖ． 凍結乾燥多粒子固形製剤
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
PT3813802T (pt) 2018-06-27 2025-01-15 Arx Llc Formulações de películas contendo dexmedetomidina e métodos de produção das mesmas
CA3129395A1 (en) 2019-02-22 2020-08-27 Catalent U.K. Swindon Zydis Limited Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen
KR20210130722A (ko) 2019-02-22 2021-11-01 카탈렌트 유.케이. 스윈던 지디스 리미티드 의약품의 붕해 시간을 안정화하기 위한 저장 동안 약물 입자 코팅 물질의 응집 최소화
EP3927313A1 (en) 2019-02-22 2021-12-29 Catalent U.K. Swindon Zydis Limited Preserving functionally-coated api particles produced by solventless mixing processes in aqueous suspension
BR112022000992A2 (pt) 2019-07-19 2022-06-14 Arx Llc Regimes de tratamento de dexmedetomidina não sedantes
CN115968281A (zh) 2020-07-31 2023-04-14 康特伦英国斯温顿捷迪斯有限公司 包含经包衣api的药物组合物
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN117529324A (zh) 2021-06-11 2024-02-06 奥夫艾治疗公司 稳定的阿匹莫德组合物和其用途
CA3229017A1 (en) * 2021-08-19 2023-02-23 Mind Medicine, Inc. Lyophilized orally disintegrating tablet formulations of d-lysergic acid diethylamide for therapeutic applications
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens

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Also Published As

Publication number Publication date
SG184091A1 (en) 2012-10-30
AU2011227446B2 (en) 2016-06-30
CN103118662A (zh) 2013-05-22
BR112012023324A2 (pt) 2016-05-24
BR112012023324B8 (pt) 2021-05-25
EP2547324B1 (en) 2019-07-24
KR20130060179A (ko) 2013-06-07
EP2547324A2 (en) 2013-01-23
MX2012010607A (es) 2013-03-21
DK2547324T3 (da) 2019-10-28
BR112012023324B1 (pt) 2021-04-27
CA2793302A1 (en) 2011-09-22
CA2793302C (en) 2017-04-04
JP5723965B2 (ja) 2015-05-27
WO2011115969A3 (en) 2012-04-26
KR101573510B1 (ko) 2015-12-01
ES2751329T3 (es) 2020-03-31
US20110229573A1 (en) 2011-09-22
IL221932A (en) 2017-06-29
WO2011115969A2 (en) 2011-09-22
US10548839B2 (en) 2020-02-04
JP2013522308A (ja) 2013-06-13
AU2011227446A1 (en) 2012-10-04
CN103118662B (zh) 2016-08-10

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