BRPI0712353B8 - comprimidos sublinguais de analgésicos de opióide de dose baixa e processo de preparação - Google Patents

comprimidos sublinguais de analgésicos de opióide de dose baixa e processo de preparação

Info

Publication number
BRPI0712353B8
BRPI0712353B8 BRPI0712353A BRPI0712353A BRPI0712353B8 BR PI0712353 B8 BRPI0712353 B8 BR PI0712353B8 BR PI0712353 A BRPI0712353 A BR PI0712353A BR PI0712353 A BRPI0712353 A BR PI0712353A BR PI0712353 B8 BRPI0712353 B8 BR PI0712353B8
Authority
BR
Brazil
Prior art keywords
preparation process
low dose
opioid analgesic
sublingual tablets
dose opioid
Prior art date
Application number
BRPI0712353A
Other languages
English (en)
Inventor
Herry Catherine
Oury Pascal
Original Assignee
Ethypharm Sa
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 Ethypharm Sa filed Critical Ethypharm Sa
Publication of BRPI0712353A2 publication Critical patent/BRPI0712353A2/pt
Publication of BRPI0712353B1 publication Critical patent/BRPI0712353B1/pt
Publication of BRPI0712353B8 publication Critical patent/BRPI0712353B8/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
    • A61K9/20—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
    • A61K9/0012—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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/2095—Tabletting processes

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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (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)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

comprimidos sublinguais de analgésicos de opióide de dose baixa e processo de preparação. a presente invenção refere-se a um comprimido sublingual e ao método para a preparação do mesmo.
BRPI0712353A 2006-06-09 2007-06-08 comprimidos sublinguais de analgésicos de opióide de dose baixa e processo de preparação BRPI0712353B8 (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/423,339 US20070286900A1 (en) 2006-06-09 2006-06-09 Low dose tablets of opioid analgesics and preparation process
US11/423.339 2006-06-09
US11/423339 2006-06-09
PCT/EP2007/055652 WO2007141328A1 (en) 2006-06-09 2007-06-08 Low dose sublingual tablets of opioid analgesics and preparation process

Publications (3)

Publication Number Publication Date
BRPI0712353A2 BRPI0712353A2 (pt) 2012-12-25
BRPI0712353B1 BRPI0712353B1 (pt) 2021-02-09
BRPI0712353B8 true BRPI0712353B8 (pt) 2021-05-25

Family

ID=38543859

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0712353A BRPI0712353B8 (pt) 2006-06-09 2007-06-08 comprimidos sublinguais de analgésicos de opióide de dose baixa e processo de preparação

Country Status (14)

Country Link
US (1) US20070286900A1 (pt)
EP (1) EP2037885B1 (pt)
JP (1) JP5537935B2 (pt)
KR (1) KR101406918B1 (pt)
CN (1) CN101505732B (pt)
AU (1) AU2007255351A1 (pt)
BR (1) BRPI0712353B8 (pt)
CA (1) CA2654512C (pt)
ES (1) ES2534262T3 (pt)
IL (1) IL195814A (pt)
MX (1) MX2008015731A (pt)
NZ (1) NZ573443A (pt)
RU (1) RU2444360C2 (pt)
WO (1) WO2007141328A1 (pt)

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US8865743B2 (en) 2006-01-06 2014-10-21 Acelrx Pharmaceuticals, Inc. Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US9066847B2 (en) 2007-01-05 2015-06-30 Aceirx Pharmaceuticals, Inc. Storage and dispensing devices for administration of oral transmucosal dosage forms
US9289583B2 (en) * 2006-01-06 2016-03-22 Acelrx Pharmaceuticals, Inc. Methods for administering small volume oral transmucosal dosage forms using a dispensing device
US8202535B2 (en) 2006-01-06 2012-06-19 Acelrx Pharmaceuticals, Inc. Small-volume oral transmucosal dosage forms
US8357114B2 (en) 2006-01-06 2013-01-22 Acelrx Pharmaceuticals, Inc. Drug dispensing device with flexible push rod
US8753308B2 (en) 2006-01-06 2014-06-17 Acelrx Pharmaceuticals, Inc. Methods for administering small volume oral transmucosal dosage forms using a dispensing device
US8535714B2 (en) 2006-01-06 2013-09-17 Acelrx Pharmaceuticals, Inc. Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8252329B2 (en) 2007-01-05 2012-08-28 Acelrx Pharmaceuticals, Inc. Bioadhesive drug formulations for oral transmucosal delivery
US8252328B2 (en) 2006-01-06 2012-08-28 Acelrx Pharmaceuticals, Inc. Bioadhesive drug formulations for oral transmucosal delivery
KR101560176B1 (ko) 2007-10-31 2015-10-14 맥네일-피피씨, 인코포레이티드 구강내 붕해성 투여 형태
BRPI0918253A2 (pt) * 2008-09-12 2015-12-15 Critical Pharmaceuticals Ltd aperfeicoamento na absorcao de agentes terapeuticos atraves das membranas mucosas ou da pele
US8945592B2 (en) 2008-11-21 2015-02-03 Acelrx Pharmaceuticals, Inc. Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
US8548623B2 (en) 2009-03-18 2013-10-01 Acelrx Pharmaceuticals, Inc. Storage and dispensing devices for administration of oral transmucosal dosage forms
PT2952191T (pt) * 2009-06-12 2018-11-30 Sunovion Pharmaceuticals Inc Apomorfina sublingual
US8343533B2 (en) 2009-09-24 2013-01-01 Mcneil-Ppc, Inc. Manufacture of lozenge product with radiofrequency
GB2483579A (en) * 2010-06-30 2012-03-14 Londonpharma Ltd Sublingual formulations comprising methadone and ethanol for use in reducing pain
PH12014500316B1 (en) 2011-09-19 2018-10-03 Orexo Ab New abuse-resistant pharmaceutical composition for the treatment of opioid dependence
US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
US9445971B2 (en) 2012-05-01 2016-09-20 Johnson & Johnson Consumer Inc. Method of manufacturing solid dosage form
US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
TR201815935T4 (tr) 2012-05-02 2018-11-21 Orexo Ab Akut ağrının tedavisi için yeni alfentanil bileşimi.
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
CN115671064A (zh) * 2014-02-07 2023-02-03 讯唐制药公司 全天然无毒舌下药物递送系统
EP3169315B1 (en) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form
US11058856B2 (en) 2014-12-23 2021-07-13 Acelrx Pharmaceuticals, Inc. Systems, devices and methods for dispensing oral transmucosal dosage forms
US10493026B2 (en) 2017-03-20 2019-12-03 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
CN112089683A (zh) * 2018-04-27 2020-12-18 首都医科大学附属北京天坛医院 依达拉奉药物组合物
FR3099881B1 (fr) 2019-08-13 2022-08-26 Ethypharm Sa Comprimé orodispersible d’opioide à faible dosage et son procédé de préparation.

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JPS6327424A (ja) * 1986-07-17 1988-02-05 Shionogi & Co Ltd 徐放性製剤およびその製造法
US5202128A (en) * 1989-01-06 1993-04-13 F. H. Faulding & Co. Limited Sustained release pharmaceutical composition
US5286493A (en) * 1992-01-27 1994-02-15 Euroceltique, S.A. Stabilized controlled release formulations having acrylic polymer coating
US5411745A (en) * 1994-05-25 1995-05-02 Euro-Celtique, S.A. Powder-layered morphine sulfate formulations
RS49982B (sr) * 1997-09-17 2008-09-29 Euro-Celtique S.A., Sinergistička analgetička kombinacija analgetičkog opijata i inhibitora ciklooksigenaze-2
FR2771291B1 (fr) * 1997-11-21 2000-02-25 Ethypharm Lab Prod Ethiques Spheroides, procede de preparation et compositions pharmaceutiques
FR2769524B1 (fr) * 1998-01-06 1999-12-31 Ethypharm Lab Prod Ethiques Dispositif d'enrobage pour granules a absorber par voie orale
FR2774910B1 (fr) * 1998-02-16 2001-09-07 Ethypharm Lab Prod Ethiques Microgranules de sulfate de morphine, procede de fabrication et preparations pharmaceutiques
SE9803239D0 (sv) * 1998-09-24 1998-09-24 Diabact Ab Composition for the treatment of acute pain
SE9803240D0 (sv) * 1998-09-24 1998-09-24 Diabact Ab A pharmaceutical composition having a rapid action
US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
FR2794646B1 (fr) * 1999-06-09 2001-09-21 Ethypharm Lab Prod Ethiques Microgranules de sulfate de morphine, procede de preparation et composition les contenant
KR20040060917A (ko) * 2001-08-06 2004-07-06 유로-셀티크 소시에떼 아노뉨 오피오이드 남용을 방지하기 위한 조성물 및 방법
US20030191147A1 (en) * 2002-04-09 2003-10-09 Barry Sherman Opioid antagonist compositions and dosage forms
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Also Published As

Publication number Publication date
MX2008015731A (es) 2009-04-22
CA2654512C (en) 2015-04-28
JP2009539808A (ja) 2009-11-19
IL195814A0 (en) 2009-09-01
US20070286900A1 (en) 2007-12-13
CA2654512A1 (en) 2007-12-13
BRPI0712353B1 (pt) 2021-02-09
RU2008152066A (ru) 2010-07-20
JP5537935B2 (ja) 2014-07-02
EP2037885A1 (en) 2009-03-25
IL195814A (en) 2014-05-28
CN101505732A (zh) 2009-08-12
CN101505732B (zh) 2012-05-23
ES2534262T3 (es) 2015-04-20
AU2007255351A1 (en) 2007-12-13
KR20090029788A (ko) 2009-03-23
BRPI0712353A2 (pt) 2012-12-25
RU2444360C2 (ru) 2012-03-10
NZ573443A (en) 2011-11-25
KR101406918B1 (ko) 2014-06-19
EP2037885B1 (en) 2015-01-21
WO2007141328A1 (en) 2007-12-13
HK1128425A1 (en) 2009-10-30

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 09/02/2021, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/06/2007 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF