BRPI0608505B8 - comprimido sublingual revestido - Google Patents

comprimido sublingual revestido

Info

Publication number
BRPI0608505B8
BRPI0608505B8 BRPI0608505A BRPI0608505A BRPI0608505B8 BR PI0608505 B8 BRPI0608505 B8 BR PI0608505B8 BR PI0608505 A BRPI0608505 A BR PI0608505A BR PI0608505 A BRPI0608505 A BR PI0608505A BR PI0608505 B8 BRPI0608505 B8 BR PI0608505B8
Authority
BR
Brazil
Prior art keywords
sublingual tablet
coated
coated sublingual
tablet
fentanyl
Prior art date
Application number
BRPI0608505A
Other languages
English (en)
Inventor
Herry Catherine
Benoist Guillaume
Duvochel Joseph
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 BRPI0608505A2 publication Critical patent/BRPI0608505A2/pt
Publication of BRPI0608505B1 publication Critical patent/BRPI0608505B1/pt
Publication of BRPI0608505B8 publication Critical patent/BRPI0608505B8/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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • 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
    • A61K9/0012—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
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Formation And Processing Of Food Products (AREA)

Abstract

comprimido sublingual revestido. a presente invenção está relacionada a um comprimido sublingual revestido e ao método para a sua preparação. o comprimido compreende um núcleo sem uma substância farmaceuticamente ativa e um revestimento compreendendo pelo menos uma substância ativa. a substância ativa preferida é um analgésico opióide.
BRPI0608505A 2005-03-18 2006-03-20 comprimido sublingual revestido BRPI0608505B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0502727 2005-03-18
FR0502727A FR2883179B1 (fr) 2005-03-18 2005-03-18 Comprime enrobe
PCT/EP2006/003304 WO2006097361A1 (en) 2005-03-18 2006-03-20 Sublingual coated tablet

Publications (3)

Publication Number Publication Date
BRPI0608505A2 BRPI0608505A2 (pt) 2010-01-05
BRPI0608505B1 BRPI0608505B1 (pt) 2021-05-04
BRPI0608505B8 true BRPI0608505B8 (pt) 2021-05-25

Family

ID=35309611

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0608505A BRPI0608505B8 (pt) 2005-03-18 2006-03-20 comprimido sublingual revestido

Country Status (25)

Country Link
US (2) US8709479B2 (pt)
EP (1) EP1858491B1 (pt)
JP (1) JP5138577B2 (pt)
KR (1) KR101239926B1 (pt)
CN (1) CN101141951B (pt)
AT (1) ATE507824T1 (pt)
AU (1) AU2006224690B2 (pt)
BR (1) BRPI0608505B8 (pt)
CA (1) CA2599502C (pt)
CY (1) CY1111729T1 (pt)
DE (1) DE602006021713D1 (pt)
DK (1) DK1858491T3 (pt)
ES (1) ES2365984T3 (pt)
FR (1) FR2883179B1 (pt)
IL (1) IL185626A (pt)
MX (1) MX2007011440A (pt)
NO (1) NO338771B1 (pt)
NZ (1) NZ561154A (pt)
PL (1) PL1858491T3 (pt)
PT (1) PT1858491E (pt)
RU (1) RU2403043C2 (pt)
SI (1) SI1858491T1 (pt)
UA (1) UA88509C2 (pt)
WO (1) WO2006097361A1 (pt)
ZA (1) ZA200707900B (pt)

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FR2883179B1 (fr) * 2005-03-18 2009-04-17 Ethypharm Sa Comprime enrobe
US20090082466A1 (en) * 2006-01-27 2009-03-26 Najib Babul Abuse Resistant and Extended Release Formulations and Method of Use Thereof
US8497258B2 (en) 2005-11-12 2013-07-30 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US8252328B2 (en) * 2006-01-06 2012-08-28 Acelrx Pharmaceuticals, Inc. Bioadhesive drug formulations for oral transmucosal delivery
CN101378732A (zh) * 2006-01-06 2009-03-04 阿塞尔Rx制药有限公司 用于口腔经粘膜递送的生物粘附药物制剂
US8865743B2 (en) 2006-01-06 2014-10-21 Acelrx Pharmaceuticals, Inc. Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8357114B2 (en) 2006-01-06 2013-01-22 Acelrx Pharmaceuticals, Inc. Drug dispensing device with flexible push rod
US9066847B2 (en) 2007-01-05 2015-06-30 Aceirx Pharmaceuticals, Inc. Storage and dispensing devices for administration of oral transmucosal dosage forms
US8535714B2 (en) 2006-01-06 2013-09-17 Acelrx Pharmaceuticals, Inc. Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
US8202535B2 (en) 2006-01-06 2012-06-19 Acelrx Pharmaceuticals, Inc. Small-volume 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
US8252329B2 (en) 2007-01-05 2012-08-28 Acelrx Pharmaceuticals, Inc. Bioadhesive drug formulations for oral transmucosal delivery
US8753308B2 (en) 2006-01-06 2014-06-17 Acelrx Pharmaceuticals, Inc. Methods for administering small volume oral transmucosal dosage forms using a dispensing device
US20070286900A1 (en) * 2006-06-09 2007-12-13 Catherine Herry Low dose tablets of opioid analgesics and preparation process
US20100233257A1 (en) * 2006-06-09 2010-09-16 Ethypharm Low dose sublingual tablets of opioid analgesics and preparation process
DE102006054638B4 (de) * 2006-11-16 2014-12-04 Laburnum Gmbh Pharmazeutische Einzeldosisform
KR101445891B1 (ko) * 2007-01-05 2014-10-02 아셀알엑스 파마슈티컬스 인코퍼레이티드 경구 경점막 제형의 투여를 위한 저장 및 분배 장치
WO2008100434A1 (en) * 2007-02-09 2008-08-21 Durect Corporation Transoral dosage forms comprising sufentanil and naloxone
CN101820838B (zh) * 2007-08-07 2013-06-05 阿塞尔Rx制药有限公司 采用口腔经粘膜剂型的用于程序镇静和镇痛的组合物和方法
FR2920308B1 (fr) * 2007-09-05 2011-02-25 Unither Dev Forme pharmaceutique pour l'administration par voie orale de principes actifs.
CA2709905A1 (en) * 2007-12-17 2009-06-25 Alfred Liang Abuse-resistant oxycodone composition
US20090263476A1 (en) * 2008-04-16 2009-10-22 Jobdevairakkam Christopher N Composition of Rapid Disintegrating Direct Compression Buccal Tablet
US8945592B2 (en) 2008-11-21 2015-02-03 Acelrx Pharmaceuticals, Inc. Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
PT2952191T (pt) * 2009-06-12 2018-11-30 Sunovion Pharmaceuticals Inc Apomorfina sublingual
US20110097401A1 (en) 2009-06-12 2011-04-28 Meritage Pharma, Inc. Methods for treating gastrointestinal disorders
US20110091544A1 (en) * 2009-10-16 2011-04-21 Acelrx Pharmaceuticals, Inc. Compositions and Methods for Mild Sedation, Anxiolysis and Analgesia in the Procedural Setting
US20110288128A1 (en) * 2010-05-21 2011-11-24 Acelrx Pharmaceuticals, Inc. Oral Transmucosal Administration of Sufentanil
EP2455069A1 (de) * 2010-11-11 2012-05-23 Laburnum GMBH Wirkstofffreie Darreichungsform, Verfahren zu deren Herstellung sowie deren Verwendung
PH12013501345A1 (en) * 2010-12-23 2022-10-24 Purdue Pharma Lp Tamper resistant solid oral dosage forms
KR102158948B1 (ko) * 2011-05-13 2020-09-24 이비 아이피 하이브리탭스 비.브이. 약물 전달 시스템
SMT202100546T1 (it) 2011-09-19 2021-11-12 Orexo Ab Compresse per via sublinguale resistenti all'abuso comprendenti buprenorfina e naloxone
SMT201800585T1 (it) 2012-05-02 2019-01-11 Orexo Ab Nuova composizione di alfentanil per il trattamento di dolore acuto
CN102755322B (zh) * 2012-07-24 2013-12-11 兆科药业（广州）有限公司 一种乐卡地平和阿托伐他汀复方制剂
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP2886103A1 (en) * 2013-12-23 2015-06-24 Hexal AG Pharmaceutical orodispersible film comprising buprenorphine particles with a particular size
CA2955229C (en) 2014-07-17 2020-03-10 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
WO2016064873A1 (en) 2014-10-20 2016-04-28 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
EP3578164A1 (en) * 2018-06-05 2019-12-11 Bio-Gate AG Thixotropic composition
JP7657457B2 (ja) * 2018-10-19 2025-04-07 ノバ サウスイースタン ユニバーシティー ｐＨ修飾賦形剤及び浸入促進剤を含む舌下エピネフリン組成物及びそれを使用する方法
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Also Published As

Publication number Publication date
MX2007011440A (es) 2007-11-14
ES2365984T3 (es) 2011-10-14
RU2403043C2 (ru) 2010-11-10
NZ561154A (en) 2010-12-24
EP1858491A1 (en) 2007-11-28
FR2883179A1 (fr) 2006-09-22
CN101141951A (zh) 2008-03-12
WO2006097361A1 (en) 2006-09-21
HK1109730A1 (en) 2008-06-20
CA2599502C (en) 2013-05-14
US8709479B2 (en) 2014-04-29
CA2599502A1 (en) 2006-09-21
RU2007138647A (ru) 2009-04-27
DK1858491T3 (da) 2011-08-22
UA88509C2 (ru) 2009-10-26
PT1858491E (pt) 2011-08-18
US20080226717A1 (en) 2008-09-18
JP2008533084A (ja) 2008-08-21
BRPI0608505A2 (pt) 2010-01-05
KR20070114756A (ko) 2007-12-04
PL1858491T3 (pl) 2012-03-30
SI1858491T1 (sl) 2011-09-30
IL185626A0 (en) 2008-01-06
NO20075345L (no) 2007-12-17
NO338771B1 (no) 2016-10-17
AU2006224690B2 (en) 2011-09-29
JP5138577B2 (ja) 2013-02-06
ATE507824T1 (de) 2011-05-15
IL185626A (en) 2014-09-30
CY1111729T1 (el) 2015-10-07
EP1858491B1 (en) 2011-05-04
KR101239926B1 (ko) 2013-03-07
AU2006224690A1 (en) 2006-09-21
DE602006021713D1 (de) 2011-06-16
CN101141951B (zh) 2011-02-09
ZA200707900B (en) 2009-01-28
BRPI0608505B1 (pt) 2021-05-04
FR2883179B1 (fr) 2009-04-17
US20060210632A1 (en) 2006-09-21

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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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]
B06A Patent application procedure suspended [chapter 6.1 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: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/03/2006, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME MEDIDA CAUTELAR DE 07/04/2021 - ADI 5.529/DF

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 20/03/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF