[go: up one dir, main page]

HK1198131A1 - Tamper-resistant tablet providing immediate drug release - Google Patents

Tamper-resistant tablet providing immediate drug release Download PDF

Info

Publication number
HK1198131A1
HK1198131A1 HK14111669.1A HK14111669A HK1198131A1 HK 1198131 A1 HK1198131 A1 HK 1198131A1 HK 14111669 A HK14111669 A HK 14111669A HK 1198131 A1 HK1198131 A1 HK 1198131A1
Authority
HK
Hong Kong
Prior art keywords
particulates
tablet
active compound
pharmacologically active
matrix material
Prior art date
Application number
HK14111669.1A
Other languages
German (de)
English (en)
Chinese (zh)
Other versions
HK1198131B (en
Inventor
Sebastian Schwier
Marcel Haupts
Udo RÜTTGERS
Lutz Barnscheid
Jana Denker
Original Assignee
Grünenthal GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44951601&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HK1198131(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grünenthal GmbH filed Critical Grünenthal GmbH
Publication of HK1198131A1 publication Critical patent/HK1198131A1/en
Publication of HK1198131B publication Critical patent/HK1198131B/en

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
    • A61K9/2072—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Emergency Medicine (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Plant Substances (AREA)

Claims (12)

  1. Comprimé résistant aux violations comprenant
    (i) un matériau de matrice à une teneur d'au moins 40 % en masse par rapport à la masse totale du comprimé ; et
    (ii) une multitude de particules à une teneur maximale de 60 % en masse de la masse totale du comprimé ; où lesdites particules comprennent un principe actif pharmacologique et un oxyde de polyalkylène ; et forment une phase discontinue dans le matériau de matrice ;
    où l'oxyde de polyalkylène présente une masse moléculaire de plus de 20 000 g/mol ; le comprimé permet d'obtenir dans des conditions in vitro la libération immédiate du principe actif pharmacologique selon la pharmacopée européenne ; et le composé pharmacologiquement actif est un opioïde.
  2. Comprimé selon la revendication 1, qui a dans des conditions in vitro une durée de désintégration mesurée selon la pharmacopée européenne d'un maximum de 3 minutes.
  3. Comprimé selon l'une quelconque des revendications précédentes, où les particules présentent un diamètre moyen d'environ 1000 ± 250 µm et/ou une longueur moyenne d'environ 750 ± 250 µm.
  4. Comprimé selon l'une quelconque des revendications précédentes, où le principe actif pharmacologique est dispersé dans l'oxyde de polyalkylène.
  5. Comprimé selon l'une quelconque des revendications précédentes, où la teneur en l'oxyde de polyalkylène est d'au moins 25 % en masse, par rapport à la masse totale d'une particule.
  6. Comprimé selon l'une quelconque des revendications précédentes, où la teneur en le principe actif pharmacologique est d'au moins 25 % en masse, par rapport à la masse totale d'une particule.
  7. Comprimé selon l'une quelconque des revendications précédentes, où les particules sont extrudées à l'état fondu.
  8. Comprimé selon l'une quelconque des revendications précédentes, où les particules sont enrobées d'une pellicule.
  9. Comprimé selon l'une quelconque des revendications précédentes, où le matériau de matrice est également présent sous forme de particules.
  10. Comprimé selon l'une quelconque des revendications précédentes, où le matériau de matrice est granulé à sec ou compacté.
  11. Comprimé selon l'une quelconque des revendications précédentes, où le matériau de matrice comprend un agent liant, une charge, un agent délitant et/ou un lubrifiant.
  12. Composé selon la revendication 11, où l'agent délitant est réticulé.
HK14111669.1A 2011-07-29 2012-07-27 Tamper-resistant tablet providing immediate drug release HK1198131B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11006253 2011-07-29
EP11006253.6 2011-07-29
PCT/EP2012/003196 WO2013017242A1 (fr) 2011-07-29 2012-07-27 Comprimé anti-manipulation permettant une libération immédiate de médicament

Publications (2)

Publication Number Publication Date
HK1198131A1 true HK1198131A1 (en) 2015-03-13
HK1198131B HK1198131B (en) 2018-05-18

Family

ID=

Also Published As

Publication number Publication date
ES2648129T3 (es) 2017-12-28
BR112014001091A2 (pt) 2017-02-14
HRP20171458T1 (hr) 2017-11-17
MX348054B (es) 2017-05-25
US20190269621A1 (en) 2019-09-05
HUE034710T2 (hu) 2018-02-28
AU2012292418B2 (en) 2017-02-16
JP6316394B2 (ja) 2018-04-25
CY1119503T1 (el) 2018-03-07
DK2736497T3 (da) 2017-11-13
PT2736497T (pt) 2017-11-30
CO6821948A2 (es) 2013-12-31
PE20141650A1 (es) 2014-11-22
CA2839126A1 (fr) 2013-02-07
US20130028972A1 (en) 2013-01-31
NO2736497T3 (fr) 2018-01-20
AR087359A1 (es) 2014-03-19
NZ619016A (en) 2016-03-31
RS56527B1 (sr) 2018-02-28
CN103857386A (zh) 2014-06-11
LT2736497T (lt) 2017-11-10
EA201400173A1 (ru) 2014-06-30
AU2012292418A1 (en) 2014-01-16
US20160199306A1 (en) 2016-07-14
ZA201309299B (en) 2015-05-27
KR20140053158A (ko) 2014-05-07
PL2736497T3 (pl) 2018-01-31
US20180369149A1 (en) 2018-12-27
ECSP14013169A (es) 2014-11-28
EP2736497B1 (fr) 2017-08-23
US10695297B2 (en) 2020-06-30
WO2013017242A1 (fr) 2013-02-07
CL2013003331A1 (es) 2014-06-06
JP6063462B2 (ja) 2017-01-18
SI2736497T1 (sl) 2017-12-29
EP2736497A1 (fr) 2014-06-04
JP2017075167A (ja) 2017-04-20
JP2014524926A (ja) 2014-09-25
MX2014001167A (es) 2014-04-30
IL229516A0 (en) 2014-01-30

Similar Documents

Publication Publication Date Title
US10695297B2 (en) Tamper-resistant tablet providing immediate drug release
US10864164B2 (en) Tamper-resistant tablet providing immediate drug release
US20200276188A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
EP2838512B1 (fr) Forme pharmaceutique inviolable et résistante au basculement de dose
AU2012289764A1 (en) Tamper-resistant tablet providing immediate drug release
US20200009055A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US20200268748A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US20200338069A1 (en) Tamper-resistant dosage form with immediate release and resistance against solvent extraction
EP3698776A1 (fr) Forme posologique inviolable à libération immédiate et résistance à l'extraction par solvant
HK1198131B (en) Tamper-resistant tablet providing immediate drug release
HK1198132B (en) Tamper-resistant tablet providing immediate drug release
NZ619016B2 (en) Tamper-resistant tablet providing immediate drug release
NZ618168B2 (en) Tamper-resistant tablet providing immediate drug release
HK1206647B (en) Tamper resistant and dose-dumping resistant pharmaceutical dosage form

Legal Events

Date Code Title Description
CHRG Changes in the register

Free format text: CORRECTION OF NAME OF INVENTOR FROM P

PC Patent ceased (i.e. patent has lapsed due to the failure to pay the renewal fee)

Effective date: 20210722