PE06572013A1 - pharmaceutical compositions comprising hydromorphone and naloxone - Google Patents

pharmaceutical compositions comprising hydromorphone and naloxone

Info

Publication number
PE06572013A1
PE06572013A1 PE2012002146A PE0021462012A PE06572013A1 PE 06572013 A1 PE06572013 A1 PE 06572013A1 PE 2012002146 A PE2012002146 A PE 2012002146A PE 0021462012 A PE0021462012 A PE 0021462012A PE 06572013 A1 PE06572013 A1 PE 06572013A1
Authority
PE
Peru
Prior art keywords
hydromorphone
naloxone
composition
long acting
prolonged release
Prior art date
Application number
PE2012002146A
Other languages
Spanish (es)
Inventor
Helen Kathleen Danagher
Hassan Mohammad
Malcolm Walden
Jonathon Oliver Whitehouse
Thinnayam Nagathan Krishnamurthy
Rincon Ricardo Alberto Vargas
Geoffrey Gerard Hayes
Original Assignee
Euro Celtique 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
Family has litigation
Priority to EP10162428 priority Critical
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of PE06572013A1 publication Critical patent/PE06572013A1/en
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42983574&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE06572013(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Abstract

SE REFIERE A UNA COMPOSICION FARMACEUTICA ORAL DE LIBERACION PROLONGADA QUE COMPRENDE: A) HIDROMORFONA Y NALOXONA COMO PRINCIPIOS ACTIVOS O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LOS MISMOS TAL COMO CLORHIDRATO DE HIDROMORFONA Y CLORHIDRATO DE NALOXONA, LOS CUALES ESTAN PRESENTES EN UNA PROPORCION EN PESO DE 2:1, 1:1, 1:2 O 1:3; REFERS TO A PHARMACEUTICAL COMPOSITION ORAL Long Acting comprising: a) hydromorphone naloxone ACTIVE or a pharmaceutically acceptable salt THEREOF AS hydromorphone hydrochloride and naloxone hydrochloride, which are present in a weight ratio of 2 : 1, 1: 1, 1: 2 or 1: 3; B) UN MATERIAL DE LIBERACION PROLONGADA TAL COMO UN COPOLIMERO NEUTRO DE BASE METACRILICA, UN ETER DE CELULOSA HIDROFOBICO Y UN ALCOHOL GRASO; B) A PROLONGED RELEASE MATERIAL AS NEUTRAL BASE copolymer methacrylic, a cellulose ether HYDROPHOBIC AND FATTY ALCOHOL; C) UN MATERIAL DE RELLENO TAL COMO LACTOSA ANHIDRA; C) a filler material AS ANHYDROUS LACTOSE; D) UN LUBRICANTE TAL COMO TALCO O ESTEARATO DE MAGNESIO; D) a lubricant such as talc or magnesium stearate; E) UN AGLOMERANTE TAL COMO HIDROXIPROPIL CELULOSA; E) a binder such as hydroxypropylcellulose; F) UN AGENTE ESFERONIZANTE O UN MODIFICADOR DE LA VELOCIDAD DE LIBERACION; F) spheronizing AN AGENT OR MODIFIER release rate; EN DONDE LA MATRIZ DE LIBERACION PROLONGADA ES TRATADA TERMICAMENTE A UNA HUMEDAD AMBIENTAL A UNA TEMPERATURA DE 30°CA 95°C POR UN TIEMPO DE 10 MINUTOS A 3 HORAS. Wherein the matrix PROLONGED RELEASE IS MOISTURE HEAT-TREATED TO ENVIRONMENTAL TEMPERATURE 30 ° CA 95 ° C for a period of 10 minutes to 3 hours. TAMBIEN SE REFIERE A UN PROCEDIMIENTO DE PREPARACION DE LA COMPOSICION DE LIBERACION PROLONGADA. Also it relates to a process for preparing the composition of Long Acting. DICHA COMPOSICION ES UTIL EN EL TRATAMIENTO DEL DOLOR Said composition is USEFUL IN THE TREATMENT OF PAIN
PE2012002146A 2010-05-10 2011-05-10 pharmaceutical compositions comprising hydromorphone and naloxone PE06572013A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP10162428 2010-05-10

Publications (1)

Publication Number Publication Date
PE06572013A1 true PE06572013A1 (en) 2013-06-15

Family

ID=42983574

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2012002146A PE06572013A1 (en) 2010-05-10 2011-05-10 pharmaceutical compositions comprising hydromorphone and naloxone

Country Status (34)

Country Link
US (1) US9700508B2 (en)
EP (1) EP2568967B1 (en)
JP (1) JP5671609B2 (en)
KR (2) KR101858797B1 (en)
CN (2) CN105832687A (en)
AP (1) AP3441A (en)
AR (1) AR083150A1 (en)
AU (1) AU2011252039B2 (en)
BR (1) BR112012028773A2 (en)
CA (1) CA2739751C (en)
CH (1) CH705273B1 (en)
CL (1) CL2012003012A1 (en)
CO (1) CO6640216A2 (en)
CR (1) CR20120549A (en)
DE (1) DE112011101605T5 (en)
DK (1) DK178741B1 (en)
EA (1) EA201291211A1 (en)
EC (1) ECSP12012236A (en)
ES (1) ES2408343B2 (en)
GB (1) GB2492037A (en)
GT (1) GT201200304A (en)
IL (1) IL222772A (en)
MX (1) MX347105B (en)
MY (1) MY157673A (en)
NO (1) NO20121414A1 (en)
NZ (2) NZ603497A (en)
PE (1) PE06572013A1 (en)
SE (1) SE1251371A1 (en)
SG (1) SG184523A1 (en)
TN (1) TN2012000488A1 (en)
TW (2) TWI590835B (en)
UA (1) UA106278C2 (en)
WO (1) WO2011141488A2 (en)
ZA (1) ZA201207603B (en)

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CA2798885C (en) 2010-05-10 2014-11-18 Euro-Celtique S.A. Combination of active loaded granules with additional actives
AU2011252040C1 (en) 2010-05-10 2015-04-02 Euro-Celtique S.A. Manufacturing of active-free granules and tablets comprising the same
EP2893928B1 (en) * 2012-09-03 2018-10-24 Daiichi Sankyo Company, Limited Hydromorphone hydrochloride-containing oral sustained-release pharmaceutical composition
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
US9517208B2 (en) * 2013-03-15 2016-12-13 Purdue Pharma L.P. Abuse-deterrent dosage forms
GB201313915D0 (en) 2013-08-02 2013-09-18 Johnson Matthey Plc Process
DE112014005175T5 (en) * 2013-11-13 2016-07-21 Euro-Celtique S.A. Hydromorphone and naloxone for the treatment of pain and opioid bowel dysfunction syndrome
CA2847781C (en) * 2014-03-28 2019-03-12 Purdue Pharma Reducing drug liking in a subject
EP3229785A2 (en) * 2014-12-08 2017-10-18 Develco Pharma Schweiz AG Naloxone monopreparation and multi-layer tablet

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