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MX2015005534A - Composiciones farmaceuticas que comprenden hidromorfona y naloxona. - Google Patents

Composiciones farmaceuticas que comprenden hidromorfona y naloxona.

Info

Publication number
MX2015005534A
MX2015005534A MX2015005534A MX2015005534A MX2015005534A MX 2015005534 A MX2015005534 A MX 2015005534A MX 2015005534 A MX2015005534 A MX 2015005534A MX 2015005534 A MX2015005534 A MX 2015005534A MX 2015005534 A MX2015005534 A MX 2015005534A
Authority
MX
Mexico
Prior art keywords
hydromorphone
naloxone
dosage form
prolonged release
pharmaceutical compositions
Prior art date
Application number
MX2015005534A
Other languages
English (en)
Other versions
MX363142B (es
Inventor
Ricardo Alberto Vargas Rincon
Original Assignee
Purdue Pharma
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=50679506&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2015005534(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Purdue Pharma filed Critical Purdue Pharma
Publication of MX2015005534A publication Critical patent/MX2015005534A/es
Publication of MX363142B publication Critical patent/MX363142B/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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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
    • A61K9/5078—Microcapsules 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
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)

Abstract

Se divulga una forma de dosificación farmacéutica de liberación prolongada que comprende una pluralidad de perlas recubiertas, cada una de las perlas recubiertas comprende: (a) un gránulo; (b) una primera capa de recubrimiento en el gránulo, la primera capa comprende: (i) hidromorfona o una sal farmacéuticamente aceptable, (ii) naloxona o una sal farmacéuticamente aceptable, (iii) un compuesto antioxidante y (iii) un agente quelante; y (c) una segunda capa de recubrimiento sobre la primera capa, la segunda capa comprende un agente de liberación prolongada. La forma de dosificación ha mejorado las propiedades de estabilidad y de disolución. Otro aspecto de la invención se refiere al uso de una combinación de un antioxidante (tal como metabisulfito de sodio) y un agente quelante (tal como dihidrato de sal disódica de ácido etilendiaminotetraacético) para mejorar las propiedades de estabilidad y/o disolución de una forma de dosificación de liberación prolongada que comprende (i) hidromorfona o una sal farmacéuticamente aceptable de la misma y (ii) naloxona o una sal farmacéuticamente aceptable de la misma.
MX2015005534A 2012-11-09 2013-11-06 Composiciones farmaceuticas que comprenden hidromorfona y naloxona. MX363142B (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261796390P 2012-11-09 2012-11-09
CA2795324A CA2795324C (en) 2012-11-09 2012-11-09 Pharmaceutical compositions comprising hydromorphone and naloxone
PCT/CA2013/000932 WO2014071499A1 (en) 2012-11-09 2013-11-06 Pharmaceutical compositions comprising hydromorphone and naloxone

Publications (2)

Publication Number Publication Date
MX2015005534A true MX2015005534A (es) 2016-06-02
MX363142B MX363142B (es) 2019-03-12

Family

ID=50679506

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015005534A MX363142B (es) 2012-11-09 2013-11-06 Composiciones farmaceuticas que comprenden hidromorfona y naloxona.

Country Status (12)

Country Link
US (2) US20150283091A1 (es)
JP (2) JP6359022B2 (es)
KR (1) KR101774676B1 (es)
CN (1) CN104902880B (es)
AU (1) AU2013344281B2 (es)
BR (1) BR112015009871A2 (es)
CA (2) CA2881144A1 (es)
MX (1) MX363142B (es)
PH (1) PH12015501015B1 (es)
SA (1) SA515360408B1 (es)
SG (1) SG11201502752VA (es)
WO (1) WO2014071499A1 (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9901540B2 (en) 2010-05-10 2018-02-27 Euro-Celtique S.A. Combination of active loaded granules with additional actives
EP2568968B1 (en) 2010-05-10 2017-07-12 Euro-Celtique S.A. Manufacturing of active-free granules and tablets comprising the same
US9814710B2 (en) 2013-11-13 2017-11-14 Euro-Celtique S.A. Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome
CA2847781C (en) * 2014-03-28 2019-03-12 Purdue Pharma Reducing drug liking in a subject
CA2954370A1 (en) * 2014-07-08 2016-01-14 Insys Pharma, Inc. Sublingual naloxone spray
US10617686B2 (en) 2014-07-08 2020-04-14 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US11135155B2 (en) 2014-07-08 2021-10-05 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US10722510B2 (en) 2014-07-08 2020-07-28 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
WO2018034920A1 (en) * 2016-08-17 2018-02-22 Insys Development Company, Inc. Liquid naloxone spray
CN108186599A (zh) * 2018-03-05 2018-06-22 上海祺宇生物科技有限公司 一种高隔氧率的羟丙甲基纤维素空心胶囊及其制备方法
CA3134943A1 (en) * 2019-03-26 2020-10-01 Pocket Naloxone Corp. Devices and methods for delivering pharmaceutical compositions
CN114144224B (zh) 2019-03-26 2024-08-09 保科特纳洛克斯恩公司 药物合成物输送器械和方法
WO2022101408A1 (en) * 2020-11-13 2022-05-19 Ferrer Internacional, S.A. Synthesis of hydromorphone base
US11278709B1 (en) 2021-03-12 2022-03-22 Pocket Naloxone Corp. Drug delivery device and methods for using same

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5866154A (en) * 1994-10-07 1999-02-02 The Dupont Merck Pharmaceutical Company Stabilized naloxone formulations
ES2141631T3 (es) * 1997-02-14 2000-03-16 Goedecke Ag Estabilizacion del hidrocloruro de naloxon.
ATE210983T1 (de) * 1997-11-03 2002-01-15 Stada Arzneimittel Ag Stabilisiertes kombinationsarzneimittel enthaltend naloxone und ein opiatanalgetikum
TWI223598B (en) * 1998-06-22 2004-11-11 Pfizer Ireland Pharmaceuticals An intranasal pharmaceutical composition for the treatment of male erectile dysfunction or female sexual disorders, an intranasal delivery system or device and sildenafil mesylate
US6071952A (en) * 1998-12-02 2000-06-06 Mylan Pharmaceuticals, Inc. Stabilized injectable pharmaceutical compositions containing taxoid anti-neoplastic agents
ES2616981T3 (es) * 2002-03-14 2017-06-15 Euro-Celtique S.A. Composiciones de hidrocloruro de naltrexona
ES2327034T3 (es) * 2002-03-26 2009-10-23 Euro-Celtique S.A. Composiciones recubiertas con gel de liberacion sostenida.
JP2006076971A (ja) * 2004-09-13 2006-03-23 Basf Ag 口腔内崩壊錠
EP3228308A1 (en) * 2005-01-28 2017-10-11 Euro-Celtique S.A. Alcohol resistant dosage forms
US20060270611A1 (en) * 2005-05-25 2006-11-30 Dries Willy M A Pediatric formulation of topiramate
RS51313B (sr) * 2007-11-09 2010-12-31 Acino Pharma Ag.51311 Retard tablete sa hidromorfonom
US20110237614A1 (en) * 2008-09-16 2011-09-29 Nektar Therapeutics Pegylated Opioids with Low Potential for Abuse
GB0909680D0 (en) * 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
ES2428938T3 (es) * 2009-07-22 2013-11-12 Grünenthal GmbH Forma de dosificación resistente a la manipulación y estabilizada frente a la oxidación
US8597681B2 (en) * 2009-12-22 2013-12-03 Mallinckrodt Llc Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
SE1251371A1 (sv) * 2010-05-10 2012-12-27 Euro Celtique Sa Farmaceutiska kompositioner innefattande hydromorfon och naloxon
US9901540B2 (en) * 2010-05-10 2018-02-27 Euro-Celtique S.A. Combination of active loaded granules with additional actives
PE20141171A1 (es) * 2011-10-06 2014-09-21 Gruenenthal Chemie Forma de dosificacion farmaceutica oral resistente a alteracion comprendiendo agonista opioide y antagonista opioide

Also Published As

Publication number Publication date
JP6359022B2 (ja) 2018-07-18
SG11201502752VA (en) 2015-05-28
CA2881144A1 (en) 2014-05-09
AU2013344281A1 (en) 2015-05-07
HK1210042A1 (en) 2016-04-15
JP2015536956A (ja) 2015-12-24
CA2795324A1 (en) 2014-05-09
CN104902880B (zh) 2017-08-11
PH12015501015A1 (en) 2015-07-27
US20150283091A1 (en) 2015-10-08
PH12015501015B1 (en) 2015-07-27
AU2013344281B2 (en) 2016-07-28
US20190224130A1 (en) 2019-07-25
JP2017149725A (ja) 2017-08-31
MX363142B (es) 2019-03-12
CA2795324C (en) 2015-07-14
WO2014071499A1 (en) 2014-05-15
CN104902880A (zh) 2015-09-09
BR112015009871A2 (pt) 2017-07-11
KR20150085825A (ko) 2015-07-24
KR101774676B1 (ko) 2017-09-04
SA515360408B1 (ar) 2017-04-03

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