WO2011087765A3 - Procédés de production de compositions pharmaceutiques galéniques solides stabilisées contenant des morphinanes - Google Patents

Procédés de production de compositions pharmaceutiques galéniques solides stabilisées contenant des morphinanes Download PDF

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Publication number
WO2011087765A3
WO2011087765A3 PCT/US2010/061400 US2010061400W WO2011087765A3 WO 2011087765 A3 WO2011087765 A3 WO 2011087765A3 US 2010061400 W US2010061400 W US 2010061400W WO 2011087765 A3 WO2011087765 A3 WO 2011087765A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
pharmaceutical compositions
compositions containing
solid pharmaceutical
producing stabilized
Prior art date
Application number
PCT/US2010/061400
Other languages
English (en)
Other versions
WO2011087765A2 (fr
Inventor
Jae Han Park
Tiffani Eisenhauer
Anish Dhanarajan
Vishal K. Gupta
Stephen Overholt
Original Assignee
Mallinckrodt Llc
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 Mallinckrodt Llc filed Critical Mallinckrodt Llc
Priority to AU2011345329A priority Critical patent/AU2011345329B2/en
Priority to US13/166,770 priority patent/US8597681B2/en
Priority to CA2822553A priority patent/CA2822553A1/fr
Priority to CN201180068100.2A priority patent/CN103402499B/zh
Priority to RU2013132138/15A priority patent/RU2013132138A/ru
Priority to MX2013007057A priority patent/MX2013007057A/es
Priority to KR1020137019037A priority patent/KR101748906B1/ko
Priority to BR112013015622A priority patent/BR112013015622A2/pt
Priority to JP2013546107A priority patent/JP5897036B2/ja
Priority to PCT/US2011/041533 priority patent/WO2012087377A1/fr
Priority to EP11731589.5A priority patent/EP2654727A1/fr
Priority to US13/995,810 priority patent/US9198861B2/en
Publication of WO2011087765A2 publication Critical patent/WO2011087765A2/fr
Publication of WO2011087765A3 publication Critical patent/WO2011087765A3/fr
Priority to ZA2013/03988A priority patent/ZA201303988B/en
Priority to US14/092,375 priority patent/US8980319B2/en
Priority to JP2015154715A priority patent/JP2015193668A/ja
Priority to US14/921,188 priority patent/US20160184232A1/en

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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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4355—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having oxygen as a ring hetero atom
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • 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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • 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
    • 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
    • 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
    • A61K9/2072—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
    • 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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

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

Abstract

La présente invention concerne des procédés de production de compositions pharmaceutiques galéniques solides stabilisées. En particulier, l'invention concerne des procédés de préparation de granules enrobés contenant des morphinanes, et des compositions pharmaceutiques galéniques solides produites en utilisant les granules enrobés à base de morphinanes.
PCT/US2010/061400 2009-12-22 2010-12-21 Procédés de production de compositions pharmaceutiques galéniques solides stabilisées contenant des morphinanes WO2011087765A2 (fr)

Priority Applications (16)

Application Number Priority Date Filing Date Title
BR112013015622A BR112013015622A2 (pt) 2010-12-21 2011-06-22 métodos de produção de composições farmacêuticas de dosagem sólida estabilizadas contendo morfinanos
PCT/US2011/041533 WO2012087377A1 (fr) 2010-12-21 2011-06-22 Procédés de production de compositions pharmaceutiques dosifiées solides stabilisées contenant des morphinanes
US13/166,770 US8597681B2 (en) 2009-12-22 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
EP11731589.5A EP2654727A1 (fr) 2010-12-21 2011-06-22 Procédés de production de compositions pharmaceutiques dosifiées solides stabilisées contenant des morphinanes
RU2013132138/15A RU2013132138A (ru) 2010-12-21 2011-06-22 Способы получения стабилизированной твёрдой дозированной формы фармацевтических композиций, содержащих морфинаны
MX2013007057A MX2013007057A (es) 2010-12-21 2011-06-22 Metodos para producir composiciones farmaceuticas estabilizadas de dosis solida que contienen morfinanos.
KR1020137019037A KR101748906B1 (ko) 2010-12-21 2011-06-22 모르피난을 함유한 안정화된 고체 투여 제약 조성물의 제조 방법
AU2011345329A AU2011345329B2 (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
JP2013546107A JP5897036B2 (ja) 2010-12-21 2011-06-22 モルフィナンを含む安定した固体剤形の薬学的組成物を生成する方法
CA2822553A CA2822553A1 (fr) 2010-12-21 2011-06-22 Procedes de production de compositions pharmaceutiques dosifiees solides stabilisees contenant des morphinanes
CN201180068100.2A CN103402499B (zh) 2010-12-21 2011-06-22 制备包含吗啡喃的稳定的固体剂型药物组合物的方法
US13/995,810 US9198861B2 (en) 2009-12-22 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
ZA2013/03988A ZA201303988B (en) 2010-12-21 2013-05-31 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US14/092,375 US8980319B2 (en) 2009-12-22 2013-11-27 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
JP2015154715A JP2015193668A (ja) 2010-12-21 2015-08-05 モルフィナンを含む安定した固体剤形の薬学的組成物を生成する方法
US14/921,188 US20160184232A1 (en) 2009-12-22 2015-10-23 Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28465109P 2009-12-22 2009-12-22
US61/284,651 2009-12-22

Publications (2)

Publication Number Publication Date
WO2011087765A2 WO2011087765A2 (fr) 2011-07-21
WO2011087765A3 true WO2011087765A3 (fr) 2012-01-12

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/061400 WO2011087765A2 (fr) 2009-12-22 2010-12-21 Procédés de production de compositions pharmaceutiques galéniques solides stabilisées contenant des morphinanes

Country Status (1)

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WO (1) WO2011087765A2 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8741885B1 (en) 2011-05-17 2014-06-03 Mallinckrodt Llc Gastric retentive extended release pharmaceutical compositions
US8858963B1 (en) 2011-05-17 2014-10-14 Mallinckrodt Llc Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia
US8658631B1 (en) 2011-05-17 2014-02-25 Mallinckrodt Llc Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
CN103432107A (zh) * 2013-08-20 2013-12-11 安徽省先锋制药有限公司 一种盐酸他喷他多对乙酰氨基酚口腔崩解片及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030182A1 (fr) * 2003-09-26 2005-04-07 Alza Corporation Formulations a liberation commandee presentant un taux croisssant de liberation
US20070207200A1 (en) * 2006-03-06 2007-09-06 Pozen Inc. Dosage forms for administering combinations of drugs
WO2008015221A2 (fr) * 2006-08-04 2008-02-07 Ethypharm Comprimé multicouches se désintégrant par voie orale
WO2009114648A1 (fr) * 2008-03-11 2009-09-17 Depomed Inc. Formes médicamenteuses à libération étendue de rétention gastrique comprenant des combinaisons d'un analgésique non opioïde et d'un analgésique opioïde

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Publication number Priority date Publication date Assignee Title
US4851226A (en) 1987-11-16 1989-07-25 Mcneil Consumer Products Company Chewable medicament tablet containing means for taste masking
US5075114A (en) 1990-05-23 1991-12-24 Mcneil-Ppc, Inc. Taste masking and sustained release coatings for pharmaceuticals
CA2128820A1 (fr) 1993-07-27 1995-01-28 Walter G. Gowan, Jr. Forme pharmaceutique a desintegration rapide et methode de preparation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030182A1 (fr) * 2003-09-26 2005-04-07 Alza Corporation Formulations a liberation commandee presentant un taux croisssant de liberation
US20070207200A1 (en) * 2006-03-06 2007-09-06 Pozen Inc. Dosage forms for administering combinations of drugs
WO2008015221A2 (fr) * 2006-08-04 2008-02-07 Ethypharm Comprimé multicouches se désintégrant par voie orale
WO2009114648A1 (fr) * 2008-03-11 2009-09-17 Depomed Inc. Formes médicamenteuses à libération étendue de rétention gastrique comprenant des combinaisons d'un analgésique non opioïde et d'un analgésique opioïde

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ALTAF S A ET AL: "BEAD COMPACTS. II. EVALUATION OF RAPIDLY DISINTEGRATING NONSEGREGATING COMPRESSED BEAD FORMULATIONS", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, NEW YORK, NY, US, vol. 25, no. 5, 1 May 1999 (1999-05-01), pages 635 - 642, XP001070236, ISSN: 0363-9045, DOI: 10.1081/DDC-100102219 *

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