WO2011087765A3 - Methods of producing stabilized solid pharmaceutical compositions containing morphinans - Google Patents

Methods of producing stabilized solid pharmaceutical compositions containing morphinans 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
French (fr)
Other versions
WO2011087765A2 (en
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 RU2013132138/15A priority Critical patent/RU2013132138A/en
Priority to AU2011345329A priority patent/AU2011345329B2/en
Priority to PCT/US2011/041533 priority patent/WO2012087377A1/en
Priority to MX2013007057A priority patent/MX2013007057A/en
Priority to BR112013015622A priority patent/BR112013015622A2/en
Priority to CA2822553A priority patent/CA2822553A1/en
Priority to EP11731589.5A priority patent/EP2654727A1/en
Priority to CN201180068100.2A priority patent/CN103402499B/en
Priority to JP2013546107A priority patent/JP5897036B2/en
Priority to US13/166,770 priority patent/US8597681B2/en
Priority to US13/995,810 priority patent/US9198861B2/en
Priority to KR1020137019037A priority patent/KR101748906B1/en
Publication of WO2011087765A2 publication Critical patent/WO2011087765A2/en
Publication of WO2011087765A3 publication Critical patent/WO2011087765A3/en
Priority to ZA2013/03988A priority patent/ZA201303988B/en
Priority to US14/092,375 priority patent/US8980319B2/en
Priority to JP2015154715A priority patent/JP2015193668A/en
Priority to US14/921,188 priority patent/US20160184232A1/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
    • A61K9/14—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]

Abstract

Methods for producing stabilized solid dosage form pharmaceutical compositions are provided. In particular, methods for preparing protected granules containing morphinans, and solid dosage form pharmaceutical compositions produced using the morphinan-protected granules are provided.
PCT/US2010/061400 2009-12-22 2010-12-21 Methods of producing stabilized solid pharmaceutical compositions containing morphinans WO2011087765A2 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
CN201180068100.2A CN103402499B (en) 2010-12-21 2011-06-22 Preparation comprises the method for the stable pharmaceutical composition as solid dosage form of morphinan
US13/166,770 US8597681B2 (en) 2009-12-22 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
AU2011345329A AU2011345329B2 (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
US13/995,810 US9198861B2 (en) 2009-12-22 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
BR112013015622A BR112013015622A2 (en) 2010-12-21 2011-06-22 methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
CA2822553A CA2822553A1 (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
EP11731589.5A EP2654727A1 (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
RU2013132138/15A RU2013132138A (en) 2010-12-21 2011-06-22 METHODS FOR PRODUCING A STABILIZED SOLID DOSED FORM OF PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANES
JP2013546107A JP5897036B2 (en) 2010-12-21 2011-06-22 Method for producing a stable solid dosage form pharmaceutical composition comprising morphinan
PCT/US2011/041533 WO2012087377A1 (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
MX2013007057A MX2013007057A (en) 2010-12-21 2011-06-22 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans.
KR1020137019037A KR101748906B1 (en) 2010-12-21 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 (en) 2010-12-21 2015-08-05 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
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 (en) 2011-07-21
WO2011087765A3 true WO2011087765A3 (en) 2012-01-12

Family

ID=43498619

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/061400 WO2011087765A2 (en) 2009-12-22 2010-12-21 Methods of producing stabilized solid pharmaceutical compositions containing morphinans

Country Status (1)

Country Link
WO (1) WO2011087765A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9050335B1 (en) 2011-05-17 2015-06-09 Mallinckrodt Llc Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
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
US8741885B1 (en) 2011-05-17 2014-06-03 Mallinckrodt Llc Gastric retentive extended release pharmaceutical compositions
CN103432107A (en) * 2013-08-20 2013-12-11 安徽省先锋制药有限公司 Tapentadol hydrochloride paracetamol orally disintegrating tablet and preparation method thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030182A1 (en) * 2003-09-26 2005-04-07 Alza Corporation Controlled release formulations exhibiting an ascending rate of release
US20070207200A1 (en) * 2006-03-06 2007-09-06 Pozen Inc. Dosage forms for administering combinations of drugs
WO2008015221A2 (en) * 2006-08-04 2008-02-07 Ethypharm Multilayer orally disintegrating tablet
WO2009114648A1 (en) * 2008-03-11 2009-09-17 Depomed Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic

Family Cites Families (3)

* Cited by examiner, † Cited by third party
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 (en) 1993-07-27 1995-01-28 Walter G. Gowan, Jr. Rapidly disintegrating pharmaceutical dosage form and process for preparation thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005030182A1 (en) * 2003-09-26 2005-04-07 Alza Corporation Controlled release formulations exhibiting an ascending rate of release
US20070207200A1 (en) * 2006-03-06 2007-09-06 Pozen Inc. Dosage forms for administering combinations of drugs
WO2008015221A2 (en) * 2006-08-04 2008-02-07 Ethypharm Multilayer orally disintegrating tablet
WO2009114648A1 (en) * 2008-03-11 2009-09-17 Depomed Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic

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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