EP2405754A4 - Modified release pharmaceutical compositions of buprenorphine - Google Patents

Modified release pharmaceutical compositions of buprenorphine

Info

Publication number
EP2405754A4
EP2405754A4 EP09841608.4A EP09841608A EP2405754A4 EP 2405754 A4 EP2405754 A4 EP 2405754A4 EP 09841608 A EP09841608 A EP 09841608A EP 2405754 A4 EP2405754 A4 EP 2405754A4
Authority
EP
European Patent Office
Prior art keywords
buprenorphine
pharmaceutical compositions
modified release
release pharmaceutical
modified
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP09841608.4A
Other languages
German (de)
French (fr)
Other versions
EP2405754A1 (en
Inventor
Najib Babul
Ashish Kumar Rehni
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Relmada Therapeutics Inc
Original Assignee
Relmada Therapeutics Inc
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
Priority claimed from PCT/US2009/001502 external-priority patent/WO2009114118A2/en
Application filed by Relmada Therapeutics Inc filed Critical Relmada Therapeutics Inc
Publication of EP2405754A1 publication Critical patent/EP2405754A1/en
Publication of EP2405754A4 publication Critical patent/EP2405754A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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 TOILETRY 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 TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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 TOILETRY 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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 TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY 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
EP09841608.4A 2009-03-09 2009-09-28 Modified release pharmaceutical compositions of buprenorphine Withdrawn EP2405754A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US2009/001502 WO2009114118A2 (en) 2008-03-08 2009-03-09 Oral pharmaceutical compositions of buprenorphine and method of use
PCT/US2009/005394 WO2010104494A1 (en) 2009-03-09 2009-09-28 Modified release pharmaceutical compositions of buprenorphine

Publications (2)

Publication Number Publication Date
EP2405754A1 EP2405754A1 (en) 2012-01-18
EP2405754A4 true EP2405754A4 (en) 2015-10-14

Family

ID=42728703

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09841608.4A Withdrawn EP2405754A4 (en) 2009-03-09 2009-09-28 Modified release pharmaceutical compositions of buprenorphine

Country Status (2)

Country Link
EP (1) EP2405754A4 (en)
WO (1) WO2010104494A1 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10493027B2 (en) 2014-08-07 2019-12-03 Mucodel Pharma Llc Chemically stable compositions of a pharmaceutical active agent in a multi- chambered delivery system for mucosal delivery
EP3177270A4 (en) * 2014-08-07 2018-01-24 Mucodel Pharma LLC Chemically stable and oromucosally absorbable gel compositions of a pharmaceutical active agent in a multi-chambered delivery system
WO2023187225A1 (en) * 2022-04-01 2023-10-05 Amplicon Ab Alkaline intraoral products

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050226929A1 (en) * 2004-04-12 2005-10-13 Jianbo Xie Controlled release opioid analgesic formulation
WO2006069030A1 (en) * 2004-12-20 2006-06-29 Collegium Pharmaceutical, Inc. Pharmaceutical compositions for sleep disorders
WO2006079853A1 (en) * 2005-01-28 2006-08-03 Pharmakodex Ltd Analgesic compositions
US20070184112A1 (en) * 2002-03-29 2007-08-09 Alza Corporation Volume Efficient Controlled Release Dosage Form
EP1849460A2 (en) * 2005-10-31 2007-10-31 ALZA Corporation Methods of reducing alcohol-induced dose dumping for opioid sustained release oral dosage forms
WO2008086804A2 (en) * 2007-01-16 2008-07-24 Egalet A/S Use of i) a polyglycol and n) an active drug substance for the preparation of a pharmaceutical composition for i) mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse
WO2008134071A1 (en) * 2007-04-26 2008-11-06 Theraquest Biosciences, Inc. Multimodal abuse resistant extended release formulations
WO2008148798A2 (en) * 2007-06-04 2008-12-11 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
WO2009114118A2 (en) * 2008-03-08 2009-09-17 Theraquest Biosciences, Inc. Oral pharmaceutical compositions of buprenorphine and method of use
WO2011018583A2 (en) * 2009-08-12 2011-02-17 Debregeas Et Associes Pharma Novel pharmaceutical formulations against drug misuse

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070184112A1 (en) * 2002-03-29 2007-08-09 Alza Corporation Volume Efficient Controlled Release Dosage Form
US20050226929A1 (en) * 2004-04-12 2005-10-13 Jianbo Xie Controlled release opioid analgesic formulation
WO2006069030A1 (en) * 2004-12-20 2006-06-29 Collegium Pharmaceutical, Inc. Pharmaceutical compositions for sleep disorders
WO2006079853A1 (en) * 2005-01-28 2006-08-03 Pharmakodex Ltd Analgesic compositions
EP1849460A2 (en) * 2005-10-31 2007-10-31 ALZA Corporation Methods of reducing alcohol-induced dose dumping for opioid sustained release oral dosage forms
WO2008086804A2 (en) * 2007-01-16 2008-07-24 Egalet A/S Use of i) a polyglycol and n) an active drug substance for the preparation of a pharmaceutical composition for i) mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse
WO2008134071A1 (en) * 2007-04-26 2008-11-06 Theraquest Biosciences, Inc. Multimodal abuse resistant extended release formulations
WO2008148798A2 (en) * 2007-06-04 2008-12-11 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
WO2009114118A2 (en) * 2008-03-08 2009-09-17 Theraquest Biosciences, Inc. Oral pharmaceutical compositions of buprenorphine and method of use
WO2011018583A2 (en) * 2009-08-12 2011-02-17 Debregeas Et Associes Pharma Novel pharmaceutical formulations against drug misuse

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2010104494A1 *

Also Published As

Publication number Publication date
EP2405754A1 (en) 2012-01-18
WO2010104494A1 (en) 2010-09-16

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Owner name: RELMADA THERAPEUTICS, INC.

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Effective date: 20150914

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