CA2980328A1 - Combination dosage form of a mu opioid receptor antagonist and an opioid agent - Google Patents
Combination dosage form of a mu opioid receptor antagonist and an opioid agent Download PDFInfo
- Publication number
- CA2980328A1 CA2980328A1 CA2980328A CA2980328A CA2980328A1 CA 2980328 A1 CA2980328 A1 CA 2980328A1 CA 2980328 A CA2980328 A CA 2980328A CA 2980328 A CA2980328 A CA 2980328A CA 2980328 A1 CA2980328 A1 CA 2980328A1
- Authority
- CA
- Canada
- Prior art keywords
- dosage form
- axelopran
- weight
- polyvinyl alcohol
- combination dosage
- 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.)
- Abandoned
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- 239000007916 tablet composition Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 229940035024 thioglycerol Drugs 0.000 description 1
- CWERGRDVMFNCDR-UHFFFAOYSA-N thioglycolic acid Chemical compound OC(=O)CS CWERGRDVMFNCDR-UHFFFAOYSA-N 0.000 description 1
- 235000010215 titanium dioxide Nutrition 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
- 108020001612 μ-opioid receptors Proteins 0.000 description 1
Classifications
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- 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
- A61K31/47—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
- 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
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
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| US201562141981P | 2015-04-02 | 2015-04-02 | |
| US62/141,981 | 2015-04-02 | ||
| PCT/US2016/025176 WO2016161069A1 (en) | 2015-04-02 | 2016-03-31 | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
Publications (1)
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| CA2980328A1 true CA2980328A1 (en) | 2016-10-06 |
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| CA2980328A Abandoned CA2980328A1 (en) | 2015-04-02 | 2016-03-31 | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
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| ME (1) | ME03671B (enExample) |
| MX (1) | MX2017012474A (enExample) |
| PH (1) | PH12017501767A1 (enExample) |
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| SM (1) | SMT202000157T1 (enExample) |
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| WO (1) | WO2016161069A1 (enExample) |
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| US20160287573A1 (en) | 2015-04-02 | 2016-10-06 | Theravance Biopharma R&D Ip, Llc | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
| WO2019031560A1 (ja) * | 2017-08-08 | 2019-02-14 | 日本合成化学工業株式会社 | 医薬錠剤、およびその製造方法 |
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| TR200001942T2 (tr) | 1997-12-22 | 2000-11-21 | Euro-Celtique, S.A. | Opioid agonist/antagonist kombinasyonlar |
| US6419960B1 (en) | 1998-12-17 | 2002-07-16 | Euro-Celtique S.A. | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
| US6451806B2 (en) | 1999-09-29 | 2002-09-17 | Adolor Corporation | Methods and compositions involving opioids and antagonists thereof |
| AR029538A1 (es) * | 2000-07-06 | 2003-07-02 | Wyeth Corp | Composiciones farmaceuticas de agentes estrogenicos |
| ES2326794T3 (es) * | 2001-08-06 | 2009-10-20 | Euro-Celtique S.A. | Formulaciones de agonistas opioides con antagonista liberable y secuestrado. |
| US7842307B2 (en) | 2001-08-06 | 2010-11-30 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent |
| US20040224020A1 (en) * | 2002-12-18 | 2004-11-11 | Schoenhard Grant L. | Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats |
| US20050013863A1 (en) | 2003-07-18 | 2005-01-20 | Depomed, Inc., A Corporation Of The State Of California | Dual drug dosage forms with improved separation of drugs |
| KR20060092255A (ko) | 2003-09-26 | 2006-08-22 | 알자 코포레이션 | 고도의 약물적재를 제공하는 약물코팅제 및 그의 제조방법 |
| TWI415635B (zh) | 2004-05-28 | 2013-11-21 | 必治妥施貴寶公司 | 加衣錠片調製物及製備彼之方法 |
| BRPI0608392A2 (pt) | 2005-03-02 | 2009-12-29 | Theravance Inc | compostos de quinolinona como agonistas do receptor 5-ht4 |
| ES2366058T3 (es) * | 2006-03-01 | 2011-10-14 | Theravance, Inc. | Compuestos de 8-azabiciclo[3.2.1]octano como antagonistas de los receptores opioides mu. |
| MY145633A (en) | 2006-03-01 | 2012-03-15 | Theravance Inc | 8-azabicyclo[3.2.1]octane compounds as mu opioid receptor antagonists |
| CN101500542A (zh) * | 2006-07-11 | 2009-08-05 | 共有药物有限公司 | 控释制剂 |
| TWI409067B (zh) | 2007-02-28 | 2013-09-21 | Theravance Inc | ８-氮雜雙環〔３．２．１〕辛烷化合物之結晶型 |
| TWI415850B (zh) | 2007-07-20 | 2013-11-21 | Theravance Inc | 製備ｍｕ類鴉片受體拮抗劑之中間物的方法 |
| HRP20140939T1 (hr) * | 2008-05-07 | 2014-11-21 | Salix Pharmaceuticals, Ltd. | Davanje preparata za äśišä†enje crijeva i antibiotika za lijeäśenje bolesti crijeva |
| EP2210595A1 (en) | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
| WO2010132204A1 (en) * | 2009-05-12 | 2010-11-18 | Bpsi Holdings, Llc. | Enhanced moisture barrier immediate release film coating systems and substrates coated therewith |
| IT1398930B1 (it) * | 2010-03-24 | 2013-03-28 | Molteni & C | Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi. |
| CN103370064A (zh) * | 2010-09-03 | 2013-10-23 | 百时美施贵宝公司 | 使用水溶性抗氧化剂的药物制剂 |
| AU2012212448B9 (en) | 2011-02-01 | 2015-06-25 | Astrazeneca Uk Limited | Pharmaceutical formulations including an amine compound |
| WO2014144512A1 (en) * | 2013-03-15 | 2014-09-18 | Aprecia Pharmaceuticals Company | Rapid disperse dosage form containing levetiracetam |
| US20160287573A1 (en) | 2015-04-02 | 2016-10-06 | Theravance Biopharma R&D Ip, Llc | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
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2016
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- 2016-03-31 ME MEP-2020-48A patent/ME03671B/me unknown
- 2016-03-31 SI SI201630671T patent/SI3277278T1/sl unknown
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- 2016-03-31 HK HK18106740.0A patent/HK1247105A1/zh unknown
- 2016-03-31 LT LTEP16718062.9T patent/LT3277278T/lt unknown
- 2016-03-31 CA CA2980328A patent/CA2980328A1/en not_active Abandoned
- 2016-03-31 PT PT167180629T patent/PT3277278T/pt unknown
- 2016-03-31 RS RS20200315A patent/RS60074B1/sr unknown
- 2016-03-31 RU RU2017134794A patent/RU2017134794A/ru not_active Application Discontinuation
- 2016-03-31 AU AU2016243691A patent/AU2016243691A1/en not_active Abandoned
- 2016-03-31 SM SM20200157T patent/SMT202000157T1/it unknown
- 2016-03-31 JP JP2017550832A patent/JP6713483B2/ja active Active
- 2016-03-31 PL PL16718062T patent/PL3277278T3/pl unknown
- 2016-03-31 ES ES16718062T patent/ES2774473T3/es active Active
- 2016-03-31 EP EP16718062.9A patent/EP3277278B1/en active Active
- 2016-03-31 TW TW105110406A patent/TW201642856A/zh unknown
- 2016-03-31 WO PCT/US2016/025176 patent/WO2016161069A1/en not_active Ceased
- 2016-03-31 DK DK16718062.9T patent/DK3277278T3/da active
- 2016-03-31 HU HUE16718062A patent/HUE048785T2/hu unknown
- 2016-03-31 MX MX2017012474A patent/MX2017012474A/es unknown
- 2016-03-31 KR KR1020177031800A patent/KR20170132325A/ko not_active Withdrawn
- 2016-03-31 HR HRP20200432TT patent/HRP20200432T1/hr unknown
- 2016-03-31 BR BR112017021120-3A patent/BR112017021120A2/pt not_active Application Discontinuation
-
2017
- 2017-09-19 IL IL254593A patent/IL254593A0/en unknown
- 2017-09-26 PH PH12017501767A patent/PH12017501767A1/en unknown
- 2017-10-31 US US15/798,647 patent/US10369142B2/en active Active
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2019
- 2019-06-27 US US16/454,353 patent/US10946009B2/en active Active
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2020
- 2020-02-04 JP JP2020016858A patent/JP2020073583A/ja not_active Withdrawn
- 2020-03-17 CY CY20201100246T patent/CY1122828T1/el unknown
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2021
- 2021-02-08 US US17/248,787 patent/US11452723B2/en active Active
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |
Effective date: 20200831 |