RU2017134794A - Комбинированная лекарственная форма антагониста мю-опиоидного рецептора и опиоидного средства - Google Patents
Комбинированная лекарственная форма антагониста мю-опиоидного рецептора и опиоидного средства Download PDFInfo
- Publication number
- RU2017134794A RU2017134794A RU2017134794A RU2017134794A RU2017134794A RU 2017134794 A RU2017134794 A RU 2017134794A RU 2017134794 A RU2017134794 A RU 2017134794A RU 2017134794 A RU2017134794 A RU 2017134794A RU 2017134794 A RU2017134794 A RU 2017134794A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- weight
- polyethylene glycol
- polyvinyl alcohol
- sulfate
- Prior art date
Links
- 239000005557 antagonist Substances 0.000 title 1
- 102000051367 mu Opioid Receptors Human genes 0.000 title 1
- 108020001612 μ-opioid receptors Proteins 0.000 title 1
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 20
- 239000002552 dosage form Substances 0.000 claims 17
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 13
- QNFFAKFVKCGLPK-WTKDUOFSSA-N chembl3137319 Chemical compound OS(O)(=O)=O.NC(=O)C1=CC=CC([C@H]2C[C@H]3CC[C@H](N3CCN(CC3CCCCC3)C(=O)[C@@H](O)CO)C2)=C1 QNFFAKFVKCGLPK-WTKDUOFSSA-N 0.000 claims 13
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 13
- 239000007909 solid dosage form Substances 0.000 claims 12
- 229960005070 ascorbic acid Drugs 0.000 claims 10
- 235000010323 ascorbic acid Nutrition 0.000 claims 10
- 239000011668 ascorbic acid Substances 0.000 claims 10
- 238000000034 method Methods 0.000 claims 10
- 239000000014 opioid analgesic Substances 0.000 claims 10
- 229940050929 polyethylene glycol 3350 Drugs 0.000 claims 10
- 239000011248 coating agent Substances 0.000 claims 7
- 238000000576 coating method Methods 0.000 claims 7
- 229940079593 drug Drugs 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 6
- 239000007864 aqueous solution Substances 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 4
- 239000008247 solid mixture Substances 0.000 claims 4
- 241000124008 Mammalia Species 0.000 claims 3
- 239000002202 Polyethylene glycol Substances 0.000 claims 3
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 3
- 239000011247 coating layer Substances 0.000 claims 3
- 239000010410 layer Substances 0.000 claims 3
- 229920001223 polyethylene glycol Polymers 0.000 claims 3
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims 2
- UQCNKQCJZOAFTQ-ISWURRPUSA-N Oxymorphone Chemical compound O([C@H]1C(CC[C@]23O)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O UQCNKQCJZOAFTQ-ISWURRPUSA-N 0.000 claims 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 229960002085 oxycodone Drugs 0.000 claims 2
- 229960005118 oxymorphone Drugs 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 239000003612 morphinomimetic agent Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 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)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (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 |
|---|---|---|---|
| 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)
| Publication Number | Publication Date |
|---|---|
| RU2017134794A true RU2017134794A (ru) | 2019-04-04 |
Family
ID=55806767
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017134794A RU2017134794A (ru) | 2015-04-02 | 2016-03-31 | Комбинированная лекарственная форма антагониста мю-опиоидного рецептора и опиоидного средства |
Country Status (27)
| Country | Link |
|---|---|
| US (4) | US20160287573A1 (https=) |
| EP (1) | EP3277278B1 (https=) |
| JP (2) | JP6713483B2 (https=) |
| KR (1) | KR20170132325A (https=) |
| CN (1) | CN107820424B (https=) |
| AU (1) | AU2016243691A1 (https=) |
| BR (1) | BR112017021120A2 (https=) |
| CA (1) | CA2980328A1 (https=) |
| CY (1) | CY1122828T1 (https=) |
| DK (1) | DK3277278T3 (https=) |
| ES (1) | ES2774473T3 (https=) |
| HK (1) | HK1247105A1 (https=) |
| HR (1) | HRP20200432T1 (https=) |
| HU (1) | HUE048785T2 (https=) |
| IL (1) | IL254593A0 (https=) |
| LT (1) | LT3277278T (https=) |
| ME (1) | ME03671B (https=) |
| MX (1) | MX2017012474A (https=) |
| PH (1) | PH12017501767A1 (https=) |
| PL (1) | PL3277278T3 (https=) |
| PT (1) | PT3277278T (https=) |
| RS (1) | RS60074B1 (https=) |
| RU (1) | RU2017134794A (https=) |
| SI (1) | SI3277278T1 (https=) |
| SM (1) | SMT202000157T1 (https=) |
| TW (1) | TW201642856A (https=) |
| WO (1) | WO2016161069A1 (https=) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3277278T3 (da) | 2015-04-02 | 2020-04-06 | Theravance Biopharma R&D Ip Llc | Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid |
| EP3666261B1 (en) | 2017-08-08 | 2025-01-15 | Mitsubishi Chemical Corporation | Pharmaceutical tablet and method for producing same |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1041987B1 (en) | 1997-12-22 | 2006-04-19 | Euro-Celtique S.A. | Pharmaceutical oral dosage form comprising a combination of an opioid agonist and naltrexone |
| 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 |
| US7842307B2 (en) | 2001-08-06 | 2010-11-30 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent |
| IL160222A0 (en) * | 2001-08-06 | 2004-07-25 | Euro Celtique Sa | Opioid agonist formulations with releasable and sequestered antagonist |
| EP1572164A2 (en) * | 2002-12-18 | 2005-09-14 | Pain Therapeutics, Inc. | 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 |
| TWI354569B (en) | 2004-05-28 | 2011-12-21 | Bristol Myers Squibb Co | Coated tablet formulation and method |
| CN101163701A (zh) * | 2005-03-02 | 2008-04-16 | 施万制药 | 作为5-ht4受体激动剂的喹啉酮化合物 |
| CN101395154B (zh) * | 2006-03-01 | 2011-01-19 | 施万制药 | 作为μ阿片受体拮抗剂的8-氮杂双环[3.2.1]辛烷化合物 |
| 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 |
| WO2009137672A1 (en) * | 2008-05-07 | 2009-11-12 | Salix Pharmaceuticals, Ltd. | Methods of treating bowel disease by administering a bowel cleanser and an antibiotic |
| EP2210595A1 (en) | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
| KR101783945B1 (ko) * | 2009-05-12 | 2017-10-10 | 비피에스아이 홀딩스, 엘엘씨. | 향상된 수분차단 속방출형 필름의 코팅 시스템 및 이에 의하여 코팅된 기재 |
| 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 |
| CA2826391C (en) | 2011-02-01 | 2017-01-24 | Bristol-Myers Squibb Company | Pharmaceutical formulations including an amine compound |
| US9339489B2 (en) * | 2013-03-15 | 2016-05-17 | Aprecia Pharmaceuticals Company | Rapid disperse dosage form containing levetiracetam |
| DK3277278T3 (da) | 2015-04-02 | 2020-04-06 | Theravance Biopharma R&D Ip Llc | Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid |
-
2016
- 2016-03-31 DK DK16718062.9T patent/DK3277278T3/da active
- 2016-03-31 SI SI201630671T patent/SI3277278T1/sl unknown
- 2016-03-31 BR BR112017021120-3A patent/BR112017021120A2/pt not_active Application Discontinuation
- 2016-03-31 RS RS20200315A patent/RS60074B1/sr unknown
- 2016-03-31 US US15/086,816 patent/US20160287573A1/en not_active Abandoned
- 2016-03-31 WO PCT/US2016/025176 patent/WO2016161069A1/en not_active Ceased
- 2016-03-31 HR HRP20200432TT patent/HRP20200432T1/hr unknown
- 2016-03-31 HU HUE16718062A patent/HUE048785T2/hu unknown
- 2016-03-31 RU RU2017134794A patent/RU2017134794A/ru not_active Application Discontinuation
- 2016-03-31 JP JP2017550832A patent/JP6713483B2/ja active Active
- 2016-03-31 AU AU2016243691A patent/AU2016243691A1/en not_active Abandoned
- 2016-03-31 PL PL16718062T patent/PL3277278T3/pl unknown
- 2016-03-31 EP EP16718062.9A patent/EP3277278B1/en active Active
- 2016-03-31 TW TW105110406A patent/TW201642856A/zh unknown
- 2016-03-31 ME MEP-2020-48A patent/ME03671B/me unknown
- 2016-03-31 ES ES16718062T patent/ES2774473T3/es active Active
- 2016-03-31 LT LTEP16718062.9T patent/LT3277278T/lt unknown
- 2016-03-31 CN CN201680019821.7A patent/CN107820424B/zh active Active
- 2016-03-31 PT PT167180629T patent/PT3277278T/pt unknown
- 2016-03-31 SM SM20200157T patent/SMT202000157T1/it unknown
- 2016-03-31 MX MX2017012474A patent/MX2017012474A/es unknown
- 2016-03-31 KR KR1020177031800A patent/KR20170132325A/ko not_active Withdrawn
- 2016-03-31 CA CA2980328A patent/CA2980328A1/en not_active Abandoned
- 2016-03-31 HK HK18106740.0A patent/HK1247105A1/zh unknown
-
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
-
2019
- 2019-06-27 US US16/454,353 patent/US10946009B2/en active Active
-
2020
- 2020-02-04 JP JP2020016858A patent/JP2020073583A/ja not_active Withdrawn
- 2020-03-17 CY CY20201100246T patent/CY1122828T1/el unknown
-
2021
- 2021-02-08 US US17/248,787 patent/US11452723B2/en active Active
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA93 | Acknowledgement of application withdrawn (no request for examination) |
Effective date: 20201005 |