PE20131101A1 - Formulaciones estables al almacenamiento de oxicodona y naloxona - Google Patents
Formulaciones estables al almacenamiento de oxicodona y naloxonaInfo
- Publication number
- PE20131101A1 PE20131101A1 PE2013000252A PE2013000252A PE20131101A1 PE 20131101 A1 PE20131101 A1 PE 20131101A1 PE 2013000252 A PE2013000252 A PE 2013000252A PE 2013000252 A PE2013000252 A PE 2013000252A PE 20131101 A1 PE20131101 A1 PE 20131101A1
- Authority
- PE
- Peru
- Prior art keywords
- oxycodone
- naloxone
- storage stable
- stable formulations
- povidone
- Prior art date
Links
- 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 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 title abstract 2
- 229960002085 oxycodone Drugs 0.000 title abstract 2
- 229960004127 naloxone Drugs 0.000 title 1
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 239000000463 material Substances 0.000 abstract 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 2
- 229940069328 povidone Drugs 0.000 abstract 2
- 230000002035 prolonged effect Effects 0.000 abstract 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 abstract 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 229920002472 Starch Polymers 0.000 abstract 1
- 229920003086 cellulose ether Polymers 0.000 abstract 1
- 229920001577 copolymer Polymers 0.000 abstract 1
- 150000002191 fatty alcohols Chemical class 0.000 abstract 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 1
- 229960001021 lactose monohydrate Drugs 0.000 abstract 1
- 239000000314 lubricant Substances 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 239000008203 oral pharmaceutical composition Substances 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 239000008107 starch Substances 0.000 abstract 1
- 235000019698 starch Nutrition 0.000 abstract 1
- 239000000454 talc Substances 0.000 abstract 1
- 229910052623 talc Inorganic materials 0.000 abstract 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
- A61K31/47—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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Pulmonology (AREA)
- Urology & Nephrology (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Zoology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
REFERIDA A UNA COMPOSICION FARMACEUTICA ORAL DE LIBERACION PROLONGADA QUE COMPRENDE: a) UN MATERIAL DE LIBERACION PROLONGADA TAL COMO UN ETER DE CELULOSA, UN COPOLIMERO DE BASE METACRILICA Y/O UN ALCOHOL GRASO Y b) OXICODONA Y NALOXONA O UNA SAL DE LOS MISMOS EN UNA RELACION DE 2:1 EN PESO. TAMBIEN COMPRENDE UN MATERIAL DE RELLENO TAL COMO LACTOSA MONOHIDRATO, UN LUBRICANTE TAL COMO ESTEARATO DE MAGNESIO Y/O TALCO Y UN AGLUTINANTE TAL COMO HIDROXIPROPILCELULOSA, POVIDONA, CO-POVIDONA, ALMIDON, ENTRE OTROS. DICHA COMPOSICION ES ESTABLE EN ALMACENAMIENTO DURANTE PERIODOS PROLONGADOS DE TIEMPO
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US37334410P | 2010-08-13 | 2010-08-13 | |
| EP10172759 | 2010-08-13 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20131101A1 true PE20131101A1 (es) | 2013-09-23 |
Family
ID=43382375
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2013000252A PE20131101A1 (es) | 2010-08-13 | 2011-08-11 | Formulaciones estables al almacenamiento de oxicodona y naloxona |
Country Status (29)
| Country | Link |
|---|---|
| US (2) | US20130245054A1 (es) |
| EP (2) | EP3505162A1 (es) |
| JP (1) | JP6007176B2 (es) |
| KR (1) | KR101518143B1 (es) |
| CN (1) | CN103118668B (es) |
| AR (1) | AR082688A1 (es) |
| AU (1) | AU2011288413B2 (es) |
| BR (1) | BR112013003150B1 (es) |
| CA (1) | CA2805974C (es) |
| CH (1) | CH705678B1 (es) |
| CL (1) | CL2013000444A1 (es) |
| CO (1) | CO6680640A2 (es) |
| DE (1) | DE112011102708T5 (es) |
| DK (1) | DK178702B1 (es) |
| EC (1) | ECSP13012467A (es) |
| ES (1) | ES2409069B2 (es) |
| GB (1) | GB2495676B (es) |
| MX (1) | MX355644B (es) |
| MY (1) | MY165149A (es) |
| NO (1) | NO20130366A1 (es) |
| NZ (1) | NZ606123A (es) |
| PE (1) | PE20131101A1 (es) |
| PH (1) | PH12013500172A1 (es) |
| RU (1) | RU2572695C2 (es) |
| SE (1) | SE537698C2 (es) |
| SG (1) | SG187678A1 (es) |
| SI (1) | SI2603205T1 (es) |
| TW (1) | TWI469781B (es) |
| WO (1) | WO2012020097A2 (es) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001526228A (ja) | 1997-12-22 | 2001-12-18 | ユーロ−セルティーク，エス．エイ． | オピオイド作動薬／拮抗薬の併用 |
| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| CA2446550C (en) | 2001-05-11 | 2012-03-06 | Endo Pharmaceuticals, Inc. | Abuse-resistant controlled-release opioid dosage form |
| PT2425825T (pt) | 2002-04-05 | 2017-02-13 | Euro Celtique Sa | Preparação farmacêutica contendo oxicodona e naloxona |
| EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
| JP5886632B2 (ja) | 2009-03-10 | 2016-03-16 | ユーロ−セルティーク エス．エイ． | オキシコドンおよびナロキソンを含む即時放出医薬組成物 |
| US9901540B2 (en) | 2010-05-10 | 2018-02-27 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
| KR20130030261A (ko) | 2010-05-10 | 2013-03-26 | 유로-셀티큐 에스.에이. | 활성제-무함유 과립 및 그를 포함하는 정제의 제조 |
| US20140271893A1 (en) * | 2013-03-15 | 2014-09-18 | Mcneil-Ppc, Inc. | Coated phenylephrine particles and use thereof in pharmaceutical formulations |
| EP3024461B1 (en) | 2013-07-23 | 2020-05-13 | Euro-Celtique S.A. | A combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation |
| CA3042642A1 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| CN105916505A (zh) | 2013-11-13 | 2016-08-31 | 欧洲凯尔特公司 | 用于治疗疼痛和阿片样物质肠功能障碍综合征的氢吗啡酮和纳洛酮 |
| US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| AU2015290098B2 (en) | 2014-07-17 | 2018-11-01 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| US20160106737A1 (en) | 2014-10-20 | 2016-04-21 | Pharmaceutical Manufacturing Research Services, Inc. | Extended Release Abuse Deterrent Liquid Fill Dosage Form |
| EP3229785A2 (de) * | 2014-12-08 | 2017-10-18 | Develco Pharma Schweiz AG | Naloxon-monopräparat und mehrschichttablette |
| WO2018055199A1 (en) | 2016-09-26 | 2018-03-29 | Euro-Celtique S.A. | Methods of treatment comprising administering a high daily dose of oxycodone and naloxone in a 2:1 weight ratio |
| BR112019021324A2 (pt) * | 2017-04-13 | 2020-06-16 | Paul Remon Jean | Composições baseadas em xanthohumol |
| CN111686094A (zh) * | 2020-07-13 | 2020-09-22 | 云南民族大学 | 一种脂肪醇类化合物在制备通便药物中的应用 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3581428D1 (de) | 1984-06-13 | 1991-02-28 | Roehm Gmbh | Verfahren zum ueberziehen von arzneiformen. |
| HU218673B (hu) * | 1993-10-07 | 2000-10-28 | Euroceltique S.A. | Opioid analgetikumot tartalmazó elnyújtott hatóanyag-felszabadítású orális gyógyszerkészítmény és eljárás előállítására |
| US6245357B1 (en) * | 1998-03-06 | 2001-06-12 | Alza Corporation | Extended release dosage form |
| JP4848558B2 (ja) * | 2001-05-08 | 2011-12-28 | トーアエイヨー株式会社 | 塩酸メトホルミン含有速放性錠剤 |
| DE60230632D1 (de) * | 2001-07-18 | 2009-02-12 | Euro Celtique Sa | Pharmazeutische kombinationen von oxycodon und naloxon |
| US7332182B2 (en) * | 2001-08-06 | 2008-02-19 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and irritant |
| JP2003160487A (ja) * | 2001-11-20 | 2003-06-03 | Ohara Yakuhin Kogyo Kk | プラバスタチンナトリウム含有錠剤およびその製造法 |
| PT2425825T (pt) * | 2002-04-05 | 2017-02-13 | Euro Celtique Sa | Preparação farmacêutica contendo oxicodona e naloxona |
| US20060009478A1 (en) * | 2003-10-15 | 2006-01-12 | Nadav Friedmann | Methods for the treatment of back pain |
| EP1604666A1 (en) * | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
| EP1604667A1 (en) * | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the restless leg syndrome |
| EP1695700A1 (en) * | 2005-02-28 | 2006-08-30 | Euro-Celtique S.A. | Dosage form containing oxycodone and naloxone |
| DE102005048293A1 (de) * | 2005-10-08 | 2007-04-12 | Sanofi-Aventis Deutschland Gmbh | Retardformulierung für Pralnacasan |
| KR100753480B1 (ko) * | 2006-01-27 | 2007-08-31 | 씨제이 주식회사 | 잘토프로펜 함유 서방성 정제 및 그 제조방법 |
| US8133506B2 (en) * | 2008-03-12 | 2012-03-13 | Aptalis Pharmatech, Inc. | Drug delivery systems comprising weakly basic drugs and organic acids |
| JP2009298707A (ja) * | 2008-06-11 | 2009-12-24 | Ohara Yakuhin Kogyo Kk | 粒子加工方法 |
| US20120065221A1 (en) * | 2009-02-26 | 2012-03-15 | Theraquest Biosciences, Inc. | Extended Release Oral Pharmaceutical Compositions of 3-Hydroxy-N-Methylmorphinan and Method of Use |
-
2011
- 2011-08-11 BR BR112013003150-6A patent/BR112013003150B1/pt active IP Right Grant
- 2011-08-11 US US13/816,685 patent/US20130245054A1/en not_active Abandoned
- 2011-08-11 EP EP18197869.3A patent/EP3505162A1/en active Pending
- 2011-08-11 CN CN201180039157.XA patent/CN103118668B/zh not_active Expired - Fee Related
- 2011-08-11 RU RU2013110820/15A patent/RU2572695C2/ru not_active IP Right Cessation
- 2011-08-11 DE DE112011102708T patent/DE112011102708T5/de not_active Withdrawn
- 2011-08-11 CA CA2805974A patent/CA2805974C/en active Active
- 2011-08-11 EP EP11743537.0A patent/EP2603205B1/en active Active
- 2011-08-11 MX MX2013001757A patent/MX355644B/es active IP Right Grant
- 2011-08-11 JP JP2013523625A patent/JP6007176B2/ja not_active Expired - Fee Related
- 2011-08-11 AU AU2011288413A patent/AU2011288413B2/en not_active Ceased
- 2011-08-11 WO PCT/EP2011/063864 patent/WO2012020097A2/en active Application Filing
- 2011-08-11 MY MYPI2013000345A patent/MY165149A/en unknown
- 2011-08-11 CH CH00443/13A patent/CH705678B1/de not_active IP Right Cessation
- 2011-08-11 NZ NZ60612311A patent/NZ606123A/en not_active IP Right Cessation
- 2011-08-11 SE SE1350286A patent/SE537698C2/sv not_active IP Right Cessation
- 2011-08-11 SI SI201131634T patent/SI2603205T1/sl unknown
- 2011-08-11 GB GB1301916.1A patent/GB2495676B/en not_active Expired - Fee Related
- 2011-08-11 PH PH1/2013/500172A patent/PH12013500172A1/en unknown
- 2011-08-11 KR KR1020137006255A patent/KR101518143B1/ko not_active Expired - Fee Related
- 2011-08-11 PE PE2013000252A patent/PE20131101A1/es not_active Application Discontinuation
- 2011-08-11 SG SG2013007968A patent/SG187678A1/en unknown
- 2011-08-11 ES ES201390024A patent/ES2409069B2/es not_active Expired - Fee Related
- 2011-08-12 TW TW100128862A patent/TWI469781B/zh not_active IP Right Cessation
- 2011-08-15 AR ARP110102958A patent/AR082688A1/es not_active Application Discontinuation
-
2013
- 2013-02-13 CL CL2013000444A patent/CL2013000444A1/es unknown
- 2013-02-13 DK DKPA201370075A patent/DK178702B1/en not_active IP Right Cessation
- 2013-02-13 CO CO13029565A patent/CO6680640A2/es not_active Application Discontinuation
- 2013-02-28 EC ECSP13012467 patent/ECSP13012467A/es unknown
- 2013-03-12 NO NO20130366A patent/NO20130366A1/no not_active Application Discontinuation
-
2015
- 2015-12-14 US US14/968,620 patent/US20160095853A1/en not_active Abandoned
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