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)
- Urology & Nephrology (AREA)
- Pulmonology (AREA)
- Pain & Pain Management (AREA)
- Psychology (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 (28)
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) |
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 |
---|---|---|---|---|
HU1500214D0 (hu) | 1997-12-22 | 2002-03-28 | Euro Celtique Sa | Opioid agonista és antagonista hatóanyagot tartalmazó gyógyszerkészítmény |
US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
ES2361148T3 (es) | 2001-05-11 | 2011-06-14 | Endo Pharmaceuticals Inc. | Forma de dosificación de opioides de liberación controlada resistente al abuso. |
EP2425823A1 (en) | 2002-04-05 | 2012-03-07 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
MX347106B (es) | 2009-03-10 | 2017-04-12 | Euro-Celtique S A * | Coposiciones farmacéuticas de liberación inmediata que comprenden oxicodona y naloxona. |
US9901540B2 (en) | 2010-05-10 | 2018-02-27 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
CA2798884C (en) | 2010-05-10 | 2016-09-13 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
US20140271893A1 (en) * | 2013-03-15 | 2014-09-18 | Mcneil-Ppc, Inc. | Coated phenylephrine particles and use thereof in pharmaceutical formulations |
CN105517551A (zh) | 2013-07-23 | 2016-04-20 | 欧洲凯尔特公司 | 用于在患有疼痛和导致肠生态失调和/或提高肠细菌移位风险之疾病的患者中治疗疼痛的羟考酮与纳洛酮的组合 |
WO2015023675A2 (en) | 2013-08-12 | 2015-02-19 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
BR112016009749A8 (pt) | 2013-11-13 | 2018-01-30 | Euro Celtique Sa | hidromorfona e naloxona para tratamento de dor e síndrome de disfunção intestinal opioide |
US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
WO2015095391A1 (en) | 2013-12-17 | 2015-06-25 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
CA2964628A1 (en) | 2014-10-20 | 2016-04-28 | 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 |
US11224558B2 (en) * | 2017-04-13 | 2022-01-18 | Jean Paul Remon | Xanthohumol-based compositions |
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. |
EP0647448A1 (en) * | 1993-10-07 | 1995-04-12 | Euroceltique S.A. | Orally administrable opioid formulations having extended duration of effect |
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 |
EP2425823A1 (en) * | 2002-04-05 | 2012-03-07 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
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 CN CN201180039157.XA patent/CN103118668B/zh not_active Expired - Fee Related
- 2011-08-11 MX MX2013001757A patent/MX355644B/es active IP Right Grant
- 2011-08-11 DE DE112011102708T patent/DE112011102708T5/de not_active Withdrawn
- 2011-08-11 SG SG2013007968A patent/SG187678A1/en unknown
- 2011-08-11 CH CH00443/13A patent/CH705678B1/de not_active IP Right Cessation
- 2011-08-11 JP JP2013523625A patent/JP6007176B2/ja not_active Expired - Fee Related
- 2011-08-11 KR KR1020137006255A patent/KR101518143B1/ko active IP Right Grant
- 2011-08-11 SE SE1350286A patent/SE537698C2/sv not_active IP Right Cessation
- 2011-08-11 EP EP18197869.3A patent/EP3505162A1/en active Pending
- 2011-08-11 SI SI201131634T patent/SI2603205T1/sl unknown
- 2011-08-11 RU RU2013110820/15A patent/RU2572695C2/ru not_active IP Right Cessation
- 2011-08-11 MY MYPI2013000345A patent/MY165149A/en unknown
- 2011-08-11 WO PCT/EP2011/063864 patent/WO2012020097A2/en active Application Filing
- 2011-08-11 GB GB1301916.1A patent/GB2495676B/en active Active
- 2011-08-11 NZ NZ60612311A patent/NZ606123A/en not_active IP Right Cessation
- 2011-08-11 AU AU2011288413A patent/AU2011288413B2/en active Active
- 2011-08-11 PE PE2013000252A patent/PE20131101A1/es not_active Application Discontinuation
- 2011-08-11 CA CA2805974A patent/CA2805974C/en active Active
- 2011-08-11 EP EP11743537.0A patent/EP2603205B1/en active Active
- 2011-08-11 ES ES201390024A patent/ES2409069B2/es not_active Expired - Fee Related
- 2011-08-11 US US13/816,685 patent/US20130245054A1/en not_active Abandoned
- 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 CO CO13029565A patent/CO6680640A2/es not_active Application Discontinuation
- 2013-02-13 DK DKPA201370075A patent/DK178702B1/en not_active IP Right Cessation
- 2013-02-13 CL CL2013000444A patent/CL2013000444A1/es unknown
- 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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Legal Events
Date | Code | Title | Description |
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FC | Refusal |