ES2703688T3 - Formulaciones de liberación inmediata resistentes a alteración - Google Patents

Formulaciones de liberación inmediata resistentes a alteración Download PDF

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Publication number
ES2703688T3
ES2703688T3 ES16167881T ES16167881T ES2703688T3 ES 2703688 T3 ES2703688 T3 ES 2703688T3 ES 16167881 T ES16167881 T ES 16167881T ES 16167881 T ES16167881 T ES 16167881T ES 2703688 T3 ES2703688 T3 ES 2703688T3
Authority
ES
Spain
Prior art keywords
dosage form
drug
core
barrier layer
weight
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.)
Active
Application number
ES16167881T
Other languages
English (en)
Spanish (es)
Inventor
Kevin Reilly
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.)
Purdue Pharma LP
Original Assignee
Purdue Pharma LP
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
Application filed by Purdue Pharma LP filed Critical Purdue Pharma LP
Application granted granted Critical
Publication of ES2703688T3 publication Critical patent/ES2703688T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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
    • A61K9/5078—Microcapsules 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
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
ES16167881T 2011-09-16 2012-09-14 Formulaciones de liberación inmediata resistentes a alteración Active ES2703688T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201161535758P 2011-09-16 2011-09-16

Publications (1)

Publication Number Publication Date
ES2703688T3 true ES2703688T3 (es) 2019-03-12

Family

ID=48577967

Family Applications (2)

Application Number Title Priority Date Filing Date
ES16167881T Active ES2703688T3 (es) 2011-09-16 2012-09-14 Formulaciones de liberación inmediata resistentes a alteración
ES12772421.9T Active ES2583132T3 (es) 2011-09-16 2012-09-14 Formulaciones de liberación inmediata resistentes a alteración

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES12772421.9T Active ES2583132T3 (es) 2011-09-16 2012-09-14 Formulaciones de liberación inmediata resistentes a alteración

Country Status (8)

Country Link
US (1) US20140294947A1 (enExample)
EP (2) EP2755638B1 (enExample)
JP (1) JP6138798B2 (enExample)
AU (1) AU2012310251B2 (enExample)
ES (2) ES2703688T3 (enExample)
IL (1) IL231482A (enExample)
MX (1) MX347961B (enExample)
WO (1) WO2013038268A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1429739A1 (en) 2001-09-21 2004-06-23 Egalet A/S Polymer release system
EP1429744A1 (en) 2001-09-21 2004-06-23 Egalet A/S Morphine polymer release system
DE602004031096D1 (de) 2003-03-26 2011-03-03 Egalet As Morphin-system mit kontrollierter freisetzung
CA2687192C (en) 2007-06-04 2015-11-24 Egalet A/S Controlled release pharmaceutical compositions for prolonged effect
NZ594207A (en) 2009-02-06 2013-03-28 Egalet Ltd Immediate release composition resistant to abuse by intake of alcohol
NZ597283A (en) 2009-06-24 2013-07-26 Egalet Ltd Controlled release formulations
US9549899B2 (en) 2012-07-06 2017-01-24 Egalet Ltd. Abuse deterrent pharmaceutical compositions for controlled release
CA2919892C (en) 2013-08-12 2019-06-18 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
EP3209282A4 (en) 2014-10-20 2018-05-23 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
JP2020536056A (ja) * 2017-10-02 2020-12-10 パーデュー、ファーマ、リミテッド、パートナーシップ 遅延放出ゲル化剤組成物を含む医薬組成物
IL273627B2 (en) 2017-12-20 2025-03-01 Purdue Pharma Lp Morphine sulfate dosage forms for abuse deterrence

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9401894D0 (en) * 1994-02-01 1994-03-30 Rhone Poulenc Rorer Ltd New compositions of matter
US5654005A (en) * 1995-06-07 1997-08-05 Andrx Pharmaceuticals, Inc. Controlled release formulation having a preformed passageway
WO2004026308A1 (en) * 2002-09-21 2004-04-01 Shuyi Zhang Sustained release compound of acetamidophenol and tramadol
RU2372893C2 (ru) * 2003-10-31 2009-11-20 Хексал Аг Содержащий фармацевтический агент состав с покрытием
CA2548834C (en) * 2003-12-09 2009-08-11 Euro-Celtique S.A. Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same
TW201509943A (zh) 2004-03-30 2015-03-16 Euro Celtique Sa 含有小於２５ｐｐｍ１４-羥可待因酮之羥可酮鹽酸鹽之組成物、醫藥劑型、延遲釋出口服劑型及醫藥上可以接受的包裝
US20080152595A1 (en) * 2004-11-24 2008-06-26 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of orally administered pharmaceutical products
US8652529B2 (en) * 2005-11-10 2014-02-18 Flamel Technologies Anti-misuse microparticulate oral pharmaceutical form
US9023400B2 (en) * 2006-05-24 2015-05-05 Flamel Technologies Prolonged-release multimicroparticulate oral pharmaceutical form
ES2636657T3 (es) * 2006-06-19 2017-10-06 Alpharma Pharmaceuticals Llc Composición farmacéutica
SA07280459B1 (ar) * 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
EP2187873B1 (en) * 2007-08-13 2018-07-25 Abuse Deterrent Pharmaceutical Llc Abuse resistant drugs, method of use and method of making
ES2374200T3 (es) * 2007-08-21 2012-02-14 Teva Pharmaceutical Industries Ltd. Formulación de liberación prolongada de paliperidona.
WO2009149058A2 (en) * 2008-06-02 2009-12-10 Dr. Reddy's Laboratories Ltd. Modified release niacin formulations
PH12013501345A1 (en) * 2010-12-23 2022-10-24 Purdue Pharma Lp Tamper resistant solid oral dosage forms
EA201400172A1 (ru) * 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства

Also Published As

Publication number Publication date
JP2014530185A (ja) 2014-11-17
ES2583132T3 (es) 2016-09-19
AU2012310251A1 (en) 2013-05-09
EP2755638A1 (en) 2014-07-23
EP3078370B1 (en) 2018-11-07
US20140294947A1 (en) 2014-10-02
AU2012310251A8 (en) 2013-06-20
AU2012310251B2 (en) 2016-01-21
EP2755638B1 (en) 2016-06-01
EP3078370A1 (en) 2016-10-12
WO2013038268A1 (en) 2013-03-21
IL231482A0 (en) 2014-04-30
JP6138798B2 (ja) 2017-05-31
IL231482A (en) 2017-03-30
MX347961B (es) 2017-05-19
WO2013038268A8 (en) 2013-06-13
MX2014003192A (es) 2015-04-13

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