AU2012310251B2 - Tamper resistant immediate release formulations - Google Patents

Tamper resistant immediate release formulations Download PDF

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Publication number
AU2012310251B2
AU2012310251B2 AU2012310251A AU2012310251A AU2012310251B2 AU 2012310251 B2 AU2012310251 B2 AU 2012310251B2 AU 2012310251 A AU2012310251 A AU 2012310251A AU 2012310251 A AU2012310251 A AU 2012310251A AU 2012310251 B2 AU2012310251 B2 AU 2012310251B2
Authority
AU
Australia
Prior art keywords
dosage form
drug
certain embodiments
core
active agent
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
AU2012310251A
Other languages
English (en)
Other versions
AU2012310251A1 (en
AU2012310251A8 (en
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
Publication of AU2012310251A1 publication Critical patent/AU2012310251A1/en
Publication of AU2012310251A8 publication Critical patent/AU2012310251A8/en
Application granted granted Critical
Publication of AU2012310251B2 publication Critical patent/AU2012310251B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886Dragees; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs 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)
AU2012310251A 2011-09-16 2012-09-14 Tamper resistant immediate release formulations Active AU2012310251B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161535758P 2011-09-16 2011-09-16
US61/535,758 2011-09-16
PCT/IB2012/001916 WO2013038268A1 (en) 2011-09-16 2012-09-14 Tamper resistant immediate release formulations

Publications (3)

Publication Number Publication Date
AU2012310251A1 AU2012310251A1 (en) 2013-05-09
AU2012310251A8 AU2012310251A8 (en) 2013-06-20
AU2012310251B2 true AU2012310251B2 (en) 2016-01-21

Family

ID=48577967

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2012310251A Active AU2012310251B2 (en) 2011-09-16 2012-09-14 Tamper resistant immediate release formulations

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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070224129A1 (en) * 2005-11-10 2007-09-27 Flamel Technologies, Inc. Anti-misuse microparticulate oral pharmaceutical form
EP1897545A1 (en) * 2006-08-25 2008-03-12 Purdue Pharma LP Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
US20080063725A1 (en) * 2006-05-24 2008-03-13 Flamel Technologies Prolonged-release multimicroparticulate oral pharmaceutical form
WO2009023672A2 (en) * 2007-08-13 2009-02-19 Abuse Deterrent Pharmaceutical Llc Abuse resistant drugs, method of use and method of making
WO2009025859A1 (en) * 2007-08-21 2009-02-26 Teva Pharmaceutical Industries Ltd. Paliperidone sustained release formulation

Family Cites Families (11)

* Cited by examiner, † Cited by third party
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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
ES2636657T3 (es) * 2006-06-19 2017-10-06 Alpharma Pharmaceuticals Llc Composición farmacéutica
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070224129A1 (en) * 2005-11-10 2007-09-27 Flamel Technologies, Inc. Anti-misuse microparticulate oral pharmaceutical form
US20080063725A1 (en) * 2006-05-24 2008-03-13 Flamel Technologies Prolonged-release multimicroparticulate oral pharmaceutical form
EP1897545A1 (en) * 2006-08-25 2008-03-12 Purdue Pharma LP Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
WO2009023672A2 (en) * 2007-08-13 2009-02-19 Abuse Deterrent Pharmaceutical Llc Abuse resistant drugs, method of use and method of making
WO2009025859A1 (en) * 2007-08-21 2009-02-26 Teva Pharmaceutical Industries Ltd. Paliperidone sustained release formulation

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
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
ES2703688T3 (es) 2019-03-12
MX2014003192A (es) 2015-04-13

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TH Corrigenda

Free format text: IN VOL 27 , NO 17 , PAGE(S) 2736 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME PURDUE PHARMA L.P., APPLICATION NO. 2012310251, UNDER INID (31) CORRECT THE NUMBER TO 61/535,758

FGA Letters patent sealed or granted (standard patent)