EP3082775A4 - Extruded extended release abuse deterrent pill - Google Patents

Extruded extended release abuse deterrent pill Download PDF

Info

Publication number: EP3082775A4
Authority: EP; European Patent Office
Prior art keywords: extended release; abuse deterrent; release abuse; deterrent pill; extruded
Prior art date: 2013-12-17
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 Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Withdrawn

Application number

EP14871095.7A

Other languages

German (de)

French (fr)

Other versions

EP3082775A1 (en

Inventor

Edwin R. Thompson

Eric R. Thompson

Nicholas R. MYSLINSKI

Steven F. Kemeny

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.)

Pharmaceutical Manufacturing Research Services Inc

Original Assignee

Pharmaceutical Manufacturing Research Services Inc

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.)

2013-12-17

Filing date

2014-12-17

Publication date

2017-05-17

2014-08-12 Priority claimed from US14/457,714 external-priority patent/US10195153B2/en

2014-12-17 Application filed by Pharmaceutical Manufacturing Research Services Inc filed Critical Pharmaceutical Manufacturing Research Services Inc

2016-10-26 Publication of EP3082775A1 publication Critical patent/EP3082775A1/en

2017-05-17 Publication of EP3082775A4 publication Critical patent/EP3082775A4/en

Status Withdrawn legal-status Critical Current

Links

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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
- 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
- A61K9/2027—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse

EP14871095.7A 2013-12-17 2014-12-17 Extruded extended release abuse deterrent pill Withdrawn EP3082775A4 (en)

Applications Claiming Priority (6)

Application Number	Priority Date	Filing Date	Title
US201361917074P	2013-12-17	2013-12-17
US201361917120P	2013-12-17	2013-12-17
US201461980259P	2014-04-16	2014-04-16
US201461980254P	2014-04-16	2014-04-16
US14/457,714 US10195153B2 (en)	2013-08-12	2014-08-12	Extruded immediate release abuse deterrent pill
PCT/US2014/070942 WO2015095387A1 (en)	2013-12-17	2014-12-17	Extruded extended release abuse deterrent pill

Publications (2)

Publication Number	Publication Date
EP3082775A1 EP3082775A1 (en)	2016-10-26
EP3082775A4 true EP3082775A4 (en)	2017-05-17

Family

ID=53403652

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP14871095.7A Withdrawn EP3082775A4 (en)	2013-12-17	2014-12-17	Extruded extended release abuse deterrent pill

Country Status (5)

Country	Link
EP (1)	EP3082775A4 (en)
JP (2)	JP6403780B2 (en)
AU (3)	AU2014364800A1 (en)
CA (1)	CA2934078C (en)
WO (1)	WO2015095387A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO1997049384A1 (en) *	1996-06-26	1997-12-31	Board Of Regents, The University Of Texas System	Hot-melt extrudable pharmaceutical formulation
WO2010140007A2 (en) *	2009-06-05	2010-12-09	Euro-Celtique S.A.	Dosage form
US20130028970A1 (en) *	2011-07-29	2013-01-31	Grunenthal Gmbh	Tamper-resistant tablet providing immediate drug release
US20140010873A1 (en) *	2012-07-06	2014-01-09	Egalet Ltd.	Abuse deterrent pharmaceutical compositions for controlled release
WO2015023675A2 (en) *	2013-08-12	2015-02-19	Pharmaceutical Manufacturing Research Services, Inc.	Extruded immediate release abuse deterrent pill

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
PL1765303T5 (en) *	2004-07-01	2023-05-22	Grünenthal GmbH	Oral dosage form safeguarded against abuse
US20080152595A1 (en) *	2004-11-24	2008-06-26	Acura Pharmaceuticals, Inc.	Methods and compositions for deterring abuse of orally administered pharmaceutical products
DE102007011485A1 (en) *	2007-03-07	2008-09-11	Grünenthal GmbH	Dosage form with more difficult abuse
EP2838536B1 (en) *	2012-04-18	2017-08-09	Mallinckrodt LLC	Immediate release pharmaceutical compositions with abuse deterrent properties

2014
- 2014-12-17 EP EP14871095.7A patent/EP3082775A4/en not_active Withdrawn
- 2014-12-17 AU AU2014364800A patent/AU2014364800A1/en not_active Abandoned
- 2014-12-17 CA CA2934078A patent/CA2934078C/en not_active Expired - Fee Related
- 2014-12-17 JP JP2016540580A patent/JP6403780B2/en not_active Expired - Fee Related
- 2014-12-17 WO PCT/US2014/070942 patent/WO2015095387A1/en active Application Filing
2018
- 2018-09-11 JP JP2018169278A patent/JP6678212B2/en not_active Expired - Fee Related
- 2018-10-25 AU AU2018253567A patent/AU2018253567B2/en not_active Ceased
2019
- 2019-08-16 AU AU2019216710A patent/AU2019216710A1/en not_active Abandoned

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO1997049384A1 (en) *	1996-06-26	1997-12-31	Board Of Regents, The University Of Texas System	Hot-melt extrudable pharmaceutical formulation
WO2010140007A2 (en) *	2009-06-05	2010-12-09	Euro-Celtique S.A.	Dosage form
US20130028970A1 (en) *	2011-07-29	2013-01-31	Grunenthal Gmbh	Tamper-resistant tablet providing immediate drug release
US20140010873A1 (en) *	2012-07-06	2014-01-09	Egalet Ltd.	Abuse deterrent pharmaceutical compositions for controlled release
WO2015023675A2 (en) *	2013-08-12	2015-02-19	Pharmaceutical Manufacturing Research Services, Inc.	Extruded immediate release abuse deterrent pill

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2015095387A1 *

Also Published As

Publication number	Publication date
WO2015095387A1 (en)	2015-06-25
CA2934078C (en)	2019-08-06
AU2018253567A1 (en)	2018-11-08
JP2019001816A (en)	2019-01-10
JP2017503780A (en)	2017-02-02
AU2018253567B2 (en)	2019-05-23
AU2019216710A1 (en)	2019-09-12
EP3082775A1 (en)	2016-10-26
JP6403780B2 (en)	2018-10-10
CA2934078A1 (en)	2015-06-25
JP6678212B2 (en)	2020-04-08
AU2014364800A1 (en)	2016-07-07

Legal Events

Date	Code	Title	Description
2016-09-23	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2016-10-26	17P	Request for examination filed	Effective date: 20160713
2016-10-26	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2016-10-26	AX	Request for extension of the european patent	Extension state: BA ME
2017-03-29	DAX	Request for extension of the european patent (deleted)
2017-05-17	A4	Supplementary search report drawn up and despatched	Effective date: 20170413
2017-05-17	RIC1	Information provided on ipc code assigned before grant	Ipc: A61P 25/36 20060101ALI20170408BHEP Ipc: A61K 9/22 20060101AFI20170408BHEP
2018-06-01	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: EXAMINATION IS IN PROGRESS
2018-07-04	17Q	First examination report despatched	Effective date: 20180605
2020-10-24	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: EXAMINATION IS IN PROGRESS
2021-05-10	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN
2021-06-09	18D	Application deemed to be withdrawn	Effective date: 20210112

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