JP5964940B2 - 制御放出性医薬剤形 - Google Patents

制御放出性医薬剤形 Download PDF

Info

Publication number
JP5964940B2
JP5964940B2 JP2014500486A JP2014500486A JP5964940B2 JP 5964940 B2 JP5964940 B2 JP 5964940B2 JP 2014500486 A JP2014500486 A JP 2014500486A JP 2014500486 A JP2014500486 A JP 2014500486A JP 5964940 B2 JP5964940 B2 JP 5964940B2
Authority
JP
Japan
Prior art keywords
sustained release
dosage form
pharmaceutical dosage
solid oral
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
JP2014500486A
Other languages
English (en)
Japanese (ja)
Other versions
JP2014510094A (ja
JP2014510094A5 (enExample
Inventor
ヒュー ヒュアン，ハイヨン
ヒュー ヒュアン，ハイヨン
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 JP2014510094A publication Critical patent/JP2014510094A/ja
Publication of JP2014510094A5 publication Critical patent/JP2014510094A5/ja
Application granted granted Critical
Publication of JP5964940B2 publication Critical patent/JP5964940B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or 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
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • 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
    • A61K9/2893—Tablet coating processes
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2014500486A 2011-03-25 2012-03-22 制御放出性医薬剤形 Active JP5964940B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161467824P 2011-03-25 2011-03-25
US61/467,824 2011-03-25
PCT/IB2012/000595 WO2012131463A2 (en) 2011-03-25 2012-03-22 Controlled release pharmaceutical dosage forms

Publications (3)

Publication Number Publication Date
JP2014510094A JP2014510094A (ja) 2014-04-24
JP2014510094A5 JP2014510094A5 (enExample) 2014-12-04
JP5964940B2 true JP5964940B2 (ja) 2016-08-03

Family

ID=46018006

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2014500486A Active JP5964940B2 (ja) 2011-03-25 2012-03-22 制御放出性医薬剤形

Country Status (24)

Country Link
US (1) US20140056979A1 (enExample)
EP (1) EP2688556B1 (enExample)
JP (1) JP5964940B2 (enExample)
KR (1) KR101619579B1 (enExample)
CN (1) CN103547259A (enExample)
AU (1) AU2012235878B2 (enExample)
BR (1) BR112013024585A8 (enExample)
CA (1) CA2831218C (enExample)
CY (1) CY1116579T1 (enExample)
DK (1) DK2688556T3 (enExample)
ES (1) ES2544735T3 (enExample)
HR (1) HRP20150835T1 (enExample)
HU (1) HUE026981T2 (enExample)
IL (1) IL228441B (enExample)
ME (1) ME02189B (enExample)
MX (1) MX350875B (enExample)
PH (1) PH12013501994A1 (enExample)
PL (1) PL2688556T3 (enExample)
PT (1) PT2688556E (enExample)
RS (1) RS54152B1 (enExample)
SI (1) SI2688556T1 (enExample)
SM (1) SMT201500209B (enExample)
WO (1) WO2012131463A2 (enExample)
ZA (1) ZA201307862B (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
EP2295043A1 (en) 1999-10-29 2011-03-16 Euro-Celtique S.A. Controlled release hydrocodone formulations
AU2002227383B2 (en) 2000-10-30 2004-07-08 Euro-Celtique S.A. Controlled release hydrocodone formulations
US20040253310A1 (en) 2001-09-21 2004-12-16 Gina Fischer Morphine polymer release system
WO2003024429A1 (en) 2001-09-21 2003-03-27 Egalet A/S Polymer release system
US8877241B2 (en) 2003-03-26 2014-11-04 Egalet Ltd. Morphine controlled release system
US8821928B2 (en) 2007-06-04 2014-09-02 Egalet Ltd. 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
AU2010265213B2 (en) 2009-06-24 2012-08-23 Egalet Ltd. Controlled release formulations
PL2826467T3 (pl) 2010-12-22 2018-01-31 Purdue Pharma Lp Zamknięte, zabezpieczone przed manipulowaniem formy dozowania o kontrolowanym uwalnianiu
PH12013501345A1 (en) 2010-12-23 2022-10-24 Purdue Pharma Lp Tamper resistant solid oral dosage forms
ES2716570T3 (es) 2012-04-17 2019-06-13 Purdue Pharma Lp Sistemas y procedimientos para tratar o prevenir una respuesta farmacodinámica adversa inducida por opioides
JP2015521988A (ja) 2012-07-06 2015-08-03 イガレット・リミテッド 制御放出用乱用防止性医薬組成物
PE20151301A1 (es) 2013-02-05 2015-09-16 Purdue Pharma Lp Formulaciones farmaceuticas resistentes a la manipulacion indebida
US10751287B2 (en) 2013-03-15 2020-08-25 Purdue Pharma L.P. Tamper resistant pharmaceutical formulations
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
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
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
US9849124B2 (en) 2014-10-17 2017-12-26 Purdue Pharma L.P. Systems and methods for treating an opioid-induced adverse pharmacodynamic response
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
US9839212B2 (en) 2015-04-16 2017-12-12 Bio-Lab, Inc. Multicomponent and multilayer compacted tablets
JP2020526500A (ja) 2017-06-30 2020-08-31 パーデュー、ファーマ、リミテッド、パートナーシップ 治療方法及びその剤形
JP7335870B2 (ja) * 2017-08-31 2023-08-30 パーデュー、ファーマ、リミテッド、パートナーシップ 医薬剤形
US12161754B2 (en) 2017-12-20 2024-12-10 Purdue Pharma L.P. Abuse deterrent morphine sulfate dosage forms

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR950007907B1 (ko) * 1992-09-01 1995-07-21 동국제약 주식회사 치주질환 치료용 막형 국소약물송달제제
US5567439A (en) * 1994-06-14 1996-10-22 Fuisz Technologies Ltd. Delivery of controlled-release systems(s)
US5634702A (en) 1995-09-27 1997-06-03 Fistonich; Juraj Hands free waste container having a closed cover that automatically opens when the container is moved outside its cabinet enclosure
MXPA02007254A (es) * 2000-02-04 2002-12-09 Depomed Inc Forma de dosis de cubierta-y-nucleo que se aproxima a liberacion de droga de orden cero.
AU2002227383B2 (en) * 2000-10-30 2004-07-08 Euro-Celtique S.A. Controlled release hydrocodone formulations
CA2572491A1 (en) * 2004-07-01 2006-01-12 Gruenenthal Gmbh Oral dosage form safeguarded against abuse
US7434308B2 (en) * 2004-09-02 2008-10-14 International Business Machines Corporation Cooling of substrate using interposer channels
CN101232868A (zh) * 2005-04-19 2008-07-30 阿尔扎公司 曲马多和加巴喷丁的控释递药剂型
RU2008149702A (ru) * 2006-05-17 2010-06-27 Сандвик Интеллекчуал Проперти Аб (Se) Верхнеударный инструмент для сверления камня, стержень сверла и соединительный рукав
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
WO2009012122A1 (en) * 2007-07-13 2009-01-22 Marvell World Trade Ltd. Method for shallow trench isolation
WO2009114648A1 (en) * 2008-03-11 2009-09-17 Depomed Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
CN101933907A (zh) * 2009-06-30 2011-01-05 北京天衡药物研究院 新型骨架缓释片及其制备方法

Also Published As

Publication number Publication date
BR112013024585A8 (pt) 2018-01-09
CA2831218A1 (en) 2012-10-04
US20140056979A1 (en) 2014-02-27
AU2012235878B2 (en) 2015-10-15
HUE026981T2 (en) 2016-08-29
HRP20150835T1 (hr) 2015-09-11
AU2012235878A1 (en) 2013-05-02
KR101619579B1 (ko) 2016-05-10
SI2688556T1 (sl) 2015-09-30
JP2014510094A (ja) 2014-04-24
DK2688556T3 (en) 2015-08-03
NZ616600A (en) 2015-07-31
IL228441B (en) 2019-05-30
ME02189B (me) 2016-02-20
PT2688556E (pt) 2015-09-11
CY1116579T1 (el) 2017-03-15
PH12013501994A1 (en) 2013-12-02
WO2012131463A2 (en) 2012-10-04
KR20130135973A (ko) 2013-12-11
EP2688556B1 (en) 2015-05-06
WO2012131463A3 (en) 2012-11-29
MX350875B (es) 2017-09-19
IL228441A0 (en) 2013-12-31
MX2013010987A (es) 2014-10-13
PL2688556T3 (pl) 2015-10-30
ZA201307862B (en) 2014-06-25
RS54152B1 (sr) 2015-12-31
ES2544735T3 (es) 2015-09-03
CA2831218C (en) 2017-01-17
CN103547259A (zh) 2014-01-29
EP2688556A2 (en) 2014-01-29
SMT201500209B (it) 2015-10-30

Similar Documents

Publication Publication Date Title
JP6286491B2 (ja) オピオイド鎮痛薬を含む不正改変抵抗性経口医薬剤形
AU2012235878B2 (en) Controlled release pharmaceutical dosage forms
KR20130097807A (ko) 케이싱된 탬퍼 저항성 제어 방출 투여 형태
AU2017208264B2 (en) Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
HK1246175B (en) Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
NZ616600B2 (en) Tamper-resistant controlled release pharmaceutical dosage forms

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20141010

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20141010

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20150619

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20150623

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20150924

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20160223

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160511

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20160607

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20160630

R150 Certificate of patent or registration of utility model

Ref document number: 5964940

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250