WO2012085656A3 - Encased tamper resistant controlled release dosage forms - Google Patents

Encased tamper resistant controlled release dosage forms Download PDF

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Publication number
WO2012085656A3
WO2012085656A3 PCT/IB2011/003152 IB2011003152W WO2012085656A3 WO 2012085656 A3 WO2012085656 A3 WO 2012085656A3 IB 2011003152 W IB2011003152 W IB 2011003152W WO 2012085656 A3 WO2012085656 A3 WO 2012085656A3
Authority
WO
WIPO (PCT)
Prior art keywords
controlled release
release dosage
dosage forms
tamper resistant
opioid analgesic
Prior art date
Application number
PCT/IB2011/003152
Other languages
French (fr)
Other versions
WO2012085656A2 (en
Inventor
Haiyong Hugh Huang
Original Assignee
Purdue Pharma L.P.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45563448&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2012085656(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CN201510201476.6A priority Critical patent/CN104873455B/en
Priority to NZ613079A priority patent/NZ613079A/en
Priority to EA201300747A priority patent/EA032906B1/en
Priority to AP2013006907A priority patent/AP3815A/en
Priority to SG2013047949A priority patent/SG191288A1/en
Priority to UAA201309231A priority patent/UA114887C2/en
Priority to MX2013007465A priority patent/MX367010B/en
Priority to JP2013545524A priority patent/JP5911509B2/en
Priority to AP2016009016A priority patent/AP2016009016A0/en
Application filed by Purdue Pharma L.P. filed Critical Purdue Pharma L.P.
Priority to PH12015501410A priority patent/PH12015501410A1/en
Priority to EP11815781.7A priority patent/EP2654734A2/en
Priority to KR1020137019009A priority patent/KR101572336B1/en
Priority to CA2822790A priority patent/CA2822790C/en
Priority to AU2011346757A priority patent/AU2011346757B2/en
Priority to CN2011800615405A priority patent/CN103370058A/en
Priority to KR1020157010465A priority patent/KR101647267B1/en
Publication of WO2012085656A2 publication Critical patent/WO2012085656A2/en
Publication of WO2012085656A3 publication Critical patent/WO2012085656A3/en
Priority to IL226811A priority patent/IL226811B/en
Priority to TNP2013000264A priority patent/TN2013000264A1/en
Priority to PH12015501411A priority patent/PH12015501411B1/en
Priority to AU2015246094A priority patent/AU2015246094B2/en
Priority to AU2017208386A priority patent/AU2017208386B2/en

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
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/0012—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
    • A61K9/20—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
    • A61K9/2072—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
    • 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
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer 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
    • A61K9/20—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
    • 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

Abstract

In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in- vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.
PCT/IB2011/003152 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms WO2012085656A2 (en)

Priority Applications (21)

Application Number Priority Date Filing Date Title
PH12015501410A PH12015501410A1 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
EP11815781.7A EP2654734A2 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
EA201300747A EA032906B1 (en) 2010-12-22 2011-12-21 Solid controlled release dosage form and methods of preparation and use thereof
AP2013006907A AP3815A (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
SG2013047949A SG191288A1 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
UAA201309231A UA114887C2 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
MX2013007465A MX367010B (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms.
JP2013545524A JP5911509B2 (en) 2010-12-22 2011-12-21 Coated tamper resistant controlled release dosage form
AP2016009016A AP2016009016A0 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
NZ613079A NZ613079A (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
KR1020157010465A KR101647267B1 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
CN201510201476.6A CN104873455B (en) 2010-12-22 2011-12-21 Coated Tamper Resistant Controlled Release Dosage Forms
AU2011346757A AU2011346757B2 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
CA2822790A CA2822790C (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
KR1020137019009A KR101572336B1 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
CN2011800615405A CN103370058A (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms
IL226811A IL226811B (en) 2010-12-22 2013-06-06 Encased tamper resistant controlled release dosage forms
TNP2013000264A TN2013000264A1 (en) 2010-12-22 2013-06-20 Encased tamper resistant controlled release dosage forms
PH12015501411A PH12015501411B1 (en) 2010-12-22 2015-06-18 Encased tamper resistant controlled release dosage forms
AU2015246094A AU2015246094B2 (en) 2010-12-22 2015-10-21 Encased tamper resistant controlled release dosage forms
AU2017208386A AU2017208386B2 (en) 2010-12-22 2017-07-31 Encased tamper resistant controlled release dosage forms

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201061426306P 2010-12-22 2010-12-22
US61/426,306 2010-12-22

Publications (2)

Publication Number Publication Date
WO2012085656A2 WO2012085656A2 (en) 2012-06-28
WO2012085656A3 true WO2012085656A3 (en) 2012-11-22

Family

ID=45563448

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2011/003152 WO2012085656A2 (en) 2010-12-22 2011-12-21 Encased tamper resistant controlled release dosage forms

Country Status (41)

Country Link
US (11) US8808740B2 (en)
EP (4) EP2654734A2 (en)
JP (2) JP5911509B2 (en)
KR (2) KR101572336B1 (en)
CN (2) CN103370058A (en)
AP (2) AP3815A (en)
AR (1) AR084575A1 (en)
AU (3) AU2011346757B2 (en)
CA (3) CA2991216C (en)
CL (4) CL2013001781A1 (en)
CO (1) CO6731103A2 (en)
CR (1) CR20130544A (en)
CY (1) CY1119312T1 (en)
DK (1) DK2826467T3 (en)
DO (2) DOP2013000140A (en)
EA (1) EA032906B1 (en)
EC (1) ECSP13012760A (en)
ES (1) ES2643291T3 (en)
GT (1) GT201300166A (en)
HK (3) HK1204763A1 (en)
HR (1) HRP20171366T1 (en)
HU (1) HUE034955T2 (en)
IL (1) IL226811B (en)
LT (1) LT2826467T (en)
ME (1) ME02874B (en)
MX (1) MX367010B (en)
MY (1) MY166034A (en)
NI (1) NI201300054A (en)
NZ (2) NZ708728A (en)
PE (2) PE20141132A1 (en)
PH (2) PH12015501410A1 (en)
PL (1) PL2826467T3 (en)
PT (1) PT2826467T (en)
RS (1) RS56344B1 (en)
SA (2) SA111330106B1 (en)
SG (2) SG191288A1 (en)
SI (1) SI2826467T1 (en)
TN (1) TN2013000264A1 (en)
TW (2) TWI538699B (en)
UA (1) UA114887C2 (en)
WO (1) WO2012085656A2 (en)

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