CA2408106A1

CA2408106A1 - Opioid antagonist compositions and dosage forms

Opioid antagonist compositions and dosage forms Download PDF

Info

Publication number: CA2408106A1
Authority: CA; Canada
Prior art keywords: dosage form; antagonist; oral dosage; solid oral; amount
Prior art date: 2000-05-05
Legal status : Abandoned

Application number

CA002408106A

Other languages

English (en)

French (fr)

Inventor

Barry Sherman

Mary Remien

Remi Barbier

James W. Mcginity

Current Assignee

Albert Einstein College of Medicine

Pain Therapeutics Inc

Original Assignee

Individual

Priority date

2000-05-05

Filing date

2001-05-04

Publication date

2001-11-15

2000-05-05 Priority claimed from PCT/US2000/012493 external-priority patent/WO2000067739A2/en

2001-05-04 Application filed by Individual filed Critical Individual

2001-11-15 Publication of CA2408106A1 publication Critical patent/CA2408106A1/en

Status Abandoned legal-status Critical Current

Links

239000003401 opiate antagonist Substances 0.000 title claims abstract description 232
239000002552 dosage form Substances 0.000 title claims abstract description 179
239000000203 mixture Substances 0.000 title claims description 188
239000003402 opiate agonist Substances 0.000 claims abstract description 175
239000007787 solid Substances 0.000 claims abstract description 175
239000006186 oral dosage form Substances 0.000 claims abstract description 127
238000000034 method Methods 0.000 claims abstract description 104
239000008194 pharmaceutical composition Substances 0.000 claims abstract description 95
239000012729 immediate-release (IR) formulation Substances 0.000 claims abstract description 27
239000004480 active ingredient Substances 0.000 claims abstract description 12
DQCKKXVULJGBQN-XFWGSAIBSA-N naltrexone Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=O)O)CC1)O)CC1CC1 DQCKKXVULJGBQN-XFWGSAIBSA-N 0.000 claims description 235
229960003086 naltrexone Drugs 0.000 claims description 230
239000005557 antagonist Substances 0.000 claims description 139
239000000546 pharmaceutical excipient Substances 0.000 claims description 133
239000002775 capsule Substances 0.000 claims description 110
229940124531 pharmaceutical excipient Drugs 0.000 claims description 106
BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 99
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238000005469 granulation Methods 0.000 claims description 88
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239000003826 tablet Substances 0.000 claims description 77
239000000556 agonist Substances 0.000 claims description 69
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238000004090 dissolution Methods 0.000 claims description 52
239000011230 binding agent Substances 0.000 claims description 49
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239000008187 granular material Substances 0.000 claims description 35
BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims description 32
239000007903 gelatin capsule Substances 0.000 claims description 31
RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 28
WJBLNOPPDWQMCH-MBPVOVBZSA-N Nalmefene Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=C)O)CC1)O)CC1CC1 WJBLNOPPDWQMCH-MBPVOVBZSA-N 0.000 claims description 26
OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 claims description 26
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TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 claims description 23
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TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 claims description 23
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OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 claims description 15
USSIQXCVUWKGNF-UHFFFAOYSA-N 6-(dimethylamino)-4,4-diphenylheptan-3-one Chemical compound C=1C=CC=CC=1C(CC(C)N(C)C)(C(=O)CC)C1=CC=CC=C1 USSIQXCVUWKGNF-UHFFFAOYSA-N 0.000 claims description 14
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