WO2003072046A3 - Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances - Google Patents

Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances Download PDF

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Publication number
WO2003072046A3
WO2003072046A3 PCT/US2003/005525 US0305525W WO03072046A3 WO 2003072046 A3 WO2003072046 A3 WO 2003072046A3 US 0305525 W US0305525 W US 0305525W WO 03072046 A3 WO03072046 A3 WO 03072046A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained release
controlled substances
release pharmaceutical
pharmaceutical compounds
prevent abuse
Prior art date
Application number
PCT/US2003/005525
Other languages
French (fr)
Other versions
WO2003072046A2 (en
Inventor
Thomas Piccariello
Randal J Kirk
Original Assignee
New River Pharmaceuticals Inc
Thomas Piccariello
Randal J Kirk
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 New River Pharmaceuticals Inc, Thomas Piccariello, Randal J Kirk filed Critical New River Pharmaceuticals Inc
Priority to EP03716144.5A priority Critical patent/EP1531844B1/en
Priority to CA2740256A priority patent/CA2740256A1/en
Priority to ES03716144.5T priority patent/ES2500117T3/en
Priority to JP2003570793A priority patent/JP4878732B2/en
Priority to IL16366703A priority patent/IL163667A0/en
Priority to KR1020047013136A priority patent/KR100822498B1/en
Priority to CA2477004A priority patent/CA2477004C/en
Priority to AU2003219863A priority patent/AU2003219863C1/en
Publication of WO2003072046A2 publication Critical patent/WO2003072046A2/en
Priority to US10/858,526 priority patent/US7105486B2/en
Priority to IL163667A priority patent/IL163667A/en
Priority to US10/923,257 priority patent/US7622441B2/en
Priority to US10/953,111 priority patent/US20070066537A1/en
Priority to US10/953,116 priority patent/US7375082B2/en
Publication of WO2003072046A3 publication Critical patent/WO2003072046A3/en
Priority to US11/089,056 priority patent/US20060014697A1/en
Priority to US11/179,801 priority patent/US8133881B2/en
Priority to US11/400,304 priority patent/US7700561B2/en
Priority to US12/131,923 priority patent/US7659253B2/en
Priority to US12/201,866 priority patent/US7662788B2/en
Priority to US12/201,907 priority patent/US7713936B2/en
Priority to US12/201,586 priority patent/US7659254B2/en
Priority to US12/202,159 priority patent/US7671031B2/en
Priority to US12/202,003 priority patent/US7723305B2/en
Priority to US12/202,096 priority patent/US7718619B2/en
Priority to US12/202,067 priority patent/US7687467B2/en
Priority to US12/201,739 priority patent/US7678770B2/en
Priority to US12/201,982 priority patent/US7674774B2/en
Priority to US12/202,146 priority patent/US7678771B2/en
Priority to US12/201,794 priority patent/US7687466B2/en
Priority to US12/201,760 priority patent/US7655630B2/en
Priority to US12/201,950 priority patent/US7671030B2/en
Priority to US12/201,820 priority patent/US20090137673A1/en
Priority to US12/202,699 priority patent/US20090131322A1/en
Priority to US12/203,129 priority patent/US20090137488A1/en
Priority to US12/203,058 priority patent/US20090143306A1/en
Priority to US12/202,941 priority patent/US20090137487A1/en
Priority to US12/203,133 priority patent/US20090137490A1/en
Priority to US12/231,489 priority patent/US20090143307A1/en
Priority to US12/202,987 priority patent/US20090192093A1/en
Priority to US12/202,777 priority patent/US20090143304A1/en
Priority to US12/203,127 priority patent/US20090131332A1/en
Priority to US12/203,136 priority patent/US20090209471A1/en
Priority to US12/202,845 priority patent/US20090137486A1/en
Priority to US12/203,134 priority patent/US20090137491A1/en
Priority to US12/202,955 priority patent/US20090143305A1/en
Priority to US12/203,108 priority patent/US20090181898A1/en
Priority to US12/203,137 priority patent/US20090149392A1/en
Priority to US12/203,132 priority patent/US20090137489A1/en
Priority to US12/239,221 priority patent/US20090131324A1/en
Priority to US12/239,479 priority patent/US20090131334A1/en
Priority to US12/239,087 priority patent/US20090186828A1/en
Priority to US12/239,554 priority patent/US20090131335A1/en
Priority to US12/239,571 priority patent/US20090137461A1/en
Priority to US12/239,429 priority patent/US20090131476A1/en
Priority to US12/239,180 priority patent/US20090186825A1/en
Priority to US12/239,600 priority patent/US20090137677A1/en
Priority to US12/239,154 priority patent/US20090131323A1/en
Priority to US12/239,238 priority patent/US20090131325A1/en
Priority to US12/239,364 priority patent/US20090137515A1/en
Priority to US12/239,577 priority patent/US20090131326A1/en
Priority to US12/239,247 priority patent/US20090131333A1/en
Priority to US12/239,400 priority patent/US20090186945A1/en
Priority to AU2008229978A priority patent/AU2008229978B2/en
Priority to US12/701,483 priority patent/US20110009669A1/en
Priority to US12/756,773 priority patent/US20100197798A1/en
Priority to US12/881,008 priority patent/US8343927B2/en
Priority to US13/339,095 priority patent/US20120115950A1/en

Links

Classifications

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/542—Carboxylic acids, e.g. a fatty acid or an amino acid
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides methods for altering controlled substances in a manner that decreases their potential for abuse. The novel compounds may be combined in tablets with suitable excipients or formulated in solution for oral delivery. When delivered by the oral route the controlled substance is released in a time-dependent manner (sustained release) by acid hydrolysis and/or enzymatic cleavage. When administered by injection the controlled substance is released in a time-dependent manner (sustained release) by way of serum enzymes.
PCT/US2003/005525 2001-08-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances WO2003072046A2 (en)

Priority Applications (66)

Application Number Priority Date Filing Date Title
EP03716144.5A EP1531844B1 (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances
CA2740256A CA2740256A1 (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances
ES03716144.5T ES2500117T3 (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent the abuse of controlled substances
JP2003570793A JP4878732B2 (en) 2002-02-22 2003-02-24 Novel sustained-release pharmaceutical compounds to prevent abuse of controlled substances
IL16366703A IL163667A0 (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to preventabuse of controlled substances
KR1020047013136A KR100822498B1 (en) 2002-02-22 2003-02-24 Novel Sustained Release Pharmaceutical Compounds to Prevent Abuse of Controlled Substances
CA2477004A CA2477004C (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances
AU2003219863A AU2003219863C1 (en) 2002-02-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances
US10/858,526 US7105486B2 (en) 2002-02-22 2004-06-01 Abuse-resistant amphetamine compounds
IL163667A IL163667A (en) 2002-02-22 2004-08-22 Conjugates comprising controlled substances covalently bound to peptides or amino acids and compositions comprising same
US10/923,257 US7622441B2 (en) 2002-02-22 2004-08-23 Sustained release pharmaceutical compounds to prevent abuse of controlled substances
US10/953,111 US20070066537A1 (en) 2002-02-22 2004-09-30 Compounds and compositions for prevention of overdose of oxycodone
US10/953,116 US7375082B2 (en) 2002-02-22 2004-09-30 Abuse-resistant hydrocodone compounds
US11/089,056 US20060014697A1 (en) 2001-08-22 2005-03-25 Pharmaceutical compositions for prevention of overdose or abuse
US11/179,801 US8133881B2 (en) 2003-01-13 2005-07-13 Carbohydrate conjugates to prevent abuse of controlled substances
US11/400,304 US7700561B2 (en) 2002-02-22 2006-04-10 Abuse-resistant amphetamine prodrugs
US12/131,923 US7659253B2 (en) 2002-02-22 2008-06-02 Abuse-resistant amphetamine prodrugs
US12/201,866 US7662788B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,907 US7713936B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,586 US7659254B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,159 US7671031B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,003 US7723305B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,096 US7718619B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,067 US7687467B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,739 US7678770B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,982 US7674774B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,146 US7678771B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,794 US7687466B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,760 US7655630B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,950 US7671030B2 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/201,820 US20090137673A1 (en) 2002-02-22 2008-08-29 Abuse-resistant amphetamine prodrugs
US12/202,699 US20090131322A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,129 US20090137488A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,058 US20090143306A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/202,941 US20090137487A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,133 US20090137490A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/231,489 US20090143307A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/202,987 US20090192093A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/202,777 US20090143304A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,127 US20090131332A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,136 US20090209471A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/202,845 US20090137486A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,134 US20090137491A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/202,955 US20090143305A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,108 US20090181898A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,137 US20090149392A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/203,132 US20090137489A1 (en) 2002-02-22 2008-09-02 Abuse-resistant amphetamine prodrugs
US12/239,221 US20090131324A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,479 US20090131334A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,087 US20090186828A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,554 US20090131335A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,571 US20090137461A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,429 US20090131476A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,180 US20090186825A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,600 US20090137677A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,154 US20090131323A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,238 US20090131325A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,364 US20090137515A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,577 US20090131326A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,247 US20090131333A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
US12/239,400 US20090186945A1 (en) 2002-02-22 2008-09-26 Abuse-resistant amphetamine prodrugs
AU2008229978A AU2008229978B2 (en) 2002-02-22 2008-10-16 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances
US12/701,483 US20110009669A1 (en) 2002-02-22 2010-02-05 Abuse-resistant amphetamine prodrugs
US12/756,773 US20100197798A1 (en) 2002-02-22 2010-04-08 Abuse-resistant amphetamine prodrugs
US12/881,008 US8343927B2 (en) 2001-08-22 2010-09-13 Pharmaceutical compositions for prevention of overdose or abuse
US13/339,095 US20120115950A1 (en) 2002-02-22 2011-12-28 Abuse-resistant amphetamine prodrugs

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US35836802P 2002-02-22 2002-02-22
US60/358,368 2002-02-22
US36208202P 2002-03-07 2002-03-07
US60/362,082 2002-03-07

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
US10/156,527 Continuation-In-Part US7060708B2 (en) 1999-03-10 2002-05-29 Active agent delivery systems and methods for protecting and administering active agents
US10/923,088 Continuation-In-Part US7427600B2 (en) 2000-08-22 2004-08-23 Active agent delivery systems and methods for protecting and administering active agents

Related Child Applications (8)

Application Number Title Priority Date Filing Date
US10923257 A-371-Of-International 2003-02-24
PCT/US2004/000646 Continuation-In-Part WO2004062614A2 (en) 2003-01-13 2004-01-13 Carbohydrate conjugates to prevent abuse of controlled substances
US10/858,526 Continuation-In-Part US7105486B2 (en) 2002-02-22 2004-06-01 Abuse-resistant amphetamine compounds
US10/858,526 Continuation US7105486B2 (en) 2002-02-22 2004-06-01 Abuse-resistant amphetamine compounds
US10/857,619 Continuation-In-Part US7223735B2 (en) 2002-02-22 2004-06-01 Abuse resistant lysine amphetamine compounds
US10/923,088 Continuation-In-Part US7427600B2 (en) 2000-08-22 2004-08-23 Active agent delivery systems and methods for protecting and administering active agents
US10/923,257 Continuation-In-Part US7622441B2 (en) 2001-08-22 2004-08-23 Sustained release pharmaceutical compounds to prevent abuse of controlled substances
US10/927,257 Continuation-In-Part US7574503B2 (en) 2004-08-27 2004-08-27 Method and system for using abstract classes to extract status information from networked devices

Publications (2)

Publication Number Publication Date
WO2003072046A2 WO2003072046A2 (en) 2003-09-04
WO2003072046A3 true WO2003072046A3 (en) 2005-03-10

Family

ID=27767540

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/005525 WO2003072046A2 (en) 2001-08-22 2003-02-24 Novel sustained release pharmaceutical compounds to prevent abuse of controlled substances

Country Status (9)

Country Link
US (1) US7622441B2 (en)
EP (2) EP1531844B1 (en)
JP (1) JP4878732B2 (en)
KR (1) KR100822498B1 (en)
AU (2) AU2003219863C1 (en)
CA (1) CA2477004C (en)
ES (1) ES2500117T3 (en)
IL (2) IL163667A0 (en)
WO (1) WO2003072046A2 (en)

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