BRPI0515600A - formas farmacêuticas opióides tendo cmédia e auc em estado estável proporcionais à dose e cmax de dose única inferior ao proporcional à dose - Google Patents

formas farmacêuticas opióides tendo cmédia e auc em estado estável proporcionais à dose e cmax de dose única inferior ao proporcional à dose

Info

Publication number
BRPI0515600A
BRPI0515600A BRPI0515600-9A BRPI0515600A BRPI0515600A BR PI0515600 A BRPI0515600 A BR PI0515600A BR PI0515600 A BRPI0515600 A BR PI0515600A BR PI0515600 A BRPI0515600 A BR PI0515600A
Authority
BR
Brazil
Prior art keywords
dose
proportional
pharmaceutical
dosage forms
steady
Prior art date
Application number
BRPI0515600-9A
Other languages
English (en)
Inventor
Curtis Wright
Robert Colucci
Ahmed El-Tahtawy
Original Assignee
Euro Celtique Sa
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 Euro Celtique Sa filed Critical Euro Celtique Sa
Publication of BRPI0515600A publication Critical patent/BRPI0515600A/pt

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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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

"FORMAS FARMACêUTICAS OPóIDES TENDO C~ MéDIA~ E AUC EM ESTADO ESTáVEL PROPORCIONAIS à DOSE E c~ MAX~ DE DOSE úNICA INFERIOR AO PROPORCIONAL à DOSE". A presente invenção refere-se a diversas formas farmacêuticas compreendendo uma primeira forma farmacêutica e uma segunda forma farmacêutica, cada uma compreendendo um agente terapêutico, por exemplo, um opióide; caracterizadas pelo fato de que a potência de dose da segunda forma farmacêutica é a maior que a potência de dose da primeira forma farmacêutica; e onde c~ media~ em estado estável e a AUC em estado estável da primeira e segunda formas farmacêuticas são proporcionais à dose e a c~ max~ de dose única da segunda forma farmacêutica é inferior ao nível mínimo de proporcionalidade de dose em relação à primeira forma farmacêutica. A presente invenção também refere-se a métodos de adminsitração dessas formas farmacêuticas a um paciente, bem como a kits compreendendo essas formas farmacêuticas e instruções para a administração das formas farmacêuticas a um paciente. Os inventores acreditam que as formas farmacêuticas e os métodos da presente invenção resultarão em maior segurança e aceitação por parte do paciente.
BRPI0515600-9A 2004-09-01 2005-08-30 formas farmacêuticas opióides tendo cmédia e auc em estado estável proporcionais à dose e cmax de dose única inferior ao proporcional à dose BRPI0515600A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60635404P 2004-09-01 2004-09-01
PCT/US2005/030892 WO2006028830A2 (en) 2004-09-01 2005-08-30 Opioid dosage forms having dose proportional steady state cave and auc and less than dose proportional single dose cmax

Publications (1)

Publication Number Publication Date
BRPI0515600A true BRPI0515600A (pt) 2008-07-29

Family

ID=35759199

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0515600-9A BRPI0515600A (pt) 2004-09-01 2005-08-30 formas farmacêuticas opióides tendo cmédia e auc em estado estável proporcionais à dose e cmax de dose única inferior ao proporcional à dose

Country Status (15)

Country Link
US (2) US9326959B2 (pt)
EP (1) EP1786404A2 (pt)
JP (1) JP4997109B2 (pt)
KR (2) KR20070048272A (pt)
CN (1) CN101010072A (pt)
AU (1) AU2005282784B2 (pt)
BR (1) BRPI0515600A (pt)
CA (1) CA2578540A1 (pt)
EA (1) EA010627B1 (pt)
IL (1) IL181600A0 (pt)
MX (1) MX2007002135A (pt)
NO (1) NO20071352L (pt)
UA (1) UA85750C2 (pt)
WO (1) WO2006028830A2 (pt)
ZA (1) ZA200700620B (pt)

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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
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CA2665841C (en) 2006-10-09 2016-04-05 Charleston Laboratories, Inc. Pharmaceutical compositions
CA2905541C (en) 2008-01-09 2020-02-11 Charleston Laboratories, Inc. Pharmaceutical compositions comprising an antiemetic and an opioid analgesic
JP2011511782A (ja) 2008-02-12 2011-04-14 アボット・ラボラトリーズ 長期放出性ヒドロコドンアセトアミノフェンならびにその関連方法および用途
US8372432B2 (en) * 2008-03-11 2013-02-12 Depomed, Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
EP2262484B1 (en) * 2008-03-11 2013-01-23 Depomed, Inc. Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
US20100069887A1 (en) * 2008-09-16 2010-03-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Multiple chamber ex vivo adjustable-release final dosage form
US20100068233A1 (en) * 2008-09-16 2010-03-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Modifiable dosage form
US20100068254A1 (en) * 2008-09-16 2010-03-18 Mahalaxmi Gita Bangera Modifying a medicament availability state of a final dosage form
US20100068235A1 (en) * 2008-09-16 2010-03-18 Searete LLC, a limited liability corporation of Deleware Individualizable dosage form
US20100068256A1 (en) * 2008-09-16 2010-03-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Ex vivo modifiable medicament release-substance
US20100068275A1 (en) * 2008-09-16 2010-03-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Personalizable dosage form
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US10335375B2 (en) 2017-05-30 2019-07-02 Patheon Softgels, Inc. Anti-overingestion abuse deterrent compositions

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Also Published As

Publication number Publication date
NO20071352L (no) 2007-05-30
KR20080046751A (ko) 2008-05-27
MX2007002135A (es) 2007-04-02
US20080132532A1 (en) 2008-06-05
JP4997109B2 (ja) 2012-08-08
AU2005282784A1 (en) 2006-03-16
WO2006028830A2 (en) 2006-03-16
IL181600A0 (en) 2007-07-04
KR20070048272A (ko) 2007-05-08
EP1786404A2 (en) 2007-05-23
AU2005282784B2 (en) 2008-06-19
CA2578540A1 (en) 2006-03-16
JP2008511657A (ja) 2008-04-17
UA85750C2 (uk) 2009-02-25
EA200700500A1 (ru) 2007-08-31
EA010627B1 (ru) 2008-10-30
WO2006028830A3 (en) 2006-05-26
US20140187572A1 (en) 2014-07-03
US9034377B2 (en) 2015-05-19
ZA200700620B (en) 2008-04-30
CN101010072A (zh) 2007-08-01
US9326959B2 (en) 2016-05-03

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Legal Events

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B25G Requested change of headquarter approved

Owner name: EURO-CELTIQUE S.A (LU)

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07C Technical examination (opinion): republication [chapter 7.3 patent gazette]

Free format text: REF. A RPI 2482 DE 31/07/2018.

B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]

Free format text: MANTIDO O INDEFERIMENTO UMA VEZ QUE NAO FOI APRESENTADO RECURSO DENTRO DO PRAZO LEGAL