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WO2006078811A3 - Pharmaceutical formulations and methods of use - Google Patents

Pharmaceutical formulations and methods of use Download PDF

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Publication number
WO2006078811A3
WO2006078811A3 PCT/US2006/001887 US2006001887W WO2006078811A3 WO 2006078811 A3 WO2006078811 A3 WO 2006078811A3 US 2006001887 W US2006001887 W US 2006001887W WO 2006078811 A3 WO2006078811 A3 WO 2006078811A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulations
release component
methods
component
formulations
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.)
Ceased
Application number
PCT/US2006/001887
Other languages
French (fr)
Other versions
WO2006078811A2 (en
Inventor
Rodney A Brown
Stephen H Curry
Michael Rubenstein
Michael R Violante
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.)
Quay Pharmaceuticals Ltd
Pharmanova Inc
Original Assignee
Quay Pharmaceuticals Ltd
Pharmanova Inc
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=36692870&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2006078811(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to JP2007552260A priority Critical patent/JP2008528494A/en
Priority to MX2007008833A priority patent/MX2007008833A/en
Priority to AU2006206423A priority patent/AU2006206423A1/en
Priority to EP06718892A priority patent/EP1838291A4/en
Priority to BRPI0614021-1A priority patent/BRPI0614021A2/en
Application filed by Quay Pharmaceuticals Ltd, Pharmanova Inc filed Critical Quay Pharmaceuticals Ltd
Priority to CA002595470A priority patent/CA2595470A1/en
Publication of WO2006078811A2 publication Critical patent/WO2006078811A2/en
Publication of WO2006078811A3 publication Critical patent/WO2006078811A3/en
Priority to IL184735A priority patent/IL184735A0/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Addiction (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

This invention relates to new pharmaceutical formulations, and to new medical uses, of gabapentin and pregabalin. The formulations may comprise up to three components including an immediate release component, a sustained release component and a delayed release component. The proportion of each component in the formulation may be adjusted to achieve the desired AUC and therapeutic effect following oral administration in a human subject.
PCT/US2006/001887 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use Ceased WO2006078811A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
CA002595470A CA2595470A1 (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use
MX2007008833A MX2007008833A (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use.
AU2006206423A AU2006206423A1 (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use
EP06718892A EP1838291A4 (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use
BRPI0614021-1A BRPI0614021A2 (en) 2005-01-21 2006-01-20 pharmaceutical formulations and methods of use
JP2007552260A JP2008528494A (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use
IL184735A IL184735A0 (en) 2005-01-21 2007-07-19 Pharmaceutical formulations and methods of use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US64585705P 2005-01-21 2005-01-21
US60/645,857 2005-01-21

Publications (2)

Publication Number Publication Date
WO2006078811A2 WO2006078811A2 (en) 2006-07-27
WO2006078811A3 true WO2006078811A3 (en) 2007-03-01

Family

ID=36692870

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/001887 Ceased WO2006078811A2 (en) 2005-01-21 2006-01-20 Pharmaceutical formulations and methods of use

Country Status (12)

Country Link
EP (1) EP1838291A4 (en)
JP (1) JP2008528494A (en)
KR (1) KR20070116588A (en)
CN (1) CN101137352A (en)
AR (1) AR062647A1 (en)
AU (1) AU2006206423A1 (en)
BR (1) BRPI0614021A2 (en)
CA (1) CA2595470A1 (en)
IL (1) IL184735A0 (en)
MX (1) MX2007008833A (en)
TW (1) TW200640497A (en)
WO (1) WO2006078811A2 (en)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2009006575A (en) 2006-12-22 2009-07-02 Recordati Ireland Ltd Combination therapy of lower urinary tract disorders with î±2î´ ligands and nsaids.
EP2018854A1 (en) * 2007-07-27 2009-01-28 Merz Pharma GmbH & Co. KGaA Novel combinations of neramexane for the treatment of neurodegenerative disorders
KR101607112B1 (en) * 2007-11-23 2016-03-29 그뤼넨탈 게엠베하 Tapentadol compositions
US8454993B2 (en) 2007-11-23 2013-06-04 Lupin Limited Controlled release pharmaceutical compositions of pregabalin
AU2012204162B2 (en) 2011-01-07 2017-04-20 Anji Pharmaceuticals Inc. Chemosensory receptor ligand-based therapies
US9211263B2 (en) 2012-01-06 2015-12-15 Elcelyx Therapeutics, Inc. Compositions and methods of treating metabolic disorders
US9572784B2 (en) 2011-01-07 2017-02-21 Elcelyx Therapeutics, Inc. Compositions comprising statins, biguanides and further agents for reducing cardiometabolic risk
US11759441B2 (en) 2011-01-07 2023-09-19 Anji Pharmaceuticals Inc. Biguanide compositions and methods of treating metabolic disorders
US11974971B2 (en) 2011-01-07 2024-05-07 Anji Pharmaceuticals Inc. Compositions and methods for treating metabolic disorders
US8796338B2 (en) 2011-01-07 2014-08-05 Elcelyx Therapeutics, Inc Biguanide compositions and methods of treating metabolic disorders
PL2704698T3 (en) * 2011-05-05 2020-01-31 Hennig Arzneimittel Gmbh&Co. Kg Dosage form for the controlled release of active ingredients
KR101438546B1 (en) * 2011-08-26 2014-09-17 근화제약주식회사 Controlled-release formulations comprising pregabalin
WO2013100873A1 (en) * 2011-12-19 2013-07-04 Mahmut Bilgic Pharmaceutical formulation of pregabalin (particle size 300-2500 micrometer)
KR102035879B1 (en) 2012-01-06 2019-10-23 엘셀릭스 테라퓨틱스 인코포레이티드 Biguanide compositions and methods of treating metabolic disorders
KR102231554B1 (en) 2012-01-06 2021-03-23 앤지 파마 유에스 엘엘씨 Compositions and methods for treating metabolic disorders
KR102221846B1 (en) * 2014-04-07 2021-02-26 영진약품 주식회사 Pharmaceutical composition of pregabalin with improved stability and method for preparing thereof
US20170273326A1 (en) * 2014-08-29 2017-09-28 Wakamoto Pharmaceutical Co., Ltd. Lactic acid bacteria-containing composition
CA2936748C (en) 2014-10-31 2017-08-08 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
MA44212A (en) 2015-05-26 2018-12-26 Isa Odidi Sustained-release pregabalin
BR112018071363A2 (en) * 2016-04-19 2019-02-05 Ferring Bv oral nicotinamide pharmaceutical compositions
AU2017300185B2 (en) * 2016-07-17 2023-02-02 Mapi Pharma Ltd. Extended release dosage forms of pregabalin
JP6919119B2 (en) * 2017-01-23 2021-08-18 日新製薬株式会社 A compressed solid pharmaceutical composition containing a γ-aminobutyric acid derivative substituted at the 3-position.
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder
CN112023032B (en) * 2020-09-14 2022-03-18 广东鼎信医药科技有限公司 Pharmaceutical composition containing digestive enzyme and preparation method thereof
JP7720911B2 (en) 2020-12-04 2025-08-08 ラボラトリオス シラネス、エセ．ア．デ セ．べ． Coated stable solid pharmaceutical compositions of opioid analgesics for pain and antiepileptic drugs
CN116898819B (en) * 2023-06-09 2024-02-06 则正(上海)生物科技有限公司 Pregabalin sustained release agent and preparation method thereof

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RU2004123792A (en) * 2002-01-04 2005-04-10 Ивэкс Рисеч, Инк. (Us) DEVICE DELIVERY DEVICE FOR PROLONGED GLIPYSIT DELIVERY
EP2316469A1 (en) * 2002-02-22 2011-05-04 Shire LLC Delivery system and methods for protecting and administering dextroamphetamine
JP2008530131A (en) * 2005-02-15 2008-08-07 ジャズ、ファーマシューティカルズ、インコーポレイテッド Dosage forms and methods for sustained release of substituted pyrazine compounds

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Non-Patent Citations (2)

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CHOURASIA M.K. ET AL.: "Pharmaceutical approaches to colon targeted drug delivery systems", J. PHARM. PHARMACEUT. SCI., vol. 6, no. 1, 2003, pages 33 - 65, XP008078133 *
MAGNUS L.: "Nonepileptic Uses of Gabapentin", IPILEPSIA, vol. 40, no. SUPPL. 6, 1999, pages S66 - S72, XP000866519 *

Also Published As

Publication number Publication date
BRPI0614021A2 (en) 2011-03-01
CA2595470A1 (en) 2006-07-27
WO2006078811A2 (en) 2006-07-27
JP2008528494A (en) 2008-07-31
EP1838291A4 (en) 2008-12-03
IL184735A0 (en) 2007-12-03
CN101137352A (en) 2008-03-05
TW200640497A (en) 2006-12-01
KR20070116588A (en) 2007-12-10
EP1838291A2 (en) 2007-10-03
AU2006206423A1 (en) 2006-07-27
MX2007008833A (en) 2008-03-25
AR062647A1 (en) 2008-11-26

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