WO2007079195A3 - Gastric retentive gabapentin dosage forms and methods for using same - Google Patents

Gastric retentive gabapentin dosage forms and methods for using same Download PDF

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Publication number
WO2007079195A3
WO2007079195A3 PCT/US2006/049511 US2006049511W WO2007079195A3 WO 2007079195 A3 WO2007079195 A3 WO 2007079195A3 US 2006049511 W US2006049511 W US 2006049511W WO 2007079195 A3 WO2007079195 A3 WO 2007079195A3
Authority
WO
WIPO (PCT)
Prior art keywords
gabapentin
gastric
dosage forms
methods
same
Prior art date
Application number
PCT/US2006/049511
Other languages
French (fr)
Other versions
WO2007079195A2 (en
Inventor
Bret Berner
Sui Yuen Eddie Hou
Theophilus J Gana
Marilou S Cramer
Original Assignee
Depomed Inc
Bret Berner
Sui Yuen Eddie Hou
Theophilus J Gana
Marilou S Cramer
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
Priority claimed from US11/322,448 external-priority patent/US20060159743A1/en
Application filed by Depomed Inc, Bret Berner, Sui Yuen Eddie Hou, Theophilus J Gana, Marilou S Cramer filed Critical Depomed Inc
Priority to EP06848292A priority Critical patent/EP1976503A2/en
Priority to CA002635466A priority patent/CA2635466A1/en
Priority to AU2006332690A priority patent/AU2006332690A1/en
Priority to JP2008548754A priority patent/JP2009522294A/en
Publication of WO2007079195A2 publication Critical patent/WO2007079195A2/en
Publication of WO2007079195A3 publication Critical patent/WO2007079195A3/en

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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • 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
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61P25/04—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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A61P5/12—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH for decreasing, blocking or antagonising the activity of the posterior pituitary hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Rheumatology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Endocrinology (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Provided is a method of treating a patient suffering from a pain state by administering to the patient a gastric retentive dosage form of gabapentin that is capable of administration in once-daily or twice daily dosing regimens. By reducing the need to administer gabapentin from the thrice-daily administrations characteristic of immediate release gabapentin, the gastric rententive gabapentin dosage forms provided herein have the advantages of improving patient compliance for gabapentin treatment. In addition to the foregoing, the gastric rententive gabapentin dosages forms also exhibit decreased blood plasma concentrations and increased bioavailability throughout the dosing regimen.
PCT/US2006/049511 2005-12-29 2006-12-29 Gastric retentive gabapentin dosage forms and methods for using same WO2007079195A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP06848292A EP1976503A2 (en) 2005-12-29 2006-12-29 Gastric retentive gabapentin dosage forms and methods for using same
CA002635466A CA2635466A1 (en) 2005-12-29 2006-12-29 Gastric retentive gabapentin dosage forms and methods for using same
AU2006332690A AU2006332690A1 (en) 2005-12-29 2006-12-29 Gastric retentive gabapentin dosage forms and methods for using same
JP2008548754A JP2009522294A (en) 2005-12-29 2006-12-29 Gastric retention type gabapentin dosage form and method of use thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/322,448 2005-12-29
US11/322,448 US20060159743A1 (en) 2001-10-25 2005-12-29 Methods of treating non-nociceptive pain states with gastric retentive gabapentin
US85253406P 2006-10-17 2006-10-17
US60/852,534 2006-10-17

Publications (2)

Publication Number Publication Date
WO2007079195A2 WO2007079195A2 (en) 2007-07-12
WO2007079195A3 true WO2007079195A3 (en) 2007-08-30

Family

ID=38157949

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/049511 WO2007079195A2 (en) 2005-12-29 2006-12-29 Gastric retentive gabapentin dosage forms and methods for using same

Country Status (6)

Country Link
EP (1) EP1976503A2 (en)
JP (1) JP2009522294A (en)
AU (1) AU2006332690A1 (en)
CA (1) CA2635466A1 (en)
TW (1) TW200800155A (en)
WO (1) WO2007079195A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9238616B2 (en) 2001-06-11 2016-01-19 Xenoport, Inc. Prodrugs of gaba analogs, compositions and uses thereof

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2010005680A (en) * 2007-11-23 2010-12-21 Protect Pharmaceutical Corp Tapentadol compositions.
CA2706575C (en) * 2008-01-25 2015-07-14 Xenoport, Inc. Enantiomerically resolving acyloxyalkyl thiocarbonates used in synthesizing acyloxyalkyl carbamate prodrugs
WO2009102734A1 (en) * 2008-02-11 2009-08-20 Depomed Inc. Methods for treating vasomotor symptoms using gaba analogs in a gastric retentive dosage form
US20100190752A1 (en) 2008-09-05 2010-07-29 Gruenenthal Gmbh Pharmaceutical Combination
EP2575798B1 (en) * 2010-06-01 2017-08-09 Rubicon Research Private Limited Gastroretentive dosage forms of gaba analogs
AU2011276170B2 (en) * 2010-07-06 2016-03-10 Grunenthal Gmbh Novel gastro- retentive dosage forms comprising a GABA Analog and an opioid
EP2415460A1 (en) * 2010-08-03 2012-02-08 ratiopharm GmbH Formulations of pregabalin for oral administration
CN113577036B (en) * 2021-05-31 2023-04-04 石药集团欧意药业有限公司 Pregabalin gastric floating sustained release tablet and preparation method thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6310098B1 (en) * 1999-07-22 2001-10-30 University Of Rochester Method of treating symptoms of hormonal variation, including hot flashes
US20030031711A1 (en) * 2001-05-29 2003-02-13 Fara John W. Method of treating gastroesophageal reflux disease and nocturnal acid breakthrough
US20030100611A1 (en) * 2001-10-25 2003-05-29 Bret Berner Methods of treatment using a gastric retained gabapentin dosage
US20030104053A1 (en) * 2001-10-25 2003-06-05 Depomed, Inc. Optimal polymer mixtures for gastric retentive tablets
US20050064036A1 (en) * 2001-10-25 2005-03-24 Bret Berner Methods of treatment using a gastric retained gabapentin dosage
US20060159743A1 (en) * 2001-10-25 2006-07-20 Depomed, Inc. Methods of treating non-nociceptive pain states with gastric retentive gabapentin

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6310098B1 (en) * 1999-07-22 2001-10-30 University Of Rochester Method of treating symptoms of hormonal variation, including hot flashes
US20030031711A1 (en) * 2001-05-29 2003-02-13 Fara John W. Method of treating gastroesophageal reflux disease and nocturnal acid breakthrough
US20030100611A1 (en) * 2001-10-25 2003-05-29 Bret Berner Methods of treatment using a gastric retained gabapentin dosage
US20030104053A1 (en) * 2001-10-25 2003-06-05 Depomed, Inc. Optimal polymer mixtures for gastric retentive tablets
US20050064036A1 (en) * 2001-10-25 2005-03-24 Bret Berner Methods of treatment using a gastric retained gabapentin dosage
US20060159743A1 (en) * 2001-10-25 2006-07-20 Depomed, Inc. Methods of treating non-nociceptive pain states with gastric retentive gabapentin

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
BENNETT M I ET AL: "GABAPENTIN IN THE TREATMENT OF NEUROPATHIC PAIN", PALLIATIVE MEDICINE, LONDON, GB, vol. 18, no. 1, January 2004 (2004-01-01), pages 5 - 11, XP009047587, ISSN: 0269-2163 *
RICHTER R W ET AL: "PREGABALIN OR MORPHINE AND GABAPENTIN FOR NEUROPATHIC PAIN", EXPERT OPINION ON PHARMACOTHERAPY, ASHLEY, LONDON,, GB, vol. 6, no. 14, November 2005 (2005-11-01), pages 2535 - 2539, XP009075939, ISSN: 1465-6566 *
See also references of EP1976503A2 *
WESCHE D ET AL: "A pharmacokinetic comparison of pregabalin and gabapentin", JOURNAL OF PAIN, SAUNDERS, PHILADELPHIA, PA, US, vol. 6, no. 3, March 2005 (2005-03-01), pages S29, XP004796228, ISSN: 1526-5900 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9238616B2 (en) 2001-06-11 2016-01-19 Xenoport, Inc. Prodrugs of gaba analogs, compositions and uses thereof

Also Published As

Publication number Publication date
AU2006332690A1 (en) 2007-07-12
EP1976503A2 (en) 2008-10-08
WO2007079195A2 (en) 2007-07-12
JP2009522294A (en) 2009-06-11
TW200800155A (en) 2008-01-01
CA2635466A1 (en) 2007-07-12

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