WO2001028516A3 - Sustained-release formulations for treating cns-mediated disorders - Google Patents

Sustained-release formulations for treating cns-mediated disorders Download PDF

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Publication number
WO2001028516A3
WO2001028516A3 PCT/US2000/041267 US0041267W WO0128516A3 WO 2001028516 A3 WO2001028516 A3 WO 2001028516A3 US 0041267 W US0041267 W US 0041267W WO 0128516 A3 WO0128516 A3 WO 0128516A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
release formulations
mediated disorders
treating cns
compositions
Prior art date
Application number
PCT/US2000/041267
Other languages
French (fr)
Other versions
WO2001028516A2 (en
Inventor
David S Wells
Thomas B Marriott
Lian G Rajewski
James D Pipkin
John L Haslam
Original Assignee
Nps Pharma Inc
David S Wells
Thomas B Marriott
Lian G Rajewski
James D Pipkin
John L Haslam
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 Nps Pharma Inc, David S Wells, Thomas B Marriott, Lian G Rajewski, James D Pipkin, John L Haslam filed Critical Nps Pharma Inc
Priority to EP00982701A priority Critical patent/EP1225888A2/en
Priority to JP2001531111A priority patent/JP2003512311A/en
Priority to MXPA02003976A priority patent/MXPA02003976A/en
Priority to AU19695/01A priority patent/AU780505B2/en
Priority to CA002387819A priority patent/CA2387819A1/en
Publication of WO2001028516A2 publication Critical patent/WO2001028516A2/en
Publication of WO2001028516A3 publication Critical patent/WO2001028516A3/en
Priority to AU2005202728A priority patent/AU2005202728A1/en

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    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • 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
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/255—Esters, e.g. nitroglycerine, selenocyanates of sulfoxy acids or sulfur analogues thereof
    • 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
    • A61K9/48—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61P25/18—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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin

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)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Reproductive Health (AREA)
  • Anesthesiology (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Sustained-release compositions for delivering therapeutic concentrations of isovaleramide, isovaleric acid, and certain structurally related compounds are provided for the treatment for a variety of pathological conditions, including epilepsy and spasticity, which are ameliorated by effecting a modulation of CNS activity. The ability of the compositions to sustain relatively constant levels of the drug at a therapeutic dose in the serum for extended periods of time enables a once or twice daily administration schedule.
PCT/US2000/041267 1999-10-19 2000-10-19 Sustained-release formulations for treating cns-mediated disorders WO2001028516A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP00982701A EP1225888A2 (en) 1999-10-19 2000-10-19 Sustained-release formulations for treating cns-mediated disorders
JP2001531111A JP2003512311A (en) 1999-10-19 2000-10-19 Sustained release formulations for treating CNS mediated disorders
MXPA02003976A MXPA02003976A (en) 1999-10-19 2000-10-19 Sustained-release formulations for treating cns-mediated disorders.
AU19695/01A AU780505B2 (en) 1999-10-19 2000-10-19 Sustained-release formulations for treating CNS-mediated disorders
CA002387819A CA2387819A1 (en) 1999-10-19 2000-10-19 Sustained-release formulations for treating cns-mediated disorders
AU2005202728A AU2005202728A1 (en) 1999-10-19 2005-06-22 Sustained-release formulations for treating CNS-mediated disorders

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16021099P 1999-10-19 1999-10-19
US60/160,210 1999-10-19

Publications (2)

Publication Number Publication Date
WO2001028516A2 WO2001028516A2 (en) 2001-04-26
WO2001028516A3 true WO2001028516A3 (en) 2002-02-21

Family

ID=22575965

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/041267 WO2001028516A2 (en) 1999-10-19 2000-10-19 Sustained-release formulations for treating cns-mediated disorders

Country Status (8)

Country Link
EP (1) EP1225888A2 (en)
JP (1) JP2003512311A (en)
CN (1) CN1409630A (en)
AU (1) AU780505B2 (en)
CA (1) CA2387819A1 (en)
MX (1) MXPA02003976A (en)
TW (1) TWI252761B (en)
WO (1) WO2001028516A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6589994B1 (en) 1996-08-30 2003-07-08 Nps Pharmaceuticals, Inc. Treating a variety of pathological conditions, including spasticity and convulsions, by effecting a modulation of CNS activity with isovaleramide, isovaleric acid, or a related compound
PA8578501A1 (en) 2002-07-25 2005-02-04 Pharmacia Corp DOSAGE FORM ONCE A DAY OF PRAMIPEXOL
US20060025477A1 (en) * 2004-07-22 2006-02-02 Artman Linda D Analogs of isovaleramide, a pharmaceutical composition including the same, and a method of treating central nervous system conditions or diseases
CA2576386A1 (en) 2004-08-13 2006-02-16 Boehringer Ingelheim International Gmbh Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof
BRPI0513846A (en) * 2004-08-13 2008-05-20 Boehringer Ingelheim Int prolonged-release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method of manufacture thereof and use thereof
US20070134315A1 (en) * 2005-12-08 2007-06-14 Viera Michael L Orally administrable extended release pellet and tablet formulations of a highly water soluble compound

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998008498A1 (en) * 1996-08-30 1998-03-05 Nps Pharmaceuticals, Inc. Treatment of spasticity, convulsions by isovaleric acid derivatives cns depressants

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998008498A1 (en) * 1996-08-30 1998-03-05 Nps Pharmaceuticals, Inc. Treatment of spasticity, convulsions by isovaleric acid derivatives cns depressants

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, vol. 83, no. 14, 6 October 1975, Columbus, Ohio, US; abstract no. 120779, GROSHOVYI, T. A. ET AL: "Development of an optimum intestine soluble film-forming composition fro cellulose acetate phthalate for tablet coating in a fluidized bed" XP002169901 *
FARM. ZH. (KIEV) (1975), 30(2), 47-51 *

Also Published As

Publication number Publication date
EP1225888A2 (en) 2002-07-31
CA2387819A1 (en) 2001-04-26
AU780505B2 (en) 2005-03-24
JP2003512311A (en) 2003-04-02
TWI252761B (en) 2006-04-11
AU1969501A (en) 2001-04-30
MXPA02003976A (en) 2003-09-25
CN1409630A (en) 2003-04-09
WO2001028516A2 (en) 2001-04-26

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