WO1998014168A3 - Dosage form providing a sustained and ascending drug release - Google Patents

Dosage form providing a sustained and ascending drug release

Info

Publication number
WO1998014168A3
WO1998014168A3 PCT/US1997/016599 US9716599W WO9814168A3 WO 1998014168 A3 WO1998014168 A3 WO 1998014168A3 US 9716599 W US9716599 W US 9716599W WO 9814168 A3 WO9814168 A3 WO 9814168A3
Authority
WO
WIPO (PCT)
Prior art keywords
sustained
dosage form
drug release
form providing
ascending drug
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/US1997/016599
Other languages
French (fr)
Other versions
WO1998014168A2 (en
Inventor
Suneel K Gupta
Diane R Guinta
Carol A Christopher
Samuel R Saks
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.)
Alza Corp
Original Assignee
Alza Corp
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=27363329&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1998014168(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alza Corp filed Critical Alza Corp
Priority to AU48014/97A priority Critical patent/AU4801497A/en
Priority to DK97910713.3T priority patent/DK0932388T5/en
Priority to DE69735581T priority patent/DE69735581T2/en
Priority to JP51658798A priority patent/JP4714313B2/en
Priority to EP97910713A priority patent/EP0932388B1/en
Priority to CA002264852A priority patent/CA2264852C/en
Publication of WO1998014168A2 publication Critical patent/WO1998014168A2/en
Publication of WO1998014168A3 publication Critical patent/WO1998014168A3/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer 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
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

Landscapes

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

Abstract

A dosage form and a method are disclosed and claimed for administering a drug in a sustained and constantly ascending rate per unit time to provide an intended therapeutic effect while concomitantly lessening the development of unwanted effects.
PCT/US1997/016599 1996-09-30 1997-09-16 Dosage form providing a sustained and ascending drug release Ceased WO1998014168A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AU48014/97A AU4801497A (en) 1996-09-30 1997-09-16 Dosage form and method for administering drug
DK97910713.3T DK0932388T5 (en) 1996-09-30 1997-09-16 Dosage form and method of administration of drugs
DE69735581T DE69735581T2 (en) 1996-09-30 1997-09-16 DOSAGE FOR A DELAYED AND INCREASING INGREDIENTS
JP51658798A JP4714313B2 (en) 1996-09-30 1997-09-16 Dosage form and method of drug administration
EP97910713A EP0932388B1 (en) 1996-09-30 1997-09-16 Dosage form and method for administering drug
CA002264852A CA2264852C (en) 1996-09-30 1997-09-16 Use of methylphenidate or a pharmaceutically acceptable salt thereof

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US2872696P 1996-09-30 1996-09-30
US60/028,726 1996-09-30
US3051496P 1996-11-12 1996-11-12
US60/030,514 1996-11-12
US4412197P 1997-04-22 1997-04-22
US60/044,121 1997-04-22

Publications (2)

Publication Number Publication Date
WO1998014168A2 WO1998014168A2 (en) 1998-04-09
WO1998014168A3 true WO1998014168A3 (en) 1998-07-30

Family

ID=27363329

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/016599 Ceased WO1998014168A2 (en) 1996-09-30 1997-09-16 Dosage form providing a sustained and ascending drug release

Country Status (11)

Country Link
EP (1) EP0932388B1 (en)
JP (3) JP4714313B2 (en)
CN (1) CN1231603A (en)
AT (1) ATE321529T1 (en)
AU (1) AU4801497A (en)
CA (1) CA2264852C (en)
DE (1) DE69735581T2 (en)
DK (1) DK0932388T5 (en)
ES (1) ES2262174T3 (en)
PT (1) PT932388E (en)
WO (1) WO1998014168A2 (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6919373B1 (en) 1996-11-12 2005-07-19 Alza Corporation Methods and devices for providing prolonged drug therapy
US7431944B2 (en) 1995-12-04 2008-10-07 Celgene Corporation Delivery of multiple doses of medications
US8951555B1 (en) 2000-10-30 2015-02-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8975273B2 (en) 1999-10-29 2015-03-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9180100B2 (en) 2012-08-15 2015-11-10 Tris Pharma, Inc. Methylphenidate extended release chewable tablet
US9283214B2 (en) 2011-03-23 2016-03-15 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9393192B2 (en) 2002-07-29 2016-07-19 Alza Corporation Methods and dosage forms for controlled delivery of paliperidone and risperidone
US9498447B2 (en) 2011-03-23 2016-11-22 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9511032B2 (en) 2011-03-23 2016-12-06 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder

Families Citing this family (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6440457B1 (en) 1993-05-27 2002-08-27 Alza Corporation Method of administering antidepressant dosage form
PT932388E (en) * 1996-09-30 2006-07-31 Alza Corp DOSAGE AND METHOD FOR ADMINISTRATION OF DRUGS
US6962997B1 (en) 1997-05-22 2005-11-08 Celgene Corporation Process and intermediates for resolving piperidyl acetamide steroisomers
KR100827254B1 (en) 1998-06-03 2008-05-07 알자 코포레이션 Methods and apparatus for providing prolonged drug treatment
CN1209098C (en) * 1998-06-03 2005-07-06 阿尔扎有限公司 Methods and devices for providing prolonged drug therapy
AU2012232984B2 (en) * 1998-06-03 2015-10-29 Alza Corporation Methods and devices for providing prolonged drug therapy
AU2004200938B2 (en) * 1998-06-03 2006-09-14 Alza Corporation Methods and devices for providing prolonged drug therapy
US6322819B1 (en) 1998-10-21 2001-11-27 Shire Laboratories, Inc. Oral pulsed dose drug delivery system
IL142896A0 (en) 1998-11-02 2002-04-21 Elan Corp Plc Multiparticulate modified release composition
US7083808B2 (en) 1998-12-17 2006-08-01 Euro-Celtique S.A. Controlled/modified release oral methylphenidate formulations
US6673367B1 (en) * 1998-12-17 2004-01-06 Euro-Celtique, S.A. Controlled/modified release oral methylphenidate formulations
US6419960B1 (en) 1998-12-17 2002-07-16 Euro-Celtique S.A. Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
WO2003037244A2 (en) * 2001-10-29 2003-05-08 Therics, Inc. System for manufacturing controlled release dosage forms, such as a zero-order release profile dosage form manufactured by three-dimensional printing
JP2010229140A (en) * 2002-02-22 2010-10-14 Shire Llc Active agent delivery system and method for protecting and administering active agent
US7988993B2 (en) 2002-12-09 2011-08-02 Andrx Pharmaceuticals, Inc. Oral controlled release dosage form
JP2008509144A (en) * 2004-08-04 2008-03-27 アルザ・コーポレーシヨン Sustained drug release composition exhibiting a rising zero-order release pattern, and a method for making such a composition
DK1791530T3 (en) 2004-08-23 2008-10-27 Pejo Iserlohn Heilmittel Und D Pharmaceutical composition containing a psychostimulant
US8541026B2 (en) 2004-09-24 2013-09-24 Abbvie Inc. Sustained release formulations of opioid and nonopioid analgesics
ATE536867T1 (en) 2006-03-16 2011-12-15 Tris Pharma Inc MODIFIED RELEASE FORMULATIONS WITH DRUG ION EXCHANGE RESIN COMPLEXES
US8846100B2 (en) 2006-05-12 2014-09-30 Shire Llc Controlled dose drug delivery system
EP1920768A1 (en) * 2006-11-10 2008-05-14 Abbott GmbH & Co. KG Solid dosage form with a film containing an active substance, as well as its method of production
JP2011511782A (en) 2008-02-12 2011-04-14 アボット・ラボラトリーズ Extended release hydrocodone acetaminophen and related methods and uses
US8927010B2 (en) 2011-03-23 2015-01-06 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
WO2012129551A1 (en) 2011-03-23 2012-09-27 Ironshore Pharmaceuticals & Development, Inc. Methods and compositions for treatment of attention deficit disorder
US10292937B2 (en) 2011-03-23 2019-05-21 Ironshore Pharmaceuticals & Development, Inc. Methods of treatment of attention deficit hyperactivity disorder
US8916588B2 (en) 2011-03-23 2014-12-23 Ironshore Pharmaceuticals & Development, Inc. Methods for treatment of attention deficit hyperactivity disorder
US11241391B2 (en) 2011-03-23 2022-02-08 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9603809B2 (en) 2011-03-23 2017-03-28 Ironshore Pharmaceuticals & Development, Inc. Methods of treatment of attention deficit hyperactivity disorder
US10905652B2 (en) 2011-03-23 2021-02-02 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
BR112015020261A2 (en) 2013-03-29 2017-07-18 Wockhardt Ltd pharmaceutical compositions of dexmethylphenidate or modified release salts thereof
DE102013014417A1 (en) 2013-08-29 2015-03-05 Klinipharm Gmbh Sponge collagen comprehensive preparations with defined in vivo release profile especially in the colon, their production and use
WO2015188092A1 (en) * 2014-06-06 2015-12-10 Rhodes Pharmaceuticals, L.P. Methods for treating attention deficit hyperactivity disorder with methylphenidate
CA3018328A1 (en) 2014-10-31 2016-04-30 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
US11590228B1 (en) 2015-09-08 2023-02-28 Tris Pharma, Inc Extended release amphetamine compositions
US11590081B1 (en) 2017-09-24 2023-02-28 Tris Pharma, Inc Extended release amphetamine tablets
US12458592B1 (en) 2017-09-24 2025-11-04 Tris Pharma, Inc. Extended release amphetamine tablets
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2738303A (en) * 1952-07-18 1956-03-13 Smith Kline French Lab Sympathomimetic preparation
BE675379A (en) * 1965-01-26 1966-05-31
EP0094123A2 (en) * 1982-05-06 1983-11-16 THE PROCTER & GAMBLE COMPANY Therapeutic granules
EP0212747A2 (en) * 1985-08-16 1987-03-04 The Procter & Gamble Company Drug particles having constant release and immediate release
EP0216743A2 (en) * 1985-09-18 1987-04-01 "PHARLYSE", Société Anonyme Galenical forms of verapamil, preparation thereof and medicaments containing them
EP0348808A2 (en) * 1988-06-30 1990-01-03 Klinge Pharma GmbH Pharmaceutical formulations and process for preparing them
FR2635460A1 (en) * 1988-08-16 1990-02-23 Ss Pharmaceutical Co PREPARATION OF LONG-TERM ACTION DICLOFENAC SODIUM
EP0381219A2 (en) * 1989-02-02 1990-08-08 Warner-Lambert Company Modified release gemfibrozil composition
WO1993005769A1 (en) * 1991-09-17 1993-04-01 Martti Lauri Antero Marvola Controlled release pharmaceutical preparations
WO1998006380A2 (en) * 1996-08-16 1998-02-19 Alza Corporation Dosage form for providing ascending dose of drug

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3625214A (en) * 1970-05-18 1971-12-07 Alza Corp Drug-delivery device
DE2336218C3 (en) * 1973-07-17 1985-11-14 Byk Gulden Lomberg Chemische Fabrik Gmbh, 7750 Konstanz Oral dosage form
US4304591A (en) * 1978-01-25 1981-12-08 Ciba-Geigy Corporation Water-insoluble hydrophilic copolymers used as carriers for medicaments and pesticides
EP0664118B1 (en) * 1991-10-04 1999-08-25 Yoshitomi Pharmaceutical Industries, Ltd. Sustained-release tablet
PT932388E (en) * 1996-09-30 2006-07-31 Alza Corp DOSAGE AND METHOD FOR ADMINISTRATION OF DRUGS

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2738303A (en) * 1952-07-18 1956-03-13 Smith Kline French Lab Sympathomimetic preparation
BE675379A (en) * 1965-01-26 1966-05-31
EP0094123A2 (en) * 1982-05-06 1983-11-16 THE PROCTER & GAMBLE COMPANY Therapeutic granules
EP0212747A2 (en) * 1985-08-16 1987-03-04 The Procter & Gamble Company Drug particles having constant release and immediate release
EP0216743A2 (en) * 1985-09-18 1987-04-01 "PHARLYSE", Société Anonyme Galenical forms of verapamil, preparation thereof and medicaments containing them
EP0348808A2 (en) * 1988-06-30 1990-01-03 Klinge Pharma GmbH Pharmaceutical formulations and process for preparing them
FR2635460A1 (en) * 1988-08-16 1990-02-23 Ss Pharmaceutical Co PREPARATION OF LONG-TERM ACTION DICLOFENAC SODIUM
EP0381219A2 (en) * 1989-02-02 1990-08-08 Warner-Lambert Company Modified release gemfibrozil composition
WO1993005769A1 (en) * 1991-09-17 1993-04-01 Martti Lauri Antero Marvola Controlled release pharmaceutical preparations
WO1998006380A2 (en) * 1996-08-16 1998-02-19 Alza Corporation Dosage form for providing ascending dose of drug

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7431944B2 (en) 1995-12-04 2008-10-07 Celgene Corporation Delivery of multiple doses of medications
US6919373B1 (en) 1996-11-12 2005-07-19 Alza Corporation Methods and devices for providing prolonged drug therapy
US6930129B2 (en) 1996-11-12 2005-08-16 Alza Corporation Methods and devices for providing prolonged drug therapy
US9029416B2 (en) 1996-11-12 2015-05-12 Alza Corporation Methods and devices for providing prolonged drug therapy
US9144549B2 (en) 1996-11-12 2015-09-29 Alza Corporation Methods and devices for providing prolonged drug therapy
US9320717B2 (en) 1999-10-29 2016-04-26 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8975273B2 (en) 1999-10-29 2015-03-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8980291B2 (en) 1999-10-29 2015-03-17 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9278074B2 (en) 1999-10-29 2016-03-08 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9056107B1 (en) 1999-10-29 2015-06-16 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9205055B2 (en) 2000-10-30 2015-12-08 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8951555B1 (en) 2000-10-30 2015-02-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9572805B2 (en) 2000-10-30 2017-02-21 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9205056B2 (en) 2000-10-30 2015-12-08 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9023401B1 (en) 2000-10-30 2015-05-05 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9572804B2 (en) 2000-10-30 2017-02-21 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9289391B2 (en) 2000-10-30 2016-03-22 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9198863B2 (en) 2000-10-30 2015-12-01 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9526724B2 (en) 2000-10-30 2016-12-27 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9517236B2 (en) 2000-10-30 2016-12-13 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9504681B2 (en) 2000-10-30 2016-11-29 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9393192B2 (en) 2002-07-29 2016-07-19 Alza Corporation Methods and dosage forms for controlled delivery of paliperidone and risperidone
US9511032B2 (en) 2011-03-23 2016-12-06 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9498447B2 (en) 2011-03-23 2016-11-22 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9283214B2 (en) 2011-03-23 2016-03-15 Ironshore Pharmaceuticals & Development, Inc. Compositions for treatment of attention deficit hyperactivity disorder
US9180100B2 (en) 2012-08-15 2015-11-10 Tris Pharma, Inc. Methylphenidate extended release chewable tablet

Also Published As

Publication number Publication date
PT932388E (en) 2006-07-31
WO1998014168A2 (en) 1998-04-09
CN1231603A (en) 1999-10-13
JP2010195822A (en) 2010-09-09
DK0932388T3 (en) 2006-07-17
JP2014028854A (en) 2014-02-13
JP5697893B2 (en) 2015-04-08
JP4714313B2 (en) 2011-06-29
DE69735581D1 (en) 2006-05-18
CA2264852A1 (en) 1998-04-09
ATE321529T1 (en) 2006-04-15
EP0932388A2 (en) 1999-08-04
CA2264852C (en) 2005-11-01
AU4801497A (en) 1998-04-24
JP2001501223A (en) 2001-01-30
DE69735581T2 (en) 2007-01-25
HK1127997A1 (en) 2009-10-16
DK0932388T5 (en) 2011-06-27
EP0932388B1 (en) 2006-03-29
ES2262174T3 (en) 2006-11-16

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