WO2001047498A3 - Hydrogel-driven layered drug dosage form comprising sertraline - Google Patents

Hydrogel-driven layered drug dosage form comprising sertraline Download PDF

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Publication number
WO2001047498A3
WO2001047498A3 PCT/IB2000/001871 IB0001871W WO0147498A3 WO 2001047498 A3 WO2001047498 A3 WO 2001047498A3 IB 0001871 W IB0001871 W IB 0001871W WO 0147498 A3 WO0147498 A3 WO 0147498A3
Authority
WO
WIPO (PCT)
Prior art keywords
sertraline
dosage form
hour
water
use environment
Prior art date
Application number
PCT/IB2000/001871
Other languages
French (fr)
Other versions
WO2001047498A2 (en
Inventor
William John Curatolo
Michael Bruce Fergione
Michael Christopher Roy
Avinash Govind Thombre
Kenneth Craig Waterman
Leah Elizabeth Appel
Ronald Arthur Beyerinck
Mark Brian Chidlaw
Dwayne Thomas Friesen
Danielle Supplee
Original Assignee
Pfizer Prod Inc
William John Curatolo
Michael Bruce Fergione
Michael Christopher Roy
Avinash Govind Thombre
Kenneth Craig Waterman
Leah Elizabeth Appel
Ronald Arthur Beyerinck
Mark Brian Chidlaw
Dwayne Thomas Friesen
Danielle Supplee
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 Pfizer Prod Inc, William John Curatolo, Michael Bruce Fergione, Michael Christopher Roy, Avinash Govind Thombre, Kenneth Craig Waterman, Leah Elizabeth Appel, Ronald Arthur Beyerinck, Mark Brian Chidlaw, Dwayne Thomas Friesen, Danielle Supplee filed Critical Pfizer Prod Inc
Priority to MXPA02006335A priority Critical patent/MXPA02006335A/en
Priority to AU17243/01A priority patent/AU1724301A/en
Priority to CA002395231A priority patent/CA2395231C/en
Priority to JP2001548093A priority patent/JP2003518487A/en
Priority to EP00979866A priority patent/EP1239839A2/en
Priority to BR0016707-0A priority patent/BR0016707A/en
Publication of WO2001047498A2 publication Critical patent/WO2001047498A2/en
Publication of WO2001047498A3 publication Critical patent/WO2001047498A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt.% per hour from the second to the twentieth hour after introduction to a use environment and less than about 25 wt.% for the first two hours and at least 70 wt.% by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet. In another embodiment, the dosage form releases less than about 25 wt.% of sertraline to the use environment by the second hour after introduction of the dosage form to the use environment, and delivers at least 25 wt.% from the eighth to the twenty-fourth hour.
PCT/IB2000/001871 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form comprising sertraline WO2001047498A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
MXPA02006335A MXPA02006335A (en) 1999-12-23 2000-12-13 Hydrogeldriven layered drug dosage form.
AU17243/01A AU1724301A (en) 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form
CA002395231A CA2395231C (en) 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form
JP2001548093A JP2003518487A (en) 1999-12-23 2000-12-13 Hydrogel-driven laminated drug formulation
EP00979866A EP1239839A2 (en) 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form comprising sertraline
BR0016707-0A BR0016707A (en) 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17210899P 1999-12-23 1999-12-23
US60/172,108 1999-12-23

Publications (2)

Publication Number Publication Date
WO2001047498A2 WO2001047498A2 (en) 2001-07-05
WO2001047498A3 true WO2001047498A3 (en) 2001-11-15

Family

ID=22626396

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2000/001871 WO2001047498A2 (en) 1999-12-23 2000-12-13 Hydrogel-driven layered drug dosage form comprising sertraline

Country Status (15)

Country Link
US (1) US6899896B2 (en)
EP (1) EP1239839A2 (en)
JP (1) JP2003518487A (en)
AR (1) AR027066A1 (en)
AU (1) AU1724301A (en)
BR (1) BR0016707A (en)
CA (1) CA2395231C (en)
CO (1) CO5271728A1 (en)
GT (1) GT200000220A (en)
MX (1) MXPA02006335A (en)
PA (1) PA8508901A1 (en)
PE (1) PE20010983A1 (en)
TN (1) TNSN00251A1 (en)
UY (1) UY26493A1 (en)
WO (1) WO2001047498A2 (en)

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US9060941B2 (en) 2002-09-20 2015-06-23 Actavis, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative

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US20040146559A1 (en) * 2002-09-28 2004-07-29 Sowden Harry S. Dosage forms having an inner core and outer shell with different shapes
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ES2529180T3 (en) * 2002-09-20 2015-02-17 Andrx Labs Llc Multi-stage formulation containing a biguanide and a thiazolidinedione derivative
US7959946B2 (en) 2002-09-20 2011-06-14 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US8084058B2 (en) 2002-09-20 2011-12-27 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US7785627B2 (en) 2002-09-20 2010-08-31 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US20040081695A1 (en) * 2002-09-28 2004-04-29 Sowden Harry S Dosage forms having an inner core and an outer shell
RU2310647C2 (en) * 2002-11-07 2007-11-20 Торрент Фармасьютикалз Лтд Method for preparing sertraline hydrochloride polymorphous formulation
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WO2005117911A2 (en) * 2004-05-06 2005-12-15 Cydex, Inc. Taste-masked formulations containing sertraline and sulfoalkyl ether cyclodextrin
WO2006072878A1 (en) * 2005-01-07 2006-07-13 Ranbaxy Laboratories Limited Oral dosage forms of sertraline having controlled particle size and processes for their preparation
US20060233882A1 (en) * 2005-04-15 2006-10-19 Sowden Harry S Osmotic dosage form
US20060239956A1 (en) * 2005-04-26 2006-10-26 Lulu Henson Preparation and use of hydrogels
CN101299993A (en) * 2005-11-04 2008-11-05 伊士曼化工公司 Carboxyalkylcellulose esters for administration of poorly soluble pharmaceutically active agents
WO2007057762A2 (en) * 2005-11-16 2007-05-24 Pfizer Limited Osmotic bi-layer tablet
CN100563637C (en) * 2006-10-13 2009-12-02 北京红林制药有限公司 A kind of medicated core compositions of controlled release drug administration and controlled release preparation and preparation method thereof
ECSP077628A (en) * 2007-05-03 2008-12-30 Smithkline Beechman Corp NEW PHARMACEUTICAL COMPOSITION
AU2010325894B2 (en) * 2009-12-04 2015-07-30 Sunovion Pharmaceuticals Inc. Formulations, salts and polymorphs of transnorsertraline and uses thereof
US10485770B2 (en) 2009-12-21 2019-11-26 Aptapharma, Inc. Functionally-coated multilayer tablets
WO2016020936A2 (en) * 2014-07-21 2016-02-11 Patel Jayendrakumar Dasharathlal A novel oral gastroretentive pharmaceutical dosage form
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Also Published As

Publication number Publication date
AU1724301A (en) 2001-07-09
CA2395231C (en) 2006-08-15
JP2003518487A (en) 2003-06-10
AR027066A1 (en) 2003-03-12
WO2001047498A2 (en) 2001-07-05
US6899896B2 (en) 2005-05-31
MXPA02006335A (en) 2002-12-13
PE20010983A1 (en) 2001-10-01
UY26493A1 (en) 2001-07-31
BR0016707A (en) 2002-09-03
GT200000220A (en) 2002-06-14
CO5271728A1 (en) 2003-04-30
PA8508901A1 (en) 2003-12-10
TNSN00251A1 (en) 2002-05-30
EP1239839A2 (en) 2002-09-18
US20010044474A1 (en) 2001-11-22
CA2395231A1 (en) 2001-07-05

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