WO2003103637A3 - MODIFIED RELEASE MULTIPLE UNIT DRUG DELIVERY SYSTEMS - Google Patents

MODIFIED RELEASE MULTIPLE UNIT DRUG DELIVERY SYSTEMS Download PDF

Info

Publication number
WO2003103637A3
WO2003103637A3 PCT/IB2003/002186 IB0302186W WO03103637A3 WO 2003103637 A3 WO2003103637 A3 WO 2003103637A3 IB 0302186 W IB0302186 W IB 0302186W WO 03103637 A3 WO03103637 A3 WO 03103637A3
Authority
WO
WIPO (PCT)
Prior art keywords
systems
unit
release
active pharmaceutical
pharmaceutical ingredients
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/IB2003/002186
Other languages
French (fr)
Other versions
WO2003103637A2 (en
Inventor
Pratik Kumar
Girish Kumar Jain
Ashok Rampal
Ravikumar Nithiyanandam
Sankar Ramakrishnan
Rajeev Singh Raghuvanshi
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.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
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 Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Priority to BR0312445-2A priority Critical patent/BR0312445A/en
Priority to EP03735864A priority patent/EP1545473A2/en
Priority to US10/517,101 priority patent/US20060257482A1/en
Priority to AU2003236947A priority patent/AU2003236947A1/en
Publication of WO2003103637A2 publication Critical patent/WO2003103637A2/en
Publication of WO2003103637A3 publication Critical patent/WO2003103637A3/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
    • A61K9/50—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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne de nouveaux systèmes à unités multiples et à libération modifiée, ainsi que des procédés de préparation de ces systèmes. Lesdits systèmes peuvent être facilement conditionnés sous forme de comprimés, ou en capsules ou sachets, sans que les caractéristiques de libération désirées des ingrédients actifs pharmaceutiques incorporés dans ces systèmes en soient affectées. Le comprimé à unités multiples comprend plusieurs unités. Chaque unité contient au moins un noyau possédant une surface extérieure, une première couche de revêtement entourant au moins une partie de la surface extérieure du noyau et possédant une surface extérieure, un ou plusieurs polymères de contrôle du taux de libération, ainsi qu'un ou plusieurs ingrédients pharmaceutiques actifs. La couche de revêtement contient ce ou ces ingrédients pharmaceutiques actifs et/ou ce ou ces polymères de contrôle du taux de libération. Ledit comprimé peut comporter également une couche extérieure appliquée sur la surface extérieure de l'unité, cette couche extérieure contenant une matière élastique et/ou compressible pouvant être une matière de type cire, telle que des polyéthylèneglycols (PEG).The present invention relates to novel multi-unit, modified-release systems, and methods of preparing these systems. Said systems can be easily packaged in the form of tablets, or in capsules or sachets, without the desired release characteristics of the active pharmaceutical ingredients incorporated in these systems being affected. The multi-unit tablet comprises several units. Each unit contains at least one core having an outer surface, a first coating layer surrounding at least a portion of the outer surface of the core and having an outer surface, one or more polymers for controlling the rate of release, as well as one or more several active pharmaceutical ingredients. The coating layer contains this or these active pharmaceutical ingredients and / or this or these release rate control polymers. Said tablet may also include an outer layer applied to the outer surface of the unit, this outer layer containing an elastic and / or compressible material which may be a wax type material, such as polyethylene glycols (PEG).

PCT/IB2003/002186 2002-01-10 2003-06-09 Modified release, multiple unit drug delivery systems Ceased WO2003103637A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
BR0312445-2A BR0312445A (en) 2002-06-07 2003-06-09 Multi-unit systems for delivery of modified-release drug
EP03735864A EP1545473A2 (en) 2002-06-07 2003-06-09 Modified release, multiple unit drug delivery systems
US10/517,101 US20060257482A1 (en) 2002-06-07 2003-06-09 Modified release, multiple unit drug delivery systems
AU2003236947A AU2003236947A1 (en) 2002-06-07 2003-06-09 Modified release, multiple unit drug delivery systems

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
IN1157/DEL/2002 2002-01-10
IN617/DEL/2002 2002-06-07
IN617DE2002 2002-06-07
IN1157DE2002 2002-11-15
IN234/DEL/2003 2003-03-06
IN234DE2003 2003-03-06

Publications (2)

Publication Number Publication Date
WO2003103637A2 WO2003103637A2 (en) 2003-12-18
WO2003103637A3 true WO2003103637A3 (en) 2004-05-13

Family

ID=29740489

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/002186 Ceased WO2003103637A2 (en) 2002-01-10 2003-06-09 Modified release, multiple unit drug delivery systems

Country Status (5)

Country Link
US (1) US20060257482A1 (en)
CN (1) CN1674877A (en)
AU (1) AU2003236947A1 (en)
BR (1) BR0312445A (en)
WO (1) WO2003103637A2 (en)

Families Citing this family (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0957073A1 (en) 1998-05-12 1999-11-17 Schwarz Pharma Ag Novel derivatives of 3,3-diphenylpropylamines
GB0203296D0 (en) 2002-02-12 2002-03-27 Glaxo Group Ltd Novel composition
US8637512B2 (en) 2002-07-29 2014-01-28 Glaxo Group Limited Formulations and method of treatment
CA2507685A1 (en) * 2002-11-28 2004-06-10 Themis Laboratories Private Limited Process for manufacturing sustained release microbeads containing venlafaxine hci
WO2004056336A2 (en) * 2002-12-20 2004-07-08 Ranbaxy Laboratories Limited Controlled release, multiple unit drug delivery systems
DE10315917A1 (en) * 2003-04-08 2004-11-18 Schwarz Pharma Ag Highly pure bases of 3,3-diphenylpropylamine monoesters
WO2005013939A1 (en) 2003-08-06 2005-02-17 Nirmal Mulye Pharmaceutical composition containing water soluble drug
FR2861990B1 (en) * 2003-11-10 2006-02-10 Nouveaux Produits Pharma LOW DOSAGE TABLETS WITH POLYMER NETWORK
DK1711169T3 (en) * 2004-02-04 2007-09-17 Alembic Ltd Coated microdeposition tablets with venlafaxine hydrochloride
DE102004036641A1 (en) * 2004-07-28 2006-03-23 Krka Tovarna Zdravil, D.D. Delayed release pharmaceutical composition containing venlafaxine
US8778395B2 (en) * 2005-08-11 2014-07-15 Andrx Labs, Llc Diltiazem controlled release formulation and method of manufacture
US8158146B2 (en) 2005-09-28 2012-04-17 Teva Pharmaceutical Industries Ltd. Stable combinations of amlodipine besylate and benazepril hydrochloride
KR100831771B1 (en) * 2005-10-27 2008-05-27 주식회사종근당 Pharmaceutical composition having pH-dependant immediate release and extended release
US20090130206A1 (en) * 2006-05-09 2009-05-21 Umesh Nandkumar Khatavkar Controlled Release Compositions of an Antidepressant Agent
WO2008023869A1 (en) * 2006-08-24 2008-02-28 Hanall Pharmaceutical Co., Ltd. Combined pharmeceutical formulation with controlled-release comprising dihydropyridine calcium channel blockers and hmg-coa reductase inhibitors
KR20090045945A (en) * 2006-08-25 2009-05-08 베링거 인겔하임 인터내셔날 게엠베하 Controlled Release System and Manufacturing Method Thereof
EP1923053A1 (en) 2006-09-27 2008-05-21 Novartis AG Pharmaceutical compositions comprising nilotinib or its salt
KR100812538B1 (en) * 2006-10-23 2008-03-11 한올제약주식회사 Drug-controlled metformin-glymepiride combination
GB0624084D0 (en) * 2006-12-01 2007-01-10 Selamine Ltd Ramipril amino acid salts
GB0624087D0 (en) * 2006-12-01 2007-01-10 Selamine Ltd Ramipril combination salt
EP1970056A1 (en) * 2007-03-15 2008-09-17 Polichem S.A. Time-specific delayed/pulsatile release dosage forms
PL2187876T3 (en) 2007-09-21 2013-01-31 Evonik Roehm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
EP2044929A1 (en) * 2007-10-04 2009-04-08 Laboratorios del Dr. Esteve S.A. Oral fast distintegrating tablets
EP2044932A1 (en) * 2007-10-04 2009-04-08 Laboratorios del Dr. Esteve S.A. Mechanical protective layer for solid dosage forms
US9011904B2 (en) 2009-07-06 2015-04-21 Aptapharma, Inc. Self-breaking tablets
CN102188386B (en) * 2010-03-02 2013-09-04 海南葫芦娃制药有限公司 Nimesulide sustained-release pellets and preparation method thereof
GB201003731D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Immediate/delayed drug delivery
GB201003766D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Pulsatile drug release
GB201003734D0 (en) 2010-03-05 2010-04-21 Univ Strathclyde Delayed prolonged drug delivery
JP5860480B2 (en) 2011-01-11 2016-02-16 キャプシュゲル・ベルジウム・エヌ・ヴィ New hard capsule containing pullulan
KR101378973B1 (en) * 2012-04-13 2014-03-28 한미약품 주식회사 Hard capsule complex formulations comprising a multi-dose unit tablet of a near-spherical form and method for preparing the same
EA201590776A1 (en) * 2012-12-19 2015-11-30 Ратиофарм Гмбх PELLETS WITH FILM COATING
CN107412178A (en) * 2016-12-14 2017-12-01 北京满格医药科技有限公司 A kind of paroxetine hydrochloride sustained release tablets and preparation method
CN110678170A (en) 2017-04-14 2020-01-10 比利时胶囊公司 Pullulan Capsules
CA3059529A1 (en) 2017-04-14 2018-10-18 Capsugel Belgium Nv Process for making pullulan
CN107875450A (en) * 2017-11-17 2018-04-06 河北点云生物科技有限公司 A kind of method of 3D printing artificial bone manufacture drying type preparation
WO2020255097A1 (en) * 2019-06-21 2020-12-24 Amruth Gowda Doddaveerappa Method of producing multiunit tablet formulations
CN110403912A (en) * 2019-09-04 2019-11-05 西安科力康医药科技有限公司 Sustained release coating powder
CN112978739B (en) * 2021-03-16 2021-11-26 复旦大学 Synthesis method of uniform symmetrical or asymmetrical nanoparticles, large-size and modified nanoparticles
JP2023127913A (en) * 2022-03-02 2023-09-14 共和薬品工業株式会社 Granules containing venlafaxine hydrochloride
CN114831956B (en) * 2022-05-25 2024-03-22 山东新华制药股份有限公司 Effervescent tablet containing voglibose and preparation method thereof
CN116473935B (en) * 2023-04-25 2025-02-21 南京易亨制药有限公司 Glipizide controlled-release tablet

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4713248A (en) * 1984-02-10 1987-12-15 A/S Alfred Benzon Diffusion coated multiple-units dosage form
US5783215A (en) * 1994-07-08 1998-07-21 Astra Aktiebolag Pharmaceutical preparation
WO1999012524A1 (en) * 1997-09-11 1999-03-18 Nycomed Danmark A/S MODIFIED RELEASE MULTIPLE-UNITS COMPOSITIONS OF NON-STEROID ANTI-INFLAMMATORY DRUG SUBSTANCES (NSAIDs)
WO2003041692A1 (en) * 2001-11-13 2003-05-22 Karma Pharm Ltd. Extended release compositions comprising as active compound venlafaxine hydrochloride

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6274171B1 (en) * 1996-03-25 2001-08-14 American Home Products Corporation Extended release formulation of venlafaxine hydrochloride

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4713248A (en) * 1984-02-10 1987-12-15 A/S Alfred Benzon Diffusion coated multiple-units dosage form
US5783215A (en) * 1994-07-08 1998-07-21 Astra Aktiebolag Pharmaceutical preparation
WO1999012524A1 (en) * 1997-09-11 1999-03-18 Nycomed Danmark A/S MODIFIED RELEASE MULTIPLE-UNITS COMPOSITIONS OF NON-STEROID ANTI-INFLAMMATORY DRUG SUBSTANCES (NSAIDs)
WO2003041692A1 (en) * 2001-11-13 2003-05-22 Karma Pharm Ltd. Extended release compositions comprising as active compound venlafaxine hydrochloride

Also Published As

Publication number Publication date
AU2003236947A1 (en) 2003-12-22
BR0312445A (en) 2005-05-10
CN1674877A (en) 2005-09-28
US20060257482A1 (en) 2006-11-16
WO2003103637A2 (en) 2003-12-18

Similar Documents

Publication Publication Date Title
WO2003103637A3 (en) MODIFIED RELEASE MULTIPLE UNIT DRUG DELIVERY SYSTEMS
Rathbone et al. Modified-release drug delivery technology
Gilhotra et al. A clinical perspective on mucoadhesive buccal drug delivery systems
TR200200562T2 (en) Pharmaceutical compositions for oral release that can be secreted in the body in a controlled manner and prevent unpleasant taste
CA2446712C (en) System for osmotic delivery of pharmaceutically active agents
NO981793D0 (en) Process for the preparation of multilayer solid form drugs for oral or rectal administration
AU2925295A (en) A novel drug delivery system
MXPA04001491A (en) Mucoadhesive erodible drug delivery device for controlled administration of pharmaceuticals and other active compounds.
BRPI0110038C1 (en) multilayer controlled release tablet containing ropinirole, and use of ropinirole
EP1649851A3 (en) Pregelatinized starch in a controlled release formulation
WO2001052823A3 (en) Compositions to effect the release profile in the transdermal administration of drugs
BR0312870A (en) Sustained-release tablet comprising reboxetine
WO2002078601A8 (en) Drug release from polymer matrices through mechanical stimulation
BR0212475A (en) Pharmaceutical Compositions
ATE302616T1 (en) MEDICINAL COMPOSITIONS FOR ORAL APPLICATION WITH CONTROLLED RELEASE OF ACTIVE INGREDIENTS
DE69814122D1 (en) PHARMACEUTICAL FORM FOR DELAYED, FULL DELIVERY OF ACTIVE SUBSTANCES IN THE DIGESTIVE TRACT
WO2006122165A3 (en) Ocular therapy using alpha-2 adrenergic receptor agonists having enhanced anterior clearance rates
CA2385890A1 (en) Controlled release compositions comprising nimesulide
CA2282082A1 (en) Microgranules containing cisplatin
IL154731A0 (en) Ion-strength independent sustained release pharmaceutical formulation
BRPI0509276A (en) flavored drugs disguised in rupture multiparticulates
WO1997020582A3 (en) Transdermal patch for comparative evaluations
ATE375789T1 (en) ORAL DELIVERY SYSTEM CONTAINING AN ANTIBACTERIAL AND AN ANTI-INFLAMMATORY AGENT
DE69922017D1 (en) MEDICINAL PRODUCT AND METHOD FOR TREATING INTRACELLULAR INFECTIONS
Dowson et al. Comparison of a Fixed Combination of Domperidone and Paracetamol (Domperamol®) with Sumatriptan 50mg in Moderate to Severe Migraine: A Randomised UK Primary Care Study

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NI NO NZ OM PH PL PT RO RU SC SD SE SG SK SL TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2003735864

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 20038189011

Country of ref document: CN

WWP Wipo information: published in national office

Ref document number: 2003735864

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2006257482

Country of ref document: US

Ref document number: 10517101

Country of ref document: US

NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP

WWP Wipo information: published in national office

Ref document number: 10517101

Country of ref document: US

WWW Wipo information: withdrawn in national office

Ref document number: 2003735864

Country of ref document: EP