WO1999017742A3 - Taste masked formulations - Google Patents

Taste masked formulations Download PDF

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Publication number
WO1999017742A3
WO1999017742A3 PCT/IE1998/000081 IE9800081W WO9917742A3 WO 1999017742 A3 WO1999017742 A3 WO 1999017742A3 IE 9800081 W IE9800081 W IE 9800081W WO 9917742 A3 WO9917742 A3 WO 9917742A3
Authority
WO
WIPO (PCT)
Prior art keywords
powders
taste
micromatrix
drug
masked
Prior art date
Application number
PCT/IE1998/000081
Other languages
French (fr)
Other versions
WO1999017742A2 (en
Inventor
Kenneth Iain Cumming
Elaine Marie Harris
Original Assignee
Elan Corp Plc
Kenneth Iain Cumming
Elaine Marie Harris
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 Elan Corp Plc, Kenneth Iain Cumming, Elaine Marie Harris filed Critical Elan Corp Plc
Priority to AU91824/98A priority Critical patent/AU9182498A/en
Priority to JP2000514619A priority patent/JP2001518490A/en
Priority to EP98944190A priority patent/EP1027036A2/en
Priority to CA002304630A priority patent/CA2304630A1/en
Publication of WO1999017742A2 publication Critical patent/WO1999017742A2/en
Publication of WO1999017742A3 publication Critical patent/WO1999017742A3/en

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Abstract

A taste-masked micromatrix powder in which the ratio of a cationic copolymer synthesized from dimethylaminoethyl methacrylate and neutral methacrylic acid esters compared to a drug having poor organoleptic properties is greater than 2 to 1, preferably 4 to 1, most preferably 6 to 1 (wt/wt). Taste masked immediate release micromatrix powders can be formed by spray drying the drug and cationic copolymer whereas sustained release micromatrix powders can be formed by granulating controlled release powders, which can be made by spray drying the drug with a retarding polymer, with the cationic copolymer. The immediate release or sustained release taste-masked powders of this invention can be incorporated into conventional oral dosage forms such as sprinkles, suspension, chewable tablets or effervescent tablets.
PCT/IE1998/000081 1997-10-03 1998-09-30 Taste masked formulations WO1999017742A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU91824/98A AU9182498A (en) 1997-10-03 1998-09-30 Taste masked formulations
JP2000514619A JP2001518490A (en) 1997-10-03 1998-09-30 Taste-masked preparation
EP98944190A EP1027036A2 (en) 1997-10-03 1998-09-30 Taste masked formulations
CA002304630A CA2304630A1 (en) 1997-10-03 1998-09-30 Taste masked formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6089497P 1997-10-03 1997-10-03
US60/060,894 1997-10-03

Publications (2)

Publication Number Publication Date
WO1999017742A2 WO1999017742A2 (en) 1999-04-15
WO1999017742A3 true WO1999017742A3 (en) 1999-06-17

Family

ID=22032403

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IE1998/000081 WO1999017742A2 (en) 1997-10-03 1998-09-30 Taste masked formulations

Country Status (7)

Country Link
US (1) US6153220A (en)
EP (1) EP1027036A2 (en)
JP (1) JP2001518490A (en)
AU (1) AU9182498A (en)
CA (1) CA2304630A1 (en)
WO (1) WO1999017742A2 (en)
ZA (1) ZA989013B (en)

Cited By (2)

* Cited by examiner, † Cited by third party
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US8936813B2 (en) 2001-11-01 2015-01-20 Novartis Ag Spray drying methods and related compositions
US9120031B2 (en) 2000-11-09 2015-09-01 Nektar Therapeutics Compositions of particulate coformulation

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US6395303B1 (en) * 1996-06-10 2002-05-28 Edward Mendell Co., Inc. Process for preparing a directly compressible solid dosage form containing microcrystalline cellulose
US6057139A (en) 1995-06-29 2000-05-02 Mcneil-Ppc, Inc. Preblend of microcrystalline cellulose and lactase for making tablets
US8071128B2 (en) 1996-06-14 2011-12-06 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
WO2000002574A1 (en) * 1998-07-08 2000-01-20 Kirin-Amgen Inc. Powdery preparation for mucosal administration containing polymeric medicine
DE19918435A1 (en) * 1998-07-23 2000-01-27 Roehm Gmbh Coating or binding agent for medicaments, prepared using finely divided acrylic copolymer powder, used e.g. for taste-masking coatings or in transdermal delivery systems
EP1231896A4 (en) * 1999-11-16 2003-07-09 Ranbaxy Lab Ltd Taste masked oral compositions
KR100863146B1 (en) * 2000-07-17 2008-10-14 아스텔라스세이야쿠 가부시키가이샤 Pharmaceutical composition improved in peroral absorbability
JP4446463B2 (en) * 2000-10-16 2010-04-07 第一三共株式会社 Oral rapidly disintegrating pharmaceutical composition and method for producing the same
FR2826274B1 (en) * 2001-06-21 2003-09-26 Aventis Pharma Sa PHARMACEUTICAL FORMULATION FOR MASK TASTE AND METHOD FOR PREPARING THE SAME
GB0208742D0 (en) 2002-04-17 2002-05-29 Bradford Particle Design Ltd Particulate materials
US9358214B2 (en) 2001-10-04 2016-06-07 Adare Pharmaceuticals, Inc. Timed, sustained release systems for propranolol
US11207805B2 (en) 2001-10-12 2021-12-28 Aquestive Therapeutics, Inc. Process for manufacturing a resulting pharmaceutical film
US20070281003A1 (en) 2001-10-12 2007-12-06 Fuisz Richard C Polymer-Based Films and Drug Delivery Systems Made Therefrom
US10285910B2 (en) 2001-10-12 2019-05-14 Aquestive Therapeutics, Inc. Sublingual and buccal film compositions
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
US20110033542A1 (en) 2009-08-07 2011-02-10 Monosol Rx, Llc Sublingual and buccal film compositions
US20190328679A1 (en) 2001-10-12 2019-10-31 Aquestive Therapeutics, Inc. Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US8900498B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for manufacturing a resulting multi-layer pharmaceutical film
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US8900497B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for making a film having a substantially uniform distribution of components
US6753017B2 (en) * 2001-11-07 2004-06-22 Jrs Pharma Lp Process for preparing dry extracts
AU2002217982A1 (en) * 2001-11-29 2003-06-17 Penwest Pharmaceutical Company Process for co-spray drying liquid herbal extracts with dry silicified mcc
US7179488B2 (en) * 2001-11-29 2007-02-20 Bob Sherwood Process for co-spray drying liquid herbal extracts with dry silicified MCC
US20030206978A1 (en) * 2001-11-29 2003-11-06 Bob Sherwood Agglomerated particles including an active agent coprocessed with silicified microcrystalline cellulose
US9339459B2 (en) 2003-04-24 2016-05-17 Nektar Therapeutics Particulate materials
US6930119B2 (en) * 2002-07-17 2005-08-16 Reliant Pharmaceuticals, Inc. Liquid pharmaceutical composition
RU2005109909A (en) * 2002-09-04 2006-10-10 Рэнбакси Лабораториз Лимитед (In) MEDICINAL FORMS WITH MASKED TASTE AND METHODS FOR PRODUCING THEM
EP1555996A2 (en) * 2002-10-31 2005-07-27 Euro-Celtique Pharmaceutical identification
US8367111B2 (en) 2002-12-31 2013-02-05 Aptalis Pharmatech, Inc. Extended release dosage forms of propranolol hydrochloride
DE10304403A1 (en) 2003-01-28 2004-08-05 Röhm GmbH & Co. KG Process for the preparation of an oral dosage form with immediate disintegration and drug release
US20050196439A1 (en) * 2003-10-24 2005-09-08 J. Rettenmaier & Soehne Gmbh + Co. Kg Process for co-spray drying agents with dry silicified MCC
EP1694302A1 (en) * 2003-12-15 2006-08-30 Council of Scientific and Industrial Research TASTE MASKED PHARMACEUTICAL COMPOSITIONS COMPRISING BITTER DRUG AND pH SENSITIVE POLYMER
EP1694303A1 (en) * 2003-12-15 2006-08-30 Council Of Scientific And Industrial Research Taste masked pharmaceutical composition comprising ph sensitive polymer
US20060024335A1 (en) * 2004-07-29 2006-02-02 Roger Stier E Oral compositions which mask the bitter taste of a bitter-tasting agent
WO2006016602A1 (en) * 2004-08-10 2006-02-16 Ajinomoto Co., Inc. Nateglinide-containing preparation reduced in bitterness
US8747895B2 (en) 2004-09-13 2014-06-10 Aptalis Pharmatech, Inc. Orally disintegrating tablets of atomoxetine
ES2360293T5 (en) * 2004-10-01 2014-06-02 Firmenich Sa Perfume or flavoring microcapsules comprising an explosion suppressor
US8057820B2 (en) * 2004-10-08 2011-11-15 Mcneil-Ppc, Inc. Enteric coated aspirin granules comingled with binder
US9884014B2 (en) 2004-10-12 2018-02-06 Adare Pharmaceuticals, Inc. Taste-masked pharmaceutical compositions
US20060105039A1 (en) 2004-10-21 2006-05-18 Jin-Wang Lai Taste-masked pharmaceutical compositions with gastrosoluble pore-formers
US20060228487A1 (en) * 2005-04-11 2006-10-12 J. Rettenmaier & Söehne GmbH + Co. KG Methods of combining active agents with augmented microcrystalline cellulose
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
US20070134277A1 (en) * 2005-12-09 2007-06-14 Children's Medical Center Corporation Pharmaceutical formulation for sulfur-containing drugs in liquid dosage forms
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9120031B2 (en) 2000-11-09 2015-09-01 Nektar Therapeutics Compositions of particulate coformulation
US8936813B2 (en) 2001-11-01 2015-01-20 Novartis Ag Spray drying methods and related compositions

Also Published As

Publication number Publication date
AU9182498A (en) 1999-04-27
WO1999017742A2 (en) 1999-04-15
EP1027036A2 (en) 2000-08-16
CA2304630A1 (en) 1999-04-15
ZA989013B (en) 1999-04-13
JP2001518490A (en) 2001-10-16
US6153220A (en) 2000-11-28

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