CA2835293C - Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration - Google Patents

Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration Download PDF

Info

Publication number
CA2835293C
CA2835293C CA2835293A CA2835293A CA2835293C CA 2835293 C CA2835293 C CA 2835293C CA 2835293 A CA2835293 A CA 2835293A CA 2835293 A CA2835293 A CA 2835293A CA 2835293 C CA2835293 C CA 2835293C
Authority
CA
Canada
Prior art keywords
particles
poly
naproxen
particle diameter
less
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.)
Active
Application number
CA2835293A
Other languages
English (en)
French (fr)
Other versions
CA2835293A1 (en
Inventor
David F. Counts
Donald P. Cox
Anup K. Dam
Michael E. Stalhamer
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.)
STI Pharma LLC
Original Assignee
STI Pharma LLC
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 STI Pharma LLC filed Critical STI Pharma LLC
Publication of CA2835293A1 publication Critical patent/CA2835293A1/en
Application granted granted Critical
Publication of CA2835293C publication Critical patent/CA2835293C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2835293A 2011-06-08 2012-06-07 Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration Active CA2835293C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161494659P 2011-06-08 2011-06-08
US61/494,659 2011-06-08
PCT/US2012/041331 WO2012170676A1 (en) 2011-06-08 2012-06-07 Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration

Publications (2)

Publication Number Publication Date
CA2835293A1 CA2835293A1 (en) 2012-12-13
CA2835293C true CA2835293C (en) 2020-08-18

Family

ID=47296440

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2835293A Active CA2835293C (en) 2011-06-08 2012-06-07 Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration

Country Status (5)

Country Link
US (3) US10463611B2 (enExample)
EP (1) EP2717860A4 (enExample)
JP (2) JP2014516080A (enExample)
CA (1) CA2835293C (enExample)
WO (1) WO2012170676A1 (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8445018B2 (en) 2006-09-15 2013-05-21 Cima Labs Inc. Abuse resistant drug formulation
US10265311B2 (en) 2009-07-22 2019-04-23 PureTech Health LLC Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation
HUE044653T2 (hu) 2009-07-22 2019-11-28 PureTech Health LLC Készítmények olyan rendellenességek kezelésére, amelyek muszkarin-receptor aktiválással enyhíthetõk
EP2717860A4 (en) * 2011-06-08 2014-11-05 Sti Pharma Llc FORMULATION FROM A WATER SOLUBLE AND PHARMACEUTICALLY ACTIVE ORGANIC COMPOUND WITH CONTROLLED ABSORPTION FOR ONLY DAILY APPLICATION
TWI649100B (zh) * 2013-06-17 2019-02-01 地平線罕見醫學製藥有限責任公司 延遲釋放型半胱胺珠粒調配物,以及其製備及使用方法
KR102242391B1 (ko) 2013-07-22 2021-04-21 듀체스나이 아이엔씨 오심 및 구토의 관리용 조성물
US9452181B2 (en) 2013-07-22 2016-09-27 Duchesnay Inc. Composition for the management of nausea and vomiting
CN111704543A (zh) 2014-11-14 2020-09-25 燿石治疗公司 用于制备α,ω-二羧酸封端的二烷醚的方法和中间体
WO2017055935A1 (en) * 2015-09-30 2017-04-06 Symed Labs Limited Amorphous co-precipitates of flibanserin
US10143665B2 (en) 2015-11-17 2018-12-04 Horizon Orphan Llc Methods for storing cysteamine formulations and related methods of treatment
CN106866546A (zh) * 2015-12-10 2017-06-20 常州爱诺新睿医药技术有限公司 氟班色林或其药学上可接受的盐与药用辅料的固体分散体及其制备方法
WO2018047002A1 (en) * 2016-09-12 2018-03-15 St Ip Holding Ag Formulations of 4-methyl-5-(pyrazin-2-yl)-3h-1.2-dithiole-3-thione, taste-modified formulations, and methods of making and using same
EP3509642A1 (en) 2016-09-12 2019-07-17 ST IP Holding AG Formulations of 4-methyl-5-(pyrazin-2-yl)-3h-1, 2-dithiole-3-thione, and methods of making and using same
AU2017322544B2 (en) * 2016-09-12 2022-06-02 St Ip Holding Ag Formulations of 4-methyl-5-(pyrazin-2-yl)-3H-1.2-dithiole-3-thione, taste-modified formulations, and methods of making and using same
WO2018047013A1 (en) * 2016-09-12 2018-03-15 St Ip Holding Ag Formulations of 4-methyl-5-(pyrazin-2-yl)-3h-1, 2-dithiole-3-thione, and methods of making and using same
RS60392B1 (sr) * 2016-09-27 2020-07-31 Bayer Pharma AG Postupak za proizvodnju kristalnog oblika modifikacije a kalkobutrola
EP3518910A4 (en) 2016-09-30 2020-11-04 Xenamed Corporation COMPOSITIONS OF MIDODRINE AND THEIR METHODS OF USE
US20180297929A1 (en) * 2017-04-18 2018-10-18 Gemphire Therapeutics Inc. Gemcabene, pharmaceutically acceptable salts thereof, compositions thereof and methods of use therefor
WO2019126770A1 (en) 2017-12-22 2019-06-27 Xenamed Corp. Extended release midodrine hydrochloride compositions and methods of use
BR112021005802B1 (pt) 2018-09-28 2022-02-15 Karuna Therapeutics, Inc Composição farmacêutica oral
WO2020087031A1 (en) 2018-10-26 2020-04-30 The Research Foundation For The State University Of New York Combination serotonin specific reuptake inhibitor and serotonin 1a receptor partial agonist for reducing l-dopa-induced dyskinesia
AU2020316931A1 (en) * 2019-07-22 2022-02-24 Nanomi, B.V. Sustained release treprostinil-compound microparticle compositions
AU2021235395B2 (en) * 2020-03-09 2025-11-13 Drotastar Llc Controlled release formulations comprising Drotaverine or salt thereof
US11135220B1 (en) 2020-04-08 2021-10-05 St Ip Holding Ag Methods of treating viral infections with formulated compositions comprising 4-methyl-5-(pyrazin-2-yl)-3H-1,2-dithiole-3-thione
KR20220048341A (ko) * 2020-10-12 2022-04-19 뉴지랩테라퓨틱스 주식회사 나파모스타트 또는 이의 약제학적으로 허용가능한 염을 함유하는 방출 조절 제형 및 이의 제조방법
CA3209336A1 (en) * 2021-03-09 2022-09-15 Lynn Kirkpatrick Modified release compositions of nafamostat and methods of using same

Family Cites Families (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS521867A (en) 1975-06-24 1977-01-08 Tonichi Kotsu Consultant:Kk Rotary vertical garrage
JPS6327424A (ja) * 1986-07-17 1988-02-05 Shionogi & Co Ltd 徐放性製剤およびその製造法
GB8618811D0 (en) 1986-08-01 1986-09-10 Approved Prescription Services Sustained release ibuprofen formulation
GB8724763D0 (en) 1987-10-22 1987-11-25 Aps Research Ltd Sustained-release formulations
US4971805A (en) * 1987-12-23 1990-11-20 Teysan Pharmaceuticals Co., Ltd. Slow-releasing granules and long acting mixed granules comprising the same
DE69033967T2 (de) * 1989-06-23 2002-12-19 Syntex (U.S.A.) Llc, Palo Alto Ranolazin und verwandte Piperazine zur Behandlung von Schockzuständen
IE66933B1 (en) * 1990-01-15 1996-02-07 Elan Corp Plc Controlled absorption naproxen formulation for once-daily administration
US5431922A (en) 1991-03-05 1995-07-11 Bristol-Myers Squibb Company Method for administration of buspirone
KR100221695B1 (ko) * 1991-08-12 1999-09-15 그린 마틴, 브라이언 쥐 테슬리 약학적 구상 제형
US5376384A (en) * 1992-12-23 1994-12-27 Kinaform Technology, Inc. Delayed, sustained-release pharmaceutical preparation
DK66493D0 (da) 1993-06-08 1993-06-08 Ferring A S Praeparater, isaer til brug ved behandling af inflammatoriske tarmsygdomme eller til at opnaa forbedret saarheling
US5558879A (en) * 1995-04-28 1996-09-24 Andrx Pharmaceuticals, Inc. Controlled release formulation for water soluble drugs in which a passageway is formed in situ
SE9600070D0 (sv) * 1996-01-08 1996-01-08 Astra Ab New oral pharmaceutical dosage forms
AU6283299A (en) 1998-10-01 2000-04-17 Elan Pharma International Limited Controlled release nanoparticulate compositions
US6528090B2 (en) 1998-12-18 2003-03-04 Abbott Laboratories Controlled release formulation of divalproex sodium
FR2796790B1 (fr) 1999-07-23 2002-11-29 Sagem Procedes de transmission et de diffusion de paquets de donnees et recepteurs pour la mise en oeuvre des procedes
EP2260837A1 (en) * 2001-06-01 2010-12-15 Pozen, Inc. Pharmaceutical compositions for the coordinated delivery of NSAIDs
US7101573B2 (en) * 2001-09-28 2006-09-05 Mcneil-Pcc, Inc. Simethicone solid oral dosage form
US20040224020A1 (en) * 2002-12-18 2004-11-11 Schoenhard Grant L. Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats
JP2006522099A (ja) 2003-04-04 2006-09-28 ファルマシア コーポレーション 複合粒状体からなる経口徐放性圧縮錠
US20040219210A1 (en) 2003-05-01 2004-11-04 Jian-Hwa Guo Controlled release solid dosage nifedipine formulations
SI21638A (sl) * 2003-11-12 2005-06-30 LEK farmacevtska dru�ba d.d. Farmacevtska oblika z nadzorovanim sproščanjem ketoprofena
US8389032B2 (en) * 2005-05-23 2013-03-05 Kraft Foods Global Brands Llc Delivery system for active components as part of an edible composition having selected particle size
US9161918B2 (en) * 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
JP4936420B2 (ja) 2005-08-02 2012-05-23 塩野義製薬株式会社 徐放性顆粒剤
US20070184115A1 (en) * 2005-12-30 2007-08-09 Biovail Laboratories International S.R.L. Modified release formulations of tramadol and uses thereof
US20070160667A1 (en) 2006-01-11 2007-07-12 Nava Shterman Controlled release formulation of divalproex sodium
JP2010529994A (ja) * 2007-06-13 2010-09-02 オースペックス・ファーマシューティカルズ・インコーポレイテッド 置換ピペラジン
US20100008986A1 (en) * 2008-07-14 2010-01-14 Glenmark Generics, Ltd. Pharmaceutical compositions comprising sumatriptan and naproxen
WO2010009432A1 (en) * 2008-07-17 2010-01-21 Horizon Therapeutics, Inc. Nsaid dose unit formulations with h2-receptor antagonists and methods of use
WO2010014502A1 (en) * 2008-07-31 2010-02-04 Aptapharma, Inc. Functionally coated breakable tablets
US20100305163A1 (en) * 2009-05-20 2010-12-02 Pramod Dattatray Yedurkar Pharmaceutical formulations comprising nsaid and proton pump inhibitor drugs
EP2717860A4 (en) * 2011-06-08 2014-11-05 Sti Pharma Llc FORMULATION FROM A WATER SOLUBLE AND PHARMACEUTICALLY ACTIVE ORGANIC COMPOUND WITH CONTROLLED ABSORPTION FOR ONLY DAILY APPLICATION

Also Published As

Publication number Publication date
JP2014516080A (ja) 2014-07-07
US11191719B2 (en) 2021-12-07
WO2012170676A1 (en) 2012-12-13
JP2017137354A (ja) 2017-08-10
EP2717860A4 (en) 2014-11-05
US20140154313A1 (en) 2014-06-05
US20200000719A1 (en) 2020-01-02
CA2835293A1 (en) 2012-12-13
EP2717860A1 (en) 2014-04-16
US20220047505A1 (en) 2022-02-17
US10463611B2 (en) 2019-11-05

Similar Documents

Publication Publication Date Title
US11191719B2 (en) Controlled absorption water-soluble pharmaceutically active organic compound formulation for once-daily administration
US8158152B2 (en) Lyophilization process and products obtained thereby
US7905852B2 (en) Skin-contacting-adhesive free dressing
US9016221B2 (en) Surface topographies for non-toxic bioadhesion control
US8454582B2 (en) Methods and devices for the treatment of ocular conditions
US7951398B2 (en) Pharmaceutical preparation comprising an active dispersed on a matrix
US8268352B2 (en) Modified release composition for highly soluble drugs
AU2002216073A1 (en) Pharmaceutical preparation comprising an active dispersed on a matrix
US20060018933A1 (en) Novel drug delivery system
DE10061137A1 (de) Neue pharmazeutische Zubereitung
WO2023118074A1 (en) Compressible and free flowing co-processed mesoporous silica
Policy The use of common stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances
World Health Organization The use of common stems in the selection of International Nonproprietary names (INN) for pharmaceutical substances: 2002