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

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth 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
    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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 (https=)
EP (1) EP2717860A4 (https=)
JP (2) JP2014516080A (https=)
CA (1) CA2835293C (https=)
WO (1) WO2012170676A1 (https=)

Families Citing this family (27)

* 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
PT3061821T (pt) 2009-07-22 2019-09-05 PureTech Health LLC Composições para tratamento de distúrbios melhorados por ativação de recetores muscarínicos
JP2014516080A (ja) * 2011-06-08 2014-07-07 エスティーアイ ファーマ， エルエルシー 一日一回の投与のための吸収が制御された水溶性の薬学的に活性な有機化合物製剤
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
US9452181B2 (en) 2013-07-22 2016-09-27 Duchesnay Inc. Composition for the management of nausea and vomiting
MY191347A (en) 2013-07-22 2022-06-17 Duchesnay Inc Composition for the management of nausea and vomiting
WO2016077832A2 (en) 2014-11-14 2016-05-19 Gemphire Therapeutics Inc. PROCESSES AND INTERMEDIATES FOR PREPARING α,ω-DICARBOXYLIC ACID-TERMINATED DIALKANE ETHERS
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
EP3509641A1 (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, 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
JP2019531344A (ja) 2016-09-12 2019-10-31 エスティー アイピー ホールディング エージー ４−メチル−５−（ピラジン−２−イル）−３ｈ−１，２−ジチオール−３−チオンの処方物、ならびにそれらの製造方法及び使用方法
CA3038036C (en) * 2016-09-27 2024-01-23 Bayer Pharma Aktiengesellschaft Method for producing the crystalline form of modification a of calcobutrol
JP7057365B2 (ja) 2016-09-30 2022-04-19 ゼナメッド コーポレーション ミドドリンの組成物およびその使用方法
EP3612171A4 (en) 2017-04-18 2020-10-21 Gemphire Therapeutics Inc. GEMCABENE, PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, COMPOSITIONS THEREOF AND PROCEDURES FOR THE USE OF THE SAME
JP7364568B2 (ja) 2017-12-22 2023-10-18 ゼナメッド コーポレーション 持続放出ミドドリン塩酸塩組成物及び使用方法
KR102408292B1 (ko) 2018-09-28 2022-06-10 카루나 세러퓨틱스 인코포레이티드 무스카린성 수용체 활성화에 의해 개선된 장애의 치료를 위한 조성물 및 방법
US20210393621A1 (en) 2018-10-26 2021-12-23 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
CN114401716A (zh) * 2019-07-22 2022-04-26 纳诺米有限公司 持续释放的曲前列环素-化合物微粒组合物
CR20220506A (es) * 2020-03-09 2023-01-17 Sushma Paul Berlia Formulaciones de liberación controlada que comprenden drotaverina o sal de la misma
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
US12599578B2 (en) 2021-03-09 2026-04-14 Ensysce Biosciences Inc. Compositions comprising enzyme-cleavable prodrugs and controlled release nafamostat and methods of use thereof
CN116981447A (zh) * 2021-03-09 2023-10-31 恩赛斯生物科学股份有限公司 奈莫司他的修饰释放组合物及其使用方法

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
ATE142497T1 (de) * 1989-06-23 1996-09-15 Syntex Inc Ranolazin und verwandte piperazine zur behandlung von geweben, von physischen oder chemischen schäden betroffen
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
WO2000018374A1 (en) 1998-10-01 2000-04-06 Elan Pharma International, Ltd. 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
EP1572164A2 (en) 2002-12-18 2005-09-14 Pain Therapeutics, Inc. Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats
EP1613333A1 (en) 2003-04-04 2006-01-11 Pharmacia Corporation Oral extended release compressed tablets of multiparticulates
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
US20110313009A1 (en) * 2008-07-17 2011-12-22 Horizon Pharma Usa, 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
JP2014516080A (ja) * 2011-06-08 2014-07-07 エスティーアイ ファーマ， エルエルシー 一日一回の投与のための吸収が制御された水溶性の薬学的に活性な有機化合物製剤

Also Published As

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

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
WO1999030690A1 (en) Oral delivery formulation
WO2023118074A1 (en) Compressible and free flowing co-processed mesoporous silica
World Health Organization The use of common stems in the selection of International Nonproprietary names (INN) for pharmaceutical substances: 2002

Legal Events

Date Code Title Description
MPN Maintenance fee for patent paid

Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 13TH ANNIV.) - STANDARD

Year of fee payment: 13

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250604

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250604