AU2016258624B2 - Sprinkle formulations of acamprosate - Google Patents

Sprinkle formulations of acamprosate Download PDF

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Publication number
AU2016258624B2
AU2016258624B2 AU2016258624A AU2016258624A AU2016258624B2 AU 2016258624 B2 AU2016258624 B2 AU 2016258624B2 AU 2016258624 A AU2016258624 A AU 2016258624A AU 2016258624 A AU2016258624 A AU 2016258624A AU 2016258624 B2 AU2016258624 B2 AU 2016258624B2
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AU
Australia
Prior art keywords
pharmaceutical formulation
sprinkles
disorder
coating
disease
Prior art date
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Active
Application number
AU2016258624A
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English (en)
Other versions
AU2016258624A1 (en
Inventor
Badrinath R. Doniparthi
Steven L. Johns
Shivaraj B. Munianjanappa
Kenneth G. Payie
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.)
Confluence Pharmaceuticals LLC
Original Assignee
Confluence Pharmaceuticals 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 Confluence Pharmaceuticals LLC filed Critical Confluence Pharmaceuticals LLC
Publication of AU2016258624A1 publication Critical patent/AU2016258624A1/en
Application granted granted Critical
Publication of AU2016258624B2 publication Critical patent/AU2016258624B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/5026—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
    • A61K9/48—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
    • 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
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hospice & Palliative Care (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
AU2016258624A 2015-05-04 2016-05-04 Sprinkle formulations of acamprosate Active AU2016258624B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562156842P 2015-05-04 2015-05-04
US62/156,842 2015-05-04
US201562260161P 2015-11-25 2015-11-25
US62/260,161 2015-11-25
PCT/US2016/030725 WO2016179252A1 (en) 2015-05-04 2016-05-04 Sprinkle formulations of acamprosate

Publications (2)

Publication Number Publication Date
AU2016258624A1 AU2016258624A1 (en) 2017-11-02
AU2016258624B2 true AU2016258624B2 (en) 2021-07-29

Family

ID=57217823

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016258624A Active AU2016258624B2 (en) 2015-05-04 2016-05-04 Sprinkle formulations of acamprosate

Country Status (10)

Country Link
US (1) US10709668B2 (enExample)
EP (1) EP3291800A4 (enExample)
JP (2) JP7026347B2 (enExample)
KR (1) KR102790656B1 (enExample)
AU (1) AU2016258624B2 (enExample)
HK (1) HK1252003A1 (enExample)
IL (1) IL255343B2 (enExample)
SG (1) SG11201708393UA (enExample)
WO (1) WO2016179252A1 (enExample)
ZA (1) ZA201708037B (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016132136A1 (en) 2015-02-18 2016-08-25 Aston University Diagnostic assay and treatment for preeclampsia
KR102790656B1 (ko) 2015-05-04 2025-04-02 컨플루언스 파마슈티컬스, 엘엘씨 아캄프로세이트의 스프링클 제형
AU2016303610A1 (en) * 2015-08-04 2018-02-01 Confluence Pharmaceuticals, Llc Combination therapy using acamprosate and D-cycloserine
EP3624788A4 (en) * 2017-05-17 2021-03-03 Confluence Pharmaceuticals, LLC FORMULATIONS OF HOMOTAURIN AND SALT THEREOF
ES2938609T3 (es) * 2017-09-20 2023-04-13 Tillotts Pharma Ag Preparación de formas farmacéuticas sólidas que comprenden anticuerpos mediante estratificación de solución/suspensión
EP4213817A1 (en) * 2020-09-21 2023-07-26 Sun Pharmaceutical Industries Limited Multi-particulate pharmaceutical composition of quetiapine
US20240382133A1 (en) 2021-09-24 2024-11-21 Sumitomo Bakelite Co., Ltd. Brain wave detection electrode, brain wave measuring device, and brain wave measuring method

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120077878A1 (en) * 2010-09-28 2012-03-29 Depomed, Inc. Gastric retentive dosage forms for extended release of acamprosate into the upper gastrointestinal tract

Family Cites Families (15)

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US6514530B2 (en) 1997-09-09 2003-02-04 Alza Corporation Dosage form comprising means for changing drug delivery shape
AU765603C (en) 1998-04-14 2004-08-05 General Hospital Corporation, The Methods for treating neuropsychiatric disorders
RU2375048C2 (ru) * 2003-07-17 2009-12-10 Д-Р Редди'С Лабораторис Инк. Фармацевтическая композиция с набухающим покрытием
DE102007009243A1 (de) 2007-02-22 2008-09-18 Evonik Röhm Gmbh Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets
WO2009004082A2 (en) 2007-07-05 2009-01-08 INSERM (Institut National de la Santé et de la Recherche Médicale) Anticonvulsive pharmaceutical compositions
ES2530047T3 (es) 2009-02-12 2015-02-26 Indiana University Research And Technology Corporation Material y métodos para el tratamiento de trastornos del desarrollo que incluyen autismo idiopático y comórbido
US20100216805A1 (en) 2009-02-25 2010-08-26 Braincells, Inc. Modulation of neurogenesis using d-cycloserine combinations
US20110142889A1 (en) 2009-12-16 2011-06-16 Nod Pharmaceuticals, Inc. Compositions and methods for oral drug delivery
RS53227B (sr) 2011-03-01 2014-08-29 Pharnext Terapija neuroloških poremećaja kombinacijom baklofena i akamprosata
WO2012129551A1 (en) * 2011-03-23 2012-09-27 Ironshore Pharmaceuticals & Development, Inc. Methods and compositions for treatment of attention deficit disorder
WO2013002584A2 (ko) 2011-06-28 2013-01-03 주식회사 비보존 다중 타겟팅의 상승 효과를 유발하는 유효물질의 조합 및 그 용도
AU2012345659B2 (en) * 2011-12-02 2017-09-28 Synchroneuron Inc. Acamprosate formulations, methods of using the same, and combinations comprising the same
WO2014197744A1 (en) * 2013-06-05 2014-12-11 Synchroneuron, Inc. Acamprosate formulations, methods of using the same, and combinations comprising the same
EP3104850A1 (en) 2014-02-11 2016-12-21 Pharnext Combination of baclofen, acamprosate and medium chain triglycerides for the treatment of neurological disorders
KR102790656B1 (ko) 2015-05-04 2025-04-02 컨플루언스 파마슈티컬스, 엘엘씨 아캄프로세이트의 스프링클 제형

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120077878A1 (en) * 2010-09-28 2012-03-29 Depomed, Inc. Gastric retentive dosage forms for extended release of acamprosate into the upper gastrointestinal tract

Also Published As

Publication number Publication date
EP3291800A4 (en) 2018-09-26
IL255343A0 (en) 2017-12-31
WO2016179252A1 (en) 2016-11-10
JP2021155434A (ja) 2021-10-07
IL255343B1 (en) 2024-06-01
HK1252003A1 (zh) 2019-05-10
KR20170142180A (ko) 2017-12-27
ZA201708037B (en) 2020-03-25
JP7026347B2 (ja) 2022-02-28
US20190046458A1 (en) 2019-02-14
SG11201708393UA (en) 2017-11-29
IL255343B2 (en) 2024-10-01
AU2016258624A1 (en) 2017-11-02
JP2018515506A (ja) 2018-06-14
US10709668B2 (en) 2020-07-14
KR102790656B1 (ko) 2025-04-02
EP3291800A1 (en) 2018-03-14

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