AU2014349782B2 - Slow-release solid oral compositions - Google Patents

Slow-release solid oral compositions Download PDF

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Publication number
AU2014349782B2
AU2014349782B2 AU2014349782A AU2014349782A AU2014349782B2 AU 2014349782 B2 AU2014349782 B2 AU 2014349782B2 AU 2014349782 A AU2014349782 A AU 2014349782A AU 2014349782 A AU2014349782 A AU 2014349782A AU 2014349782 B2 AU2014349782 B2 AU 2014349782B2
Authority
AU
Australia
Prior art keywords
pharmaceutically acceptable
composition
same
acceptable salt
shellac
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
AU2014349782A
Other languages
English (en)
Other versions
AU2014349782A1 (en
Inventor
Marco Berna
Daniele Giovannone
Niccolo Miraglia
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.)
Gnosis SpA
Original Assignee
Gnosis SpA
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 Gnosis SpA filed Critical Gnosis SpA
Publication of AU2014349782A1 publication Critical patent/AU2014349782A1/en
Application granted granted Critical
Publication of AU2014349782B2 publication Critical patent/AU2014349782B2/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/20—Agglomerating; Granulating; Tabletting
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • 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
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Zoology (AREA)
  • Botany (AREA)
  • Psychiatry (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Pain & Pain Management (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Psychology (AREA)
  • Rheumatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2014349782A 2013-11-18 2014-11-06 Slow-release solid oral compositions Active AU2014349782B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
ITMI2013A001906 2013-11-18
IT001906A ITMI20131906A1 (it) 2013-11-18 2013-11-18 Composizioni solide orali a lento rilascio
US201461989645P 2014-05-07 2014-05-07
US61/989,645 2014-05-07
PCT/IB2014/065852 WO2015071806A1 (en) 2013-11-18 2014-11-06 Slow-release solid oral compositions

Publications (2)

Publication Number Publication Date
AU2014349782A1 AU2014349782A1 (en) 2016-05-12
AU2014349782B2 true AU2014349782B2 (en) 2019-04-04

Family

ID=49780196

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014349782A Active AU2014349782B2 (en) 2013-11-18 2014-11-06 Slow-release solid oral compositions

Country Status (26)

Country Link
US (1) US10702482B2 (enExample)
EP (1) EP3071191B1 (enExample)
JP (1) JP6401270B2 (enExample)
KR (1) KR102224087B1 (enExample)
CN (1) CN105764493B (enExample)
AU (1) AU2014349782B2 (enExample)
BR (1) BR112016011142B1 (enExample)
CA (1) CA2929426C (enExample)
DK (1) DK3071191T3 (enExample)
EA (1) EA039558B1 (enExample)
ES (1) ES2908924T3 (enExample)
GE (1) GEP20186884B (enExample)
HR (1) HRP20220271T1 (enExample)
HU (1) HUE058086T2 (enExample)
IL (1) IL245167B (enExample)
IT (1) ITMI20131906A1 (enExample)
LT (1) LT3071191T (enExample)
MX (1) MX367664B (enExample)
NZ (1) NZ719000A (enExample)
PH (1) PH12016500693A1 (enExample)
PL (1) PL3071191T3 (enExample)
PT (1) PT3071191T (enExample)
RS (1) RS62916B1 (enExample)
UA (1) UA119856C2 (enExample)
WO (1) WO2015071806A1 (enExample)
ZA (1) ZA201602659B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201700074957A1 (it) * 2017-07-04 2019-01-04 Gnosis Spa Sale di (ss)-adenosil metionina con inositolo esafosfato e procedimento per ottenerlo
CN109939077B (zh) * 2017-12-04 2022-07-22 深圳奥萨制药有限公司 一种含有5-甲基四氢叶酸的控释制剂
CN111990674B (zh) * 2020-01-14 2021-07-02 青岛圣邦健康食品有限公司 肠溶包衣材料及其制备方法和肠溶制品
IT202000006127A1 (it) * 2020-03-23 2021-09-23 Fmc S R L Formulazione farmaceutica, dietetica e/o alimentare a base ademetionina e processo di realizzazione di detta formulazione
IT202300007692A1 (it) * 2023-04-19 2024-10-19 Vifra S R L Formulazione farmaceutica, dietetica e/o alimentare a base ademetionina e processo di realizzazione di detta formulazione

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003043608A1 (en) * 2001-11-22 2003-05-30 Gnosis Srl Process for the preparation of tablets comprising s-adenosylmethionine
US20050181047A1 (en) * 2004-02-18 2005-08-18 Jaime Romero Compositions and methods for timed release of water-soluble nutritional supplements
WO2007113885A2 (en) * 2006-03-31 2007-10-11 Gnosis Spa Solid oral compositions based on s-adenosyl methionine and/or nadh and process for obtaining them

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1200589B (it) * 1985-02-14 1989-01-27 Gibipharma Spa Derivati naturali attivita farmagologica
JP2008519071A (ja) 2004-11-05 2008-06-05 ファーブル−クレイマー・ホールディングス・インコーポレイテッド ゲピロンの高用量徐放性製剤
US20090088404A1 (en) 2007-01-31 2009-04-02 Methylation Sciences International Srl Extended Release Pharmaceutical Formulations of S-Adenosylmethionine
KR20070093972A (ko) * 2007-06-05 2007-09-19 파브르-크래머 홀딩스. 인크 게피론의 고용량 서방성 제제
US7947662B2 (en) * 2008-02-20 2011-05-24 Gnosis S.P.A. Folates, compositions and uses thereof
US20110027342A1 (en) 2009-07-28 2011-02-03 Msi Methylation Sciences, Inc. S-adenosylmethionine formulations with enhanced bioavailability
US8329208B2 (en) 2009-07-28 2012-12-11 Methylation Sciences International Srl Pharmacokinetics of S-adenosylmethionine formulations
IT1401146B1 (it) * 2010-07-27 2013-07-12 Gnosis Spa Composizione comprendente shellac e/o un suo sale e sodio amido glicolato

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003043608A1 (en) * 2001-11-22 2003-05-30 Gnosis Srl Process for the preparation of tablets comprising s-adenosylmethionine
US20050181047A1 (en) * 2004-02-18 2005-08-18 Jaime Romero Compositions and methods for timed release of water-soluble nutritional supplements
WO2007113885A2 (en) * 2006-03-31 2007-10-11 Gnosis Spa Solid oral compositions based on s-adenosyl methionine and/or nadh and process for obtaining them

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Doug Nelson ET AL, "Effects of Magnesium Stearate on Tablet Properties", (2009-07-23), URL: http://www.osd.rutgers.edu/gs/09papers/PharmaDC.pdf, (2014-05-08) *

Also Published As

Publication number Publication date
EA039558B1 (ru) 2022-02-10
UA119856C2 (uk) 2019-08-27
CA2929426C (en) 2021-08-31
PL3071191T3 (pl) 2022-04-04
DK3071191T3 (da) 2022-03-07
WO2015071806A1 (en) 2015-05-21
ITMI20131906A1 (it) 2015-05-19
HRP20220271T1 (hr) 2022-05-13
LT3071191T (lt) 2022-04-25
ZA201602659B (en) 2017-08-30
JP2016539112A (ja) 2016-12-15
IL245167A0 (en) 2016-06-30
PH12016500693B1 (en) 2016-05-30
RS62916B1 (sr) 2022-03-31
CN105764493A (zh) 2016-07-13
CA2929426A1 (en) 2015-05-21
ES2908924T3 (es) 2022-05-04
PT3071191T (pt) 2022-04-05
JP6401270B2 (ja) 2018-10-10
EP3071191B1 (en) 2022-01-05
NZ719000A (en) 2017-06-30
GEP20186884B (en) 2018-07-25
BR112016011142A2 (enExample) 2017-08-08
BR112016011142B1 (pt) 2023-01-03
EP3071191A1 (en) 2016-09-28
CN105764493B (zh) 2020-02-21
US10702482B2 (en) 2020-07-07
KR102224087B1 (ko) 2021-03-10
KR20160086829A (ko) 2016-07-20
MX367664B (es) 2019-08-30
MX2016006442A (es) 2016-12-09
HUE058086T2 (hu) 2022-07-28
US20160287519A1 (en) 2016-10-06
IL245167B (en) 2020-04-30
PH12016500693A1 (en) 2016-05-30
EA201691034A1 (ru) 2016-09-30

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