DK2802311T3 - Sublingual farmaceutisk sammensætning indeholdende et antihistaminmiddel og fremgangsmåde til fremstilling deraf - Google Patents

Sublingual farmaceutisk sammensætning indeholdende et antihistaminmiddel og fremgangsmåde til fremstilling deraf Download PDF

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Publication number
DK2802311T3
DK2802311T3 DK11779098.0T DK11779098T DK2802311T3 DK 2802311 T3 DK2802311 T3 DK 2802311T3 DK 11779098 T DK11779098 T DK 11779098T DK 2802311 T3 DK2802311 T3 DK 2802311T3
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DK
Denmark
Prior art keywords
sublingual
dimenhydrinate
numbness
excipient
tablets
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Application number
DK11779098.0T
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English (en)
Inventor
Evangelos Karavas
Efthimios Koutris
Vicky Samara
Amalia Diakidou
Aggelos Karatzas
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Expermed S A
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Publication of DK2802311T3 publication Critical patent/DK2802311T3/da

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    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Claims (4)

SUBLINGUAL FARMACEUTISK SAMMENSÆTNING INDEHOLDENDE ET ANTIHISTAMINMIDDEL OG FREMGANGSMÅDE TIL FREMSTILLING DERAF
1. Tablet til sublingual administration omfattende dimenhydrinat eller et farmaceutisk acceptabelt salt deraf, en effektiv mængde pH-afhængigt hjælpestof som smagsmaskerende middel til at reducere slimhindens følelsesløshed, hvori hjælpestoffet er uopløseligt i surt miljø og opløseligt under neutrale eller basiske betingelser, og et ekstragranulært desintegrerende middel, hvori det smagsmaskerende middel, som reducerer slimhindens følelsesløshed, er poly(methacylsyre-co-methylmethacrylat) 1:1 i en mængde fra 5 til 50 vægt-% af sammensætningens samlede vægt, og det ekstragranulære desintegrerende middel er natriumstivelsesglycolat.
2. Farmaceutisk sammensætning ifølge krav 1, yderligere omfattende mindst et farmaceutisk acceptabelt hjælpestof valgt fra diluenter, smagsforbedrende midler, flydereguleringsmidler og smøremidler.
3. Farmaceutisk sammensætning ifølge krav 1, yderligere omfattende mikrokrystallinsk cellulose, spraytørret mannitol, natriumstivelsesglycolat, vaniljearoma, saccharinsyre, vandfri koloid silica, magnesiumstearat, menthol og talkum.
4. Fremgangsmåde til fremstilling af en tablet til sublingual administration omfattende dimenhydrinat eller et farmaceutisk acceptabelt salt deraf, en effektiv mængde pH-afhængigt hjælpestof som smagsmaskerende middel til at reducere slimhindens følelsesløshed, hvori hjælpestoffet er uopløseligt i surt miljø og opløseligt under neutrale eller basiske betingelser og et ekstragranulært desintegrerende middel, hvori fremgangsmåden omfatter: - blanding af det aktive indholdsstof med det pH-afhængige hjælpestof, med mindst et farmaceutisk acceptabelt hjælpestof valgt fra diluenter, smagsforbedrende midler, flydereguleringsmidler og smøremidler indtil fuldstændig homogenitet; - æltning af ovenstående blanding med ethanol og blanding indtil ensartethed; - tørring af den befugtede masse; - sining af den tørrede masse og tilsætning til den siede blanding af det ekstragranulære desintegrerende middel og blanding indtil ensartet; - tilsætning til den opnåede blanding af mindst et farmaceutisk acceptabelt hjælpestof valgt fra flydereguleringsmidler og smøremidler og blanding indtil fuldstændig ensartethed er opnået; - komprimering af den resulterende blanding til en sublingual tabletdoseringsform; - valgfrit, påføring af et overtræk, hvori det smagsmaskerende middel, som reducerer slimhindens følelsesløshed, er poly(methacylsyre-co-methylmethacrylat) 1:1 i en mængde fra 5 til 50 vægt-% af sammensætningens samlede vægt, og det ekstragranulære desintegrerende middel er natriumstivelsesglycolat.
DK11779098.0T 2011-10-25 2011-10-25 Sublingual farmaceutisk sammensætning indeholdende et antihistaminmiddel og fremgangsmåde til fremstilling deraf DK2802311T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2011/005374 WO2013060343A1 (en) 2011-10-25 2011-10-25 Sublingual pharmaceutical composition containing an antihistamine agent and method for the preparation thereof

Publications (1)

Publication Number Publication Date
DK2802311T3 true DK2802311T3 (da) 2019-04-08

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DK11779098.0T DK2802311T3 (da) 2011-10-25 2011-10-25 Sublingual farmaceutisk sammensætning indeholdende et antihistaminmiddel og fremgangsmåde til fremstilling deraf

Country Status (7)

Country Link
US (1) US9675551B2 (da)
EP (1) EP2802311B1 (da)
AU (1) AU2011379627B2 (da)
CA (1) CA2853117C (da)
DK (1) DK2802311T3 (da)
PT (1) PT2802311T (da)
WO (1) WO2013060343A1 (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140341988A1 (en) * 2013-05-15 2014-11-20 Apr Applied Pharma Research Sa Orally dispersible drug formulations
US9855227B2 (en) 2015-12-18 2018-01-02 The Procter & Gamble Company Quick dissolving diphenhydramine oral dosage form
US11364244B2 (en) 2018-04-25 2022-06-21 Oncocross Co., Ltd. Compositions for treatment of muscular disorders
WO2022153334A1 (en) * 2021-01-15 2022-07-21 Jubilant Generics Ltd Transmucosal dosage forms of foscarnet

Family Cites Families (14)

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IT1274241B (it) * 1993-12-03 1997-07-15 Smithkline Beecham Farma Complessi agente terapeutico/matrice polimerica dotati di migliorate caratteristiche di sapore e composizioni farmaceutiche che li contengono
AR016827A1 (es) * 1997-08-22 2001-08-01 Smithkline Beecham Corp PROCEDIMIENTO PARA LA PREPARACIoN DE UNA TABLETA FARMACÉUTICA
US6127385A (en) * 1999-03-04 2000-10-03 Pharmaquest Limited Method of treating depression using l-threo-methylphenidate
US20020119196A1 (en) 2000-12-21 2002-08-29 Narendra Parikh Texture masked particles containing an active ingredient
KR100672184B1 (ko) * 2004-09-21 2007-01-19 주식회사종근당 파록세틴의 콜린산 또는 콜린산 유도체 염
US20060127479A1 (en) 2004-10-08 2006-06-15 Natrajan Kumaraperumal Solvent free taste masked pharmaceutical compositions
US20070077300A1 (en) 2005-09-30 2007-04-05 Wynn David W Oral compositions containing a salivation inducing agent
US20070092553A1 (en) * 2005-10-21 2007-04-26 Pfab Lp Compositions and methods of making rapidly dissolving lonically masked formulations
RU2472493C2 (ru) * 2007-05-08 2013-01-20 Геркулес Инкорпорейтед Композиция прочной быстро распадающейся таблетки
US20090004254A1 (en) * 2007-06-19 2009-01-01 Todd Maibach Film comprising active drugs
ITMI20071971A1 (it) * 2007-10-10 2009-04-11 Altergon Sa Composizione farmaceutica per la somministrazione sublinguale di progesterone, e metodo per la sua preparazione
WO2009078034A2 (en) * 2007-11-26 2009-06-25 Rubicon Research Private Limited Oral disintegrating tablets of ropinirole hydrochloride
US20100215730A1 (en) * 2009-02-20 2010-08-26 Intrepid Therapeutics, Inc. Compositions for Nasal Administration of Phenothiazines
WO2011024029A1 (en) 2009-08-24 2011-03-03 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Fast disintegrating dosage forms of cinnarizine and dimenhydrinate combination

Also Published As

Publication number Publication date
EP2802311A1 (en) 2014-11-19
US9675551B2 (en) 2017-06-13
EP2802311B1 (en) 2018-12-12
WO2013060343A1 (en) 2013-05-02
CA2853117C (en) 2018-08-07
CA2853117A1 (en) 2013-05-02
AU2011379627A1 (en) 2014-05-22
US20140235656A1 (en) 2014-08-21
PT2802311T (pt) 2019-03-19
AU2011379627B2 (en) 2015-09-10

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