JP6482552B2 - 界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形 - Google Patents

界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形 Download PDF

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Publication number
JP6482552B2
JP6482552B2 JP2016530631A JP2016530631A JP6482552B2 JP 6482552 B2 JP6482552 B2 JP 6482552B2 JP 2016530631 A JP2016530631 A JP 2016530631A JP 2016530631 A JP2016530631 A JP 2016530631A JP 6482552 B2 JP6482552 B2 JP 6482552B2
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JP
Japan
Prior art keywords
film
oral film
copolymer
oral
vinylpyrrolidone
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.)
Expired - Fee Related
Application number
JP2016530631A
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English (en)
Japanese (ja)
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JP2016527262A5 (enExample
JP2016527262A (ja
Inventor
オルスト・ジ・ゼルブ
アンジェラ・アングスティ
ナディーヌ・ペマン
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Nualtis Corp
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IntelGenx Corp
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Application filed by IntelGenx Corp filed Critical IntelGenx Corp
Publication of JP2016527262A publication Critical patent/JP2016527262A/ja
Publication of JP2016527262A5 publication Critical patent/JP2016527262A5/ja
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Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/422—Oxazoles not condensed and containing further 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0012—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/20—Hypnotics; Sedatives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2016530631A 2013-07-31 2014-07-30 界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形 Expired - Fee Related JP6482552B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361860345P 2013-07-31 2013-07-31
US61/860,345 2013-07-31
PCT/IB2014/002047 WO2015015303A2 (en) 2013-07-31 2014-07-30 Instantly wettable oral film dosage form without surfactant or polyalcohol

Publications (3)

Publication Number Publication Date
JP2016527262A JP2016527262A (ja) 2016-09-08
JP2016527262A5 JP2016527262A5 (enExample) 2017-09-07
JP6482552B2 true JP6482552B2 (ja) 2019-03-13

Family

ID=52428223

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016530631A Expired - Fee Related JP6482552B2 (ja) 2013-07-31 2014-07-30 界面活性剤および多価アルコールを有さず直ちに湿潤可能な経口フィルム剤形

Country Status (18)

Country Link
US (1) US9301948B2 (enExample)
EP (2) EP3427732A1 (enExample)
JP (1) JP6482552B2 (enExample)
KR (1) KR102272442B1 (enExample)
CN (1) CN105530921B (enExample)
AU (1) AU2014298130A1 (enExample)
BR (1) BR112016002074B1 (enExample)
CA (1) CA2919442A1 (enExample)
CL (1) CL2016000160A1 (enExample)
DK (1) DK3027179T3 (enExample)
ES (1) ES2706481T3 (enExample)
HK (1) HK1222796A1 (enExample)
IL (1) IL243651A0 (enExample)
MX (1) MX366595B (enExample)
RU (1) RU2016106907A (enExample)
SG (1) SG11201600455XA (enExample)
WO (1) WO2015015303A2 (enExample)
ZA (1) ZA201600785B (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160220480A1 (en) * 2015-02-03 2016-08-04 Intelgenx Corp. Oral dosage film exhibiting enhanced mucosal penetration
US20190133925A1 (en) 2016-03-11 2019-05-09 Intelgenx Corp. Method of treatment and device for the improved bioavailability of leukotriene receptor antagonists
CN122182527A (zh) 2016-05-05 2026-06-12 阿奎斯蒂弗医疗股份有限公司 增强递送的肾上腺素组合物
CN105997955B (zh) 2016-06-28 2017-09-12 力品药业（厦门）有限公司 一种帕洛诺司琼口腔膜剂及其制备方法
KR101802183B1 (ko) * 2016-11-16 2017-11-28 주식회사 유영제약 팔로노세트론을 활성성분으로 함유하는 약제학적 조성물
JP7431724B2 (ja) * 2017-09-27 2024-02-15 アクエスティブ セラピューティクス インコーポレイテッド 増強された透過を有する医薬組成物
DE102017127452A1 (de) * 2017-11-21 2019-05-23 Lts Lohmann Therapie-Systeme Ag Wasserlösliche Polymerklebschichten
US10828254B2 (en) 2018-09-28 2020-11-10 Intelgenx Corp. Oral film formulation for modulating absorption profile
US12303501B2 (en) 2018-11-05 2025-05-20 Intelgenx Corp. Lipophilic active oral film formulation and method of making the same
US12440472B2 (en) 2021-06-16 2025-10-14 Intelgenx Corp. Stable tryptamine oral films
US12629380B2 (en) 2021-08-25 2026-05-19 Swipp Ab Oral film unit dosage form
WO2023076281A1 (en) 2021-10-25 2023-05-04 Aquestive Therapeutics, Inc. Oral and nasal compositions and methods of treatment
US12648905B2 (en) 2022-01-19 2026-06-09 Intelgenx Corp. Oral films with flavor entrapment

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19646392A1 (de) 1996-11-11 1998-05-14 Lohmann Therapie Syst Lts Zubereitung zur Anwendung in der Mundhöhle mit einer an der Schleimhaut haftklebenden, Pharmazeutika oder Kosmetika zur dosierten Abgabe enthaltenden Schicht
JP3460538B2 (ja) * 1997-10-08 2003-10-27 救急薬品工業株式会社 速溶性フィルム製剤
US7027414B2 (en) * 2001-08-09 2006-04-11 Hughes Network Systems, Llc Method, apparatus, and system for identifying and efficiently treating classes of traffic
CA2543350C (en) * 2003-10-24 2011-04-26 Adhesives Research, Inc. Disintegratable films for diagnostic devices
KR20070007299A (ko) * 2004-01-30 2007-01-15 코리움 인터네셔널, 인크. 활성제의 전달을 위한 급속 용해 필름
US20050281757A1 (en) * 2004-06-17 2005-12-22 Sayed Ibrahim Oral care film
KR20100095581A (ko) * 2007-12-11 2010-08-31 노파르티스 아게 다-영역 필름
PT2361081T (pt) * 2008-10-14 2016-09-05 Mcneil Ab Forma de dosagem intra-oral multiporção e seu uso
US8715715B2 (en) * 2008-11-03 2014-05-06 Nal Pharmaceuticals Ltd. Dosage form for insertion into the mouth
US20100285130A1 (en) * 2009-05-06 2010-11-11 Monosol Rx, Llc Coating of complexed actives in film formulations
US20120244197A1 (en) * 2009-11-24 2012-09-27 Basf Se Film-Like Pharmaceutical Dosage Forms
US20110136815A1 (en) 2009-12-08 2011-06-09 Horst Zerbe Solid oral film dosage forms and methods for making same
US20110263606A1 (en) * 2010-04-26 2011-10-27 Horst Zerbe Solid oral dosage forms comprising tadalafil
JP2012031164A (ja) * 2010-07-06 2012-02-16 Teika Seiyaku Kk フィルム状製剤
JP5587168B2 (ja) * 2010-12-28 2014-09-10 花王株式会社 医療器具用洗浄剤組成物
JP5600747B2 (ja) * 2011-01-17 2014-10-01 武田薬品工業株式会社 口腔内分散性製剤
KR101303479B1 (ko) * 2011-07-28 2013-09-06 (주)씨엘팜 가식성 필름형성 조성물 및 약물이 함유된 가식성 필름형 제제
RU2671487C2 (ru) * 2013-05-10 2018-11-01 СиТиСи БАЙО, ИНК. Препарат в форме пленки, содержащий свободное основание донепезила, и способ его получения

Also Published As

Publication number Publication date
HK1222796A1 (zh) 2017-07-14
US9301948B2 (en) 2016-04-05
CN105530921B (zh) 2021-02-26
EP3027179A2 (en) 2016-06-08
MX2016001399A (es) 2016-10-28
EP3027179A4 (en) 2017-02-22
WO2015015303A2 (en) 2015-02-05
CN105530921A (zh) 2016-04-27
RU2016106907A (ru) 2017-09-01
ES2706481T3 (es) 2019-03-29
WO2015015303A3 (en) 2015-05-21
EP3027179B1 (en) 2018-10-17
MX366595B (es) 2019-07-15
US20150038540A1 (en) 2015-02-05
DK3027179T3 (en) 2019-02-11
EP3427732A1 (en) 2019-01-16
CA2919442A1 (en) 2015-02-05
JP2016527262A (ja) 2016-09-08
SG11201600455XA (en) 2016-02-26
BR112016002074B1 (pt) 2023-01-24
ZA201600785B (en) 2017-04-26
CL2016000160A1 (es) 2016-11-18
AU2014298130A1 (en) 2016-02-11
IL243651A0 (en) 2016-02-29
KR20160089335A (ko) 2016-07-27
BR112016002074A2 (pt) 2017-08-01
KR102272442B1 (ko) 2021-07-02

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