CN105530921B - 不含表面活性剂或多元醇的即时可湿性口服薄膜剂型 - Google Patents

不含表面活性剂或多元醇的即时可湿性口服薄膜剂型 Download PDF

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Publication number
CN105530921B
CN105530921B CN201480043392.8A CN201480043392A CN105530921B CN 105530921 B CN105530921 B CN 105530921B CN 201480043392 A CN201480043392 A CN 201480043392A CN 105530921 B CN105530921 B CN 105530921B
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China
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dosage form
instant
wettable
film
fast disintegrating
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CN201480043392.8A
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English (en)
Chinese (zh)
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CN105530921A (zh
Inventor
霍斯特·G·泽布
A·安格斯提
N·帕耶蒙特
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Lizha Oral Film Company
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IntelGenx Corp
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    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201480043392.8A 2013-07-31 2014-07-30 不含表面活性剂或多元醇的即时可湿性口服薄膜剂型 Active CN105530921B (zh)

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 (2)

Publication Number Publication Date
CN105530921A CN105530921A (zh) 2016-04-27
CN105530921B true CN105530921B (zh) 2021-02-26

Family

ID=52428223

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CN201480043392.8A Active CN105530921B (zh) 2013-07-31 2014-07-30 不含表面活性剂或多元醇的即时可湿性口服薄膜剂型

Country Status (18)

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

Families Citing this family (10)

* 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
KR20230137362A (ko) 2016-05-05 2023-10-04 어퀘스티브 테라퓨틱스, 아이엔씨. 강화된 전달 에프네프린 조성물
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
CA3076815A1 (en) * 2017-09-27 2019-04-04 Aquestive Therapeutics, Inc. Pharmaceutical compositions with enhanced permeation
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
EP4422607A4 (en) 2021-10-25 2025-09-03 Aquestive Therapeutics Inc ORAL AND NASAL COMPOSITIONS AND METHODS OF TREATMENT

Citations (2)

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CA2704079A1 (en) * 2007-12-11 2009-06-18 Novartis Ag Multi-zone films
CN102186461A (zh) * 2008-10-14 2011-09-14 麦克内尔股份公司 多部分口腔内剂型及其用途

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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
US7470397B2 (en) * 2003-10-24 2008-12-30 Adhesives Research, Inc. Disintegratable films for diagnostic devices
WO2005074894A1 (en) * 2004-01-30 2005-08-18 Corium International Rapidly dissolving film for delivery of an active agent
US20050281757A1 (en) * 2004-06-17 2005-12-22 Sayed Ibrahim Oral care film
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
JP2013511565A (ja) * 2009-11-24 2013-04-04 ビーエーエスエフ ソシエタス・ヨーロピア フィルム様医薬剤形
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
UY33869A (es) * 2011-01-17 2012-08-31 Takeda Pharmaceutical Comprimido dispersable por vía oral
KR101303479B1 (ko) * 2011-07-28 2013-09-06 (주)씨엘팜 가식성 필름형성 조성물 및 약물이 함유된 가식성 필름형 제제
CN105324111B (zh) * 2013-05-10 2019-06-28 西梯茜生命工学股份有限公司 含多奈哌齐游离碱的薄膜制剂及其制备方法

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CN102186461A (zh) * 2008-10-14 2011-09-14 麦克内尔股份公司 多部分口腔内剂型及其用途

Also Published As

Publication number Publication date
EP3027179A2 (en) 2016-06-08
RU2016106907A (ru) 2017-09-01
BR112016002074A2 (pt) 2017-08-01
MX366595B (es) 2019-07-15
US9301948B2 (en) 2016-04-05
BR112016002074B1 (pt) 2023-01-24
CN105530921A (zh) 2016-04-27
CA2919442A1 (en) 2015-02-05
EP3427732A1 (en) 2019-01-16
SG11201600455XA (en) 2016-02-26
KR102272442B1 (ko) 2021-07-02
CL2016000160A1 (es) 2016-11-18
ZA201600785B (en) 2017-04-26
MX2016001399A (es) 2016-10-28
US20150038540A1 (en) 2015-02-05
JP6482552B2 (ja) 2019-03-13
KR20160089335A (ko) 2016-07-27
EP3027179B1 (en) 2018-10-17
IL243651A0 (en) 2016-02-29
JP2016527262A (ja) 2016-09-08
WO2015015303A3 (en) 2015-05-21
WO2015015303A2 (en) 2015-02-05
DK3027179T3 (en) 2019-02-11
HK1222796A1 (zh) 2017-07-14
AU2014298130A1 (en) 2016-02-11
EP3027179A4 (en) 2017-02-22
ES2706481T3 (es) 2019-03-29

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