BR112016002074B1 - Película oral de desintegração rápida e instantaneamente molhável isenta de tensoativo ou poliálcool - Google Patents

Película oral de desintegração rápida e instantaneamente molhável isenta de tensoativo ou poliálcool Download PDF

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Publication number
BR112016002074B1
BR112016002074B1 BR112016002074-0A BR112016002074A BR112016002074B1 BR 112016002074 B1 BR112016002074 B1 BR 112016002074B1 BR 112016002074 A BR112016002074 A BR 112016002074A BR 112016002074 B1 BR112016002074 B1 BR 112016002074B1
Authority
BR
Brazil
Prior art keywords
film
oral film
oral
water
vinylpyrrolidone
Prior art date
Application number
BR112016002074-0A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112016002074A2 (pt
Inventor
Horst G. Zerbe
Angela Angusti
Nadine Paiement
Original Assignee
Intelgenx Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52428223&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016002074(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Intelgenx Corp filed Critical Intelgenx Corp
Publication of BR112016002074A2 publication Critical patent/BR112016002074A2/pt
Publication of BR112016002074B1 publication Critical patent/BR112016002074B1/pt

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41961,2,4-Triazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/42Oxazoles
    • A61K31/422Oxazoles not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/473Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • A61K31/55131,4-Benzodiazepines, e.g. diazepam or clozapine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551Heterocyclic 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
    • A61K31/55131,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/55171,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives

Landscapes

  • 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)
BR112016002074-0A 2013-07-31 2014-07-30 Película oral de desintegração rápida e instantaneamente molhável isenta de tensoativo ou poliálcool BR112016002074B1 (pt)

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
BR112016002074A2 BR112016002074A2 (pt) 2017-08-01
BR112016002074B1 true BR112016002074B1 (pt) 2023-01-24

Family

ID=52428223

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016002074-0A BR112016002074B1 (pt) 2013-07-31 2014-07-30 Película oral de desintegração rápida e instantaneamente molhável isenta de tensoativo ou poliálcool

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

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
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
BRPI0821608A2 (pt) * 2007-12-11 2015-09-29 Novartis Ag filmes de multizona
JP2012505878A (ja) * 2008-10-14 2012-03-08 マクニール アーベー 複数部分口内剤形及びその使用
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

Also Published As

Publication number Publication date
EP3027179A2 (en) 2016-06-08
CN105530921B (zh) 2021-02-26
RU2016106907A (ru) 2017-09-01
BR112016002074A2 (pt) 2017-08-01
MX366595B (es) 2019-07-15
US9301948B2 (en) 2016-04-05
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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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/07/2014, OBSERVADAS AS CONDICOES LEGAIS