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 PDFInfo
- 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
Links
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
- A61K9/0012—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
- A61K31/33—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
- 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)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Anesthesiology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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 (enExample) |
| EP (2) | EP3027179B1 (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 (10)
| 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 |
| CA3022840A1 (en) | 2016-05-05 | 2017-11-09 | Aquestive Therapeutics, Inc. | Enhanced delivery epinephrine compositions |
| 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 |
| EP3687509A1 (en) * | 2017-09-27 | 2020-08-05 | 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)
| 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 |
| RU2380092C2 (ru) * | 2004-01-30 | 2010-01-27 | Кориум Интернэшнл, Инк. | Быстро растворяющаяся пленка для доставки активного агента |
| 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 |
| EP2361081B1 (en) * | 2008-10-14 | 2016-06-29 | McNeil AB | Multi portion intra-oral dosage form and use thereof |
| 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 |
| CN102665762A (zh) * | 2009-11-24 | 2012-09-12 | 巴斯夫欧洲公司 | 膜状药物剂型 |
| 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 |
| MX2013008314A (es) * | 2011-01-17 | 2013-09-26 | Takeda Pharmaceutical | Tableta dispersable en forma oral. |
| KR101303479B1 (ko) * | 2011-07-28 | 2013-09-06 | (주)씨엘팜 | 가식성 필름형성 조성물 및 약물이 함유된 가식성 필름형 제제 |
| TWI671085B (zh) * | 2013-05-10 | 2019-09-11 | 韓商西梯茜生命工學股份有限公司 | 含有多奈哌齊游離鹽基之膜配方及其之製造方法 |
-
2014
- 2014-07-30 HK HK16111016.9A patent/HK1222796A1/zh unknown
- 2014-07-30 EP EP14832172.2A patent/EP3027179B1/en active Active
- 2014-07-30 AU AU2014298130A patent/AU2014298130A1/en not_active Abandoned
- 2014-07-30 WO PCT/IB2014/002047 patent/WO2015015303A2/en not_active Ceased
- 2014-07-30 RU RU2016106907A patent/RU2016106907A/ru not_active Application Discontinuation
- 2014-07-30 JP JP2016530631A patent/JP6482552B2/ja not_active Expired - Fee Related
- 2014-07-30 MX MX2016001399A patent/MX366595B/es active IP Right Grant
- 2014-07-30 ES ES14832172T patent/ES2706481T3/es active Active
- 2014-07-30 KR KR1020167005581A patent/KR102272442B1/ko active Active
- 2014-07-30 DK DK14832172.2T patent/DK3027179T3/en active
- 2014-07-30 BR BR112016002074-0A patent/BR112016002074B1/pt active IP Right Grant
- 2014-07-30 EP EP18192084.4A patent/EP3427732A1/en not_active Withdrawn
- 2014-07-30 CN CN201480043392.8A patent/CN105530921B/zh active Active
- 2014-07-30 CA CA2919442A patent/CA2919442A1/en not_active Abandoned
- 2014-07-30 SG SG11201600455XA patent/SG11201600455XA/en unknown
- 2014-07-30 US US14/447,071 patent/US9301948B2/en active Active
-
2016
- 2016-01-18 IL IL243651A patent/IL243651A0/en unknown
- 2016-01-21 CL CL2016000160A patent/CL2016000160A1/es unknown
- 2016-02-04 ZA ZA2016/00785A patent/ZA201600785B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| IL243651A0 (en) | 2016-02-29 |
| CA2919442A1 (en) | 2015-02-05 |
| JP2016527262A (ja) | 2016-09-08 |
| ZA201600785B (en) | 2017-04-26 |
| US20150038540A1 (en) | 2015-02-05 |
| SG11201600455XA (en) | 2016-02-26 |
| KR102272442B1 (ko) | 2021-07-02 |
| KR20160089335A (ko) | 2016-07-27 |
| EP3027179B1 (en) | 2018-10-17 |
| MX2016001399A (es) | 2016-10-28 |
| MX366595B (es) | 2019-07-15 |
| WO2015015303A2 (en) | 2015-02-05 |
| HK1222796A1 (zh) | 2017-07-14 |
| WO2015015303A3 (en) | 2015-05-21 |
| JP6482552B2 (ja) | 2019-03-13 |
| BR112016002074A2 (pt) | 2017-08-01 |
| CL2016000160A1 (es) | 2016-11-18 |
| RU2016106907A (ru) | 2017-09-01 |
| EP3427732A1 (en) | 2019-01-16 |
| CN105530921B (zh) | 2021-02-26 |
| AU2014298130A1 (en) | 2016-02-11 |
| DK3027179T3 (en) | 2019-02-11 |
| CN105530921A (zh) | 2016-04-27 |
| US9301948B2 (en) | 2016-04-05 |
| EP3027179A2 (en) | 2016-06-08 |
| EP3027179A4 (en) | 2017-02-22 |
| ES2706481T3 (es) | 2019-03-29 |
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Legal Events
| Date | Code | Title | Description |
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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 |
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| 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 |