JP6294479B2 - 経口分散性フィルム - Google Patents

経口分散性フィルム Download PDF

Info

Publication number
JP6294479B2
JP6294479B2 JP2016531580A JP2016531580A JP6294479B2 JP 6294479 B2 JP6294479 B2 JP 6294479B2 JP 2016531580 A JP2016531580 A JP 2016531580A JP 2016531580 A JP2016531580 A JP 2016531580A JP 6294479 B2 JP6294479 B2 JP 6294479B2
Authority
JP
Japan
Prior art keywords
dispersible film
film
weight
oral
mouth
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
JP2016531580A
Other languages
English (en)
Japanese (ja)
Other versions
JP2016525572A (ja
JP2016525572A5 (enExample
Inventor
ボージェス，アナ フィリパ シルバ
ボージェス，アナ フィリパ シルバ
シルバ，ブランカ マルガリーダ アルメイダ
シルバ，ブランカ マルガリーダ アルメイダ
コエルホ，ジョージ フェルナンド ジョルダン
コエルホ，ジョージ フェルナンド ジョルダン
シルバ，クラウディア ソウサ
シルバ，クラウディア ソウサ
パウロ シモンエス，セルジオ
パウロ シモンエス，セルジオ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bluepharma Industria Farmaceutica sA
Original Assignee
Bluepharma Industria Farmaceutica sA
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
Application filed by Bluepharma Industria Farmaceutica sA filed Critical Bluepharma Industria Farmaceutica sA
Publication of JP2016525572A publication Critical patent/JP2016525572A/ja
Publication of JP2016525572A5 publication Critical patent/JP2016525572A5/ja
Application granted granted Critical
Publication of JP6294479B2 publication Critical patent/JP6294479B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Manufacture Of Macromolecular Shaped Articles (AREA)
JP2016531580A 2013-07-31 2014-07-31 経口分散性フィルム Expired - Fee Related JP6294479B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361860516P 2013-07-31 2013-07-31
US61/860,516 2013-07-31
PCT/PT2014/000050 WO2015016727A2 (en) 2013-07-31 2014-07-31 Oral dispersible films

Publications (3)

Publication Number Publication Date
JP2016525572A JP2016525572A (ja) 2016-08-25
JP2016525572A5 JP2016525572A5 (enExample) 2017-09-07
JP6294479B2 true JP6294479B2 (ja) 2018-03-14

Family

ID=51535496

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2016531580A Expired - Fee Related JP6294479B2 (ja) 2013-07-31 2014-07-31 経口分散性フィルム

Country Status (8)

Country Link
US (1) US9603935B2 (enExample)
EP (1) EP3027172B1 (enExample)
JP (1) JP6294479B2 (enExample)
CN (1) CN105682639B (enExample)
BR (1) BR112016002205A2 (enExample)
ES (1) ES2835258T3 (enExample)
HK (1) HK1225624A1 (enExample)
WO (1) WO2015016727A2 (enExample)

Families Citing this family (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8701671B2 (en) 2011-02-04 2014-04-22 Joseph E. Kovarik Non-surgical method and system for reducing snoring
US9549842B2 (en) 2011-02-04 2017-01-24 Joseph E. Kovarik Buccal bioadhesive strip and method of treating snoring and sleep apnea
US11998479B2 (en) 2011-02-04 2024-06-04 Seed Health, Inc. Method and system for addressing adverse effects on the oral microbiome and restoring gingival health caused by sodium lauryl sulphate exposure
US11844720B2 (en) 2011-02-04 2023-12-19 Seed Health, Inc. Method and system to reduce the likelihood of dental caries and halitosis
US12257272B2 (en) 2015-12-24 2025-03-25 Seed Health, Inc. Method and system for reducing the likelihood of developing depression in an individual
US11951139B2 (en) 2015-11-30 2024-04-09 Seed Health, Inc. Method and system for reducing the likelihood of osteoporosis
US11357722B2 (en) 2011-02-04 2022-06-14 Seed Health, Inc. Method and system for preventing sore throat in humans
US12279989B2 (en) 2011-02-04 2025-04-22 Seed Health, Inc. Method and system for increasing beneficial bacteria and decreasing pathogenic bacteria in the oral cavity
US11951140B2 (en) 2011-02-04 2024-04-09 Seed Health, Inc. Modulation of an individual's gut microbiome to address osteoporosis and bone disease
US12005085B2 (en) 2013-12-20 2024-06-11 Seed Health, Inc. Probiotic method and composition for maintaining a healthy vaginal microbiome
US11969445B2 (en) 2013-12-20 2024-04-30 Seed Health, Inc. Probiotic composition and method for controlling excess weight, obesity, NAFLD and NASH
US11998574B2 (en) 2013-12-20 2024-06-04 Seed Health, Inc. Method and system for modulating an individual's skin microbiome
US11826388B2 (en) 2013-12-20 2023-11-28 Seed Health, Inc. Topical application of Lactobacillus crispatus to ameliorate barrier damage and inflammation
US12246043B2 (en) 2013-12-20 2025-03-11 Seed Health, Inc. Topical application to treat acne vulgaris
US11839632B2 (en) 2013-12-20 2023-12-12 Seed Health, Inc. Topical application of CRISPR-modified bacteria to treat acne vulgaris
US11833177B2 (en) 2013-12-20 2023-12-05 Seed Health, Inc. Probiotic to enhance an individual's skin microbiome
US11980643B2 (en) 2013-12-20 2024-05-14 Seed Health, Inc. Method and system to modify an individual's gut-brain axis to provide neurocognitive protection
US12329783B2 (en) 2013-12-20 2025-06-17 Seed Health, Inc. Method and system to improve the health of a person's skin microbiome
PL3381448T3 (pl) * 2015-11-25 2025-04-14 Tbm Company Błona hemostatyczna i do ochrony ran w jamie ustnej
US12239706B2 (en) 2015-11-30 2025-03-04 Seed Health, Inc. Method and system for protecting monarch butterflies from pesticides
HRP20240453T1 (hr) * 2016-04-14 2024-06-21 Sensorion (+)-azasetron za uporabu u liječenju poremećaja uha
CN106619577A (zh) * 2016-10-08 2017-05-10 中国药科大学 一种新型氯雷他定口腔速溶膜及其制备方法
MY195591A (en) 2017-01-11 2023-02-02 Ferring Bv A Fast Disintegrating Pharmaceutical Composition
US11154585B2 (en) * 2017-01-18 2021-10-26 Pharmathen S.A. Orodispersible film composition comprising enalapril for the treatment of hypertension in a pediatric population
US20200197366A1 (en) * 2017-08-08 2020-06-25 Kashiv Biosciences, Llc Pharmaceutical composition comprising eliglustat
US12472144B2 (en) 2017-08-08 2025-11-18 Amneal Pharmaceuticals Llc Pharmaceutical composition comprising eliglustat
WO2020055547A2 (en) 2018-08-18 2020-03-19 Seed Health, Inc. Methods and compositions for honey bee health
US11235013B2 (en) * 2018-09-04 2022-02-01 Babak Ghalili Cannabinoid, menthol and caffeine dissolvable film compositions, devices and methods
US11185526B2 (en) * 2018-09-04 2021-11-30 Babak Ghalili Cannabinoid, menthol and caffeine dissolvable film compositions, devices and methods
CN108785289A (zh) * 2018-09-06 2018-11-13 北京太阳升高科医药研究股份有限公司 盐酸那拉曲坦口溶膜剂及其制备方法
WO2020061584A1 (en) * 2018-09-21 2020-03-26 Msb Holdings, Inc. Taste-masked dosage forms
CN111166730A (zh) * 2018-11-13 2020-05-19 杨守忠 盐酸金刚烷胺的速释口溶膜及其制备方法和应用
IT201800020185A1 (it) * 2018-12-19 2020-06-19 Davide Fiumi Formulazioni contenenti vitamina d3 in film edibile per il trattamento di pazienti affetti da malassorbimento
CN109793201B (zh) * 2019-03-26 2022-08-09 武汉轻工大学 一种天然复合甜味剂及其制备方法和新型挤压面筋
CN112569208B (zh) * 2019-09-29 2023-10-31 四川科伦药物研究院有限公司 一种盐酸普拉克索药物组合物及其制备方法
US20210187858A1 (en) * 2019-12-18 2021-06-24 Dieu Cam Vuong Method and system for manufacturing of pharmaceutical formulas in form of orally disintegrating films (odf)
MX2022012499A (es) 2020-04-07 2022-12-15 Church & Dwight Co Inc Composicion detergente de lavanderia.
CN111388455B (zh) * 2020-04-09 2022-09-02 沈阳药科大学 一种依维莫司口腔膜剂及其制备方法
US20230330036A1 (en) * 2022-04-13 2023-10-19 Oak Therapeutics, Inc. Long acting, continuous oral release from oral dispersing strips (ods) addressing the need for high dosage of active ingredients
US12109303B2 (en) 2022-04-18 2024-10-08 ISHA Therapeutics LLC Orally dissolving antimicrobial film compositions and methods of their use
CN119317415A (zh) * 2022-05-21 2025-01-14 纽视发展有限责任公司 用于眼部疼痛的氨溴索的表面眼部施用
CN114886877B (zh) * 2022-06-16 2024-02-02 北京海泰天正医药科技有限公司 奥氮平氟西汀复方口溶膜及其制备方法
CN114983984B (zh) * 2022-07-26 2023-09-01 山东达因海洋生物制药股份有限公司 一种用于哮喘治疗复方口溶膜剂及其制备方法
CN118045064B (zh) * 2022-11-16 2025-08-26 上海云晟研新生物科技有限公司 一种地氯雷他定口溶膜组合物、其制备方法及应用
WO2024224405A1 (en) * 2023-04-28 2024-10-31 Lucky 4U Exims Oral dispersible film of mitragynine
GB2629820A (en) 2023-05-11 2024-11-13 Fitabeo Therapeutics Ltd Oral thin film formulations
WO2025026438A1 (zh) * 2023-08-03 2025-02-06 上海云晟研新生物科技有限公司 普拉克索口溶膜组合物、其制备方法及应用
CN118252821B (zh) * 2024-05-28 2024-08-13 山东则正医药技术有限公司 与片剂生物等效的特立氟胺口溶膜及其制备方法和应用
CN118236356B (zh) * 2024-05-28 2024-08-16 山东则正医药技术有限公司 一种特立氟胺口溶膜及其制备方法、应用和药物组合物
CN118453550A (zh) * 2024-06-13 2024-08-09 上海欣峰制药有限公司 一种昂丹司琼口溶膜剂及其制备方法
CN119139272A (zh) * 2024-09-02 2024-12-17 华中药业股份有限公司 一种艾司唑仑口腔速溶膜剂及其制备方法
CN120324355B (zh) * 2025-06-16 2025-08-26 山东第一医科大学附属省立医院(山东省立医院) 一种依托考昔口崩片及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2656338B2 (ja) * 1989-01-31 1997-09-24 日東電工株式会社 口腔粘膜貼付製剤
DE19961897A1 (de) * 1999-12-20 2001-06-28 Basf Ag Verwendung eines Filmüberzuges als geschmacksmaskierendes Coating von pharmazeutischen Darreichungsformen
US6585997B2 (en) * 2001-08-16 2003-07-01 Access Pharmaceuticals, Inc. Mucoadhesive erodible drug delivery device for controlled administration of pharmaceuticals and other active compounds
AU2002348432B2 (en) * 2001-10-12 2007-08-09 Aquestive Therapeutics, Inc. Thin film with non-self-aggregating uniform heterogeneity, process for their production and drug delivery systems made thereform
DK2332523T4 (da) * 2001-10-12 2022-02-21 Aquestive Therapeutics Inc Ensartede film til hurtigtopløsende doseringsform indeholdende smagsmaskerende præparater
MXPA05010422A (es) 2003-05-02 2005-11-04 Warner Lambert Co Peliculas consumibles oralmente de disolucion rapida que contienen un almidon modificado para la mejora de la resistencia al calor y a la humedad.
EP2161021B1 (en) * 2007-06-07 2017-03-08 Sato Pharmaceutical Co. Ltd. Medicinal film preparation with rapidly dissolving property and flexibility
WO2010086989A1 (ja) 2009-01-29 2010-08-05 日東電工株式会社 口腔内フィルム状基剤及び製剤
CN102892405A (zh) * 2009-12-28 2013-01-23 莫诺索尔克斯有限公司 包含昂丹司琼的可经口施用的膜剂型
PH12013501156A1 (en) * 2010-12-23 2019-09-02 Colgate Palmolive Co Films and compositions comprising the same

Also Published As

Publication number Publication date
WO2015016727A3 (en) 2015-04-16
ES2835258T3 (es) 2021-06-22
HK1225624A1 (zh) 2017-09-15
BR112016002205A2 (pt) 2017-08-01
WO2015016727A2 (en) 2015-02-05
JP2016525572A (ja) 2016-08-25
CN105682639A (zh) 2016-06-15
CN105682639B (zh) 2021-02-05
EP3027172A2 (en) 2016-06-08
WO2015016727A4 (en) 2015-06-04
EP3027172B1 (en) 2020-09-16
US20150038594A1 (en) 2015-02-05
US9603935B2 (en) 2017-03-28

Similar Documents

Publication Publication Date Title
JP6294479B2 (ja) 経口分散性フィルム
KR101077468B1 (ko) 안정한 경구용 속용 필름 제제
Dixit et al. Oral strip technology: Overview and future potential
JP5941558B2 (ja) シルデナフィルを有効成分として含有し、且つ、苦味の隠蔽された高含量速溶フィルム
JP4284017B2 (ja) 固形製剤
CZ20012566A3 (cs) Jednotková dávka a způsob přípravy jednotkové dávky pro slizniční podávání
PT1998762E (pt) Forma farmacêutica sólida contendo um agente activo de sabor mascarado
US10335443B2 (en) Orodispersible film
WO2007119792A1 (ja) 乾式直打速崩壊性錠剤
US20150272889A1 (en) Orally Disintegrating Tablet
US20180296495A1 (en) A fast acting orally disintegrating film for administration of local anesthesia
JP2010270110A (ja) ネオテームを含有する経口製剤
JP5101191B2 (ja) フィルム状製剤およびその製造方法
Kulkarni et al. A systematic review on oral drug delivery as a fast dissolving film to improve therapeutic effectiveness
JP6360795B2 (ja) 経口製剤
Kumar et al. A Comprehensive Review on Pharmaceutical Oral Dissolving Films.
KR20120100683A (ko) 안정한 경구용 속용 필름 제제
Gupta et al. An overview of mouth dissolving films: Formulation aspects
JP2023549381A (ja) 抗ヒスタミン活性化合物を含む口内分散性粉末組成物
Nagpal et al. Patent innovations in fast dissolving/disintegrating dosage forms
Menra et al. A REVIEW ON BUCCAL FILM: AN INOVATIVE DOSAGE FORM.
MISHRA et al. An Overview of Buccal Drug Delivery System.
TWI704932B (zh) 包含局部麻醉劑之快速崩解口腔薄膜
Deshmukh et al. A REVIEW ON FAST DISSOLVING TABLET.
Tanwar Formulation Characterization and Optimization of Buccal Film of Local Anesthetic

Legal Events

Date Code Title Description
A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A525

Effective date: 20160325

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170728

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20170728

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20170728

A975 Report on accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A971005

Effective date: 20170816

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170830

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20171130

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180122

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20180131

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20180215

R150 Certificate of patent or registration of utility model

Ref document number: 6294479

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

LAPS Cancellation because of no payment of annual fees