EA201690751A1 - WATER-SOLUBLE PHARMACEUTICAL FILM WITH INCREASED STABILITY - Google Patents

WATER-SOLUBLE PHARMACEUTICAL FILM WITH INCREASED STABILITY

Info

Publication number
EA201690751A1
EA201690751A1 EA201690751A EA201690751A EA201690751A1 EA 201690751 A1 EA201690751 A1 EA 201690751A1 EA 201690751 A EA201690751 A EA 201690751A EA 201690751 A EA201690751 A EA 201690751A EA 201690751 A1 EA201690751 A1 EA 201690751A1
Authority
EA
Eurasian Patent Office
Prior art keywords
film
water
casting
melt
resistant
Prior art date
Application number
EA201690751A
Other languages
Russian (ru)
Other versions
EA038558B1 (en
Inventor
Анвар Сирадж Дауд
Нидхи Пракаш Сапкал
Минал Нандкумар Бонде
Original Assignee
Зим Лэбораториз Лимитед
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 Зим Лэбораториз Лимитед filed Critical Зим Лэбораториз Лимитед
Publication of EA201690751A1 publication Critical patent/EA201690751A1/en
Publication of EA038558B1 publication Critical patent/EA038558B1/en

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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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

Abstract

Настоящее изобретение включает пероральную тонкую пленку, являющуюся быстросмачиваемой, быстрорастворимой, неприлипающей, нелипкой и неизгибающейся, при этом указанная пленка способна нести на себе активный ингредиент для пероральной доставки, при этом пленка является гидролитически стаблизированной пленкой, которая сохраняет свои свойства неприлипаемости и неизгибаемости в условиях воздействия на нее 70±5% относительной влажности при 25°С, по меньшей мере, в течение периода времени от 2 мин до 2 ч в открытом состоянии без упаковки; и технологический процесс (способ) изготовления пленки. Активный ингредиент может включать без ограничения активный фармацевтический, нутрацевтический или космецевтический ингредиент. Технологический процесс/способ, включающий (а) сушку литой пленки в два или несколько этапов, (b) сушку пленки после литья осуществляют поочередно на обеих сторонах, (с) нанесение покрытия на высушенную пленку из синтетических водонерастворимых влагостойких/водоотталкивающих гидрофобных полимеров, которые не плавятся при высокой температуре, (d) добавление синтетического водонерастворимого влагостойкого/водоотталкивающего гидрофобного полимера, не плавящегося при высокой температуре, к раствору, литье которого осуществляют для изготовления пленки.The present invention includes an oral thin film that is fast-wound, instant, non-stick, non-sticky and non-bending, while this film is capable of carrying the active ingredient for oral delivery, while the film is a hydrolytically stabilized film that retains its non-stick properties and non-bendability under exposure conditions on it, 70 ± 5% relative humidity at 25 ° C, at least for a period of time from 2 minutes to 2 hours in the open state without packaging; and technological process (method) of film production. The active ingredient may include, without limitation, an active pharmaceutical, nutraceutical or cosmeceutical ingredient. The technological process / method, which includes (a) drying the cast film in two or more stages, (b) drying the film after casting is carried out alternately on both sides, (c) coating the dried film from synthetic water-insoluble, moisture-resistant / water-repellent hydrophobic polymers that are not melt at high temperature, (d) adding a synthetic water-insoluble moisture-resistant / water-repellent hydrophobic polymer that does not melt at a high temperature to the solution, the casting of which is carried out to produce Lenia film.

EA201690751A 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability EA038558B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/IN2014/000652 WO2015083181A2 (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability
IN3221MU2013 IN2013MU03221A (en) 2013-10-14 2014-10-13

Publications (2)

Publication Number Publication Date
EA201690751A1 true EA201690751A1 (en) 2016-08-31
EA038558B1 EA038558B1 (en) 2021-09-14

Family

ID=53274239

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201690751A EA038558B1 (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability

Country Status (8)

Country Link
BR (1) BR112016008356B1 (en)
CA (1) CA2927334C (en)
CL (1) CL2016000880A1 (en)
EA (1) EA038558B1 (en)
IN (1) IN2013MU03221A (en)
MY (1) MY184297A (en)
UA (1) UA123893C2 (en)
WO (1) WO2015083181A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015107544A2 (en) * 2013-12-17 2015-07-23 Zim Laboratories Limited Pharmaceutical microemulsion immobilized in a thin polymer matrix and methods of making them
EP3600265A1 (en) * 2017-03-30 2020-02-05 Intelgenx Corp. Method of treatment and device for the improved bioavailability of leukotriene receptor antagonists
FR3082851B1 (en) * 2018-06-25 2022-09-02 Biomerieux Sa METHOD FOR DETECTING AND/OR IDENTIFYING AT LEAST ONE TARGET MICROORGANISM PRESENT ON A SURFACE.

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5947987B2 (en) * 1979-10-08 1984-11-22 富士写真フイルム株式会社 Matsuto film that can be added/edited
US4664859A (en) * 1983-12-02 1987-05-12 Vcf Films Inc. Div. Of Pmc Process for solvent casting a film
US5272191A (en) * 1991-08-21 1993-12-21 Fmc Corporation Cold water soluble films and film forming compositions
US6966960B2 (en) * 2003-05-07 2005-11-22 Hewlett-Packard Development Company, L.P. Fusible water-soluble films for fabricating three-dimensional objects
WO2005084636A2 (en) * 2004-02-27 2005-09-15 Ranbaxy Laboratories Limited A process for the preparation of controlled-release pharmaceutical composition of metoprolol
WO2006080630A1 (en) * 2004-09-23 2006-08-03 Handok Pharmaceuticals Co., Ltd. Pharmaceutical combination preparation for oral delivery for the treatment of diabetes mellitus
US20090162516A1 (en) * 2007-12-21 2009-06-25 Brown Solomon E Edible, water-soluble film

Also Published As

Publication number Publication date
BR112016008356A2 (en) 2017-08-01
EA038558B1 (en) 2021-09-14
MY184297A (en) 2021-03-31
IN2013MU03221A (en) 2015-07-03
WO2015083181A2 (en) 2015-06-11
BR112016008356B1 (en) 2022-12-13
WO2015083181A3 (en) 2015-12-03
CA2927334A1 (en) 2015-06-11
CL2016000880A1 (en) 2017-01-27
UA123893C2 (en) 2021-06-23
CA2927334C (en) 2023-08-29

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