WO2015083181A3 - Water soluble pharmaceutical film with enhanced stability - Google Patents

Water soluble pharmaceutical film with enhanced stability Download PDF

Info

Publication number
WO2015083181A3
WO2015083181A3 PCT/IN2014/000652 IN2014000652W WO2015083181A3 WO 2015083181 A3 WO2015083181 A3 WO 2015083181A3 IN 2014000652 W IN2014000652 W IN 2014000652W WO 2015083181 A3 WO2015083181 A3 WO 2015083181A3
Authority
WO
WIPO (PCT)
Prior art keywords
film
moisture
curving
sticky
melt
Prior art date
Application number
PCT/IN2014/000652
Other languages
French (fr)
Other versions
WO2015083181A2 (en
Inventor
Anwar Siraj DAUD
Nidhi Prakash SAPKAL
Minal Nandkumar BONDE
Original Assignee
Zim Laboratories Limited
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 Zim Laboratories Limited filed Critical Zim Laboratories Limited
Priority to EA201690751A priority Critical patent/EA038558B1/en
Priority to BR112016008356-3A priority patent/BR112016008356B1/en
Priority to UAA201605185A priority patent/UA123893C2/en
Priority to MYPI2016701359A priority patent/MY184297A/en
Priority to CA2927334A priority patent/CA2927334C/en
Publication of WO2015083181A2 publication Critical patent/WO2015083181A2/en
Publication of WO2015083181A3 publication Critical patent/WO2015083181A3/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

This invention comprises an Oral Thin Film that is instantly wettable, rapid dissolving, non-sticky, non-tacky and non-curving, the said Film capable of carrying an active ingredient for oral delivery being a moisture stabilized film that remains non-sticky and non-curving when exposed to 70±5 % RH (Relative Humidity) at 25°C for at least 2 minutes up to 2 hours in open conditions without packaging.; and a process/method of making them. The active ingredient may comprise, without limitation, an active pharmaceutical, nutraceutical or cosmaceutical ingredient. The processes/method comprising (a) drying a casted film in two or more stages, (b) drying of the film after casting is done alternately both the sides, (c) coating the dried film with synthetic water insoluble moisture resistant/moisture repellant hydrophobic polymers that does not melt at high temperature, (d) adding a synthetic water insoluble moisture resistant/moisture repellant hydrophobic polymer that does not melt at high temperature to the solution to be casted as a film.
PCT/IN2014/000652 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability WO2015083181A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EA201690751A EA038558B1 (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability
BR112016008356-3A BR112016008356B1 (en) 2013-10-14 2014-10-13 PROCESS/METHOD FOR PREPARING A WATER-SOLUBLE FILM OF RAPID ORAL DISSOLUTION AND THIN ORAL FILM
UAA201605185A UA123893C2 (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability
MYPI2016701359A MY184297A (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability
CA2927334A CA2927334C (en) 2013-10-14 2014-10-13 Water soluble pharmaceutical film with enhanced stability

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3221/MUM/2013 2013-10-14
IN3221MU2013 IN2013MU03221A (en) 2013-10-14 2014-10-13

Publications (2)

Publication Number Publication Date
WO2015083181A2 WO2015083181A2 (en) 2015-06-11
WO2015083181A3 true WO2015083181A3 (en) 2015-12-03

Family

ID=53274239

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2014/000652 WO2015083181A2 (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
JP2020512309A (en) * 2017-03-30 2020-04-23 インテルジェンクス コーポレーションＩｎｔｅｌｇｅｎｘ Ｃｏｒｐ． Treatment methods and devices for improving 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.

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4366239A (en) * 1979-10-08 1982-12-28 Fuji Photo Film Co., Ltd. Polyester base drafting film with nitrocellulose and polymethylmethacrylate layer
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
WO2005084636A2 (en) * 2004-02-27 2005-09-15 Ranbaxy Laboratories Limited A process for the preparation of controlled-release pharmaceutical composition of metoprolol
US6966960B2 (en) * 2003-05-07 2005-11-22 Hewlett-Packard Development Company, L.P. Fusible water-soluble films for fabricating three-dimensional objects
WO2006080630A1 (en) * 2004-09-23 2006-08-03 Handok Pharmaceuticals Co., Ltd. Pharmaceutical combination preparation for oral delivery for the treatment of diabetes mellitus
WO2009085692A1 (en) * 2007-12-21 2009-07-09 Monosol, Llc Edible, water-soluble film

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4366239A (en) * 1979-10-08 1982-12-28 Fuji Photo Film Co., Ltd. Polyester base drafting film with nitrocellulose and polymethylmethacrylate layer
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
WO2009085692A1 (en) * 2007-12-21 2009-07-09 Monosol, Llc Edible, water-soluble film

Also Published As

Publication number Publication date
MY184297A (en) 2021-03-31
EA201690751A1 (en) 2016-08-31
IN2013MU03221A (en) 2015-07-03
BR112016008356A2 (en) 2017-08-01
CL2016000880A1 (en) 2017-01-27
BR112016008356B1 (en) 2022-12-13
EA038558B1 (en) 2021-09-14
WO2015083181A2 (en) 2015-06-11
CA2927334C (en) 2023-08-29
UA123893C2 (en) 2021-06-23
CA2927334A1 (en) 2015-06-11

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