CA2927334A1 - Pellicule pharmaceutique soluble dans l'eau presentant une stabilite amelioree - Google Patents

Pellicule pharmaceutique soluble dans l'eau presentant une stabilite amelioree Download PDF

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Publication number
CA2927334A1
CA2927334A1 CA2927334A CA2927334A CA2927334A1 CA 2927334 A1 CA2927334 A1 CA 2927334A1 CA 2927334 A CA2927334 A CA 2927334A CA 2927334 A CA2927334 A CA 2927334A CA 2927334 A1 CA2927334 A1 CA 2927334A1
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CA
Canada
Prior art keywords
film
moisture
drying
range
done
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.)
Granted
Application number
CA2927334A
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English (en)
Other versions
CA2927334C (fr
Inventor
Anwar Siraj DAUD
Nidhi Prakash SAPKAL
Minal Nandkumar BONDE
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ZIM Laboratories Ltd
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ZIM Laboratories Ltd
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Publication of CA2927334A1 publication Critical patent/CA2927334A1/fr
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Publication of CA2927334C publication Critical patent/CA2927334C/fr
Active legal-status Critical Current
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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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Manufacture Of Macromolecular Shaped Articles (AREA)

Abstract

La présente invention concerne une pellicule mince orale qui est instantanément mouillable, se dissout rapidement, et est non collante, non poisseuse et non incurvée. Ladite pellicule est apte à comporter un principe actif à administrer par voie orale sous la forme d'une pellicule stabilisée humide qui reste non collante et non incurvée lorsqu'elle est exposée à 70 ± 5 % de HR (humidité relative) à 25°C, pendant au moins 2 minutes et jusqu'à 2 heures, dans des conditions ouvertes sans emballage.L'invention porte également sur un procédé de réalisation de ladite pellicule. Le principe actif peut comprendre, sans limite, un principe actif cosmaceutique, nutraceutique ou pharmaceutique. Ledit procédé comprend les étapes suivantes : (a) séchage d'une pellicule moulée en deux étapes ou davantage; (b) séchage de la pellicule après moulage, alternativement sur les deux côtés; (c) revêtement de la pellicule séchée avec des polymères hydrophobes anti-humidité, résistants à l'humidité, synthétiques, insolubles dans l'eau et ne fondant pas à haute température; et (d) ajout d'un polymère hydrophobe anti-humidité, résistant à l'humidité, synthétique, insoluble dans l'eau, et ne fondant pas à température élevée, à la solution devant être moulée en tant que pellicule.
CA2927334A 2013-10-14 2014-10-13 Pellicule pharmaceutique soluble dans l'eau presentant une stabilite amelioree Active CA2927334C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN3221/MUM/2013 2013-10-14
PCT/IN2014/000652 WO2015083181A2 (fr) 2013-10-14 2014-10-13 Pellicule pharmaceutique soluble dans l'eau présentant une stabilité améliorée
IN3221MU2013 IN2013MU03221A (fr) 2013-10-14 2014-10-13

Publications (2)

Publication Number Publication Date
CA2927334A1 true CA2927334A1 (fr) 2015-06-11
CA2927334C CA2927334C (fr) 2023-08-29

Family

ID=53274239

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2927334A Active CA2927334C (fr) 2013-10-14 2014-10-13 Pellicule pharmaceutique soluble dans l'eau presentant une stabilite amelioree

Country Status (8)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018176149A1 (fr) * 2017-03-30 2018-10-04 Intelgenx Corp. Méthode de traitement et dispositif pour la biodisponibilité améliorée d'antagonistes des récepteurs des leucotriènes

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10660862B2 (en) * 2013-12-17 2020-05-26 Zim Laboratories Limited Pharmaceutical microemulsion immobilized in a thin polymer matrix and methods of making them
DE102017127452A1 (de) * 2017-11-21 2019-05-23 Lts Lohmann Therapie-Systeme Ag Wasserlösliche Polymerklebschichten
FR3082851B1 (fr) * 2018-06-25 2022-09-02 Biomerieux Sa Procede de detection et/ou d'identification d'au moins un microorganisme cible present sur une surface.

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5947987B2 (ja) * 1979-10-08 1984-11-22 富士写真フイルム株式会社 加筆・修正可能なマツトフイルム
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 (fr) * 2004-02-27 2005-09-15 Ranbaxy Laboratories Limited Procede de preparation d'une composition pharmaceutique a liberation controlee de metoprolol
KR100705210B1 (ko) * 2004-09-23 2007-04-06 주식회사 한독약품 경구투여를 위한 당뇨병 치료용 약제학적 복합제제
US20090162516A1 (en) * 2007-12-21 2009-06-25 Brown Solomon E Edible, water-soluble film

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018176149A1 (fr) * 2017-03-30 2018-10-04 Intelgenx Corp. Méthode de traitement et dispositif pour la biodisponibilité améliorée d'antagonistes des récepteurs des leucotriènes
CN110381931A (zh) * 2017-03-30 2019-10-25 因特根克斯公司 改善的白三烯受体拮抗剂的生物利用度的治疗方法和装置

Also Published As

Publication number Publication date
EA038558B1 (ru) 2021-09-14
CA2927334C (fr) 2023-08-29
BR112016008356B1 (pt) 2022-12-13
WO2015083181A3 (fr) 2015-12-03
CL2016000880A1 (es) 2017-01-27
IN2013MU03221A (fr) 2015-07-03
BR112016008356A2 (pt) 2017-08-01
EA201690751A1 (ru) 2016-08-31
MY184297A (en) 2021-03-31
WO2015083181A2 (fr) 2015-06-11
UA123893C2 (uk) 2021-06-23

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