BR112013010043A2 - formulação farmacêutica na forma de filme e uso de uma combinação de excipientes farmacêuticas aceitáveis. - Google Patents

formulação farmacêutica na forma de filme e uso de uma combinação de excipientes farmacêuticas aceitáveis.

Info

Publication number
BR112013010043A2
BR112013010043A2 BR112013010043A BR112013010043A BR112013010043A2 BR 112013010043 A2 BR112013010043 A2 BR 112013010043A2 BR 112013010043 A BR112013010043 A BR 112013010043A BR 112013010043 A BR112013010043 A BR 112013010043A BR 112013010043 A2 BR112013010043 A2 BR 112013010043A2
Authority
BR
Brazil
Prior art keywords
combination
film form
pharmaceutical formulation
acceptable
pharmaceutical
Prior art date
Application number
BR112013010043A
Other languages
English (en)
Inventor
Obermeier Petra
Kohr Thomas
Original Assignee
Hexal Ag
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 Hexal Ag filed Critical Hexal Ag
Publication of BR112013010043A2 publication Critical patent/BR112013010043A2/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/4045Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BR112013010043A 2010-10-28 2011-10-27 formulação farmacêutica na forma de filme e uso de uma combinação de excipientes farmacêuticas aceitáveis. BR112013010043A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010049708A DE102010049708A1 (de) 2010-10-28 2010-10-28 Orale pharmazeutische Filmformulierung für bitter schmeckende Arzneistoffe
PCT/EP2011/068813 WO2012055944A1 (de) 2010-10-28 2011-10-27 Orale pharmazeutische filmformulierung für bitter schmeckende arzneistoffe

Publications (1)

Publication Number Publication Date
BR112013010043A2 true BR112013010043A2 (pt) 2019-09-24

Family

ID=44999743

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013010043A BR112013010043A2 (pt) 2010-10-28 2011-10-27 formulação farmacêutica na forma de filme e uso de uma combinação de excipientes farmacêuticas aceitáveis.

Country Status (6)

Country Link
US (2) US20130217697A1 (pt)
EP (1) EP2632429A1 (pt)
JP (1) JP6049624B2 (pt)
BR (1) BR112013010043A2 (pt)
DE (1) DE102010049708A1 (pt)
WO (1) WO2012055944A1 (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102010049708A1 (de) 2010-10-28 2012-05-03 Hexal Ag Orale pharmazeutische Filmformulierung für bitter schmeckende Arzneistoffe
CA2864322C (en) * 2012-02-28 2016-08-09 Seoul Pharma. Co., Ltd. High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient
EP2730178B1 (de) * 2012-11-12 2020-08-26 Symrise AG Zubereitungen zur oralen Aufnahme
CN104739809B (zh) * 2013-12-30 2018-06-15 广州朗圣药业有限公司 能提供高载药量的水不溶性药物的膜剂及其制备方法
NO2723977T3 (pt) * 2014-03-19 2018-03-10
WO2018122867A1 (en) * 2016-12-27 2018-07-05 Zim Laboratories Limited Thin film formulations of 4-diphenylmethyl-1-piperazine derivatives and their salts
EP3813789A1 (en) 2018-06-28 2021-05-05 Arx, LLC Dispensing method for producing dissolvable unit dose film constructs
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate
JPWO2021235424A1 (pt) * 2020-05-18 2021-11-25
WO2022106923A1 (en) 2020-11-18 2022-05-27 BioPharma Synergies, S. L. Orodispersible powder composition comprising an antihistamine compound

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1239349A (en) * 1983-10-10 1988-07-19 Eberhard F. Gottwald Pharmaceutical composition containing cimetidine
US5846557A (en) * 1996-03-20 1998-12-08 Cumberland Packing Corporation Chewing gum containing cough suppressing agent
US20030211136A1 (en) * 1998-09-25 2003-11-13 Neema Kulkarni Fast dissolving orally consumable films containing a sweetener
DE10207394B4 (de) 2002-02-21 2007-03-29 Lts Lohmann Therapie-Systeme Ag Geschmacksmaskierte oblatenförmige Arzneizubereitung
WO2004019885A2 (en) 2002-08-29 2004-03-11 Linguagen Corp. Fast dissolving film delivery of nucleotides that inhibit the unpleasant taste of bitter tasting medications
WO2004043165A1 (en) 2002-11-14 2004-05-27 Givaudan Sa Edible film containing food acid
US20060024335A1 (en) 2004-07-29 2006-02-02 Roger Stier E Oral compositions which mask the bitter taste of a bitter-tasting agent
US20060024425A1 (en) 2004-07-30 2006-02-02 Wm. Wrigley Jr. Company Edible film compositions
WO2006072921A2 (en) * 2005-01-07 2006-07-13 Ranbaxy Laboratories Limited Sweetener composition of stevia extract and maltol and processes of preparation thereof
DE102005033942A1 (de) 2005-07-20 2007-02-22 Hexal Ag Nicht-ausspuckbarer, oraler, schnell-zerfallender Film für Antiemetikum oder Antimigränemittel
DE102005033943A1 (de) 2005-07-20 2007-02-22 Hexal Ag Nicht-ausspuckbarer, oraler, schnell-zerfallender Film für ein Neuroleptikum
US20070178123A1 (en) * 2006-01-27 2007-08-02 Deborah Levenson Flavor-enhancing compositions, method of manufacture, and methods of use
PL2248519T3 (pl) 2006-10-02 2018-04-30 Apr Applied Pharma Research S.A. Niemukoadhezyjne postaci dawkowania w postaci filmu
EP2008530B1 (de) 2007-06-19 2011-01-19 Symrise AG Aromakomposition zum Verringern oder Unterdrücken von unerwünschtem bitteren und adstringierenden Eindruck
US20090047330A1 (en) 2007-08-17 2009-02-19 Ramesh Bangalore Oral fast dissolving films for erectile dysfunction bioactive agents
KR100905027B1 (ko) * 2007-10-03 2009-06-30 (주)씨엘팜 식용 필름
MX2010004265A (es) * 2007-10-19 2010-07-28 Innozen Inc Composicion para administrar un ingrediente activo y metodo para hacer y usar el mismo.
CN101574330A (zh) * 2009-06-12 2009-11-11 上海现代药物制剂工程研究中心有限公司 苯甲酸利扎曲普坦膜剂
DE102010049708A1 (de) 2010-10-28 2012-05-03 Hexal Ag Orale pharmazeutische Filmformulierung für bitter schmeckende Arzneistoffe

Also Published As

Publication number Publication date
WO2012055944A1 (de) 2012-05-03
JP6049624B2 (ja) 2016-12-21
US9789112B2 (en) 2017-10-17
DE102010049708A1 (de) 2012-05-03
US20130217697A1 (en) 2013-08-22
US20160279134A1 (en) 2016-09-29
JP2013540795A (ja) 2013-11-07
EP2632429A1 (de) 2013-09-04

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Legal Events

Date Code Title Description
B08F Application fees: dismissal - article 86 of industrial property law
B08K Lapse as no evidence of payment of the annual fee has been furnished to inpi (acc. art. 87)

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2543 DE 01-10-2019 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.