DK2552403T3 - En hurtigtopløsende farmaceutisk sammensætning - Google Patents

En hurtigtopløsende farmaceutisk sammensætning Download PDF

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Publication number
DK2552403T3
DK2552403T3 DK11711526.1T DK11711526T DK2552403T3 DK 2552403 T3 DK2552403 T3 DK 2552403T3 DK 11711526 T DK11711526 T DK 11711526T DK 2552403 T3 DK2552403 T3 DK 2552403T3
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DK
Denmark
Prior art keywords
composition
active ingredient
pharmaceutical composition
inulin
solvent
Prior art date
Application number
DK11711526.1T
Other languages
English (en)
Inventor
Varinder Ahuja
Tejas Gunjikar
Kristin Wannerberger
Original Assignee
Ferring Bv
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 Ferring Bv filed Critical Ferring Bv
Application granted granted Critical
Publication of DK2552403T3 publication Critical patent/DK2552403T3/da

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2250/00—Food ingredients
    • A23V2250/50—Polysaccharides, gums
    • A23V2250/502—Gums
    • A23V2250/5062—Inulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/50—Cyclic peptides containing at least one abnormal peptide link

Claims (10)

1. Farmaceutisk sammensætning omfattende en matrix bærende en farmaceutisk aktiv ingrediens og omfattende inulin som det primære matrix-dannende stof og mannitol som et sekundært matrix-dannende stof, hvor den farmaceutiske sammensætning opnås ved at sublimere solventet fra et flydende præparat omfattende den farmaceutiske aktive ingrediens, det primære matrix-dannende stof og det sekundære matrix-dannende stof i et solvent, og mindst 80% af den farmaceutiske sammensætning disintegrerer inden for 10 sekunder når målt ifølge Ph. Eur. 1997, paragraf 2.9.1, i vand ved 37 °C ± 0,5 °C.
2. Den farmaceutiske sammensætning ifølge krav 1, hvilken er i en oral dosisform.
3. Den farmaceutiske sammensætning ifølge krav 2, hvilken er egnet til sublingual administration.
4. Den farmaceutiske sammensætning ifølge et hvilket som helst af krav 1-3, hvor sublimeringen udføres ved at frysetørre præparatet.
5. Den farmaceutiske sammensætning ifølge et hvilket som helst af krav 1-4, hvor den aktive ingrediens er desmopressin acetat, loratidin, famotidin eller montelukast natrium.
6. Fremgangsmåde til fremstilling af den farmaceutiske sammensætning ifølge et hvilket som helst af krav 1-5, fremgangsmåden omfattende at sublimere solventet fra et flydende præparat omfattende en farmaceutisk aktiv ingrediens, inulin og mannitol i et solvent.
7. Fremgangsmåden ifølge krav 6, omfattende: (a) at introducere enhedsdosiskvantiteter af det flydende præparat i fordybninger af en åben blisterpakning; og (b) at sublimere solventet fra det flydende præparat for at opnå faststof enhedsdosisformer inden for fordybningerne.
8. Fremgangsmåden ifølge krav 7, hvor sublimeringen udføres ved at frysetørre præparatet.
9. Fremgangsmåden ifølge krav 8, hvor solventet er vand.
10. Fremgangsmåden ifølge et hvilket som helst af krav 6-9, hvor den aktive ingrediens er desmopressin, loratidin, famotidin eller montelukast natrium.
DK11711526.1T 2010-03-29 2011-03-28 En hurtigtopløsende farmaceutisk sammensætning DK2552403T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN742DE2010 2010-03-29
PCT/EP2011/054698 WO2011120903A2 (en) 2010-03-29 2011-03-28 A fast dissolving pharmaceutical composition

Publications (1)

Publication Number Publication Date
DK2552403T3 true DK2552403T3 (da) 2015-10-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
DK11711526.1T DK2552403T3 (da) 2010-03-29 2011-03-28 En hurtigtopløsende farmaceutisk sammensætning

Country Status (24)

Country Link
US (2) US10086078B2 (da)
EP (1) EP2552403B1 (da)
JP (1) JP5907945B2 (da)
KR (1) KR101725173B1 (da)
CN (1) CN102821755A (da)
AR (1) AR080736A1 (da)
AU (1) AU2011234636B2 (da)
BR (1) BR112012024428A2 (da)
CA (1) CA2793405A1 (da)
DK (1) DK2552403T3 (da)
ES (1) ES2553568T3 (da)
HK (1) HK1181649A1 (da)
HU (1) HUE026213T2 (da)
IL (1) IL222086A (da)
JO (1) JO3112B1 (da)
MX (1) MX2012011204A (da)
NZ (1) NZ602441A (da)
PL (1) PL2552403T3 (da)
PT (1) PT2552403E (da)
RU (1) RU2566270C2 (da)
SA (1) SA111320317B1 (da)
TW (1) TWI513477B (da)
WO (1) WO2011120903A2 (da)
ZA (1) ZA201207176B (da)

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Also Published As

Publication number Publication date
EP2552403A2 (en) 2013-02-06
HK1181649A1 (en) 2013-11-15
ES2553568T3 (es) 2015-12-10
HUE026213T2 (en) 2016-05-30
KR101725173B1 (ko) 2017-04-10
MX2012011204A (es) 2012-11-23
PL2552403T3 (pl) 2016-01-29
US10086078B2 (en) 2018-10-02
AU2011234636B2 (en) 2015-01-15
TWI513477B (zh) 2015-12-21
JP2013523676A (ja) 2013-06-17
KR20130008588A (ko) 2013-01-22
TW201138830A (en) 2011-11-16
AU2011234636A1 (en) 2012-10-11
JO3112B1 (ar) 2017-09-20
WO2011120903A3 (en) 2012-05-03
RU2566270C2 (ru) 2015-10-20
CN102821755A (zh) 2012-12-12
ZA201207176B (en) 2013-05-29
JP5907945B2 (ja) 2016-04-26
US10512695B2 (en) 2019-12-24
PT2552403E (pt) 2015-10-30
WO2011120903A2 (en) 2011-10-06
RU2012141141A (ru) 2014-05-10
US20130123180A1 (en) 2013-05-16
EP2552403B1 (en) 2015-09-09
NZ602441A (en) 2014-01-31
BR112012024428A2 (pt) 2016-05-31
AR080736A1 (es) 2012-05-02
US20180369392A1 (en) 2018-12-27
IL222086A (en) 2017-01-31
SA111320317B1 (ar) 2015-05-11
CA2793405A1 (en) 2011-10-06

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