DK2493457T3 - Hurtigtopløsende fast doseringsform - Google Patents

Hurtigtopløsende fast doseringsform Download PDF

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DK2493457T3
DK2493457T3 DK10827255.0T DK10827255T DK2493457T3 DK 2493457 T3 DK2493457 T3 DK 2493457T3 DK 10827255 T DK10827255 T DK 10827255T DK 2493457 T3 DK2493457 T3 DK 2493457T3
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dosage form
solid dosage
dissolving solid
disintegrating
seconds
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DK10827255.0T
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Chin Beng Stephen Lim
Vivian Bruce Sunderland
Yip Hang Eddy Lee
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Ix Biopharma Ltd
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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/40—Heterocyclic 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
    • A61K31/403—Heterocyclic 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
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • 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
    • A61K38/06—Tripeptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (34)

1. Hurtigt disintegrerende og opløsende fast porøs frysetørret wafer-doseringsform, som er egnet til frigivelse af et biologisk aktivt materiale i en mundhule, hvor doseringsformen omfatter: a) et biologisk aktivt materiale; og b) et matrix-dannende middel omfattende amylopectin i en koncentration fra 2 % til 17 % by efter tørvægt af doseringsformen; hvor doseringsformen i det væsentlige opløses i mundhulen.
2. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 1, hvor det biologisk aktive materiale er til stede i en mængde fra 0,02 til 95 vægt-% efter tørvægt af sammensætningen af doseringsformen.
3. Disintegrerende og hurtigt opløsende fast doseringsform ifølge krav 1, yderligere omfattende et andet matrix-dannende middel, hvor det andet matrix-dannende middel er mikrokrystallinsk cellulose.
4. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 3, hvor den mikrokrystallinske cellulose er til stede i en mængde fra 1 til 10 vægt-% efter tørvægt af sammensætningen af doseringsformen.
5. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 1, yderligere omfattende et andet matrix-dannende middel, hvor det andet matrix-dannende middel er glycin.
6. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 5, hvor glycin er til stede i en mængde fra 0,5 til 5 vægt-% efter tørvægt af sammensætningen af doseringsformen.
7. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 1, yderligere omfattende et andet matrix-dannende middel, hvor det andet matrix-dannende middel er mannitol.
8. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 7, hvor mannitol er til stede i en mængde fra 5 til 80 vægt-% efter tørvægt af sammensætningen af doseringsformen.
9. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et smøremiddel.
10. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 9, hvor det mindst ene smøremiddel omfatter polyethylenglycol (PEG) 2000.
11. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 10, hvor PEG 2000 er til stede i en mængde fra 0,05 til 5 vægt-% efter tørvægt af sammensætningen af doseringsformen.
12. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et bufferreagens.
13. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 12, hvor det mindst ene bufferreagens omfatter natriumcarbonat.
14. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 13, hvor natriumcarbonat er til stede i en mængde fra 0,01 til 10 vægt-% efter tørvægt af sammensætningen af doseringsformen.
15. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst en absorptionsforstærker.
16. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 15, hvor den mindst ene absorptionsforstærker omfatter β-cyclodextrin.
17. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 16, hvor β-cyclodextrin er til stede i en mængde fra 0,01 til 10 vægt-% efter tørvægt af sammensætningen af doseringsformen.
18. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et flokkule-ringsmiddel.
19. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et overfladeaktivt stof.
20. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et tilsætningsstof.
21. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et farvestof.
22. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 21, hvor det mindst ene farvestof er udvalgt fra gruppen bestående af FD & C dyes Blue nr. 2 og Red nr. 40 og blandinger deraf.
23. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst et aromastof.
24. Hurtigt disintegrerende og opløsende fast doseringsform ifølge krav 23, hvor det mindst ene aromastof er udvalgt fra gruppen bestående af appelsin, mynte, hindbær, karamel, aspartam, saccharin og blandinger deraf.
25. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, hvor doseringsformen er en wafer.
26. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, hvor doseringsformen i det væsentlige opløses, når den er anbragt i mundhulen, i løbet af et tidsrum udvalgt fra gruppen bestående af: mindre end 50 sekunder, mindre end 40 sekunder, mindre end 30 sekunder, mindre end 20 sekunder, mindre end 15 sekunder, mindre end 10 sekunder, mindre end 7,5 sekunder, mindre end 5 sekunder, mindre end 4 sekunder, mindre end 3 sekunder, mindre end 2 sekunder.
27. Hurtigt disintegrerende og opløsende fast doseringsform ifølge et hvilket som helst af de foregående krav, yderligere omfattende mindst en farmaceutisk acceptabel bærer.
28. Fremgangsmåde til fremstilling af en hurtigt disintegrerende og opløsende porøs fast wafer-doseringsform, som er egnet til frigivelse af et biologisk aktivt materiale i en mundhule, omfattende trinnene: i) at kombinere et matrix-dannende middel omfattende amylopectin i en koncentration fra 2 % til 17 % efter tørvægt af doseringsformen med et biologisk aktivt materiale til dannelse af en homogen blanding; og ii) at frysetørre blandingen til dannelse af den faste doseringsform, hvor doseringsformen i det væsentlige opløses i mundhulen.
29. Fremgangsmåde ifølge krav 28, yderligere omfattende at afmåle blandingen i en præformet plast- eller aluminiumsblisterform.
30. Fremgangsmåde ifølge krav 29, hvor frysetørringsteknikken anvendes til at fjerne opløsningsmidlet fra blisterformen.
31. Fremgangsmåde ifølge krav 30, yderligere omfattende at forsegle den faste doseringsform med en plast- eller aluminiumsfolie til forhindring af fugtabsorption.
32. Fremgangsmåde ifølge et hvilket som helst af kravene 28 til 31, yderligere omfattende at tilsætte en pH-regulator for at holde pH-værdien af blandingen inden for området mellem 3,0 og 8,0.
33. Fremgangsmåde ifølge et hvilket som helst af kravene 28 til 32, yderligere omfattende at tilsætte et opløsningsmiddel.
34. Kit, omfattende (a) en hurtigt disintegrerende og opløsende porøs fast wafer-doseringsform, som er egnet til frigivelse af et biologisk aktivt materiale i en mundhule, hvor doseringsformen omfatter: i) et biologisk aktivt materiale, og ii) et matrix-dannende middel omfattende amylopectin i en koncentration fra 2 % til 17 % efter tørvægt af doseringsformen, hvor doseringsformen i det væsentlige opløses i mundhulen, og hvor doseringsformen er fremstillet ved frysetørring, og (b) anvisning til anvendelse deraf.
DK10827255.0T 2009-10-30 2010-10-26 Hurtigtopløsende fast doseringsform DK2493457T3 (da)

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PCT/SG2010/000409 WO2011053251A1 (en) 2009-10-30 2010-10-26 Fast dissolving solid dosage form

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US (4) US10744086B2 (da)
EP (3) EP3332772A1 (da)
JP (1) JP5777170B2 (da)
KR (1) KR101612073B1 (da)
CN (2) CN102933207B (da)
AU (1) AU2010313785C1 (da)
CA (1) CA2777218C (da)
DK (2) DK2493457T3 (da)
ES (2) ES2641821T3 (da)
HK (1) HK1251914A1 (da)
MY (1) MY150626A (da)
NO (1) NO2493457T3 (da)
NZ (1) NZ599594A (da)
PL (2) PL2493457T3 (da)
SG (1) SG174465A1 (da)
TR (1) TR201902233T4 (da)
WO (1) WO2011053251A1 (da)
ZA (1) ZA201400310B (da)

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US12186426B2 (en) 2009-10-30 2025-01-07 Ix Biopharma Ltd. Solid dosage form
DK2493457T3 (da) 2009-10-30 2017-10-02 Ix Biopharma Ltd Hurtigtopløsende fast doseringsform
HUE052853T2 (hu) * 2010-10-08 2021-05-28 Scherer Technologies Llc R P Orális vakcina gyorsan oldódó dózisforma, keményítõ alkalmazásával
US8722636B2 (en) 2011-01-31 2014-05-13 New Market Pharmaceuticals, LLC Animal treatments
ES3034104T3 (en) 2012-05-02 2025-08-13 Newmarket Pharmaceuticals Llc Pharmaceutical compositions for direct systemic introduction
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