DK2247284T3 - Fremgangsmåde til minimering af polymorfisme - Google Patents

Fremgangsmåde til minimering af polymorfisme Download PDF

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Publication number
DK2247284T3
DK2247284T3 DK09713721.0T DK09713721T DK2247284T3 DK 2247284 T3 DK2247284 T3 DK 2247284T3 DK 09713721 T DK09713721 T DK 09713721T DK 2247284 T3 DK2247284 T3 DK 2247284T3
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Denmark
Prior art keywords
suspension
drug
gelatin
dosage form
disorder
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DK09713721.0T
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English (en)
Inventor
Andrew Jordan
Wei Tian
Simon A M Howes
Rosie Mclaughlin
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Scherer Technologies Llc R P
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    • 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
    • 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
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Fremgangsmade til fremstilling af en oral, fast, hurtigt dispergerende doseringsform af en farmaceutisk aktiv substans, hvor substansen udviser polymorfisme i et vandigt 5 miljo, omfattende folgende trin: (a) dannelse af en suspension af partikler af substansen i et baeremateriale i en kontinuert fase, hvor baerematerialet omfatter fiskegelatine af standardmolekylvaegt, hvori i det mindste 50% af molekylvaegtfordelingen er undeer 30.000 dalton; 10 (b) reduktion af suspensionstemperaturen til mindre end omkring 15°C og fastholdelse af suspensionstemperaturen ved mindre end omkring 15°C efter trin (b) og for trin (c); (c) dannelse af diskrete enheder af suspensionen ved en dannelsestemperatur pa mindre end omkring 15°C; og 15 (d) fjernelse af den kontinuerte fase for at efterlade suspensionen af partikler i baerematerialet.
2. Fremgangsmade ifolge krav 1, hvor den kontinuerte fase omfatter vand.
3. Fremgangsmade ifolge krav 1, hvor den farmaceutisk aktive substans er valgt fra gruppen bestaende af acyclovir, alendronatnatrium, amoxicillin, aripiprazol, atorvastatin calcium, carbamazepin, carvedilol, cephalexin, clindamycin, colchicin, donepezil-hydro-chlorid, erythromycin, esomeprazol-magnesium, fluoxetin-hydrochlorid, hydrochlor-thiazid, hydrocodon, hyoscyamin-sulfat, levofloxacin, levothyroxin-natrium, lisinopril, 25 losartan kalium, methotrexat, mirtazapin, mometason-furoat-monohydrat, morfin, nystatin, pantoprazol-natrium, paroxetin-hydrochlorid, risedronat-natrium, rosiglitazon-ma-leat, tetracyclin, theophyllin og zithromax.
4. Fremgangsmade ifolge krav 1, hvor den farmaceutisk aktive substans er et benzo-30 diazepin-laegemiddel.
5. Fremgangsmade ifolge krav 4, hvor den farmaceutisk aktive substans er alprazolam.
6. Fremgangsmade ifolge krav 1, hvor den hurtigt dispergerende doseringsform har en 35 disintegrationstid pa fra 1 til 60 sekunder.
7. Fremgangsmade ifolge krav 1, hvor suspensionen yderligere omfatter i det mindste en yderligere ingrediens valgt fra gruppen bestaende af farvestoffer, aromastoffer, excipienter, andre terapeutisk aktive stoffer og kombinationer deraf.
8. Fremgangsmade til fremstilling af en oral, fast, hurtigt dispergerende doseringsform af en farmaceutisk aktiv substans som angivet i krav 1, hvor substansen er et benzo-diazepin-klasse laegemiddel, som har krystallinsk polymorfisme i et vandigt miljo.
9. Fremgangsmade ifolge krav 8, hvor suspensionen har en temmelig konsistent visko-10 sitet over en tidsperiode pa i det mindste 48 timer.
10. Fremgangsmade ifolge krav 9, hvor den kontinuerte fase er vand.
11. Fremgangsmade ifolge krav 9, hvor suspensionen yderligere omfatter i det mindste 15 en yderligere ingrediens valgt fra gruppen bestaende af farvestoffer, aromastoffer, excipienter, andre terapeutisk aktive stoffer og kombinationer deraf.
12. Fremgangsmade ifolge krav 9, hvor fjemelsen af oplosningsmidlet fra blandingen fortrinsvis udfores ved frysetorring. 20
13. Hurtig dispergerende doseringsform fremstillet ved fremgangsmaden ifolge ethvert af kravene 1 til 12.
14. Hurtig dispergerende doseringsform fremstillet ved fremgangsmaden ifolge ethvert 25 af kravene 4 til 5 til anvendelse ved en fremgangsmade til behandling af en lidelse i centralnervesystemet.
15. Hurtig dispergerende doseringsform til anvendelse ved behandling af en lidelse i centralnervesystemet ifolge krav 14, hvor lidelsen i centralnervesystemet er valgt blandt 30 angstforstyrrelse, symptomatisk dysphasi, panikforstyrrelse, krampagtig forstyrrelse, schizophreni og bipolaer eller manio-depressiv forstyrrelse.
DK09713721.0T 2008-02-28 2009-02-26 Fremgangsmåde til minimering af polymorfisme DK2247284T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3229808P 2008-02-28 2008-02-28
PCT/US2009/035276 WO2009108775A2 (en) 2008-02-28 2009-02-26 Process to minimize polymorphism

Publications (1)

Publication Number Publication Date
DK2247284T3 true DK2247284T3 (da) 2017-07-31

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Country Status (19)

Country Link
US (1) US20090226522A1 (da)
EP (1) EP2247284B1 (da)
JP (2) JP5547096B2 (da)
KR (1) KR101473419B1 (da)
CN (2) CN102036655B (da)
AR (1) AR072245A1 (da)
AU (1) AU2009219292B2 (da)
BR (1) BRPI0908539B8 (da)
CA (1) CA2716901C (da)
DK (1) DK2247284T3 (da)
ES (1) ES2633928T3 (da)
HK (1) HK1154505A1 (da)
IL (2) IL207824A (da)
MX (1) MX2010009493A (da)
MY (1) MY173867A (da)
NZ (1) NZ587611A (da)
RU (1) RU2010139643A (da)
WO (1) WO2009108775A2 (da)
ZA (1) ZA201006421B (da)

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CN107951893B (zh) * 2016-10-18 2022-04-26 天津金耀集团有限公司 一种糠酸莫米松粉吸入剂组合物
EP4371554A3 (en) 2016-12-31 2024-08-07 BioXcel Therapeutics, Inc. Use of sublingual dexmedetomidine for the treatment of agitation
SG11202012772XA (en) 2018-06-27 2021-01-28 Bioxcel Therapeutics Inc Film formulations containing dexmedetomidine and methods of producing them
CN109010295A (zh) * 2018-08-29 2018-12-18 北京兴源联合医药科技有限公司 一种左甲状腺素钠冻干口腔崩解片
CN109316452B (zh) * 2018-09-07 2021-07-30 北京兴源联合医药科技有限公司 一种硫酸氢氯吡格雷冻干口腔崩解片
CN113490486A (zh) 2019-02-22 2021-10-08 康特伦英国斯温顿捷迪斯有限公司 最小化团聚、曝气和保持包含布洛芬的药物组合物的包衣
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WO2021016112A2 (en) 2019-07-19 2021-01-28 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
BR112023001716A2 (pt) * 2020-07-31 2023-04-04 Catalent Uk Swindon Zydis Ltd Composições farmacêuticas compreendendo api revestido
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
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Also Published As

Publication number Publication date
ES2633928T3 (es) 2017-09-26
ZA201006421B (en) 2011-05-25
IL207824A0 (en) 2010-12-30
NZ587611A (en) 2012-07-27
KR101473419B1 (ko) 2014-12-16
KR20100123740A (ko) 2010-11-24
RU2010139643A (ru) 2012-04-10
BRPI0908539B1 (pt) 2020-12-08
JP2014062119A (ja) 2014-04-10
MY173867A (en) 2020-02-25
CN103751091B (zh) 2017-08-25
CA2716901A1 (en) 2009-09-03
CN103751091A (zh) 2014-04-30
US20090226522A1 (en) 2009-09-10
WO2009108775A2 (en) 2009-09-03
EP2247284A4 (en) 2013-10-02
AU2009219292B2 (en) 2014-02-27
JP2011513324A (ja) 2011-04-28
CN102036655B (zh) 2013-11-20
IL207824A (en) 2017-11-30
EP2247284A2 (en) 2010-11-10
HK1154505A1 (en) 2012-04-27
WO2009108775A3 (en) 2009-12-03
IL252713A0 (en) 2017-08-31
EP2247284B1 (en) 2017-04-19
JP5547096B2 (ja) 2014-07-09
AR072245A1 (es) 2010-08-18
MX2010009493A (es) 2010-12-20
CN102036655A (zh) 2011-04-27
CA2716901C (en) 2018-07-03
BRPI0908539B8 (pt) 2021-05-25
AU2009219292A1 (en) 2009-09-03

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