DK2247284T3 - Fremgangsmåde til minimering af polymorfisme - Google Patents
Fremgangsmåde til minimering af polymorfisme Download PDFInfo
- 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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- DK
- Denmark
- Prior art keywords
- suspension
- drug
- gelatin
- dosage form
- disorder
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Classifications
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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
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- A—HUMAN NECESSITIES
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- 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
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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
- A61K9/10—Dispersions; Emulsions
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- 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
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- 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
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- 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
Landscapes
- 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)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Dispersion Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic 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.
Applications Claiming Priority (2)
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| US3229808P | 2008-02-28 | 2008-02-28 | |
| PCT/US2009/035276 WO2009108775A2 (en) | 2008-02-28 | 2009-02-26 | Process to minimize polymorphism |
Publications (1)
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| HUE052853T2 (hu) * | 2010-10-08 | 2021-05-28 | Scherer Technologies Llc R P | Orális vakcina gyorsan oldódó dózisforma, keményítõ alkalmazásával |
| WO2016138357A1 (en) | 2015-02-27 | 2016-09-01 | Kindred Biosciences, Inc. | Stimulation of appetite, management of weight loss, and treatment of anorexia in dogs and cats |
| 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 |
| IL267689B2 (en) | 2016-12-31 | 2025-05-01 | Bioxcel Therapeutics Inc | Use of sublingual dexmedetomidine for the treatment of agitation |
| BR112020026672A2 (pt) | 2018-06-27 | 2021-03-30 | Bioxcel Therapeutics, Inc. | Formulações de filme contendo dexmedetomidina e métodos para produzi-las |
| 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 |
| ES2961850T3 (es) | 2019-02-22 | 2024-03-14 | Catalent Uk Swindon Zydis Ltd | Minimización de la aireación de suspensiones durante la mezcla en línea |
| AU2020225818B2 (en) | 2019-02-22 | 2025-09-18 | Catalent U.K. Swindon Zydis Limited | Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension |
| JP7543291B2 (ja) | 2019-02-22 | 2024-09-02 | キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド | 医薬品の崩壊時間を安定させるための、保管中の薬物粒子コーティング材料の凝集を最小限に抑える |
| KR20210129649A (ko) | 2019-02-22 | 2021-10-28 | 카탈렌트 유.케이. 스윈던 지디스 리미티드 | 이부프로펜을 포함하는 약학적 조성물의 응집, 에어레이션 최소화 및 코팅 보존 |
| BR112022000992A2 (pt) | 2019-07-19 | 2022-06-14 | Arx Llc | Regimes de tratamento de dexmedetomidina não sedantes |
| US12208160B2 (en) * | 2020-07-31 | 2025-01-28 | Catalent U.K. Swindon Zydis Limited | Pharmaceutical compositions comprising coated API |
| WO2022103639A1 (en) | 2020-11-16 | 2022-05-19 | Orcosa Inc. | Methods of treating autoimmune or inflammatory conditions with cannabidiol or its derivatives/analogs |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
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| GB1548022A (en) * | 1976-10-06 | 1979-07-04 | Wyeth John & Brother Ltd | Pharmaceutial dosage forms |
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| CA2020018A1 (en) * | 1990-06-27 | 1991-12-28 | Don L. Simmons | Method and composition for treating the migraine complex |
| ATE216577T1 (de) * | 1992-01-29 | 2002-05-15 | Takeda Chemical Industries Ltd | Schnellösliche tablette und ihre herstellung |
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| US5457895A (en) * | 1993-10-01 | 1995-10-17 | R. P. Scherer Corporation | Method of identifying freeze-dried dosage forms |
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| US5869098A (en) * | 1997-08-20 | 1999-02-09 | Fuisz Technologies Ltd. | Fast-dissolving comestible units formed under high-speed/high-pressure conditions |
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| GB9908014D0 (en) * | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
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| GB0714223D0 (en) * | 2007-07-20 | 2007-08-29 | Fujifilm Mfg Europe Bv | Preparation of fine particles |
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- 2009-02-26 MY MYPI2010004071A patent/MY173867A/en unknown
- 2009-02-26 CN CN2009801157337A patent/CN102036655B/zh not_active Expired - Fee Related
- 2009-02-26 DK DK09713721.0T patent/DK2247284T3/da active
- 2009-02-26 ES ES09713721.0T patent/ES2633928T3/es active Active
- 2009-02-26 WO PCT/US2009/035276 patent/WO2009108775A2/en not_active Ceased
- 2009-02-26 MX MX2010009493A patent/MX2010009493A/es active IP Right Grant
- 2009-02-27 AR ARP090100677A patent/AR072245A1/es not_active Application Discontinuation
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2013
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2017
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Also Published As
| Publication number | Publication date |
|---|---|
| BRPI0908539B8 (pt) | 2021-05-25 |
| IL207824A (en) | 2017-11-30 |
| CA2716901A1 (en) | 2009-09-03 |
| EP2247284A2 (en) | 2010-11-10 |
| KR101473419B1 (ko) | 2014-12-16 |
| IL252713A0 (en) | 2017-08-31 |
| EP2247284B1 (en) | 2017-04-19 |
| MX2010009493A (es) | 2010-12-20 |
| BRPI0908539B1 (pt) | 2020-12-08 |
| RU2010139643A (ru) | 2012-04-10 |
| CN103751091A (zh) | 2014-04-30 |
| JP5547096B2 (ja) | 2014-07-09 |
| CN102036655A (zh) | 2011-04-27 |
| WO2009108775A2 (en) | 2009-09-03 |
| NZ587611A (en) | 2012-07-27 |
| US20090226522A1 (en) | 2009-09-10 |
| JP2014062119A (ja) | 2014-04-10 |
| ES2633928T3 (es) | 2017-09-26 |
| HK1154505A1 (en) | 2012-04-27 |
| IL207824A0 (en) | 2010-12-30 |
| CN103751091B (zh) | 2017-08-25 |
| ZA201006421B (en) | 2011-05-25 |
| KR20100123740A (ko) | 2010-11-24 |
| JP2011513324A (ja) | 2011-04-28 |
| CN102036655B (zh) | 2013-11-20 |
| WO2009108775A3 (en) | 2009-12-03 |
| AU2009219292B2 (en) | 2014-02-27 |
| EP2247284A4 (en) | 2013-10-02 |
| CA2716901C (en) | 2018-07-03 |
| MY173867A (en) | 2020-02-25 |
| AR072245A1 (es) | 2010-08-18 |
| AU2009219292A1 (en) | 2009-09-03 |
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