DK2085075T3 - Stabile formede partikler af krystallinske organiske forbindelser - Google Patents
Stabile formede partikler af krystallinske organiske forbindelser Download PDFInfo
- Publication number
- DK2085075T3 DK2085075T3 DK09156268.6T DK09156268T DK2085075T3 DK 2085075 T3 DK2085075 T3 DK 2085075T3 DK 09156268 T DK09156268 T DK 09156268T DK 2085075 T3 DK2085075 T3 DK 2085075T3
- Authority
- DK
- Denmark
- Prior art keywords
- particles
- organic compound
- microspheres
- stable
- particle
- Prior art date
Links
Classifications
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
- Y10T428/2989—Microcapsule with solid core [includes liposome]
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Processes Of Treating Macromolecular Substances (AREA)
Claims (15)
1. Et antal lagerstabile partikler af en bestemt størrelse og form i det væsentlige bestående af en polymert organisk forbindelse med ensartet krystalstruktur, hvilken organiske forbindelse bibeholder krystalstrukturen, og hvilke partikler bibeholder størrelsen og form ved lagring i vandigt medium i mindst ca. en måned,
2. Partiklerne ifølge krav 1, hvor partiklerne er mikrokugler.
3. Partiklerne af krav 2, hvor partiklerne er mikrokugler med en diameter på mellem ca, 1 og ca, 1,000 mikrometer.
4. Partikler ifølge ethvert af kravene 1 til 3, hvor den ønskede krystallinske form af den polymorfe organiske forbindelse er et hydrat,
5. Partikler ifølge ethvert af kravene 1 til 4, hvor den polymorfe organiske forbindelse er et steroid eller sterol,
6. Partiklerne ifølge krav 5, hvor steroidet eller sterolen er valgt fra gruppen bestående af 17p-estradiol, estrogen, testosteron, progesteron og cholesterol.
7. Partikler ifølge ethvert af kravene 1 til 4, hvor den polymorfe organiske forbindelse er astemizol, cisaprid eller oxatomid.
8. Fremgangsmåde til at påvirke krystallisation i fast tilstand af formede partikler af en polymert organisk forbindelse omfattende: a) tilvejebringelse af en polymorf organisk forbindelse, som er af blandet krystallinsk, amorf eller både krystallinsk og amorf form; b) fremstilling af den organiske forbindelse i et antal partikler med ensartet form; c) udsættelse af partiklerne af ensartet form for en atmosfære indeholdende dampe af et eller flere opløsningsmidler for den polymorf organiske forbindelse i en tilstrækkelig tid til at bevirke en krystallisation i fast tilstand af den polymorfe organiske forbindelse til dens mest stabile krystallinske form; og d) udvinding af partiklerne; hvor de udvundne partikler bibeholder den ensartede form ved lagring i vandigt medium i mindst ca. en måned.
9. Fremgangsmåden ifølge krav 8, hvor trinnet til fremstilling den organiske forbindelse i et antal partikler med ensartet form omfatter smelte-størkning af den organiske forbindelse i et antal mikrokugler.
10. Fremgangsmåden ifølge krav 8, hvor opløsningsmidlet: er valgt fra gruppen bestående af: vand, ethanol, acetone, eddikesyre, toluen, benzen, og kombinationer deraf.
11, Fremgangsmåden ifølge krav 10, hvor den pølymorfe organiske forbindelse er som defineret i ethvert af kravene 5 fil 7.
12, Fremgangsmåden Ifølge krav 8, hvor den damp-heldige atmosfære holdes ved en temperatur og et tryk tilstrækkeligt til at bevirke fordampning af opløsningsmidlet, men under smeltepunktet af den organiske forbindelse.
13. Fremgangsmåden ifølge krav 8, hvor den ensartede krystallinske form af den po ly morte organiske forbindelse er et hydrat.
14, Fremgangsmåden ifølge krav 8, hvor partiklerne er mikrøkugier, der varierer i størrelse fra 1 mikrometer til 500 mikrometer,
15. Fremgangsmåden ifølge krav 8, hver partiklerne er mikrokugler og mere end 70% af mikrokuglerne har diametre på mellem 70% og 130% af en specificeret diameter.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/030,388 US6287693B1 (en) | 1998-02-25 | 1998-02-25 | Stable shaped particles of crystalline organic compounds |
| EP06022834A EP1772141B1 (en) | 1998-02-25 | 1999-02-10 | Method for effecting solid state crystallization |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2085075T3 true DK2085075T3 (da) | 2017-01-23 |
Family
ID=21853984
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK06022834T DK1772141T3 (da) | 1998-02-25 | 1999-02-10 | Fremgangsmåde til gennemföring af krystallisation i fast tilstand |
| DK99902729T DK1056444T3 (da) | 1998-02-25 | 1999-02-10 | Stabile formede partikler af krystallinske organiske forbindelser |
| DK09156268.6T DK2085075T3 (da) | 1998-02-25 | 1999-02-10 | Stabile formede partikler af krystallinske organiske forbindelser |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK06022834T DK1772141T3 (da) | 1998-02-25 | 1999-02-10 | Fremgangsmåde til gennemföring af krystallisation i fast tilstand |
| DK99902729T DK1056444T3 (da) | 1998-02-25 | 1999-02-10 | Stabile formede partikler af krystallinske organiske forbindelser |
Country Status (35)
| Country | Link |
|---|---|
| US (7) | US6287693B1 (da) |
| EP (4) | EP2085075B1 (da) |
| JP (2) | JP4885357B2 (da) |
| KR (1) | KR100726315B1 (da) |
| CN (2) | CN1146407C (da) |
| AR (3) | AR018107A1 (da) |
| AT (2) | ATE427102T1 (da) |
| AU (1) | AU747779B2 (da) |
| BR (1) | BR9908156A (da) |
| CA (1) | CA2319176C (da) |
| CL (1) | CL2010001333A1 (da) |
| CY (1) | CY1118522T1 (da) |
| CZ (1) | CZ301042B6 (da) |
| DE (2) | DE69940684D1 (da) |
| DK (3) | DK1772141T3 (da) |
| EE (1) | EE05019B1 (da) |
| ES (3) | ES2324366T3 (da) |
| HK (2) | HK1036017A1 (da) |
| HU (1) | HUP0101271A3 (da) |
| ID (1) | ID26523A (da) |
| IL (2) | IL137970A0 (da) |
| MY (1) | MY138375A (da) |
| NO (1) | NO331804B1 (da) |
| NZ (1) | NZ505987A (da) |
| PE (1) | PE20000393A1 (da) |
| PL (1) | PL196369B1 (da) |
| PT (1) | PT2085075T (da) |
| RU (1) | RU2225708C2 (da) |
| SA (1) | SA99200098B1 (da) |
| TR (1) | TR200002462T2 (da) |
| TW (1) | TWI256308B (da) |
| UA (1) | UA73470C2 (da) |
| UY (1) | UY25404A1 (da) |
| WO (1) | WO1999043304A1 (da) |
| ZA (1) | ZA991058B (da) |
Families Citing this family (44)
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| US6287693B1 (en) | 1998-02-25 | 2001-09-11 | John Claude Savoir | Stable shaped particles of crystalline organic compounds |
| US6667344B2 (en) | 2001-04-17 | 2003-12-23 | Dey, L.P. | Bronchodilating compositions and methods |
| LT2767539T (lt) | 2002-05-16 | 2017-09-25 | Janssen Sciences Ireland Uc | Pseudopolimorfinės živ proteazės inhibitorių formos |
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| US20040028746A1 (en) * | 2002-08-06 | 2004-02-12 | Sonke Svenson | Crystalline drug particles prepared using a controlled precipitation (recrystallization) process |
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| ATE399536T1 (de) * | 2003-12-04 | 2008-07-15 | Pfizer Prod Inc | Verfahren zur herstellung von pharmazeutischen multiteilchenförmigen produkten |
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-
1998
- 1998-02-25 US US09/030,388 patent/US6287693B1/en not_active Expired - Lifetime
-
1999
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2000
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2001
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2002
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2003
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2010
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2011
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2016
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