SI9800128B - Enterična zrnca fluoksetina - Google Patents
Enterična zrnca fluoksetina Download PDFInfo
- Publication number
- SI9800128B SI9800128B SI9800128A SI9800128A SI9800128B SI 9800128 B SI9800128 B SI 9800128B SI 9800128 A SI9800128 A SI 9800128A SI 9800128 A SI9800128 A SI 9800128A SI 9800128 B SI9800128 B SI 9800128B
- Authority
- SI
- Slovenia
- Prior art keywords
- fluoxetine
- disorders
- pharmaceutically acceptable
- hpmcas
- layer
- Prior art date
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Classifications
-
- 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
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61P25/24—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
- A61P25/26—Psychostimulants, e.g. nicotine, cocaine
Claims (25)
- Patentni zahtevki 1. Enterično zrnce fluoksetina, označeno s tem, da je sestavljeno iz a) jedra, ki vsebuje fluoksetin in enega ali več farmacevtsko sprejemljivih ekscipiensov; b) opcijske ločilne plasti, ki vsebuje nereducirajoči sladkor ter enega ali več farmacevtsko sprejemljivih ekscipiensov; c) enterične plasti, ki vsebuje acetatni sukcinat hidroksipropilmetilceluloze (HPMCAS) in enega ali več farmacevtsko sprejemljivih ekscipiensov; in d) opcijske zaključne plasti.
- 2. Zrnce po zahtevku 1, označeno s tem, da vsebujejo ločilno plast.
- 3. Zrnce po zahtevku 2, označeno s tem, da ločilna plast vsebuje farmacevtsko sprejemljivi sladkor.
- 4. Zrnce po zahtevku 3, označeno s tem, daje sladkor saharoza.
- 5. Zrnce po kateremkoli od zahtevkov 1 do 4, označeno s tem, daje povprečna velikost delcev fluoksetina okrog 50 μιη ali manj.
- 6. Zrnce po kateremkoli od zahtevkov 1 do 5, označeno s tem, da njegovo jedro predstavlja inertno jedro, na katero je nanesen fluoksetin v sloju, ki ga sestavlja še farmacevtsko sprejemljivi ekscipiens.
- 7. Zrnce po kateremkoli od zahtevkov 1 do 6, označeno s tem, da je v njem HPMCAS delno nevtralizirana do take stopnje, daje od 0% do okrog 15% sukcinilnih skupin nevtraliziranih.
- 8. Zrnce po zahtevku 7, označeno s tem, da je v njem HPMCAS nevtralizirana z amoniakom.
- 9. Pripravek, označen s tem, da je sestavljen iz različnih enteričnih fluoksetinskih zrnc po kateremkoli od zahtevkov 1 do 8.
- 10. Pripravek po zahtevku 9, označen s tem, da vsebuje 20-100 mg fluoksetina (ekvivalent baze).
- 11. Pripravek po zahtevku 9, označen s tem, da vsebuje okrog 80-90 mg fluoksetina (ekvivalent baze).
- 12. Pripravek po zahtevku 9, označen s tem, da vsebuje okrog 90 mg fluoksetina (ekvivalent baze).
- 13. Pripravek po kateremkoli od zahtevkov 9 do 13, označen s tem, da je v njem fluoksetin prisoten v obliki fluoksetin hidroklorida.
- 14. Pripravek po kateremkoli od zahtevkov 9 do 13, označen s tem, daje v njem še dodatno prisoten pindolol.
- 15. Pripravek po zahtevku 9, označen s tem, da vsebuje: -2.- Jedra saharoza - “starch nonpareils”, 30-35 mesh 100-150 mg Fluoksetinska plast 100,5-100,8 mg 20-30 mg 10-15 mg 4- 12 mg 15-35 mg 25-60 mg 60-90 mg 10-20 mg 15-25 mg 35-55 mg 5- 15 mg fluoksetin hidroklorid saharoza hidroksipropilmetilceluloza Ločilna plast hidroksipropilmetilceluloza saharoza TALK, 500 mesh Enterična plast HPMCAS-LF trietil citrat talk, 500 mesh Zaključna plast bela barvna mešanica (HPMC + titanov dioksid) HPMC talk v sledovih
- 16. Kapsule iz želatine, označene s tem, da vsebujejo pripravek po kateremkoli od zahtevkov 9 do 15.
- 17. Pripravke po kateremkoli od zahtevkov 9 do 15, označene s tem, da z njimi zdravimo paciente, ki trpijo zaradi depresije, obsesivno-kompulzivne motnje, bulimije, bolečine, obsesivno-kompulzivnih osebnostnih motenj, motenj zaradi post travmatičnega stresa, hipertenzije, ateroskleroze, anksioznosti, anorexie nervose, panične reakcije, socialne fobije, jecljanja, motenj spanja, kronične utrujenosti, Alzheimerjeve bolezni, odvisnosti od alkohola, motenj apetita, izgube teže, agorafobije, izboljšanja spomina, amnezije, prenehanja kajenja, simptomov zaradi sindroma odvzetja nikotina, motenj razpoloženja in/ali apetita, ki so vezane na predmenstrualni sindrom, depresivno razpoloženje in/ali požrešnost na ogljikove hidrate, povezana s pred-menstrualnim sindromom, motenj razpoloženja, motenj apetita ali motenj, ki prispevajo k recidivom, ki so povezane z odvzetjem nikotina, motenj cirkardialnega ritma, mejnih osebnostnih motenj, hipohondrije, predmenstrualnega sindroma (PMS), disforične motnje v pozni lutealni fazi, predmenstrulne disforične motnje, trihotilomanije, simptomov, ki so posledica diskontinuitete jemanja drugih antidepresivov, -3>- agresivne/prekinjene eksplozivne motnje, kompulzivnega igranja na srečo, kompulzivnega zapravljanja, kompulzivne spolnosti, motenj zaradi uporabe psihoaktivnih snovi, spolnih motenj, shizofrenije, prezgodnje ejakulacije ali psihiatričnih simptomov, ki izvirajo iz stresa, skrbi, jeze, občutljivosti na zavračanje in pomanjkanja duševne ali telesne energije.
- 18. Postopek za pripravo enteričnega zrnca fluoksetina, označen s tem, da vključuje: a) izdelavo jedra, ki vsebuje fluoksetin in enega ali več farmacevtsko sprejemljivih ekscipiensov; b) nanašanje na jedro ločilne plasti, ki vsebuje nereducirajoči sladkor in enega ali več farmacevtsko sprejemljivih ekscipiensov (opcija); c) nanašanje enterične plasti, ki vsebuje HPMCAS in enega ali več farmacevtsko sprejemljivih ekscipiensov, pri čemer je v tej plasti HPMCAS uporabljena v obliki vodne raztopine ali suspenzije, nanašanje pa poteka v napravi s tekočim ležiščem; in d) opcijsko, nanašanje zaključne plasti.
- 19. Postopek po zahtevku 18, označen s tem, daje v njem uporabljena HPMCAS popolnoma ali delno nevtralizirana.
- 20. Postopek po zahtevku 18, označen s tem, daje v njem uporabljena HPMCAS nevtralizirana do take stopnje, da je v njej od okrog 25% do okrog 100% skupin sukcinilne kisline nevtraliziranih.
- 21. Postopek po zahtevku 18 ali 20, označen s tem, da je v njem uporabljena HPMCAS nevtralizirana z amoniakom ali amonijevim hidroksidom.
- 22. Postopek po kateremkoli zahtevku 18 do 21, označen s tem, da so pri njem jedra pripravljena z nanašanjem fluoksetina in enega ali več farmacevtsko sprejemljivih ekscipiensov na inertno jedro.
- 23. Postopek po kateremkoli zahtevku 18 do 22, označen s tem, da se pri njem uporablja ločilna plast.
- 24. Postopek po zahtevku 23, označen s tem, daje pri njem uporabljena ločilna plast sestavljena iz farmacevtsko sprejemljivega sladkoija.
- 25. Postopek po zahtevku 24, označen s tem, daje sladkor saharoza. ZA: ELI LILLY AND COMPANY, US
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/867,196 US5910319A (en) | 1997-05-29 | 1997-05-29 | Fluoxetine enteric pellets and methods for their preparation and use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI9800128A SI9800128A (sl) | 1999-02-28 |
| SI9800128B true SI9800128B (sl) | 2000-04-30 |
Family
ID=25349313
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9800128A SI9800128B (sl) | 1997-05-29 | 1998-04-29 | Enterična zrnca fluoksetina |
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| CA2134038C (en) * | 1994-06-16 | 1997-06-03 | David Taiwai Wong | Potentiation of drug response |
| US5508276A (en) * | 1994-07-18 | 1996-04-16 | Eli Lilly And Company | Duloxetine enteric pellets |
| ES2082723B1 (es) * | 1994-07-20 | 1996-10-01 | Lilly Sa | Formulacion farmaceutica de fluoxetina en forma dispersable. |
| JPH08109126A (ja) * | 1994-10-07 | 1996-04-30 | Amano Pharmaceut Co Ltd | 耐衝撃性腸溶性顆粒剤およびこれを含有する錠剤 |
| JPH08245423A (ja) * | 1995-03-06 | 1996-09-24 | Shionogi & Co Ltd | 水系腸溶性コーティング液 |
| GB9514842D0 (en) * | 1995-07-20 | 1995-09-20 | Smithkline Beecham Plc | Novel formulation |
-
1997
- 1997-05-29 US US08/867,196 patent/US5910319A/en not_active Ceased
-
1998
- 1998-04-13 IL IL12407398A patent/IL124073A/en not_active IP Right Cessation
- 1998-04-14 CA CA002234826A patent/CA2234826C/en not_active Expired - Lifetime
- 1998-04-14 RO RO98-00869A patent/RO120043B1/ro unknown
- 1998-04-14 RU RU98106998/14A patent/RU2164405C2/ru active
- 1998-04-15 NZ NZ330192A patent/NZ330192A/xx not_active IP Right Cessation
- 1998-04-15 ZA ZA9803173A patent/ZA983173B/xx unknown
- 1998-04-15 UA UA98041929A patent/UA48193C2/uk unknown
- 1998-04-15 GB GB9807939A patent/GB2325623B/en not_active Expired - Lifetime
- 1998-04-15 CZ CZ19981143A patent/CZ290582B6/cs not_active IP Right Cessation
- 1998-04-15 RS YUP-165/98A patent/RS49827B/sr unknown
- 1998-04-15 HU HU9800882A patent/HUP9800882A3/hu not_active Application Discontinuation
- 1998-04-16 FI FI980846A patent/FI119971B/fi active IP Right Grant
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- 1998-04-17 SE SE9801336A patent/SE522914C2/sv not_active IP Right Cessation
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- 1998-04-20 KR KR1019980014014A patent/KR100549473B1/ko not_active IP Right Cessation
- 1998-04-22 LT LT98-058A patent/LT4477B/lt not_active IP Right Cessation
- 1998-04-24 CN CNB981087787A patent/CN1161109C/zh not_active Expired - Lifetime
- 1998-04-24 JP JP15350198A patent/JP3210288B2/ja not_active Expired - Lifetime
- 1998-04-28 IT IT98MI000908A patent/ITMI980908A1/it unknown
- 1998-04-28 SV SV1998000052A patent/SV1998000052A/es unknown
- 1998-04-28 ES ES009800899A patent/ES2161574B1/es not_active Expired - Fee Related
- 1998-04-29 SI SI9800128A patent/SI9800128B/sl unknown
- 1998-05-01 PL PL326134A patent/PL192293B1/pl unknown
- 1998-05-07 AR ARP980102130A patent/AR011728A1/es not_active Application Discontinuation
- 1998-05-08 PT PT102152A patent/PT102152B/pt active IP Right Grant
- 1998-05-11 TW TW087107241A patent/TWI239838B/zh not_active IP Right Cessation
- 1998-05-12 CO CO98026349A patent/CO4940407A1/es unknown
- 1998-05-13 FR FR9806040A patent/FR2763846B1/fr not_active Expired - Lifetime
- 1998-05-14 NO NO19982197A patent/NO317743B1/no not_active IP Right Cessation
- 1998-05-19 BR BR9801989-9A patent/BR9801989A/pt not_active Application Discontinuation
- 1998-05-20 LU LU90245A patent/LU90245B1/fr active
- 1998-05-20 BE BE9800383A patent/BE1011925A3/fr not_active IP Right Cessation
- 1998-05-25 LV LVP-98-121A patent/LV12176B/xx unknown
- 1998-05-26 CH CH01157/98A patent/CH693018A5/de not_active IP Right Cessation
- 1998-05-26 NL NL1009259A patent/NL1009259C2/nl not_active IP Right Cessation
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- 1998-05-28 DE DE19823940A patent/DE19823940B4/de not_active Expired - Lifetime
- 1998-05-28 ID IDP980791A patent/ID20343A/id unknown
- 1998-05-28 PE PE1998000430A patent/PE75399A1/es not_active Application Discontinuation
- 1998-05-28 GR GR980100188A patent/GR980100188A/el unknown
- 1998-05-28 DK DK199800728A patent/DK176776B1/da not_active IP Right Cessation
- 1998-05-28 AU AU69048/98A patent/AU726690B2/en not_active Expired
- 1998-05-29 AT AT0093198A patent/AT408068B/de not_active IP Right Cessation
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1999
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2000
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2001
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2002
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