FI121262B - Farmaceutiska formulationer av fluoxetin - Google Patents

Farmaceutiska formulationer av fluoxetin Download PDF

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Publication number
FI121262B
FI121262B FI953515A FI953515A FI121262B FI 121262 B FI121262 B FI 121262B FI 953515 A FI953515 A FI 953515A FI 953515 A FI953515 A FI 953515A FI 121262 B FI121262 B FI 121262B
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Finland
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weight
formulation
formulation according
total weight
starch
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FI953515A
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English (en)
Finnish (fi)
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FI953515A0 (sv
FI953515A (sv
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Mendizabal Flavia Arce
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Lilly Sa
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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
    • A61K9/20—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
    • 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
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (23)

1. Farmaceutisk formulering, som lämpar sig för framställning av dispergerbara tabletter medelst direkt 5 pressning, kännetecknad av att, den bestär av fluoxe-tin eller ett syraadditionssalt därav sorti aktivt ämne i en mängd av 4 - 7,5 vikt-% av formuleringens totala vikt, tillsammans med lämpliga fyllmedel och hjälpmedel inklude-rande en disintegrant, ett utspädningsmedel och ett an-10 tiadhesionsmedel, varvid disintegranten är vald ur gruppen natriumstärkelseglykolat, polymera derivat av akrylsyra och krospovidon, och utspädningsmedlet är valt ur gruppen mikrokristallin cellulosa, laktos, hydroxipropylcellulosa (HPC), förgelatinerad stärkelse, torr flytande stärkelse 15 och kombinationer och bladningar av dessa.
2. Formulering enligt patentkrav 1, kännetecknad av att de lämpliga fyllmedlen och hjälpmedlen även omfattar ett smörjmedel.
3. Formulering enligt patent kraven 1 - 2, kän- 20 netecknad av att de lämpliga fyllmedlen även omfattar sötningsmedel och aromämnen.
4. Formulering enligt patentkraven 1 - 3, kän netecknad av att den innehäller 9,5 - 17 vikt-% natriumstärkelseglykolat, beräknat pä formuleringens totalvikt.
5. Formulering enligt patentkraven 1 - 4, kän netecknad av att den innehäller 10 - 21 vikt-% akryl-syraderivat, beräknat pä formuleringens totalvikt.
6. Formulering enligt patentkraven 1 - 5, kän netecknad av att den innehäller 9-13 vikt-% krospo- 30 vidon, beräknat pä formuleringens totalvikt.
7. Formulering enligt patentkraven 1 - 6, kän netecknad av att den innehäller 5-25 vikt-% hydroxi-propycellulosa, företrädesvis L-HPC, beräknat pä formuleringens totalvikt.
8. Formulering enligt nägot av patentkraven 1-7, kännetecknad av att den innehäller en kombination av förgelatinerad stärkelse och hydroxipropylcellulosa, fö-reträdesvis HPC, varvid mängden förgelatinerad stärkelse är 60 - 70 vikt-% av formuleringens totalvikt och mängden HPC är ca 5 vikt-% av formuleringens totalvikt.
9. Formulering enligt patentkraven 1 - 8, kän- netecknad av att den innehäller 62 - 76 vikt-% mikro-kristallin cellulosa, beräknat pä formuleringens totalvikt .
10. Formulering enligt patentkrav 9, känne- 10 tecknad av att den mikrokristallina cellulosan har en genomsnittlig partikelstorlek av 50 - 90 pm.
11. Formulering enligt nägot av patentkraven 1 -10, kännetecknad av att den innehäller en kombination av mikrokristallin cellulosa och torr flytande stärkelse, 15 varvid mängden mängden torr flytande stärkelse är 15 - 27 vikt-% av formuleringens totalvikt och mängden mikrokristallin cellulosa är 46 - 58 vikt-% av formuleringens totalvikt .
12. Formulering enligt patentkraven 2 - 11, kän- 20 netecknad av att den som smörjmedel innehäller 1-2,5 vikt-% stearylnatriumfumarat, beräknat pä formuleringens totalvikt.
13. Formulering enligt patentkraven 1 - 12, kännetecknad av att den som antiadhesionsmedel innehäller 25 1-2 vikt-% kolloid kiseldioxid, beräknat pä formulerin gens totalvikt.
14. Formulering enligt patentkraven 3 - 13, kännetecknad av att den innehäller artificiella eller na-turliga sötningsmedel.
15. Formulering enligt patentkrav 14, känne tecknad av att den som artifxciellt sötningsmedel innehäller 0,4-5 vikt-% natriumsackarin, beräknat pä formuleringens totalvikt, eller ca 1,6 vikt-% aspartam, beräknat pä formuleringens totalvikt.
16. Formulering enligt patentkrav 15, känne tecknad av att den innehäller mannitol, sorbitol eller ammoniumglyciricinat eller en blandning av dessa som som naturliga sötningsmedel.
17. Formulering enligt patentkrav 16, kanne - tecknad av att den innehäller 2,5-5 vikt-% mannitol, 5 beräknat pä formuleringens totalvikt.
18. Formulering enligt patentkrav 17, känne- tecknad av att den innehäller 1,5-4 vikt-% sorbitol, beräknat pä formuleringens totalvikt.
19. Formulering enligt patentkrav 18, känne- 10 tecknad av att den innehäller 0,5-1 vikt-% ammoniumglyciricinat, beräknat pä formuleringens totalvikt.
20. Formulering enligt patentkrav 17, kanne - tecknad av att den omfattar en blandning av natrium-sackarin och mannitol, varvid mängden natriumsackarin är 15 0,5-4,5 vikt-% av formuleringens totalvikt och mängden mannitol är 2,5 - 5 vikt-% av formuleringens totalvikt.
21. Formulering enligt patentkraven 3 - 20, kän-netecknad av att den som smakämnen innehäller 1,4 -12,5 vikt-% mintarom, pepparmintaromer, appelsinaromer, 20 persikaarom, aprikosarom, hallonarom, cxtronarom, ko-kosarom eller ananasarom eller en blandning av dessa, beräknat pä formuleringens totalvikt.
22. Formulering enligt patentkrav 21, känne-tecknad av att den innehäller mannitol och sorbitol som 25 sötningsmedel och 10 - 12 vikt-% aromämne, som omfattar jordgubbsarom, beräknat pä formuleringens vikt; eller 0,6 - 0,7 vikt-% anis, beräknat pä formuleringens vikt; eller 0,3 vikt-% pepparmint, beräknat pä formuleringens vikt; eller en kombinatxon av de tvä sistnamnda.
23. Formulering enligt patentkraven 1-22, kän - netecknad av att syraadditionssaltet av fluoxetin är hydroklorid.
FI953515A 1994-07-20 1995-07-20 Farmaceutiska formulationer av fluoxetin FI121262B (sv)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES09401593A ES2082723B1 (es) 1994-07-20 1994-07-20 Formulacion farmaceutica de fluoxetina en forma dispersable.
ES9401593 1994-07-20

Publications (3)

Publication Number Publication Date
FI953515A0 FI953515A0 (sv) 1995-07-20
FI953515A FI953515A (sv) 1996-01-21
FI121262B true FI121262B (sv) 2010-09-15

Family

ID=8286976

Family Applications (3)

Application Number Title Priority Date Filing Date
FI953515A FI121262B (sv) 1994-07-20 1995-07-20 Farmaceutiska formulationer av fluoxetin
FI20011851A FI20011851A (sv) 1994-07-20 2001-09-20 En dispergerbar tablett innehållande fluoxetin eller ett syraadditiossalt därav
FI20011852A FI20011852A (sv) 1994-07-20 2001-09-20 Förfarande för framställning av en dispergerbar tablett innehållande fluoxetin eller ett syraadditionssalt därav

Family Applications After (2)

Application Number Title Priority Date Filing Date
FI20011851A FI20011851A (sv) 1994-07-20 2001-09-20 En dispergerbar tablett innehållande fluoxetin eller ett syraadditiossalt därav
FI20011852A FI20011852A (sv) 1994-07-20 2001-09-20 Förfarande för framställning av en dispergerbar tablett innehållande fluoxetin eller ett syraadditionssalt därav

Country Status (31)

Country Link
US (1) US5747068A (sv)
EP (3) EP1072262A1 (sv)
JP (1) JPH0840884A (sv)
KR (1) KR100360130B1 (sv)
CN (2) CN1101187C (sv)
AT (1) ATE200733T1 (sv)
AU (2) AU692550B2 (sv)
BR (1) BR9503386A (sv)
CO (1) CO4410195A1 (sv)
CY (1) CY2241B1 (sv)
CZ (1) CZ287378B6 (sv)
DE (2) DE69520768T2 (sv)
DK (1) DK0693281T3 (sv)
ES (2) ES2082723B1 (sv)
FI (3) FI121262B (sv)
GR (2) GR960300064T1 (sv)
HK (1) HK1012573A1 (sv)
HU (1) HU228859B1 (sv)
IL (1) IL114641A (sv)
MY (1) MY114776A (sv)
NO (1) NO312225B2 (sv)
NZ (1) NZ272610A (sv)
PE (1) PE33996A1 (sv)
PL (1) PL181359B1 (sv)
PT (1) PT693281E (sv)
RU (1) RU2145850C1 (sv)
SI (1) SI0693281T1 (sv)
TR (1) TR199500878A2 (sv)
TW (1) TW404840B (sv)
UA (1) UA41346C2 (sv)
ZA (1) ZA956074B (sv)

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IL114641A0 (en) 1995-11-27
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EP1070501A1 (en) 2001-01-24
CO4410195A1 (es) 1997-01-09
NO312225B1 (no) 2002-04-15
NO952863L (no) 1996-01-22
CY2241B1 (en) 2003-07-04
IL114641A (en) 1999-04-11
CZ287378B6 (en) 2000-11-15
FI953515A0 (sv) 1995-07-20
ZA956074B (en) 1996-05-14
FI20011852A (sv) 2001-09-20
NZ272610A (en) 1997-08-22
FI953515A (sv) 1996-01-21
NO312225B2 (no) 2002-04-15
GR3035788T3 (en) 2001-07-31
AU2509895A (en) 1996-02-01
HUT75036A (en) 1997-03-28
NO952863D0 (no) 1995-07-19
CN1440745B (zh) 2012-03-21
UA41346C2 (uk) 2001-09-17
AU692550B2 (en) 1998-06-11
PT693281E (pt) 2001-08-30
CZ188095A3 (en) 1996-02-14
SI0693281T1 (en) 2001-12-31
ES2082723A1 (es) 1996-03-16
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DK0693281T3 (da) 2001-05-21
KR960003720A (ko) 1996-02-23
DE69520768D1 (de) 2001-05-31
CN1101187C (zh) 2003-02-12
HU228859B1 (en) 2013-06-28
BR9503386A (pt) 1996-02-27
ATE200733T1 (de) 2001-05-15
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