FI116773B - Förfarande för framställning av orala högdossuspensioner av mykofenolatmofetil - Google Patents

Förfarande för framställning av orala högdossuspensioner av mykofenolatmofetil Download PDF

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FI116773B
FI116773B FI961466A FI961466A FI116773B FI 116773 B FI116773 B FI 116773B FI 961466 A FI961466 A FI 961466A FI 961466 A FI961466 A FI 961466A FI 116773 B FI116773 B FI 116773B
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mycophenolate mofetil
agent
flavor
aine
dye
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FI961466A
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English (en)
Finnish (fi)
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FI961466A (sv
FI961466A0 (sv
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Deborah M Lidgate
Leo Gu
Li-Hua Wang-Kessler
Bindu Joshi
Sayee G Hegde
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Syntex Inc
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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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Virology (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Dental Preparations (AREA)
  • Harvesting Machines For Root Crops (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Pyridine Compounds (AREA)

Claims (2)

1. Menetelmä stabiilin farmaseuttisen valmisteen tamiseksi, joka valmiste käsittää 5 ainesosa paino/til mykofenolaattimofetiili tai 7,5 - 3C my ko f enolihappo suspendoimis-/viskositeettiaine 0,1 - 3, kostutusaine 0 - 0, 10 makeutusaineet 30,0 - 70 aromi 0,1 - 2, aromivahvenne/karvautta naamioiva aine 0-1, puskuri, pH-arvoon 5,0-7,0 0,5-1, antimikrobinen aine 0-1, 15 väriaine 0-0, puhdistettu vesi ad 10 nestemäisenä suspensiona, joka on sopiva oraalise annostamiseen, tunnettu siitä, että 20 a. antimikrobinen aine lisätään ja dispergoidaa mennettuun (noin 70 °C) veteen, jonka jälkeen lis< suspendoimis- ja/tai viskositeettiaineet (mieluim f *w\l mikrokiteinen selluloosa, jonka jälkeen ksantaani ♦ ·· ···· ·:··· 25 b. liuotetaan, samalla sekoittaen, puskuri (t) , .luimmin sitruunahappo, jonka jälkeen kaksiemäksin ··· .···. riumfosfaatti) , jonka jälkeen lisätään makeutusai • · · kostutusaine(et), väriaine(et), aromivahvenne(-va , . teet) ja aromi(t) ja • · · • * · .... 30 1*1 J w • · d ainesosa paino/til mykofenolaattimofetiili tai 7,5 - 30 myko f eno1ihappo 5 suspendoimis-/viskositeettianne 0,1 - 3, kostutusaine 0 - 0, makeutusaineet 30,0 - 70 aromi 0,1 - 2, aromivahvenne/karvautta naamioiva aine 0 - l, 10 puskuri, pH-arvoon 5,0-7,0 0,5 - 1, antimikrobinen aine 0-1, väriaine 0-0, puhdistettu vesi ad 10 nestemäisenä suspensiona, joka on sopiva oraalise 15 annostamiseen, tunnettu siitä, että a. suspendoimis- ja/tai viskositeettiaineet lisät dispergoidaan kuumennettuun veteen; 20 b. lisätään makeutusaineet, aromit ja väriaineet taen; • · · • t » »«* : c. lisätään kos tutua aineet sekoittaen; «M ·· * «•«e 25 d. valmistetaan puskuriliuos ja yhdistetään maini , puskuriliuos vaiheen c seokseen lopullisen suspen * * * mulaation pH:n säätämiseksi alueelle 5,0-7,0,- • * · . . e. lisätään antimikrobinen aine vaiheessa d saatu * · ··♦ : 30 teeseen; ja ·♦· • · • · * * Λ.
1. Förfarande för framställning av ett stabilt fa ceutiskt preparat, vilket innefattar 5 ingrediens vikt/vol. mykofenolatmofetil eller 7,5 - 30 mykofenolsyra suspenderings-/viskositetsmedel 0,1 - 3, befuktningsmedel 0 - 0, 10 sötningamedel 30,0 - 70 arom 0,1 - 2, aromförstärkare/bitterhet maskerande medel 0-1 buffert, tili pH-värde 5,0-7,0 0,5-1, antimikrobiellt medel 0-1, 15 färgämne 0-0, renat vatten ad 10 som flytande suspension, vilken passar för oral d kännetecknat därav, att 20 a. det antimikrobiella medlet tillsätts och dis i upphettat (cirka 70 °C) vatten, varefter man ti! m suspenderings- och/eller viskoaitetsmedel (heist kristallin cellulosa, varefter xantangummi) , ··» ·:··; 25 b. man upplöser, under samtidig blandning, • ·*. buffertmedel, (heist citronsyra, varefter dibasis natriumfosfat) , varefter man tillsätter sötningsm befuktningsmedel, färgmedel, aromförstärkare och • . aromämne(n) och ::: ·*· · 30 »M J w • » • « _ ___ . . __ ingrediens vikt/vol. mykofenolatmofetil eller 7,5 - 30 mykofenolsyra 5 suspenderings-/viskositetsmedel 0,1 - 3, befuktningsmedel 0-0, sötningsmedel 30,0 - 70 arom 0,1 - 2, aromförstärkare/bitterhet maskerande medel 0 10 buffert, till pH-varde 5,0-7,0 0,5-1, antimikrobiellt medel 0-1, färgämne 0-0, renat vatten ad 10 som flytande suspension, vilken passar för oral d 15 käxmetecknat därav, att a. suspenderings- och/eller viskositetsmedel till och dispergeras i upphettat vatten; 20 b. sötningsmedel, aromämnen och färgämnen tillsät blandning; « • * · « · «t« c. befuktningsmedel tillsätts under blandning; **· ···*: 25 d. man framställer en buffertlösning och förenar ; • ·*; bufferlösning med blandningen frän steget c för a ··· reglera pH-värdet för den slutliga suspensionsformulationen till omrädet 5,0-7,0; • · • · · * · · 30 e. det antimikrobiella medlet tillsätts i den i si • * «a* 411 am . rtrtU
FI961466A 1993-10-01 1996-04-01 Förfarande för framställning av orala högdossuspensioner av mykofenolatmofetil FI116773B (sv)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US13034393A 1993-10-01 1993-10-01
US13034393 1993-10-01
PCT/US1994/010926 WO1995009626A1 (en) 1993-10-01 1994-09-27 Mycophenolate mofetil high dose oral suspensions
US9410926 1994-09-27

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FI961466A FI961466A (sv) 1996-04-01
FI961466A0 FI961466A0 (sv) 1996-04-01
FI116773B true FI116773B (sv) 2006-02-28

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FI961466A FI116773B (sv) 1993-10-01 1996-04-01 Förfarande för framställning av orala högdossuspensioner av mykofenolatmofetil
FI20060003A FI117502B (sv) 1993-10-01 2006-01-02 Förfarande för framställning av torra högdosgranulat av mykofenolatmofetil

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US (1) US5688529A (sv)
EP (2) EP1475091A1 (sv)
JP (1) JP3844491B2 (sv)
CN (1) CN1089583C (sv)
AT (1) ATE303143T1 (sv)
AU (1) AU678303B2 (sv)
BR (1) BR9407728A (sv)
CZ (2) CZ301771B6 (sv)
DE (1) DE69434474T2 (sv)
DK (1) DK0721335T3 (sv)
ES (1) ES2248793T3 (sv)
FI (2) FI116773B (sv)
HK (1) HK1012583A1 (sv)
HU (1) HU228672B1 (sv)
IL (1) IL111116A (sv)
LT (1) LT4099B (sv)
LV (1) LV11428B (sv)
NO (1) NO310673B1 (sv)
NZ (1) NZ274678A (sv)
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PT (1) PT721335E (sv)
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RU (1) RU2150942C1 (sv)
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UA (1) UA39962C2 (sv)
WO (1) WO1995009626A1 (sv)
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BR9407728A (pt) 1997-02-12
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