SI9111618B - Farmacevtski pripravek brez topila za oralno uporabo s podaljšanim sproščanjem aktivne substance in postopek za njegovo izdelavo - Google Patents

Farmacevtski pripravek brez topila za oralno uporabo s podaljšanim sproščanjem aktivne substance in postopek za njegovo izdelavo Download PDF

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Publication number
SI9111618B
SI9111618B SI9111618A SI9111618A SI9111618B SI 9111618 B SI9111618 B SI 9111618B SI 9111618 A SI9111618 A SI 9111618A SI 9111618 A SI9111618 A SI 9111618A SI 9111618 B SI9111618 B SI 9111618B
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Slovenia
Prior art keywords
active substance
oral use
prolonged release
preparation
active
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SI9111618A
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English (en)
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SI9111618A (en
Inventor
Ulrich Muench
Hans-Juergen Mika
Bernhard Emschermann
Rainer Schmidt
Bernhard Sczepanik
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Schwarz Pharma Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6415859&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI9111618(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schwarz Pharma Ag filed Critical Schwarz Pharma Ag
Publication of SI9111618A publication Critical patent/SI9111618A/sl
Publication of SI9111618B publication Critical patent/SI9111618B/sl

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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
    • A61K9/14—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
    • 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
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • 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
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)

Claims (12)

1 PATENTNI ZAHTEVKI 1. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance, označen s tem, da pripravek sestoji iz ohlajenega granulata taline, brez topila, iz najmanj ene taljive učinkovine, najmanj ene taljive pomožne snovi, ki je topna v učinkovini ali učinkovinah pri povišani temperaturi, in pa iz vsaj enega tvorca strukture.
2. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevkom 1, označen s tem, da je ohlajena taljena aktivna substanca izosorbiddinitrat.
3. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevkom 1, označen s tem, da je ohlajena taljena aktivna substanca izosorbid-5-monohidrat (5-ISM).
4. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-3, označen s tem, da je pomožna substanca nek termoplast.
5. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-4, označen s tem, da je pomožna substanca polivinil acetat.
6. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-5, označen s tem, da je tvorec strukture visokodisperzen silicijev dioksid. 2
7. Farmacevtski pripravek za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-6, označen s tem, da je oblika zdravila tableta, pilula, kapsula ali draže.
8. Postopek za pripravo farmacevtskega pripravka za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-6, označen s tem, da se zmes, ki sestoji iz najmanj ene taljive aktivne substance in najmanj ene pomožne substance, topne v učinkovini ali učinkovinah pri povišani temperaturi in pa iz najmanj enega tvorca strukture, tali, gnete do nastanka enakomerno navlažene mase in se nato granulira.
9. Postopek za pripravo farmacevtskega pripravka za oralno uporabo s podaljšanim sproščanjem aktivne substance v skladu z zahtevki 1-6, označen s tem, da se zmes, ki sestoji iz najmanj ene taljive aktvne substance in najmanj ene pomožne substance, topne v učinkovini ali učinkovinah pri povišani temperaturi in pa najmanj enega tvorca strukture, podvrže ekstrudiranju taline in nato granulira.
10. Postopek za pripravo farmacevtskega pripravka za oralno uporabo s podaljšanim sproščanjem aktivne substance, ki vsebuje izosorbiddinitrat, v skladu z zahtevkom 9, označen s tem, da se zmes, ki sestoji iz izosorbiddinitrata, polivinil acetata in visokodisperznega silicijevega dioksida kot tudi nadaljnih običajnih pomožnih substanc, podvrže ekstruziji taline v temperaturnem področju od 60 °C do 110 °C in nato granulira.
11. Postopek za pripravo farmacevtskega pripravka za oralno uporabo s podaljšanim sproščanjem aktivne substance, ki vsebuje izosorbid-5- 3 mononitrat (5-ISM), v skladu z zahtevkom 9, označen s tem, da se zmes, ki sestoji iz izosorbid-5-mononitrata, polivinilacetata in visokodisperznega silicijevega dioksida kot tudi nadaljnih običajnih pomožnih substanc, podvrže ekstruziji taline v temperaturnem področju 60 °C do 110 °C in nato granulira.
12. Dobljena oblika za oralno uporabo s podaljšanim sproščanjem aktivne substance, označena s tem, da se pripravi po postopku v skladu z zahtevki 8-11.
SI9111618A 1990-10-08 1991-10-03 Farmacevtski pripravek brez topila za oralno uporabo s podaljšanim sproščanjem aktivne substance in postopek za njegovo izdelavo SI9111618B (sl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4031881A DE4031881C2 (de) 1990-10-08 1990-10-08 Lösungsmittelfreie, oral zu verabreichende pharmazeutische Zubereitung mit verzögerter Wirkstoffreisetzung und Verfahren zu deren Herstellung
YU161891A YU48766B (sh) 1990-10-08 1991-10-03 Postupak za dobijanje farmaceutskog preparata za oralnu primenu sa usporenim oslobađanjem aktivne supstance bez rastvarača

Publications (2)

Publication Number Publication Date
SI9111618A SI9111618A (en) 1997-12-31
SI9111618B true SI9111618B (sl) 1999-08-31

Family

ID=6415859

Family Applications (1)

Application Number Title Priority Date Filing Date
SI9111618A SI9111618B (sl) 1990-10-08 1991-10-03 Farmacevtski pripravek brez topila za oralno uporabo s podaljšanim sproščanjem aktivne substance in postopek za njegovo izdelavo

Country Status (24)

Country Link
US (1) US5453283A (sl)
EP (1) EP0552227B2 (sl)
JP (1) JP3233929B2 (sl)
KR (1) KR0166599B1 (sl)
AT (1) ATE116843T1 (sl)
CA (1) CA2093666C (sl)
CZ (1) CZ284923B6 (sl)
DE (2) DE4031881C2 (sl)
DK (1) DK0552227T4 (sl)
ES (1) ES2067250T5 (sl)
FI (1) FI108401B (sl)
GR (1) GR3015131T3 (sl)
HR (1) HRP920960B1 (sl)
HU (2) HUT64211A (sl)
IE (1) IE76142B1 (sl)
LV (1) LV11002B (sl)
PL (1) PL167593B1 (sl)
PT (1) PT99168B (sl)
RU (1) RU2101009C1 (sl)
SI (1) SI9111618B (sl)
SK (1) SK279446B6 (sl)
UA (1) UA26449C2 (sl)
WO (1) WO1992005774A1 (sl)
YU (1) YU48766B (sl)

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WO2017086835A1 (ru) * 2015-11-17 2017-05-26 Общество С Ограниченной Ответственностью "Валента-Интеллект" Фармацевтическая композиция, обладающая терапевтическим эффектом в отношении демиелинизирующих заболеваний (варианты)
WO2019087084A1 (en) 2017-11-02 2019-05-09 Eman Biodiscoveries Sd. Bhd. Extract of orthosiphon stamineus, formulations, and uses thereof

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Also Published As

Publication number Publication date
PT99168A (pt) 1992-09-30
CA2093666C (en) 1998-05-19
KR930701963A (ko) 1993-09-08
ES2067250T3 (es) 1995-03-16
GR3015131T3 (en) 1995-05-31
IE76142B1 (en) 1997-10-08
ES2067250T5 (es) 1999-02-01
HU9300995D0 (en) 1993-07-28
HU211845A9 (en) 1995-12-28
PT99168B (pt) 1999-04-30
LV11002B (en) 1996-06-20
DE4031881A1 (de) 1992-04-09
HUT64211A (en) 1993-12-28
ATE116843T1 (de) 1995-01-15
HRP920960A2 (en) 1995-08-31
DE59104271D1 (de) 1995-02-23
JPH06501685A (ja) 1994-02-24
YU48766B (sh) 1999-12-27
DK0552227T4 (da) 1999-07-19
DK0552227T3 (da) 1995-03-27
US5453283A (en) 1995-09-26
FI931576A0 (fi) 1993-04-07
EP0552227B1 (de) 1995-01-11
FI108401B (fi) 2002-01-31
UA26449C2 (uk) 1999-08-30
KR0166599B1 (ko) 1999-01-15
WO1992005774A1 (de) 1992-04-16
EP0552227B2 (de) 1998-11-04
DE4031881C2 (de) 1994-02-24
LV11002A (lv) 1996-02-20
IE913592A1 (en) 1992-04-08
SI9111618A (en) 1997-12-31
CA2093666A1 (en) 1992-04-09
EP0552227A1 (de) 1993-07-28
SK279446B6 (sk) 1998-11-04
RU2101009C1 (ru) 1998-01-10
JP3233929B2 (ja) 2001-12-04
CZ284923B6 (cs) 1999-04-14
CS305091A3 (en) 1992-04-15
HRP920960B1 (en) 1998-10-31
FI931576A (fi) 1993-04-07
PL167593B1 (pl) 1995-09-30
YU161891A (sh) 1994-06-10

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