FI93693B - Förfarande för framställning av en stabil farmaceutisk komposition i pressad form - Google Patents

Förfarande för framställning av en stabil farmaceutisk komposition i pressad form Download PDF

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Publication number
FI93693B
FI93693B FI885398A FI885398A FI93693B FI 93693 B FI93693 B FI 93693B FI 885398 A FI885398 A FI 885398A FI 885398 A FI885398 A FI 885398A FI 93693 B FI93693 B FI 93693B
Authority
FI
Finland
Prior art keywords
alkyl
ramipril
pharmaceutical composition
hydrogen
active substance
Prior art date
Application number
FI885398A
Other languages
English (en)
Finnish (fi)
Other versions
FI93693C (sv
FI885398A0 (sv
FI885398A (sv
Inventor
Werner Fuelberth
Richard Leeb
Manfred Radau
Willi Stammberger
Original Assignee
Hoechst Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hoechst Ag filed Critical Hoechst Ag
Publication of FI885398A0 publication Critical patent/FI885398A0/sv
Publication of FI885398A publication Critical patent/FI885398A/sv
Application granted granted Critical
Publication of FI93693B publication Critical patent/FI93693B/sv
Publication of FI93693C publication Critical patent/FI93693C/sv

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G59/00—Polycondensates containing more than one epoxy group per molecule; Macromolecules obtained by polymerising compounds containing more than one epoxy group per molecule using curing agents or catalysts which react with the epoxy groups
    • C08G59/18—Macromolecules obtained by polymerising compounds containing more than one epoxy group per molecule using curing agents or catalysts which react with the epoxy groups ; e.g. general methods of curing
    • C08G59/40—Macromolecules obtained by polymerising compounds containing more than one epoxy group per molecule using curing agents or catalysts which react with the epoxy groups ; e.g. general methods of curing characterised by the curing agents used
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; 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
    • A61K9/1617—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
    • A61K9/1629—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Polymers & Plastics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Claims (4)

1. Förfarande för framställning av en stabil far-maceutisk komposition i pressad form känneteck-5 n a d därav, att det aktiva ämnet med formeln I, 0 Π R1 c ^ C /R R5—n-^ >C(H in COOR2 W X W £ | R4-QH^ CH—CH2-CH2-R cH H V 0 ^OR3 15 väri R är väte, C^-C^-alkyl eller fenyl, R1 är C^-C^-alkyl . A eller (CH_) -N, väri m är 1, 2, 3 eller 4 och A och B z m \b är likadana eller olika och betecknar väte eller Cj-C*-20 alkyl, R2 är väte, C1-C4-alkyl eller bensyl, R3 är väte eller Cj-C^-alkyl och R4 och R5 bildar tillsammans med de atomer tili vilka de är bundna ett heterocykliskt, mono, bi- eller tricykliskt hydrerat eller delvis hydrerat ringsystem med en kväveatom och 4 - 15 i ringen befintli-25 ga kolatomer och som eventuellt är mono- eller di-substi-tuerat med C1-C4-alkoxi, eller fysiologiskt godtagbara salter av detta, för stabilisering av detta överdrages med ett skyddshölje varvid skyddshöljets viktandel är 3 -25 % av vikten hos det aktiva ämnet, och som skyddshölje 30 användes en polymer vald ur gruppen cellulosaderivat, po-lyvinylacetatftalat, polyvinylpyrrolidon, katjoniska och *; anjoniska polymerat, poly(met)akrylsyraesterbaserade neu- trala kopolymerat, anjoniska polymerat av metakrylsyra och metakrylestrar, och gelatiner, och/eller man tillsät-35 ter en fysiologiskt godtagbar buffert vald ur gruppen natriumvätefosfatdihydrat, trinatriumcitratdihydrat, nat- 93693 20 riumkarbonat och tris(hydroximetyl)aminometan, varvid bufferten säkerställer att det i den farmaceutiska kom-positionen i närvaro av fukt räder ett pH-värde som be-finner sig inom intervallet svagt surt tili svagt ba-5 siskt.
2. Förfarande enligt patentkrav 1, k ä n n e -t e c k n a t därav, att ramipril stabiliseras med ett polymert skyddshölje.
3. Förfarande enligt patentkrav 1 för framställ-10 ning av en stabil farmaceutisk komposition i pressed form kännetecknat därav, att det aktiva ämnet el-ler en aktivt ämne och buffert innehällande blandning för stabilisering av detta överdrages med ett polymert skyddshölje och efter eventuell tillsats av hjälpämnen 15 pressas.
4. Förfarande enligt patentkrav 1 för framställ-ning av en stabil farmaceutisk komposition i pressed form kännetecknat därav, att pH-värdet hos omgiv-ningen hos det aktiva ämnet regleras tili värdet 5,5 - 8, 20 företrädesvis 6,5 - 7, genom tillsats av buffrande ämnen. il
FI885398A 1987-11-24 1988-11-22 Förfarande för framställning av en stabil farmaceutisk komposition i pressad form FI93693C (sv)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3739690 1987-11-24
DE19873739690 DE3739690A1 (de) 1987-11-24 1987-11-24 Stabilisierte arzneistoffe, verfahren zu ihrer herstellung sowie stabile arzneizubereitungen

Publications (4)

Publication Number Publication Date
FI885398A0 FI885398A0 (sv) 1988-11-22
FI885398A FI885398A (sv) 1989-05-25
FI93693B true FI93693B (sv) 1995-02-15
FI93693C FI93693C (sv) 1995-05-26

Family

ID=6341084

Family Applications (1)

Application Number Title Priority Date Filing Date
FI885398A FI93693C (sv) 1987-11-24 1988-11-22 Förfarande för framställning av en stabil farmaceutisk komposition i pressad form

Country Status (21)

Country Link
US (2) US5151433A (sv)
EP (1) EP0317878B1 (sv)
JP (1) JPH0768140B2 (sv)
KR (1) KR970004908B1 (sv)
CN (1) CN1028962C (sv)
AT (1) ATE74513T1 (sv)
AU (1) AU615495B2 (sv)
CA (1) CA1338344C (sv)
DE (2) DE3739690A1 (sv)
DK (1) DK168423B1 (sv)
ES (1) ES2033400T3 (sv)
FI (1) FI93693C (sv)
GR (1) GR3004925T3 (sv)
HU (1) HU202100B (sv)
IE (1) IE61173B1 (sv)
IL (1) IL88460A0 (sv)
NO (1) NO176550C (sv)
NZ (1) NZ227032A (sv)
PH (1) PH27416A (sv)
PT (1) PT89061B (sv)
ZA (1) ZA888734B (sv)

Families Citing this family (48)

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FI94339C (sv) 1989-07-21 1995-08-25 Warner Lambert Co Förfarande för framställning av farmaceutiskt användbar /R-(R*,R*)/-2-(4-fluorfenyl)- , -dihydroxi-5-(1-metyletyl)-3-fenyl-4-/(fenylamino)karbonyl/-1H-pyrrol-1-heptansyra och farmaceutiskt användbara salter därav
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SE9903028D0 (sv) * 1999-08-27 1999-08-27 Astra Ab New use
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DE602006000402T8 (de) * 2006-06-02 2009-04-09 Teva Pharmaceutical Industries Ltd. Stabile Zubereitung enthaltend eine feuchtigkeitsempfindliche aktive Substanz und Verfahren zur Herstellung der Zubereitung.
US20070281000A1 (en) * 2006-06-02 2007-12-06 Michael Fox Stable formulation comprising moisture sensitive drug/s and manufacturing procedure thereof
JP2009538905A (ja) * 2006-06-02 2009-11-12 テバ ファーマシューティカル インダストリーズ リミティド 感湿性薬物を含んで成る安定性製剤及びその製造方法
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EP2273985B1 (en) 2008-03-28 2016-02-17 Ferrer Internacional, S.A. Capsule for the prevention of cardiovascular diseases
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TR200906322A2 (tr) 2009-08-17 2011-07-21 Bi̇lgi̇ç Mahmut Çözünürlük ve stabilite özellikleri geliştirilmiş granüller.
ES2364011B1 (es) 2009-11-20 2013-01-24 Gp Pharm, S.A. Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados para el tratamiento de enfermedades cardiovasculares.
EP2814465B1 (en) 2012-02-17 2019-07-03 Egis Gyógyszergyár Zrt. Pharmaceutical formulation having improved stability
PL227900B1 (pl) 2012-11-15 2018-01-31 Adamed Spolka Z Ograniczona Odpowiedzialnoscia Kompozycja farmaceutyczna zawierająca inhibitor ACE i bloker kanałów wapniowych, sposób jej wytwarzania i jednostka dawkowania zawierająca tę kompozycję
HUP1300496A2 (hu) 2013-08-16 2015-03-02 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Stabil kombinációs gyógyszerkészítmény
TWI668285B (zh) * 2015-12-31 2019-08-11 長興材料工業股份有限公司 可熱聚合之組合物、由此形成之組成液及其用途
EP3275432A1 (en) 2016-07-25 2018-01-31 H e x a l Aktiengesellschaft Dosage form with ace inhibitor
WO2021162562A2 (en) 2020-02-10 2021-08-19 Adamed Pharma S.A. Stable ramipril composition and fixed dose composition comprising thereof
CN115068434B (zh) * 2022-08-03 2023-05-09 昆山龙灯瑞迪制药有限公司 一种雷米普利片的制备方法

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Also Published As

Publication number Publication date
JPH0768140B2 (ja) 1995-07-26
EP0317878B1 (de) 1992-04-08
FI93693C (sv) 1995-05-26
HU202100B (en) 1991-02-28
DE3739690A1 (de) 1989-06-08
US5442008A (en) 1995-08-15
US5151433A (en) 1992-09-29
ZA888734B (en) 1989-07-26
FI885398A0 (sv) 1988-11-22
NO885213D0 (no) 1988-11-23
ES2033400T3 (es) 1993-03-16
DK168423B1 (da) 1994-03-28
DK653688D0 (da) 1988-11-23
AU615495B2 (en) 1991-10-03
ATE74513T1 (de) 1992-04-15
AU2581888A (en) 1989-05-25
DE3869919D1 (de) 1992-05-14
NO176550C (no) 1995-04-26
KR890007739A (ko) 1989-07-05
IE883505L (en) 1989-05-24
NZ227032A (en) 1991-05-28
IL88460A0 (en) 1989-06-30
PH27416A (en) 1993-06-21
NO176550B (no) 1995-01-16
NO885213L (no) 1989-05-25
JPH01165596A (ja) 1989-06-29
DK653688A (da) 1989-05-25
CN1028962C (zh) 1995-06-21
PT89061A (pt) 1988-12-01
EP0317878A1 (de) 1989-05-31
PT89061B (pt) 1993-03-31
HUT48455A (en) 1989-06-28
IE61173B1 (en) 1994-10-05
FI885398A (sv) 1989-05-25
CA1338344C (en) 1996-05-21
CN1042917A (zh) 1990-06-13
KR970004908B1 (ko) 1997-04-08
GR3004925T3 (sv) 1993-04-28

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