FI120718B - Förfarande för framställning av vätskefyllda mjuka gelatinkapslar - Google Patents

Förfarande för framställning av vätskefyllda mjuka gelatinkapslar Download PDF

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Publication number
FI120718B
FI120718B FI944452A FI944452A FI120718B FI 120718 B FI120718 B FI 120718B FI 944452 A FI944452 A FI 944452A FI 944452 A FI944452 A FI 944452A FI 120718 B FI120718 B FI 120718B
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FI
Finland
Prior art keywords
capsule
capsule shell
propylene glycol
gelatin
component
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FI944452A
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English (en)
Finnish (fi)
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FI944452A0 (sv
FI944452A (sv
Inventor
Werner Brox
Armin Meinzer
Horst Zande
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Novartis Ag
Scherer Gmbh R P
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6498793&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI120718(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag, Scherer Gmbh R P filed Critical Novartis Ag
Publication of FI944452A0 publication Critical patent/FI944452A0/sv
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Nanotechnology (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Dispersion Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Transplantation (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Cosmetics (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Claims (15)

1. Förfarande för framställning av en vätske-fylld mjuk gelatinkapsel som innehäller en farmakolo-giskt aktiv substans i ett bärarmedium och uppvisar 5 ett kapselskal och ett kapselinnehäll, kanne-tecknat av att kapselskalet innehäller gelatin och en migrerande komponent 1,2-propylenglykol som ocksä finns i kapselinnehället och som är ett lös-ningsmedel för den aktiva substansen, varvid kapselin-10 nehället är i form av en mikroemulsionsförkoncentrat, gelatinet är i form av band och vid vilket förfarande kapselskalet bildas genom att avkyla gelatinband och avkylningen genomförs genom att använda ett flytande kylmedel. 15
2. Förfarande enligt patentkrav 1, vid vilket förfarande kapselskalet innehäller gelatin, mjuknings-medel och, om det är önskvärt eller nödvändigt, andra hjälpmedel, varvid lösningsmedlet ätminstone delvis är 1,2-propylenglykol, men inte huvudsakligen polyety-20 lenglykol, kännetecknat av att kapselskalet innehäller 1,2-propylenglykol.
·*·,· 3. Förfarande enligt patentkrav 1 eller 2, • 1 kännetecknat av att kapselskalet innehäller ,·] minst 5 vikt-% migrerande komponent. 25
4. Förfarande enligt nägot av patentkraven 1- ***; 3, kännetecknat av att kapselskalet inne- ··· ·*” häller 2-40 vikt-% migrerande komponent. *·1
: 5. Förfarande enligt nägot av patentkraven 1- 4, kännetecknat av att kapselinnehället in-ϊ,ϊ ϊ 30 nehäller etanol som hjälplösningsmedel.
!***: 6. Förfarande enligt nägot av patentkraven 1- , 5, kännetecknat av att kapselskalet, efter * *j torkningen, innehäller upp till32 vikt-% migrerande ' * komponent. :]*|i 35
7. Förfarande enligt patentkrav 6, k ä n - ·*·*. netecknat av att det torkade kapselskalet in- * · nehäller 10 - 32 vikt-% migrerande komponent.
8. Förfarande enligt nägot av patentkraven 1-7, kännetecknat av att kapselskalet ocksä innehäller glycerol.
9. Förfarande enligt nägot av patentkraven 1- 5 8, kännetecknat av att förfarande den mjuka gelatinkapsel ocksä innehäller en farmakologiskt aktiv substans vars löslighet i vatten är mindre än 1% (vikt/volym).
10. Förfarande enligt patentkrav 9, k ä n -10 netecknat av att den farmakologiskt aktiva substansen är cyklosporin.
11. Förfarande enligt patentkrav 10 kännetecknat av att den farmakologiskt aktiva substansen har valts bland cyklosporin A, cyklosporin G, 15 [3'-desoxy-3'-oxo-MeBmt]1[Vai]2-ciklosporin.
12. Förfarande enligt patentkrav 9, kännetecknat av att förfarande den farmakologiskt aktiva substansen är makrolid.
13. Förfarande enligt patentkrav 12, k ä n -20 netecknat av att förfarande den farmakologiskt aktiva substansen har valts bland rapamycin, 40-0-(2- , , hydroxi)-etyl-rapamycin, FK506, askomycin eller 33- • · · epi-kloro-33-FR 520. • · i ί·ί
: 14. Förfarande enligt patentkrav 8, k ä n - 25 netecknat av att förfarande viktförhällandet ♦ ..*·* mellan migrerande komponent och glycerol är 1:1 ·;· 1:0,2.
·*:*; 15. Förfarande enligt patentkrav 1, k ä n - netecknat av att vatten används som kylmedel. ... 30 • · · • * · ·· e · • · • t· t • φ • · · • ·· « · ··· • · • * ··· 1 · • i · • e •
FI944452A 1993-09-28 1994-09-26 Förfarande för framställning av vätskefyllda mjuka gelatinkapslar FI120718B (sv)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4332931 1993-09-28
DE4332931 1993-09-28

Publications (3)

Publication Number Publication Date
FI944452A0 FI944452A0 (sv) 1994-09-26
FI944452A FI944452A (sv) 1995-03-29
FI120718B true FI120718B (sv) 2010-02-15

Family

ID=6498793

Family Applications (1)

Application Number Title Priority Date Filing Date
FI944452A FI120718B (sv) 1993-09-28 1994-09-26 Förfarande för framställning av vätskefyllda mjuka gelatinkapslar

Country Status (31)

Country Link
US (4) US5985321A (sv)
EP (3) EP1033128B2 (sv)
JP (1) JP3071642B2 (sv)
KR (1) KR100200174B1 (sv)
CN (2) CN1182842C (sv)
AT (2) ATE398448T1 (sv)
AU (1) AU690571B2 (sv)
CA (3) CA2302963C (sv)
CZ (1) CZ290314B6 (sv)
DE (2) DE69435104D1 (sv)
DK (2) DK1033128T4 (sv)
ES (2) ES2152281T3 (sv)
FI (1) FI120718B (sv)
FR (1) FR2710532B1 (sv)
GB (1) GB2282586B (sv)
GR (1) GR3035179T3 (sv)
HK (1) HK1078478A1 (sv)
HU (2) HU221681B1 (sv)
IL (1) IL111067A (sv)
IT (1) IT1274931B (sv)
NO (1) NO312334B1 (sv)
NZ (1) NZ264536A (sv)
PE (1) PE31295A1 (sv)
PL (1) PL178884B1 (sv)
PT (2) PT649651E (sv)
RU (1) RU2140783C1 (sv)
SG (1) SG46531A1 (sv)
SI (2) SI0649651T1 (sv)
SK (2) SK285204B6 (sv)
TW (1) TW438609B (sv)
ZA (1) ZA947567B (sv)

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AU7423794A (en) 1995-04-13
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ITRM940613A0 (it) 1994-09-26
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NO943563D0 (no) 1994-09-26
US6589536B1 (en) 2003-07-08
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CN1108930A (zh) 1995-09-27
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EP0649651B1 (en) 2000-12-13
HU228201B1 (en) 2013-01-28
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ATE198041T1 (de) 2000-12-15
CA2132933A1 (en) 1995-03-29
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