HRP970392A2 - Medicaments containing plant extracts - Google Patents
Medicaments containing plant extracts Download PDFInfo
- Publication number
- HRP970392A2 HRP970392A2 HR19629040.6A HRP970392A HRP970392A2 HR P970392 A2 HRP970392 A2 HR P970392A2 HR P970392 A HRP970392 A HR P970392A HR P970392 A2 HRP970392 A2 HR P970392A2
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- Croatia
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- extracts
- drugs
- contain
- plant
- extract
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Description
Predloženi izum se odnosi na pripravke aktivnih tvari, koji kao aktivne tvari sadrže biljne ekstrakte, osim ekstrakata Gingko biloba, Glycyrrhiza glabra i Eucalyptus globulus, koji se mogu dobiti ekstruzijom mješavine od najmanje jednog biljnog ekstrakta i najmanje jednog taljivog polimera i konačnim oblikovanjem. Izum se nadalje odnosi na postupak za proizvodnju takovih oblika lijekova. Proizvodnja oblika lijekova ekstrudiranjem polimernih talina koje sadrže aktivne tvari i konačnim oblikovanjem je poznata.
Tako je primjerice u DE-A 12 29 248 opisana ekstruzija polimernih talina koje sadrže aktivne tvari sa završnim oblikovanjem injekcijskim prešanjem.
U EP-A 240 904 opisana je ekstruzija taline homo- ili kopolimera N-vinilpirolidona koja sadrži aktivnu tvar.
Iz EP-A 240 906 poznata je kontinuirana proizvodnja čvrstih oblika lijekova ekstruzijom polimerne taline koja sadrži aktivnu tvar sa završnim oblikovanjem još termoplastičnog ekstrudata kalandriranjem.
Poznati postupci odnose se, međutim, isključivo na preradu kemijski jednoznačno definiranih mono-tvari, ali ne i na preradu biljnih ekstrakata.
Pod biljnim ekstraktima, u smislu ovog izuma, podrazumijevaju se suhi ekstrakti, ili ekstrakti koji sadrže otapalo, dobiveni priznatim farmaceutskim metodama pomoću vode, organskih otapala i nadkritičnih plinova.
Pod ekstraktima u smislu ovog izuma podrazumijeva se također i usitnjen biljni materijal bez daljnje obrade. Biljni ekstrakti razlikuju se od definiranih kemijskih, pojedinačnih aktivnih tvari time, da cjelokupni ekstrakt jedne biljke predstavlja po prirodi određen sistem mnoštva tvari, koje se sastoje iz aktivnih, sporednih, balastnih i kosturnih tvari. Često je terapeutski učinak drugačiji, eventualno i povoljniji, ako na organizam djeluje ne samo izolirani lijek, već zajedno djeluju glavne i sporedne tvari biljnog ekstrakta. (Voigt, Lehrbuch der pharm. Technologie, 440, (1987)).
Iz DE-C 44 34 170 poznati su ekstrakti ivančice, koji se mogu aplicirati peroralno, pri čemu su ekstrakti vezani na polivinilpirolidon.
Biljni ekstrakti često sadrže dodatno enzime, čime se utječe na postojanost lijeka pri skladištenju. To posebno vrijedi za one enzime koji dovode do djelomične ili do potpune inaktivacije farmakološki aktivnih spojeva. Ekstruzija taline, kao toplinski proces s mogućim izvlačenjem vode (evakuacijom), može djelovati dodatno stabilizirajući na formulacije te vrste, suprotno konvencionalnim postupcima, jer se enzimi, najčešće kao visokomolekulske bjelančevine koje se pri temperaturama iznad 60°C često mogu ireverzibilno oštetiti (Voigt, Lehrbuch der pharm. Technologie, 442f, (1987)), dodatno inaktiviraju izvlačenjem vode (vakuumski postupak na ekstruderu).
Zadatak predloženog izuma bio je naći pripravke koji sadrže biljne ekstrakte s dobrom postojanošću pri skladištenju, koji omogućuju ciljanu upotrebu aktivne tvari i mogu se proizvesti na jednostavan način.
S tim u skladu nađeni su uvodno definirani pripravci kao i postupak za njihovu proizvodnju.
Prema izumu mogu se upotrijebiti droge koje sadrže gorku tvar, flavonoidne droge, kumarinske droge, droge iz trijeslovine, ugljikohidratne droge, droge koje sadrže lipide, srčano-glikozidne droge, saponinske droge, antronske i antrakinonske droge, alkaloidne droge, arbutinske droge, droge koje sadrže eterična ulja, te brojne druge nenabrojene droge. Upotrebljavaju se ponajprije flavonoidne droge, kumarinske droge, droge iz trijeslovine, ugljikohidratne droge, droge koje sadrže lipide, srčano-glikozidne droge, saponinske droge, antronske i antrakinonske droge, alkaloidne droge, arbutinske droge. Međutim, s posebnom se prednošću mogu upotrijebiti srčano-glikozidne droge, antronske i antrakinonske droge, alkaloidne droge i arbutinske droge.
Postupak prema izumu prikladan je primjerice za preradu ekstrakata iz slijedećih biljaka, pri čemu su izuzeti ekstrakti Gingko biloba, Glycyrrhiza glabra i Eucalvptus globulus:
Estrakti iz biljaka koje sadrže eterična ulja kao: Mentha piperita, Melissa officinalis, Orthosiphon aristatus, Salvia officinalis, Lavandula angustifolia, Elettaria cardamomum, Thvmus vulgaris, Rosmarinus officinalis, Citrus aurantium, Juniperus communis, Matricaria recutita, Achillea millefolium, Guaiacum officinale, Syzygiuum aromaticum, Cinnamomum verum, Coriandrum sativum, Carum carvi, Pimpinella anisum, Foeniculum vulgare, Petroselini crispum, Apium graveolens, Valeriana officinalis.
Ekstrakti iz biljaka koje sadrže oštre tvari kao: Zingiber officinale, Curcuma xanthorrhiza, Curcuma longa, Acorus calmus, Capsicum annuum, Piper nigrum, Brassica nigra, Allium sativum, Allium cepa.
Ekstrakti iz biljaka koje sadrže gorke tvari kao: Gentiana lutea, Artemisia absinthium, Cnicus benedictus, Centaurium ervthraea, Marsdenia condurango, Humulus lupulus.
Ekstrakti iz biljaka koje sadrže srčane glikozide kao: Digitalis lanata, Digitalis purpurea, Strophantus gratus, Strophantus kombe, Convallaria majalis, Adonis vernalis, Nerium oleander, Urginea maritima, Helleborus niger, Xysmalobium undilatum.
Ekstrakti iz biljaka koje sadrže saponin kao: Primula veris, Saponaria officinalis, Aesculus hippocastanum, Panax ginseng, Hedera helix, Eleutherococcus senticosus, Herniaria glabra.
Ekstrakti iz biljaka koje sadrže alkaloide: Papaver somniferum, Chelidonium majus, Fumaria officinalis, Hydrastis canadensis, Berberis vulgaris, Atropa belladonna, Hyoscyamus niger, Datura stramonium, Mandragora officinarum, Nicotiana tabacum, Claviceps purpurea, Cephaelis ipecacuanha, Cephaelis acuminata, Cinchona pubescens, Rauwolfia serpentina, Pausinystalia yohimbe, Vinca minor, Catharanthus roseus, Strychnos toxifera, Chondodendron tomentosum, Coffea arabica, Camellia sinensis, Theobroma cacao, Cola nitida, Ilex paraguariensis, Paullinia čupana, Symphytum officinale, Ephedra distachya, Catha edulis, Areca catechu, Physostigma venenosum, Pilocarpus jaborandi, Lobelia inflata, Sarothamnus scoparius, Peumus boldus, Colchicum autumnale, Aconitum napellus, Myristica fragrans, Piper methysticum.
Ekstrakti iz biljaka koje sadrže eterična ulja kao: Rheum palmatum, Rhamnus frangula, Rhamnus purshianus, Rhamnus catharticus, Aloe ferox, Aloe barbadensis, Cassia angustifolia.
Ekstrakti iz biljaka koje sadrže arbutin kao: Arctostaphylos uva-ursi.
Ekstrakti iz biljaka koje sadrže flavonoide kao: Crataegus monogyna, Arnica montana, Tilia cordata, Sambucus nigra, Silybum marianum, Verbascum phlomoides, Viola trocolor, Ononis spinosa, Equisetum arvense, Betula pendula, Fagopyrum esculentum, Calendula officinalis, Filipendula ulmaria.
Ekstrakti iz biljaka koje sadrže kumarin kao: Ammi visnaga, Angelica archangelica, Levisticum officinale, Melilotus officinale, Herniara glabra.
Ekstrakti iz biljaka koje sadrže trijeslovinu kao: Juglans regia, Solidago virgaurea, Prunus spinosa, Ammi visnaga, Hamamelis virginiana, Quercus robur, Krameria triandra, Potentilla erecta, Vaccinium myrtillus.
Ekstrakti iz biljaka koje sadrže ugljikohidrate kao: Cetraria islandica, Althaea officinalis, Plantago lanceolata, Plantago psyllium, Malva sylvestris, Tussilago farfara, Limun usitatissimum, Trigonella foenum-graecum.
Ekstrakti iz drugih komercijalnih biljnih droga kao: Avena sativa, Barosma betulina, Cimicifuga racemosa, Cynara scolymus, Drosera ramentacea, Euphrasia officinalis, Fucus vesiculosus, Gelsemium sempervirens, Hibiscus sabdariffa, Hvpericum perforatum, Passiflora incarnata, Rosa canina, Petasites hybridus, Rubia tinctorum, Sabal serrulata, Taraxacum officinale, Urtica dioica, Viscum album, Vitex agnus castus, Echinacea angustifolia, Echinacea purpurea, Thuja occidentalis.
Količina ekstrakta po jediničnoj dozi i koncentracije mogu varirati u širokim granicama ovisno o učinkovitosti i brzini oslobađanja. Tako se udio ekstrakta kreće u području od 0,1 do 95, ponajprije od 20 do 90, naročito od 30 do 70 mas. %. Također se mogu upotrijebiti i kombinacije različitih ekstrakata.
Za provođenje postupka prema izumu prerađuje se najmanje jedan biljni ekstrakt s jednim taljivim fiziološki podnošljivim veznim sredstvom i po potrebi s drugim uobičajenim galenskim pomoćnim sredstvima, pri temperaturi u području od 50 do 180°C, ponajprije od 60 do 160°C. Miješanje aktivne tvari ili aktivnih tvari s polimernim veznim sredstvima i po potrebi s galenskim dodacima može se provesti prije ili nakon taljenja polimernog veznog sredstva postupcima uobičajenim u tehnici. Miješanje se vrši ponajprije u ekstruderu, ponajbolje u dvopužnom esktruderu ili u jednopužnom ekstruderu s odsječkom za miješanje.
Pri upotrebi krutih biljnih ekstrakata prerada se vrši bez otapala. Pri upotrebi vlažnih biljnih materijala, ili otopina ekstrakata, otapala se mogu odstraniti pomoću vakuuma tijekom ekstrudiranja.
Temperatura staklastog prijelaza smjese ne smije biti ispod 180, ponajprije ispod 130°C. U slučaju potrebe temperaturu staklastog prijelaza spušta se s uobičajenim farmakološki prihvatljivim omekšivačima, kao što su alkoholi dugačkog lanca, etilen glikol, propilen glikol, trimetilol-propan, trietilen glikol, butandiol, pentanol, heksanol, polietilen glikol, silikoni, esteri aromatskih karbonskih kiselina (npr. dialkil ftalati, ester trimelitne kiseline, ester benzojeve kiseline ili ester tereftalne kiseline) ili esteri alifatskih dikarbonskih kiselina (npr. dialkil adipati, esteri sebacinske kiseline, ester azelainske kiseline, esteri limunske i vinske kiseline) ili esteri masnih kiselina.
Smjese koje se mogu ekstrudirati su naročite farmaceutske smjese s biljnim ekstraktima, koje sadrže foziološki prihvatljive, termoplastične polimere (pri čemu temperatura staklišta smjese leži ispod temperature razgradnje svih sastojaka smjese), primjerice polivinilpirolidon (PVP), ili ponajprije kopolimerizate N-vinilpirolidona (NVP) i vinil acetata. K-vrijednosti (po Fikentscheru, Cellulose-Chemie 13 (1932), str. 58 do 64 i 71 i 74) takovih polimera leže u području od 10 do 100, ponajprije 12 do 70, naročito 12 do 35, za PVP ponajprije od 12 do 35, naročito od 12 do 17. Prikladni su nadalje kopolimerizati vinil acetata i krotonske kiseline, djelomično saponificirani polivinil acetat, polivinil alkoholol, etilen/vinil acetat-kopolimerizati, polihidroksietil metakrilat, celulozni esteri kao celulozni acetat, celulozni acetat propionat, celulozni acetat ftalat, celulozni acetat trimetilat, celulozni acetat butirat, hidroksipropilmetilcelulozni ftalat ili hidroksipropilmetilcelulozni sukcinat, celulozni eteri kao hidroksipropilceluloza, hidroksipropilmetilceluloza, hidroksietilceluloza, etilceluloza ili natrij karboksi-metilceluloza, polietilen glikol, polietilen.
Količine taljivih polimera mogu se kretati u području od 1 do 99,9 mas. %, ponajprije od 5 do 90 mas. %, naročito od 20 do 80 mas. %.
Uobičajene galenske pomoćne tvari, koje se mogu stavljati u uobičajenim količinama, jesu npr. ekstenderi, kao silikati ili dijatomejska zemlja, stearinska kiselina ili njene soli npr. s magnezijem ili kalcijem, metilceluloza, Na-karboksimetilceluloza, talk, saharoza, laktoza, pšenični ili kukuruzni škrob, krumpirovo brašno, šećerni alkoholi, kao npr. maltitol, manitol, sorbitol, ksilitol, izomalt, polivinil alkohol, nadalje sredstva za umreživanje, konzervansi, sredstva za rastvaranje, sredstva za apsorpciju, bojila, sredstva za korekciju okusa (usporedi npr. H. Sucker et al., Pharmazeutische Technologie, Thieme Verlag, Stuttgart 1978).
Proizvodnja čvrstih oblika, koji sadrže aktivnu tvar, u nastavku ekstruzije, može se provesti,- na primjer, injekcijskim prešanjem ili preoblikovanjem još termoplastičnog ekstrudata sukladno postupcima opisanim u EP-A 240 906, provođenjem esktrudata između dvaju valjaka suprotnog smjera vrtnje s udubljenjima koja se nalaze jedno nasuprot drugog u plastu valjaka, čiji oblik odgovara obliku tablete.
Iz ekstrudata se također mogu proizvesti pilule ili granulati.
Po želji, pripravci proizvedeni prema izumu mogu se prevući s uobičajenim prevlakama za poboljšanje izgleda i/ili okusa (dražeje) ili u svrhu dodatnog odgađanja oslobađanja aktivne tvari. Pojam čvrstog oblika u smislu izuma nije ni na koji način ograničen na jedan određeni oblik, niti na peroralnu primjenu. Čak štoviše, on uključuje također i čepiće za rektalnu primjenu (ne one koji se tale pri tjelesnoj temperaturi).
Pripravci prema izumu prikladni su za primjenu u humanoj medicini ili veterini. Oni se nadalje mogu upotrijebiti također i za druge svrhe, koje dopuštaju primjenu biljnih aktivnih tvari.
Postupkom prema izumu mogu se na jednostavan način proizvesti čvrsti oblici aktivnih tvari dobre postojanosti. Korisna je prije svega i dobra mogućnost doziranja biljnih aktivnih tvari, naročito što se tiče obrade usitnjenog biljnog materijala koji se više ne da obrađivati. Prema izumu mogu se posebno proizvesti i takozvane "krute otopine" biljnih ekstrakata u polimerima. Postojanje krutih otopina može se potvrditi DSC mjerenjima. Takove "krute otopine" imaju prednosti što se tiče biološke raspoloživosti i postojanosti.
Nije bilo za očekivati da se biljni ekstrakti, kao prirodni sistemi od više materijala, ekstrudiraju u istom opsegu kao i definirane aktivne tvari.
Ovdje se čini posebno korisnim, da se na iznenađujući način mogu preraditi i relativno velike količine ekstrakta u krute farmaceutske oblike, pa se stoga djelomično vrlo velike, terapeutski potrebne, količine ekstrakata mogu aplicirati u relativno malim količinama farmaceutskih krutih oblika. To povećava pogodnost za pacijente (mala učestalost uzimanja, jednostavnije uzimanje).
Primjeri
Mješavine navedene u slijedećim primjerima prerađene u dvopužnom ekstruderu ZSK3 tvrtke Werner & Pfleiderer s učinkom od 2 kg/sat. Oblikovanje još uvijek plastičnog ekstrudata provedeno je postupkom opisanim u EP-A 240 906.
Kao biljni ekstrakt upotrijebljen je praškasti ekstrakt iz Hyperici herba slijedećeg sastava:
75% prirodnog ekstrakta iz Herba Hyperici perforati DAC 86 3. Erg. 91 (omjer droge prema pripravku droge = 4-8 : 1) , 25% inertnih sastojaka (5% silicijevog dioksida DAB 10, 20% glukoznog sirupa), sadržaj: 0,23% Dianthrone ber. kao Hyperici (proizvođač: tvrtka Finzelberg).
Primjer 1
Mješavina od 90 mas. % kopolimerizata, s K-vrijednosti 30, od 60 mas. % N-vinilpirolidona i 40 mas. % vinil acetata (Kollidon VA 64) i 10 mas. % ekstrakta iz Hyperici herba pomiješana je u dvopužnom ekstruderu i ekstrudirana i na kraju kalandrirana.
Radna temperatura: 40, 80, 125, 125, 130, 120°C.
Mlaznica 122°C.
Primjer 2
Mješavina od 60 mas. % kopolimerizata, s K-vrijednosti 30, od 60 mas. % N-vinilpirolidona i 40 mas. % vinil acetata (Kollidon VA 64), 10 mas. % Klucela® EF, tvrtke Hercules, (hidroksipropilceluloza) i 30 mas. % ekstrakta iz Hyperici herba pomiješana je u dvopužnom ekstruderu i ekstrudirana, i na kraju kalandrirana.
Radna temperatura: 40, 80, 120, 122, 124, 120°C.
Mlaznica 124°C.
Primjer 3
Mješavina od 5 mas. % homopolimera N-vinilpirolidona (PVP, Kollidon® K30), 33 mas. % Izomalta F (Palatinit®, tvrtke Südzucker), 2 mas. % Explotaba® (sredstvo za rastvaranje, natrij-škrob-glikolat, tvrtke Mendell) i 60 mas. % ekstrakta iz Hyperici herba pomiješana je i ekstrudirana u dvopužnom ekstruderu i na kraju kalandrirana u dugoljaste tablete.
Radna temperatura: 48, 82, 88, 86, 86, 81°C.
Mlaznica 81°C.
Claims (6)
1. Čvrsti pripravci aktivnih tvari, naznačeni time, da kao aktivne tvari sadrže biljne ekstrakte, osim ekstrakata Gingko biloba, Glycyrrhiza glabra i Eucalyptus globulus, mogu se dobiti ekstruzijom mješavine od najmanje jednog biljnog ekstrakta i najmanje jednog taljivog polimera i konačnim oblikovanjem.
2. Pripravci prema zahtjevu 1, naznačeni time, da kao taljive polimere sadrže kopolimere N-vinilpirolidona.
3. Pripravci prema zahtjevu 2, naznačeni time, da kao taljiv polimer sadrže kopolimer od 60 mas. % N-vinil-pirolidona i 40 mas. % vinil acetata.
4. Pripravci prema zahtjevu 1, naznačeni time, da kao taljiv polimer sadrže hidroksipropilcelulozu.
5. Pripravci prema zahtjevu 1 ili 2, naznačeni time, da kao biljni materijal sadrže ekstrakt iz Hyperici herba.
6. Postupak za proizvodnju čvrstih pripravaka aktivnih tvari prema jednom od zahtjeva 1 do 4, naznačen time, da se ekstrudira mješavinu od najmanje jednog biljnog ekstrakta i najmanje jednog taljivog polimera i ekstrudat se preoblikuje u uobičajene oblike lijekova.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19629040A DE19629040A1 (de) | 1996-07-19 | 1996-07-19 | Pflanzenextrakthaltige Arzneiformen |
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| Publication Number | Publication Date |
|---|---|
| HRP970392A2 true HRP970392A2 (en) | 1998-06-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR19629040.6A HRP970392A2 (en) | 1996-07-19 | 1997-07-18 | Medicaments containing plant extracts |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP0912190A1 (hr) |
| AU (1) | AU3542097A (hr) |
| DE (1) | DE19629040A1 (hr) |
| HR (1) | HRP970392A2 (hr) |
| WO (1) | WO1998003188A1 (hr) |
| ZA (1) | ZA976363B (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6077534A (en) * | 1997-09-02 | 2000-06-20 | Klinge Pharma Gmbh | Production of pharmaceutical formulations for treatment of edema and venous disorders |
| JP5090588B2 (ja) * | 1998-11-04 | 2012-12-05 | フイルメニツヒ ソシエテ アノニム | 芳香成分のための固体運搬系 |
| CA2346948A1 (en) | 1999-09-06 | 2001-03-15 | Firmenich Sa | Process for the preparation of granules for the controlled release of volatile compounds |
| CN115089636B (zh) * | 2022-07-06 | 2023-12-08 | 深圳市古方中药饮片有限公司 | 一种中药组合物、包含该组合物的无过敏性透皮贴剂及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| NL297357A (hr) * | 1962-08-31 | |||
| DE3612211A1 (de) * | 1986-04-11 | 1987-10-15 | Basf Ag | Kontinuierliches verfahren zum tablettieren |
| DE3612212A1 (de) * | 1986-04-11 | 1987-10-15 | Basf Ag | Verfahren zur herstellung von festen pharmazeutischen formen |
| DE4416927C1 (de) * | 1994-05-13 | 1995-08-31 | Lohmann Therapie Syst Lts | Vorrichtung zur Abgabe von Wirkstoffen aus Haftschmelzklebern, Verfahren zu ihrer Herstellung und ihre Verwendung |
| DE4434170C1 (de) * | 1994-09-24 | 1996-03-28 | Krewel Werke Gmbh | Johanniskrautextrakte |
-
1996
- 1996-07-19 DE DE19629040A patent/DE19629040A1/de not_active Withdrawn
-
1997
- 1997-07-07 EP EP97931788A patent/EP0912190A1/de not_active Withdrawn
- 1997-07-07 WO PCT/EP1997/003572 patent/WO1998003188A1/de not_active Ceased
- 1997-07-07 AU AU35420/97A patent/AU3542097A/en not_active Abandoned
- 1997-07-18 HR HR19629040.6A patent/HRP970392A2/hr not_active Application Discontinuation
- 1997-07-18 ZA ZA976363A patent/ZA976363B/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO1998003188A1 (de) | 1998-01-29 |
| ZA976363B (en) | 1999-01-19 |
| DE19629040A1 (de) | 1998-01-22 |
| AU3542097A (en) | 1998-02-10 |
| EP0912190A1 (de) | 1999-05-06 |
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