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AU638493B2 - Preparations containing colestyramine for reducing lipid levels - Google Patents

Preparations containing colestyramine for reducing lipid levels Download PDF

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Publication number
AU638493B2
AU638493B2 AU64057/90A AU6405790A AU638493B2 AU 638493 B2 AU638493 B2 AU 638493B2 AU 64057/90 A AU64057/90 A AU 64057/90A AU 6405790 A AU6405790 A AU 6405790A AU 638493 B2 AU638493 B2 AU 638493B2
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AU
Australia
Prior art keywords
die
colestyramine
der
document
lit
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Legal status (The legal status 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 status listed.)
Ceased
Application number
AU64057/90A
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AU6405790A (en
Inventor
Thomas Moest
Erwin Spiegel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nordmark Arzneimittel GmbH and Co KG
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Knoll GmbH
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Filing date
Publication date
Priority claimed from DE19893930206 external-priority patent/DE3930206A1/en
Priority claimed from DE3930168A external-priority patent/DE3930168A1/en
Application filed by Knoll GmbH filed Critical Knoll GmbH
Publication of AU6405790A publication Critical patent/AU6405790A/en
Application granted granted Critical
Publication of AU638493B2 publication Critical patent/AU638493B2/en
Assigned to NORDMARK ARZNEIMITTEL GMBH & CO KG reassignment NORDMARK ARZNEIMITTEL GMBH & CO KG Alteration of Name(s) in Register under S187 Assignors: KNOLL AKTIENGESELLSCHAFT
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Sealing Battery Cases Or Jackets (AREA)
  • Laminated Bodies (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Preparations containing colestyramine for reducing lipid levels.

Description

O.Z. 0480/01072 Microtablet containing colestyramine as lipid-lowering agent Description The present invention relates to products which contain colestyramine as lipid-lowering agent in high concentration and are in the form of microtablets whose longest particle diameter is from 1 to 4 mm.
Colestyramine is an agent known in medicine inter alia as lipid-lowering agent and is an anion exchanger resin composed of a copolymer of styrene and divinylbenzene which contains quaternary ammonium groups.
To date it has been marketed only as powder (see Rote Liste 1990, list of finished drugs of the members of the Bundesverband der Pharmazeutischen Industrie One disadvantage of this presentation is that, on intake, colestyramine leaves an unpleasant sandy taste in the mouth (see, for example, Knodel et al., Medical Toxicology 2 (1987) 10, page 13, first paragraph of Section 1.2 in which the disadvantageous effects of lipidlowering agents are dealt with). Since it is now customary for colestyramine to have to be taken in single doses of about 4 g twice to eight times a day, this frequently results in the patients taking less than the prescribed dose or even stopping the therapy with colestyramine (see EP-A 261 693, page 2, line 7-8).
There has been no lack of attempts to offer colestyramine in a different presentation. Thus, US-A 4,814,354 describes colestyramine-containing sweets, EP-A 347 014 describes a baked product containing colestyramine, and DE-A 38 08 191 describes aqueous colestyramine-containing suspensions. However, it is not possible in this way to eliminate the unpleasant sandy taste. FR 2 382 893 describes gastroprotective products with a low colestyramine content. They are not suitable for the amounts of colestyramine needed for lipid 0.Z. 0480/01072 2 lowering.
It is furthermore known that colestyramine can be administered together with other lipid-lowering agents in order to achieve an effect which is better than that of the single components. Malmendier et al. (Clin. Chim.
Acta 162 (1987) 221), as well as Carlson et al. (in "Treatment of Hyperlipoproteinaemia", XIX 284P. Raven Press: New York 1984) describe the combined use of colestyramine and fenofibrate in patients with hereditary hypercholesterolemia. The combined use of colestyramine and bezafibrate is described, for example, in Br. Med. J.
297 (1988) 6642, the combined use of colestyramine and clofibrate for example in J. Lipid Res. 21 (1380) 65 and the combined use of colestyramine and gemfibrozil in US- A 4,814,354.
The object on which the invention was based was to prepare products which contain colestyramine as lipidlowering agent in a presentation, which do not display the abovementioned disadvantages.
Accordingly, microtablets which contain 80 to 99% colestyramine as lipid-lowering agent and whose longest particle diameter is from 1 to 4 mm have been found.
Colestyramine can be compressed to microtablets.
The microtablet as a rule is cylindrical and has a size of from 1 to 4 mm (both height and diameter), in particular of from 2.0 to 3.5 mm. Besides this, other forms such as beads are also possible in principle.
The forms can be produced in a conventional manner, for example that described in EP-A 166 315. It is possible to add the conventional pharmaceutical auxiliaries to the formulation, such as binders, inactive ingredients, preservatives, wetting agents, flow regulators, lubricants and/or antioxidants (see, for example, H. Sucker et al.: Pharmazeutische Technologie", Thieme Verlag Stuttgart, (1978)). The forms can additionally be provided with the conventional pharmaceutical coatings.
The preferred binder used for compression is O.Z. 0480/01072 3 microcrystalline cellulose, of which the drug contains from 2 to 20, preferably from 3 to 8, by weight. It is advantageous to employ in the granulation cellulose derivatives such as methylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose and polyvinylpyrrolidone in an amount of from 2 to 10, preferably 3 to 6, by weight.
The dosage depends on the age, condition and weight of the patient. As a rule, the daily dose of active compound is between 0.03 and 0.4 g/kg of body weight.
The colestyramine-containing microtablets can also contain other lipid-lowering agents. Fenofibrate and gemfibrozil are preferred, as are similar compounds of this type such as clofibrate, beclobrate, bezafibrate, ciprofibrate and etofibrate (called fibrates hereinafter).
The drug on administration can be a combination of the two active compounds in the same formulation or be in the form of a so-called kit of parts. A kit of parts is defined as a type of pharmaceutical pack in which the individual active components are present wholly or partly in separate dose form in the same pack.
In the case of separate administration, the colestyramine is in the microtablet form, and the fibrate is in a conventional commercial form such as tablet, film-coated tablet, sugar-coated tablet, capsule or else as microtablet.
The statements on the formulation of colestyramine also apply to the combination of colestyramine and fibrate.
When colestyramine and fibrate are combined in a microtablet, the latter can contain the active compounds in the colestyramine fibrate ratio of from 2 1 to 99 1 by weight, depending on the conventional dose of the fibrate active compound.
Combination of the two active compounds makes it 0.Z. 0480/01072 4 possible to lower the individual doses of these active compounds, the dosage depending specifically on the age, condition and weight of the patient. In general, the daily doses of active compounds are between 0.03 and 0.4 g of colestyramine per kg of body weight and between 1 and 15 mg of fibrate per kg of body weight.
Examples Example 1 13.5 kg of colestyramine (from R6hm Haas Deutschland GmbH, colestyramine 40 u) were mixed with 675 g of directly tablettable lactose and 600 g of microcrystalline cellulose in a conventional highperformance pharmaceutical mixer. Then 75 g of highly disperse silica and 150 g of magnesium stearate were added, and mixing was continued. This mixture for compression was then compressed to microtablets with a diameter of 3.5 mm and the same height, the individual mass being 30 mg.
Example 2 13.5 kg of colestyramine (see above) were mixed with a solution of 0.7 kg of polyvinylpyrrolidone (mean molecular mass 25,000) in 2.1 kg of isopropanol in a conventional high-performance pharmaceutical mixer with cutter, and were granulated. Drying at 50°C was followed by screening through an oscillating screen with a mesh width of 0.8 mm. The granules were then mixed with 70 g of highly disperse silica and 70 g of magnesium stearate.
The composition ready for compression was compressed to microtablets with a diameter of 3 mm and the same height, the individual mass being 17 mg.

Claims (7)

1. A colestyramine-containing product, which is in the form of microtablets whose longest particle diameter is from 1 to 4 mm and contains from 80 to 99% colestyramine, the balance being made up of conventional pharmaceutical auxiliaries.
2. A colestyramine-containing product as claimed in claim 1, which contains another lipid-lowering agent in addition to the colestyramine.
3. A colestyramine-containing product as claimed in claim 2, which contains fenofibrate or gemfibrozil as further lipid-lowering agent. DATED this 16th day of April, 1993. KNOLL AKTIENGESELLSCHAFT WATERMARK PATENT ••cc TRADEMARK ATTORNEYS I THE ATRIUM 2ND FLOOR, 290 BURWOOD RD HAWTHORN VIC 3122 c CC ,S O.Z. 0480/01072 Microtablet containing colestyramine as lipid-lowering agent Abstract of the disclosure Microtablet which contains 80 to 99% colestyramine as lipid-lowering agent and whose longest diameter is from 1 to 4 mm. C r; INTERNATIONALER RECHERCHENBERICHT rnternationales Aktenzelchen PCT /EP 90 01514 1. KLASSIFIKATION DES ANMELDUNGSGEGENSTANDS (beirmehreren Klossiflkationssymbolen sind all. anzugeber1 6 Nach der lnternationalen Patentklsslf lkaio n IIPC) ocier naci, der fl8tionalen Klassltlkation und der IP Int.Ci 5 A 61 K31/785, A,61 K31/74, A 61 K9/16, A 61 K9/20 61 K 11/7851 '1 9150-31-9 1i, RECHERCHIERTE SACHGEBIETEI Recherchierier MindesiprufStoff 7 Klesslfikaflonssystemn I Klasslf lkationssymbole Int.c 5 A 63. K Recherchier-te nlcht zumn Mindestpr~fstolf gehorendle Verof tentlI chu ngen, si)welt diese unter die recherchierten Sachgebieie fallen 6 IlL EINSCHLAGIGE VEROFFENTLICHUNGEN 9 Art' t(Onni1,4chnung der Verdffentlchung",towelt ortorderlich unier Angabe der mal~getblichen Teile 12 Beir, Anspruch Nr0 3 X FR, A, 2382893 (RECKITT a COLMAN PRODUCTS LTD.) 1
6. Oktober 1978 siehe Seite 1, Zeilen 23-26; Seite 6, Zeilen
12-13 Seite 7, Zeilen 14-15; Anspruch 2. X FR, A, 2110458 HOWARD) 2-3 2. Juni 1972 siehe Seite 1, Zeilei 13-35; Seite 7, Zeilen
15-18; Anspr~che 1,7 X US, A, 4814354 ISAAC) 2-3
21. Marz 1989 siehe bpalte 2, Zeilen 43-46, 57-64, Spalte 3, Zeilen 41-43; AnsprUche 1,4 in der Anineldung erwghnt *Besondere Kategorlen Yon angegebonen Vordffentlichungen Veroftentlichung, die den aligemelnen Stand der Technik Sp~tore Veroffentlchung, die nach dam Internationalon An, definierl. $ber nicht alt bosondors bodeutsam anzusehen Ist muldedlatumn oder dim Priorittitsdatum veroftontllcht worden itees ~okmen, dt ldoc ert m odr nch em ntens, lit und mit der Anmeidung nicht kollidiert, sondirh nut Rumn tEionien Ankmetdod su vecoc rslt a drdn a I ntere Verstindnls des der Erfindung zugruncleiiendain PrInaips tionleoAnmedodtumverbfenlict wodenlitodor det lhr zugrundelogonden Thoorle angogebon lit "Ll Verbftentlichung, die gesignet lit, omnen Priorititionspruch Vordfientiichung von bosondorat Bedeautung: die boansonich. zwelfeihaft orscholnen zu listeon, oder dutch die dat Vardf- to Edlindung kann nicht is nou odor auf orlinderin.her Titig. fontlichungidatum oie anderon im Rochorchenbericht go. kilt beuhild betrachtat warden narttn %vr~Hontlichung boeIW werden toil odor die &us einarn andiron bosonderon Grund ingegeoen lit (wit outgofljhr) Vtrbftontichung von buslonderet Bodoiitung;* die beanipruch. Verblffontiichung, die ich out tine mondlicho Offenbarung, to Ertindung kann nicht Cslt a rfinderischer Titigcmlt be. .me enuzun, e. Asuolun odt ador Malnamen ruhoend botrachtot warden, wmnn die Varbffntlichung mit toie htznen usaln dtadr mah n eintr odor mohroren andein Vordf f ntlichungen dieter Kate. bezisht gone In Vorbindlung gibracht wind und dilute Votbind~ung fur Von6fientiehung, die vor dlsm intornatlonalin Anmoideda. omnen Fschmann naholiogend lit tum. &bir lnch dim beanspruchten Priorliltdatum vorbf fent. Vorbtfontlichung, die Mitglod cnsrelbmn Patentlamillo lit licht worden lit IV, GESCHEINIGUNG_____________ Datum des Abschiussos dot internotionaltn Recherche Absonodcatumn des Intornatlonalon Rechetchonberlchtt 12. DeZeMber 1990 10. 01. 91 Internationale Rocherchonbehordt Unterschrlft dot bevollmachtigin B#sdensttn r Eurco~isches Patontamt Miss T- MORTENSEN f, '2-K~ Potmbtett PCTIISA1210 101a4i 2) UIjat 10851 INTERNATW'^4AL SEARCH REPORT Application No PCT/EP9O/01514 L. CLASSIFICATION OF SUBJECT MAfTER(-it several classification symboix apply, indicate all) According to International Patent Classification (IPC) or to both National Classification and IPC I Cl5 ,A61K 31/785, A61K 31/74, A61K 9/16, A61K 9/20 Int.l (A61K 31/785, 31:215, 31:19) 11. FIELDS SEARCHED Minimum Documentation Searched CiassltlcAtion System I-Classification Symbol,% Int.Cl 5 A61K Documentation Searched other than MinmumDocumentation to the Extent that such Documento are Included In the Fields SearchedI Ill. DOCUMENTS CONSIDERED TO ME RELEVANT'I Category *I Citation o1 Document, I' with ndclr.where sppr~iprlte, of the relevant passee Ii I~ vant to Claim No,.13 X I FR, A, 2382893 (RECKIrvr COLMAN PRODUCTS LTD.) 1 6 October 1978 see page 1, lines 23-26; page 6, lines 12-13 page 7, lines 14-15; claim 1 X FIR, A, 2110458 HOWARD) 2-3 2 June 1972 see page lines 13-35; page 7, lines 15-18; claims 1,7 X J US, A, 4814354 ISAAC) 2-3 21 March 1989 see column 2, lines 43-46, 57-64, column 3, lines 41-43; claims 1,4 (cited in the application) *Special categories of cited documents: 0 'IT" Ilt document published atter the Intetrnationall filing date "All document definng the general state of the art which It not or priority date and not In conflict with the application but consdere tobe 0 pat~cuar elevncecited to understand the principle or theory underlying the cosdocumdt buo priublsea r altethe Itra~nl Invention "Elearlier dcmnbupulseonoshtteItraial X"document ot particular relevance,, the claimed Invention filing date cannot be considered novel or cannot be considered to 11VI document which may throw doubts on priority clalm(s~ or Involve an Inventive step which Is cited to establish the publication date o1 ionoilher document of particular relevancel' the claimed Invsntloo citation or other special reason (as specified) cannot be considered to Involve an Inventive step when% the I'0" document relerrlng to an oral disclosure, use, exh,'bition or document Is combined with one or mare other such docu. other means mants. such combination being obvious to a person skilled 11131 document published prior to the International filing date but In the art. later then the Priority date claimed "A"I document member of the same patent family IV, CERTIFICATION Date Of the Actual Completion 01 the International Search Date of Mallino 01 thIs International Search Report 12 December 1990 (12.12.90) 110 January 1991 (10,01.91) International Searching Authority Signature of Authoried Officer turopean Patent Office Form PCTIISA1210 (second shoot) (January ifilbS) ANNEX TO THE INTERNATIONAL SEARCH REPORT ON INTERNATIONAL PATENT APPLICATION NO, EP 9001514 SA 40098 This annex lists the patent family members relating to the patent documents cited in the above-mentioned international search report. The nmembers are as contained In the European Patent Office EDP~ file on 04/01/91 The European Patent Office is in no WiaY liable fo these particulars ihich are merely gisen for the purpose of information, FR-A- 2382893 06-10-78 GB-A- 1566609 08-05-80 AU-B- 518596 08-10-81 AU-A- 3396978 13-09-79 BE-A- 864726 11-09-78 CA-A- 1087986 21-10-80 CH-A- 647949 28-02-85 DE-A- 2810250 14-09-78 JP-A- 53113007 03-10-78 NL-A- 7802588 12-09-78 US-A- 4172120 23-10-79 FR-A- 2110458 02-06-72 AU-B- 458705 06-03-75 AU-A- 3451371 19-04-73 CA-A- 968272 27-05-75 DE-A- 2151510 20-04-72 GB-A- 1348642 20-03-74 SE-B- 402709 17-07-78 US-A- 3846541 05-11-74 US-A- 4814354 21-03-89 None Fr more details about this annex, tee Official Journal of the turopean Patent office, No. 12182 ANHANG ZLIM INTERNATIONALEN RECHERCHENBERICHT CBER DIE INTERNATIONALE PATENTANMIELDUNG NR. EP 9001514 SA 40098 In diesem Anhang sind die NMitglieder der Patentfamilien der im obengenannten internationalen Recherchenbericht angetdhhnen Patentcdokumente angcgebcn. Die Angabcn Uhtr die Familienniltgliedcer entsprechen demn Stand der Datei des Europ~ischen Patentanils amt 04/01/91 Diesc Angaben dienen nur zur Lnterrichtun.- und criolgen ohne Geii4hr. FR-A- 2382893 06-10-78 GB-A- 1566609 08-05-80 AU-B- 518596 08-10-81 AU-A- 3396978 13-09-79 BE-A- 864726 11-09-78 CA-A- 1087986 21-10-80 CH-A- 647949 28-02-85 DE-A- 2810250 14-09-78 JP-A- 53113007 03-10-78 NL-A- 7802588 12-09-78 US-A- 4172120 23-10-79 FR-A- 2110458 02-06-72 AU-B- 458705 06-03-75 AU-A- 3451371 19-04-73 CA-A- 968272 27-05-75 OE-A- 2151510 20-04-72 GB-A- 1348642 20-03-74 SE-B- 402709 17-07-78 US-A- 3846541 05-11-74 US-A- 4814354 21-03-89 Keine Vile h~htt £ln~thelten iu d.estm Anhang tihe Amit~blatt des Europhlschen Paltntamu, Nr.112/82
AU64057/90A 1989-09-09 1990-09-07 Preparations containing colestyramine for reducing lipid levels Ceased AU638493B2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE3930168 1989-09-09
DE3930206 1989-09-09
DE19893930206 DE3930206A1 (en) 1989-09-09 1989-09-09 Hypolipaemic pharmaceutical prods. - comprising combination of cholestyramine and drug of vibrate type
DE3930168A DE3930168A1 (en) 1989-09-09 1989-09-09 Pharmaceutical compsn. contg. colestyramine to reduce lipid - in micro:tablet form levels without unpleasant taste

Publications (2)

Publication Number Publication Date
AU6405790A AU6405790A (en) 1991-04-08
AU638493B2 true AU638493B2 (en) 1993-07-01

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AU64057/90A Ceased AU638493B2 (en) 1989-09-09 1990-09-07 Preparations containing colestyramine for reducing lipid levels

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EP (1) EP0594570B1 (en)
JP (1) JPH05500213A (en)
KR (1) KR920703071A (en)
AT (1) ATE125448T1 (en)
AU (1) AU638493B2 (en)
CA (1) CA2065151A1 (en)
DE (1) DE59009451D1 (en)
DK (1) DK0594570T3 (en)
IL (1) IL95574A (en)
WO (1) WO1991003249A1 (en)

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DE59009451D1 (en) 1995-08-31
IL95574A0 (en) 1991-06-30
WO1991003249A1 (en) 1991-03-21
AU6405790A (en) 1991-04-08
DK0594570T3 (en) 1995-09-11
KR920703071A (en) 1992-12-17
IL95574A (en) 1994-11-11
ATE125448T1 (en) 1995-08-15
JPH05500213A (en) 1993-01-21
EP0594570A1 (en) 1994-05-04
EP0594570B1 (en) 1995-07-26
CA2065151A1 (en) 1991-03-10

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