WO1997015293A3 - Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung - Google Patents

Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung Download PDF

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Publication number
WO1997015293A3
WO1997015293A3 PCT/EP1996/004601 EP9604601W WO9715293A3 WO 1997015293 A3 WO1997015293 A3 WO 1997015293A3 EP 9604601 W EP9604601 W EP 9604601W WO 9715293 A3 WO9715293 A3 WO 9715293A3
Authority
WO
WIPO (PCT)
Prior art keywords
oral
rectal administration
solid form
producing multi
layer
Prior art date
Application number
PCT/EP1996/004601
Other languages
English (en)
French (fr)
Other versions
WO1997015293A2 (de
Inventor
Joerg Breitenbach
Axel Paul Haertl
Juergen Hofmann
Joerg Rosenberg
Michael Schiessl
Hans Dieter Zettler
Original Assignee
Basf Ag
Joerg Breitenbach
Axel Paul Haertl
Juergen Hofmann
Joerg Rosenberg
Michael Schiessl
Hans Dieter Zettler
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
Priority to PL96327395A priority Critical patent/PL327395A1/xx
Priority to JP9516274A priority patent/JPH11513697A/ja
Priority to AU74912/96A priority patent/AU706859B2/en
Priority to US09/051,544 priority patent/US6120802A/en
Application filed by Basf Ag, Joerg Breitenbach, Axel Paul Haertl, Juergen Hofmann, Joerg Rosenberg, Michael Schiessl, Hans Dieter Zettler filed Critical Basf Ag
Priority to AT96937214T priority patent/ATE216224T1/de
Priority to CA002232356A priority patent/CA2232356C/en
Priority to DK96937214T priority patent/DK0857062T3/da
Priority to DE59609104T priority patent/DE59609104D1/de
Priority to EP96937214A priority patent/EP0857062B1/de
Priority to HU9802996A priority patent/HUP9802996A3/hu
Priority to KR1019980702911A priority patent/KR19990066978A/ko
Publication of WO1997015293A2 publication Critical patent/WO1997015293A2/de
Publication of WO1997015293A3 publication Critical patent/WO1997015293A3/de
Priority to BG102313A priority patent/BG102313A/xx
Priority to NO981793A priority patent/NO981793L/no

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic 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
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/14—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds on a movable carrier other than a turntable or a rotating drum
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/16—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using pocketed rollers, e.g. two co-operating pocketed rollers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/18—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using profiled rollers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/34—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/30—Feeding material to presses
    • B30B15/302—Feeding material in particulate or plastic state to moulding presses
    • B30B15/308—Feeding material in particulate or plastic state to moulding presses in a continuous manner, e.g. for roller presses, screw extrusion presses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/20—Extrusion means, e.g. for producing pharmaceutical forms

Abstract

Die vorliegende Erfindung betrifft ein Verfahren zur Herstellung mehrschichtiger, fester Arzneiformen zur oralen oder rektalen Verabreichung, wobei man mindestens zwei Massen, die jeweils ein thermoplastisches, pharmakologisch akzeptables und in physiologischer Umgebung lösliches oder quellbares polymeres Bindemittel umfassen und von denen wenigstens eine einen pharmazeutischen Wirkstoff enthält, koextrudiert und das koextrudierte mehrschichtige Material zu der gewünschten Arzneiform formt.
PCT/EP1996/004601 1995-10-23 1996-10-23 Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung WO1997015293A2 (de)

Priority Applications (13)

Application Number Priority Date Filing Date Title
CA002232356A CA2232356C (en) 1995-10-23 1996-10-23 Method of producing multi-layer medicaments in solid form for oral or rectal administration
AU74912/96A AU706859B2 (en) 1995-10-23 1996-10-23 The production of multilayer, solid drug forms for oral or rectal administration
US09/051,544 US6120802A (en) 1995-10-23 1996-10-23 Method of producing multi-layer medicaments in solid form for oral or rectal administration
DE59609104T DE59609104D1 (de) 1995-10-23 1996-10-23 Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung
AT96937214T ATE216224T1 (de) 1995-10-23 1996-10-23 Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung
JP9516274A JPH11513697A (ja) 1995-10-23 1996-10-23 経口投与または直腸投与のための多層固体薬剤形の製造
DK96937214T DK0857062T3 (da) 1995-10-23 1996-10-23 Fremgangsmåde til fremstilling af multilags, faste lægemiddelformer til peroral eller rektal indgivelse
PL96327395A PL327395A1 (en) 1995-10-23 1996-10-23 Method of making multiple-layer solid drug forms for oral or rectal administration
EP96937214A EP0857062B1 (de) 1995-10-23 1996-10-23 Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung
HU9802996A HUP9802996A3 (en) 1995-10-23 1996-10-23 Method of producing multi-layer medicaments in solid form for oral or rectal administration
KR1019980702911A KR19990066978A (ko) 1995-10-23 1996-10-23 경구 또는 직장 투여용 다층 고상 제형의 제조방법
BG102313A BG102313A (en) 1995-10-23 1998-03-10 Method for the preparation of multilayer solid medicamentous forms for oral or rectal administration
NO981793A NO981793L (no) 1995-10-23 1998-04-22 FremgangsmÕte for fremstilling av flere-lag medikamenter i fast form for oral eller rektal administrering

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19539361A DE19539361A1 (de) 1995-10-23 1995-10-23 Verfahren zur Herstellung von mehrschichtigen, festen Arzneiformen zur oralen oder rektalen Verabreichung
DE19539361.9 1995-10-23

Publications (2)

Publication Number Publication Date
WO1997015293A2 WO1997015293A2 (de) 1997-05-01
WO1997015293A3 true WO1997015293A3 (de) 1997-08-14

Family

ID=7775508

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1996/004601 WO1997015293A2 (de) 1995-10-23 1996-10-23 Verfahren zur herstellung von mehrschichtigen, festen arzneiformen zur oralen oder rektalen verabreichung

Country Status (22)

Country Link
US (1) US6120802A (de)
EP (1) EP0857062B1 (de)
JP (1) JPH11513697A (de)
KR (1) KR19990066978A (de)
CN (1) CN1092955C (de)
AT (1) ATE216224T1 (de)
AU (1) AU706859B2 (de)
BG (1) BG102313A (de)
CA (1) CA2232356C (de)
CZ (1) CZ289689B6 (de)
DE (2) DE19539361A1 (de)
DK (1) DK0857062T3 (de)
ES (1) ES2175139T3 (de)
HR (1) HRP960483B1 (de)
HU (1) HUP9802996A3 (de)
IN (1) IN182500B (de)
MX (1) MX9802153A (de)
NO (1) NO981793L (de)
PL (1) PL327395A1 (de)
PT (1) PT857062E (de)
WO (1) WO1997015293A2 (de)
ZA (1) ZA968849B (de)

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US6120802A (en) 2000-09-19
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