ES2038673T3 - Un procedimiento para la preparacion de una forma de dosificacion oral, solida, de liberacion controlada. - Google Patents

Un procedimiento para la preparacion de una forma de dosificacion oral, solida, de liberacion controlada.

Info

Publication number
ES2038673T3
ES2038673T3 ES198787309333T ES87309333T ES2038673T3 ES 2038673 T3 ES2038673 T3 ES 2038673T3 ES 198787309333 T ES198787309333 T ES 198787309333T ES 87309333 T ES87309333 T ES 87309333T ES 2038673 T3 ES2038673 T3 ES 2038673T3
Authority
ES
Spain
Prior art keywords
dosage form
hydromorphone
hours
weight
controlled release
Prior art date
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.)
Expired - Lifetime
Application number
ES198787309333T
Other languages
English (en)
Inventor
Robert Stronech Goldie
Sandra Therese Antoinette Malkowska
Stewart Thomas Leslie
Ronald Brown Miller
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.)
Euro Celtique SA
Original Assignee
Euro Celtique SA
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=10606640&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2038673(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Euro Celtique SA filed Critical Euro Celtique SA
Application granted granted Critical
Publication of ES2038673T3 publication Critical patent/ES2038673T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Abstract

LA INVENCION SE REFIERE A UNA FORMA DE DOSIFICACION ORAL SOLIDA DE LIBERACION CONTROLADA, QUE CONTIENE UNA CANTIDAD TERAPEUTICAMENTE EFECTIVA DE HIDROMORFONA O UNA SAL DE ELLAS, EN UNA MATRIZ DE LA QUE LA VELOCIDAD DE DISOLUCION IN VITRO SE ENCUENTRA ENTRE 12,5 Y 42,5% EN PESO DE HIDROMORFONA LIBERADA DESPUES DE 1 HORA, ENTRE 25 Y 55% EN PESO DESPUES DE 2 HORAS, ENTRE 45 Y 75% EN PESO DESPUES DE 4 HORAS Y ENTRE 55 Y 85% EN PESO DESPUES DE 6 HORAS (CUANDO SE MIDE POR EL METODO PADDLE DE LA USP A 100 RPM EN UN TAMPON ACUOSO DE 900 ML, A PH ENTRE 1,6 Y 7,2 A 37 GRADOS C), SIENDO LA VELOCIDAD DE LIBERACION IN VITRO INDEPENDIENTE DEL PH ENTRE PH 1,6 Y 7,2 Y ELEGIDO DE FORMA QUE EL NIVEL MAXIDO DE HIDROMORFONA EN EL PLASMA OBTENIDO IN VIVO SE PRODUZCA ENTRE 2 Y 4 HORAS DESPUES DE ADMINISTRACION DE LA FORMA DE DOSIFICACION.
ES198787309333T 1986-10-31 1987-10-22 Un procedimiento para la preparacion de una forma de dosificacion oral, solida, de liberacion controlada. Expired - Lifetime ES2038673T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB868626098A GB8626098D0 (en) 1986-10-31 1986-10-31 Controlled release hydromorphone composition

Publications (1)

Publication Number Publication Date
ES2038673T3 true ES2038673T3 (es) 1993-08-01

Family

ID=10606640

Family Applications (1)

Application Number Title Priority Date Filing Date
ES198787309333T Expired - Lifetime ES2038673T3 (es) 1986-10-31 1987-10-22 Un procedimiento para la preparacion de una forma de dosificacion oral, solida, de liberacion controlada.

Country Status (12)

Country Link
US (2) US4844909A (es)
EP (1) EP0271193B1 (es)
JP (1) JP2806385B2 (es)
AT (1) ATE67933T1 (es)
AU (1) AU600765B2 (es)
CA (1) CA1297025C (es)
DE (1) DE3773468D1 (es)
DK (1) DK175139B1 (es)
ES (1) ES2038673T3 (es)
GB (2) GB8626098D0 (es)
IE (1) IE60495B1 (es)
ZA (1) ZA878018B (es)

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CA1297025C (en) 1992-03-10
ZA878018B (en) 1988-04-29
EP0271193A3 (en) 1988-07-13
GB8626098D0 (en) 1986-12-03
GB2196848A (en) 1988-05-11
DE3773468D1 (de) 1991-11-07
GB8724705D0 (en) 1987-11-25
JP2806385B2 (ja) 1998-09-30
AU8052487A (en) 1988-05-05
GB2196848B (en) 1990-11-14
DK568687D0 (da) 1987-10-30
US4990341A (en) 1991-02-05
EP0271193A2 (en) 1988-06-15
DK568687A (da) 1988-05-01
JPS63122623A (ja) 1988-05-26
US4844909A (en) 1989-07-04
DK175139B1 (da) 2004-06-14
IE60495B1 (en) 1994-07-27
AU600765B2 (en) 1990-08-23
ATE67933T1 (de) 1991-10-15
EP0271193B1 (en) 1991-10-02
IE872924L (en) 1988-04-30

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