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1. WO1996004918 - PREDNISOLONE METASULPHOBENZOATE PREPARATION FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE

Publication Number WO/1996/004918
Publication Date 22.02.1996
International Application No. PCT/GB1995/001900
International Filing Date 11.08.1995
Chapter 2 Demand Filed 05.03.1996
IPC
A61K 9/16 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
CPC
A61K 31/573
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives, e.g. steroids
57substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane, progesterone
573substituted in position 21, e.g. cortisone, dexamethasone, prednisone ; or aldosterone
A61K 9/1652
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1629Organic macromolecular compounds
1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Applicants
  • FLEXPHARM LIMITED [GB/GB]; 36 Grove Road Sutton Surrey SM1 1BS, GB (AllExceptUS)
  • SPEIRS, Christopher, James [GB/GB]; GB (UsOnly)
Inventors
  • SPEIRS, Christopher, James; GB
Agents
  • BURFORD, Anthony, F.; W.H. Beck, Greener & Co. 7 Stone Buildings Lincoln's Inn London WC2A 3SZ, GB
Priority Data
9416310.212.08.1994GB
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) PREDNISOLONE METASULPHOBENZOATE PREPARATION FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE
(FR) PREPARATION DE PREDNISOLONE METASULPHOBENZOATE UTILE POUR TRAITER LES AFFECTIONS INTESTINALES INFLAMMATOIRES NON SPECIFIQUES
Abstract
(EN)
The dissolution at pH 6.5 of prednisolone metasulphobenzoate or a pharmacologically acceptable salt thereof from a non-disintegratable solid enteric composition comprising the prednisolone metasulphobenzoate in an excipient matrix is increased by the presence in the matrix of a rheological modifying agent, especially croscarmellose, in an amount of at least 5 percent by weight of the composition but insufficient to cause disintegration. Preferably the composition is in the form of pellets coated with an enteric coating which is substantially insoluble below pH 7 and contained in a capsule or tablet coated with an enteric coating which is soluble at a pH in the range pH 5.5 to pH 7. The coated capsules and tablets are for use in the treatment of inflammatory bowel disease, especially ulcerative colitis and Crohn's disease.
(FR)
On améliore la dissolution, à un pH de 6,5, du prednisolone métasulphobenzoate ou d'un sel pharmacologiquement acceptable de ce dernier obtenu à partir d'une composition entérique solide ne se dissolvant pas comprenant le prednisolone métasulphobenzoate dans une matrice d'excipient, en incorporant dans la matrice un agent modifiant rhéologique, plus spécifiquement de la croscarmellose, en dose égale à au moins 5 pour cent en poids de la composition mais cependant insuffisante pour provoquer la dissolution. La composition se présente de préférence sous forme de granules enrobés d'un pelliculage gastro-résistant qui est sensiblement insoluble à un pH inférieur à 7 et contenu dans une capsule ou un comprimé enrobé d'un pelliculage gastro-résistant qui est soluble à un pH compris entre 5,5 et 7. Les capsules ou les comprimés enrobés sont destinés à être utilisés dans le traitement d'affections intestinales inflammatoires non spécifiques, notamment la rectocolite hémorragique et la maladie de Crohn.
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