A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/52 (2006.01) A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 31/7072 (2006.01) A61K 31/7076 (2006.01)
Patent
CA 2404687
Extended dosage forms of stavudine are provided comprising beadlets formed by extrusion-spheronization and coated with a seal coating. The beadlets are also coated with a modified release coating such that a hard gelatin capsule containing such beadlets will provide blood levels of stavudine over approximately 24 hours. The beadlets are prepared from a dry blend of stavudine, a spheronizing agent, a suitable diluent and a stabilizing amount of magnesium stearate. The magnesium stearate, in contrast to other similar pharmaceutical adjuncts, has been found to stabilize stavudine against degradation due to hydrolysis in the presence of the limited amount of water necessary for the extrusion-spheronization process. Also included in the scope of the invention are hard gelatin capsules containing, in addition to the stavudine beadlets, similar beadlets containing other therapeutic agents utilized to treat retroviral infections.
L'invention concerne des formes posologiques étendues de stavudine comprenant des granules formés par extrusion-sphéronisation et recouverts d'un revêtement hermétique. Les granules sont également recouverts d'un revêtement détachable modifié de sorte qu'une capsule de gélatine dure contenant ces granules libère un certain taux de stavudine dans le sang pendant environ 24 heures. Ces granules sont préparés à partir d'un mélange sec de stavudine, d'un agent de sphéronisation, d'un diluant approprié et d'une quantité stabilisatrice de stéarate de magnésium. On a découvert que le stéarate de magnésium, contrairement à d'autres traitements d'appoint pharmaceutiques, stabilise la stavudine contre une dégradation due à l'hydrolyse en présence de la quantité limitée d'eau nécessaire au procédé d'extrusion-sphéronisation. L'invention concerne également des capsules de gélatine dure contenant, outre les granules de stavudine, des granules semblables contenant d'autres agents thérapeutiques servant à traiter des infections rétrovirales.
Abramowitz Robert
Jain Nemichand B.
O'donoghue Denise M.
Bristol-Myers Squibb Company
Gowling Lafleur Henderson Llp
LandOfFree
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