Granules pharmaceutiques contenant des steroides

Pharmaceutical granulate containing steroids

Steroide enthaltende pharmazeutische Granulate


Disclosed is a process of preparing granules involving first preparing a carrier comprising diluent, binder, and optionally a disintegrating agent. In a container separate from said carrier, a steroid, lubricant and, optionally, an antioxidant are dissolved in an, optionally pre-heated, organic solvent. The resulting solution is added to the carrier contained within an, e.g vacuum mixer, followed by further blending of the mixture. The organic solvent is removed from the mixture. The mixture is blended further to form granules. The process may further include incorporating a flow enhancer such as colloidal silicon dioxide into the granules. A granule for making a pharmaceutical dosage unit is granule characterized in comprising: a) a carrier comprising diluent and binder, and b) a film coating said carrier, said film comprising desogestrel and a lubricant, and has the characteristic of by retaining 90% of the desogestrel at a pressure of 150 mbar and at a temperature of 70° C over 72 hours.




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Patent Citations (3)

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    EP-0491443-A1June 24, 1992Akzo Nobel N.V.Progestogen als einziges Kontrazeptivum
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Cited By (9)

    Publication numberPublication dateAssigneeTitle
    DE-19652196-A1June 18, 1998Jenapharm GmbhHomogene steroidhaltige Präformulierungen zur Herstellung niedrigdosierter fester und halbfester pharmazeutischer Zubereitungen
    EP-0927556-A1July 07, 1999Akzo Nobel N.V.Steroid enthaltende Dosierungsformen mit einer steroiddichten Umhüllung
    EP-1591121-A1November 02, 2005Ortho-Mcneil Pharmaceutical, Inc.Zubereitung enthaltend einen Steroidhormon und ein Stabilisierungsmittel in nicht-Kristallinen Form
    KR-100899032-B1July 22, 2003오르토-맥네일 파마슈티칼, 인코퍼레이티드비결정형의 안정화제를 포함하는 스테로이드 호르몬 제품
    US-6761907-B1July 13, 2004Akzo Nobel NvCoated dosage units
    US-7867990-B2January 11, 2011Ortho-Mcneil Pharmaceutical, Inc.Steroid hormone products and methods for preparing them
    WO-0247693-A2June 20, 2002Ortho-Mcneil Pharmaceutical, Inc.Produits a base d'hormone steroide et leurs procedes de fabrication
    WO-0247693-A3November 07, 2002Ortho Mcneil Pharm IncProduits a base d'hormone steroide et leurs procedes de fabrication
    WO-9915180-A1April 01, 1999Akzo Nobel N.V.Coated dosage units