A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/565 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 31/567 (2006.01) A61K 47/12 (2006.01)
Patent
CA 2111320
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, lubri- cant and, optionally, an antioxidant are dissolved in an, optionally pre-heated, organic solvent. The result- ing 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 gran- ules. 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 car- rier comprising diluent and binder, and b) a film coat- ing 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.
Dopper Jan Hendrik
Van Der Ven Cornelis Josephus Maria
Akzo N.v.
Fetherstonhaugh & Co.
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