| 摘要 |
A solid crystalline drug dispersion in particulate form comprises drug crystals dispersed in a matrix formed of a disintegrant, wherein the drug crystals generally have a median diameter D50% of not greater than 20µ, the drug is a hydrophobic drug, and substantially all of the drug in the solid dispersion is in a crystalline form. The particles of solid dispersion have a median diameter D 50% of between 1 and 50µ. The disintegrant is a superdisintegrant selected from the group consisting of: a crosspovidone or derivatives thereof; crosscarmellose sodium or derivatives thereof; sodium starch glycollate or derivatives thereof; and calcium silicate. A method of producing a solid crystalline drug dispersion is also disclosed and comprises the steps of providing a crystalline drug in which the drug crystals have a median diameter D50% of not generally more than 20µ, preparing a dispersion or suspension of drug crystals in a disintegrant solution or suspension, and spray drying the dispersion or suspension to provide a particulate composition comprising particles of solid crystalline drug dispersion. An oral dose form comprising a solid crystalline drug dispersion of the invention is also described..
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