Nanoparticulate formulations and methods for the making and use therof

  • US 20090004262A1
  • Filed: 11/28/2007
  • Published: 01/01/2009
  • Est. Priority Date: 11/28/2006
  • Status: Abandoned Application
First Claim
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17. Size-stabilized drug complexed particles comprising a drug capable of forming a cyclodextrin inclusion complex and having an aqueous solubility of less than 1 mg/ml in a pH of about 7.4 in association with effective amounts of a surface stabilizer and a complexing agent capable of forming a cyclodextrin inclusion complex, the size-stabilized drug complexed particles having a volume weighted median diameter (D50) from about 50 nm to about 500 nm;

  • the drug complexed particles exhibiting an increase in volume weighted median diameter (D50) of from 0% to not more than about 200% when the formulation is dispersed in simulated gastric fluid (SGF) or simulated intestinal fluid (SIF) at a concentration of 0.5 to 1 mg drug/mL and placed in a heated bath at 36°

    to 38°

    C. for 1 hour using a Type I or II dissolution apparatus and a stirring rate of 75 RPM, as compared to the D50 of the drug particles when the formulation is dispersed in distilled water under the same conditions.

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