Formula Optimization of Regorafenib Solid Dispersion by Orthogonal Test / 中国药师

ABSTRACT

Objective:To optimize the formula of regorafenib solid dispersion .Methods: On the basis of preliminary studies on the carrier and drug/carrier ratio, an orthogonal test was used to study the formula of regorafenib solid dispersion .The orthogonal table of L9 (34 ) was designed to study the drug/carrier ratio, ultrasound time and bath temperature .Results: Regorafenib solid dispersion was prepared by a solvent method with polyvinylpyrrolidone K 30 as the carrier.The drug/carrier ratio was 1 ∶7, the ultrasound time was 4min, and the bath temperature was 30℃.Regorafenib solid dispersion showed good stability confirmed by differential scanning calorimetry and X-ray diffraction .The dissolution in 30 min reached above 90 %.Conclusion: The preparation process is stable and reproducible , which can be used to prepare regorafenib solid dispersion .