Formulation Study for Nifedipine Spray Dried Dispersion with Taguchi Design

OBJECTIVE To determine the effect of solution formulation on characteristics and non-sink dissolution of nifedipine spray dried dispersion (SDD). METHODS Taguchi method in minitab software was used for experiment design. The area under dissolution curve within 120 min (AUC_{0-120 min}) and the ratio of released drug at 120 min to the maximum released drug (C₁₂₀/C_max) were applied as evaluation index to investigated the effect of polymers type, dosage and solid content of feed solution on drug state in nifedipine SDD and in-vitro dissolution. RESULTS Ratio of nifedipine to polymer had dramatic effect on drug state in SDD and in-vitro dissolution while solid content in feed solution affects a little. Copovidone based SDD got higher C_max compared with Hydroxypropyl methylcellulose acetate succinate (HPMCAS), but HPMCAS performed better in inhibiting recrystalization during dissolution test and storage. SDD with nifedipine-HPMCAS LG 1:4 could get highest C_max and AUC_{0-120 min}. CONCLUTION Spray drying solution with nifedipine-HPMCAS LG 1:4 with solid content of 10% can get great SDD with optimized dissolution.