Abstract:
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/
Cmax) 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
Cmax 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
Cmax 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.