[Research on nifedipine patch].
The feasibility of matrix dispersion-type nifedipine patch was verified and an HPLC method for the determination of nifedipine level both in vitro and in vivo was established. It was found that both the two formulations of the patch (R2 with azone as penetration enhancer, R1 without azone) provided zero order kinetics of permeation, the rates of skin permeation were different at less than 10.25 and greater than 10.25 h, R1 was 2.63 and 1.1 micrograms/cm2. h; R2 was 4.30 and 1.54 micrograms/cm2.h. The release profiles of nifedipine from R2 were found to follow a linear Q vs t1/2 relationship with a release flux of 68.91 micrograms/cm2. h1/2. The plasma concentration vs time profiles of nifedipine in healthy subjects, each receiving two patches (36 x 2 cm2), were investigated. A steady state plasma level within therapeutic concentration window was obtained from 1.5 h to 24.5 h. Several quality tests of the patch were evaluated in this research.
Ruan
L P
LP
Department of Pharmaceutics, Shenyang College of Pharmacy.
Zheng
J M
JM
D000279:Administration, Cutaneous; D000328:Adult; D000818:Animals; D001381:Azepines / Q000494:pharmacology; D002851:Chromatography, High Pressure Liquid; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011817:Rabbits; D012869:Skin Absorption / Q000187:drug effects
D001381:Azepines; C035229:laurocapram; D009543:Nifedipine