[Preparation of famotidine microemulsion and its quality evaluation].
OBJECTIVE
To study the preparation of famotidine microemulsion (FM) and its quality evaluation, thereby to establish the quality-control criteria for this preparation.


METHODS
The formulations of the FM were optimized by studying the pseudoternary phase diagrams and its absorption in rat jejunum using in situ perfusion method. The morphology, particle size distribution, famotidine concentration and stability of the FM were studied.


RESULTS
The optimization of formulation was completed successfully. Electron microscopy presented the FM as small spherical drops, with a mean diameter of 65 nm. The average recovery as determined by high-performance liquid chromatography was 97.63%, its mean RSD being 0.72%.


CONCLUSIONS
The FM is easy to prepare with consistent quality, whose reliable determination method may be easily reproduced.
Ye
Hai-ying
HY
Department of Pharmacy, Zhujiang Hospital, First Military Medical University, Guangzhou 510282, China. ye_haiying@sohu.com
Zhang
Zhong-yi
ZY
Gao
Shen
S
Lu
Ying
Y
Wang
Yan
Y
D000818:Animals; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004655:Emulsions; D015738:Famotidine / Q000008:administration & dosage* / Q000032:analysis / Q000493:pharmacokinetics; D005260:Female; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D007408:Intestinal Absorption; D008297:Male; D011786:Quality Control; D051381:Rats; D017207:Rats, Sprague-Dawley
D004655:Emulsions; D006635:Histamine H2 Antagonists; D015738:Famotidine