In vitro and in vivo evaluation of potassium chloride sustained release formulation prepared with saturated polyglycolyed glycerides matrices.
The aim of the present work was to evaluate the effect of sustained release of potassium chloride semi-solid matrices prepared with different kinds and added amounts of Gelucires by the in vitro dissolution test and in vivo oral absorption study, and compared with a commercial product (slow-K). The results indicating that the release rates of potassium from experimental formulations were dependent on the type of semi-solid matrices (Gelucires). The higher the melting point of the Gelucires was incorporated, the slower release rate of the active substance was observed. Moreover, the values of similarity factor of Formulae F05 and F09 versus the reference in three kinds of dissolution medium (f(2)) were higher than 50, indicating that these experimental formulations had similar sustained release effects to the reference (slow-K) in dissolution test. In vivo study, the cumulative amount (mEq) of potassium excreted curve and the excretion rate curve of F05 and F09 were found to be similar to that of slow-K, and there were no significant differences (P > 0.05) in the maximum excretion rate and the mean time to reach the maximum rate between formulations and slow-K, indicating that the potassium chloride sustained release dosage form could be prepared using the Gelucires as lipid excipients.
Wu
Pao-Chu
PC
College of Pharmacy, Kaohsiung Medical University, No. 100 Shih-Chen 1st R.D., Kaohsiung 807, Taiwan, ROC.
Tsai
Min-Jun
MJ
Huang
Yaw-Bin
YB
Chang
Jui-Sheng
JS
Tsai
Yi-Hung
YH
D000818:Animals; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D005079:Excipients; D005989:Glycerides; D007700:Kinetics; D008297:Male; D011092:Polyethylene Glycols; D011189:Potassium Chloride / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000652:urine; D011817:Rabbits; D012995:Solubility; D013810:Therapeutic Equivalency
D002214:Capsules; D003692:Delayed-Action Preparations; D005079:Excipients; D005989:Glycerides; C104509:gelucire 44-14; D011092:Polyethylene Glycols; D011189:Potassium Chloride