Accelerated stability study and microbiological tests on new oral matrix delivery systems for diclofenac sodium

ABSTRACT

An accelerated stability study was performed on diclofenac sodium controlled release matrix tablets [MT20,MT33,MT34,MT33p,MT34p] containing natural gums, semi-synthetic gum, Eudragit L100,and hydroxypropylmethylcellulose [HPMC]. Drug content was found to be in the range of 90-105% in all the five matrix formulas. Applying out of stability trend rules [OOT], the best formula was found to be MT33 which contained Guar gum 15%, and gum Arabic 15%. No changes in physical appearance, or organoleptic properties were observed. Microbiological tests for the five matrix tablets were evaluated. No growth [bacteria or fungi] was detected, in preserved or non-preserved formulas despite of the gum content in these controlled release tablets