Novel Technology of Production the Controlled Release Sodium Diclofenac Matrix Tablets, Study of Their Dissolution Rate and Stability

ABSTRACT

The controlled release formulation of sodium diclofenac have become increasingly important in the therapy as a means of reducing dosing frequency, hence improving patient compliance, better therapeutic effect and less side effects. This work was aimed to develop the controlled release sodium diclofenac granules prepared with different techniques. Various methods of granulation were used to prepare the granules of matrix tablets a wet granulation with isopropanol, a granulation with molten cetyl alcohol and a repetitive wet granulation with cetyl alcohol solution in the isopropanol, then the granules were compressed using a rotative tabletting machine. Drug release profiles of made formulations were investigated using a USP XXIII apparatus [basket] at 100 rpm and various p/h buffer media. [PH=2.5,PH=4.5,PH=6.8]. The effect of preparation's methods and various excipients used [cetyl alcohol, Avicel PH 102, Emcompress and magnesium stearate] on sodium diclofenac dissolution from controlled release hydrophobic matrix tablets were studied. It was found that the repetitive granulation with molten cetyl alcohol, repetitive wet granulation with cetyl alcohol solution, magnesium stearate, and cetyl alcohol caused a decrease in dissolution rate, but the wet granulation with isopropanol Avicel PH 102 increased the dissolution rate.The stability tests were carried out according to WHO accelerated study procedures. The formulations studied showed that the potency of prepared controlled release tablet formulations decreased after three months of incubation under stress condition [elevated temperature and humidity], and revealed faster drug release profiles