Abstract
The objective of this work was to study the efficiency of certain disintegrants in low levels on the phys. characteristics and dissoln. behavior of directly compressed tablets contg. theophylline as a model drug. A directly compressible formula based on Avicel PH 102/Emcompress 1:1 wt. ratio was used in the prepn. of theophylline tablets after being efficiently mixed together in a turbula mixer with or without the addn. of disintegrants. The used disintegrants namely were cross-linked CM-cellulose sodium (Ac-Di-Sol), sodium starch glycolate (Explotab), cross povidone (Polyplasdone XL10) and Starch 1500, in low concns. from 1 to 4 %wt./wt. The phys. properties and the dissoln. behavior of the directly compressed theophylline tablets were evaluated according to USP XXIII (1995) limits. All the formulations of theophylline tablets showed good mech. properties and complied with the std. requirements for uniformity of dosage units and friability. Directly compressed theophylline tablets without disintegrants (control) gave longer disintegration time which exceeds 30 min (outside the limits of USP), and slow dissoln. rate. While the batches of tablets contg. disintegrants exhibited rapid disintegration and faster dissoln. rate except those tablets contg. starch 1500. Mechanisms of the drug release were investigated from dissoln. data of theophylline tablets according to zero-order, first-order and the matrix-diffusion controlled kinetics. The behavior of drug release from theophylline tablets (control) and those contg. either Explotab or Starch 1500 occurred predominantly by diffusion mechanism, while the drug release from tablets contg. either Ac-Di-Sol or Polyplasidone followed first-order kinetics.
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