DEVELOPMENT AND CHARACTERIZATION OF TASTE MASKED FAST DISSOLVING LISINOPRIL TABLETS

Abstract

Objective: Fast Dissolving Tablets are solid dosage form containing medicinal substances or active ingredients which
disintegrates rapidly within few seconds when placed up on tongue. Lisinopril is a long-acting, non sulfhydryl angiotensinconverting
enzyme (ACE) inhibitor that is used for the treatment of hypertension and congestive heart failure.
Methods: Fast dissolving tablets of Lisinopril were prepared using different synthetic super disintegrants like
croscarmellose sodium, microcrystalline cellulose PH102 and sodium starch glycolate by direct compression method. Here
microcrystalline cellulose PH102 was used as a superdisintegrant. Each formulation was composed of drug and excipients
in various proportions. The blends of all formulations were evaluated for various pre-formulation factors. Tablets were
evaluated for weight variation, hardness, in vitro dispersion time, disintegration time, drug content, friability and in vitro
dissolution.
Results: The results showed that disintegration time of tablets of sodium starch glycolate is comparatively lower than the
crosscarmellose sodium. Formulation F4 disintegrated in 48 seconds. The increase in disintegrant SSG (10%) in F6
decreased the disintegration time to 43 seconds. But the drug release was only 89.96 % after 30 minutes. In the F7
formulation concentration of Avicel PH 102 was decreased to 15% and a little increase in the release profile (92.63%) was
observed. So in the F8 formulation Avicel PH 102 was reduced further to 10% and this showed marked increase in the drug
release (98.34%) and hence optimized. In vitro drug release showed that formula F8 had better 98.34% drug release within
30 minutes as compare to other formulations. The results showed that super disintegrants used in combinations shows better
disintegrating property. The FTIR spectra showed no interactions among them.
Conclusion: Among all formulations, promising formulation F8 which contains SSG (10%) and Avicel PH 102 (10%)
appeared to be the best formula as it showed good wetting time (23 sec), fastest disintegration time (38 sec) and maximum
drug release of 98.34% within 30 minutes.