Keywords
acyclovir
superdisintegrants
sodium starch glycolate
croscarmellose sodium
Abstract
Orally disintegrating tablets (ODTs) have recently
gained attention as the substitute of conventional dosage form.
Superdisintegrants, the main component in the ODTs, render fast
disintegrating properties and facilitate the dissolution of active
drug. Aims: In the present study, the main aims were to prepare
acyclovir ODTs using superdisintegrants (sodium starch
glycolate and croscarmellose sodium) by direct compression
method and investigate the outcome of using various
concentrations of superdisintegrant in single and combination
formulations. Materials and Methods: Superdisintegrants
incorporated in the formulations were croscarmellose sodium and
sodium starch glycolate in single (F1, F2, F3 and F4) and binary
combination (F5 and F6) and acyclovir tablets were directly
compressed. Critical quality attributes investigated were
uniformity of weight, thickness, hardness, friability, wetting time
and water absorption ratio, in vitro disintegration time and in vitro
dissolution study. One-way statistical ANOVA test and post hoc
test were conducted by using Statistical Package for the Social
Science (SPSS) software version 21. Results: The maximum
acyclovir release rate was achieved in formulations F5 (90.09 ±
0.43%) followed by F2 (70.29 ± 0.07%) and F1 (61.33 ± 1.15%).
Among the 7 formulations investigated, 1% w/w SSG and 5%
w/w CCS in formulation F5 demonstrated shortest disintegration
time (7.33 ± 0.246 seconds) and greatest dissolution rate (90.09 ±
0.43%). Such combination ratio provided synergism between
mechanisms of action of two superdisintegrants (swelling and
wicking) thus resulted in excellent wetting properties and water
absorption ratio (p < 0.05). Conclusion: From the present study,
combination of superdisintegrants in ratio 1:5 did result in better
disintegration and dissolution rate compared to ratio 1:1 and other
single superdisintegrant formulations in terms of critical quality
attributes investigated.
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