Pregelatinized hydroxypropyl pea starch as matrix forming material for lyophilized orodispersible tablets of tadalafil

Abstract

Oral fast-disintegrating dosage forms, also known as ‘fast-disintegrating’ or ‘fast-dissolving’ dosage forms, are a relativelynovel dosage technology that involves the rapid disintegration or dissolution of the dosage form. The objective of present study was to demonstrate pregelatinized hydroxypropyl pea starch as promising soluble matrix forming material in the preparation of orodispersible tablets (ODT) that was easy to administer and provides rapid release of the drug. The ODT was prepared by lyophilizing an aqueous dispersion of tadalafil containing modified pea starch. ODTs were investigated for tablet characteristics including dimensions, hardness, friability, in vitro dissolution and in vitro/in vivo disintegration time. The best properties exibhited by OTD are wetting time 13.5 ± 1.2 s, disintegration time of 16.6 ± 0.8 s. Results obtained from dissolution studies showed that ODT of tadalafil significantly improved the dissolution rate of the drug compared with the native drug. More than 75% of tadalafil in ODT dissolved within 1 min compared to only 30% of tadalafil native drug dissolved during 60 s. In conclusion the formation of stable and strong lyophilized orodispersible tablet using pregelatinized hydroxypropyl pea starch as sole matrix excipient is investigated. This study suggests that pregelatinized hydroxypropyl pea starch can act as a potential matrix forming material for oral drug delivery.