Pharmaceutical Formulations

Objective: The aim of the present study was to prepare ODT by using relatively a simple direct compression technique with

high mechanical strength while keeping the attributes of fast disintegration and dissolution to improve the bioavailability of

the drug.

Method: Mannitol and microcrystalline cellulose were studied as diluents in the same quantity for manufacture of montelukast

sodium tablet using crospovidone as super disintegrants and sodium bicarbonate as wicking agent. The blend was examined

for angle of repose, bulk and tapped density, compressibility index, and Hausner’s ratio. The drug-excipients interaction was

investigated by FTIR. After compression hardness, friability, disintegration and dissolution, all the formulations batches were

analyzed.

Results: It was found that microcrystalline cellulose was suitable diluent for tablets considering hardness, friability and

disintegration time. Ten formulations F1 to F10 were prepared by central composite methods (two level factorial designs) for

the selection of optimum concentration of disintegrants and diluents.

Conclusions: The overall results showed that crospovidone was the best super-disintegrant for showing the shortest

disintegration time while MCC was the good diluent in preparing montelukast Oro-dispersible tablet and this suggested the

possibility of utilizing the selected best formula (F2) in the preparation of Oro-dispersible tablet as a new dosage form for oral

administration.