Development of piroxicam orally disintegrating tablets by freeze drying
method
Abstract
Objective:
the aim of this research was to optimize piroxicam orally disintegrating
tablets (ODT) formulation by freeze drying method. Method: optimization was
done by a 22 factorial design to observe the effect of gelatin
as binder with levels of 1% and 2%, and ECG 505 as disintegrant with levels of
2.5% and 7.5%. The filler used was mannitol which also serves as sweetener. The
mixture was suspended, filled into blisters and freeze dried. The physical
characteristics of the resulting tablets were evaluated including hardness,
friability, disintegration time and dissolution. Internal microstructures of
the tablets were analyzed by Scanning Electron Microscope (SEM). Results:
Increasing level of gelatin from 1% to 2% increased the tablet hardness,
lowered the tablet friability and increased the tablet disintegration time.
Increasing levels of gelatin from 1% to 2% showed a greater influence than of
ECG 505 on the tablet disintegration time, while increasing levels of ECG 505
from 2.5% to 7.5% showed a greater influence on the amount of piroxicam
dissolved than of gelatin. Conclusion: evaluation of tablets physical quality
showed that within the "feasible area" of the design space, the
tablets met the specifications of hardness, disintegration time and % piroxicam
dissolved but did not meet the friability specification. The SEM
photomicrographs showed that the tablets have a porous structure.
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