Objective:
The aim of the present study was to prepare the ond
ansetron hydrochloride Mouth Dissolving Tablets (MD
Ts) followed by its
comparison with ethical and non-ethical (generic) m
arketed tablets.
Methods:
Prior to the formulation, drug excipient compatibil
ity study was carried out by FTIR spectroscopy. The
λ
max
was determined by UV
spectroscopy. The ondansetron hydrochloride MDTs we
re prepared by direct compression method using Sodi
um Starch Glycolate (SSG) as super
disintegrant and camphor as a sublimating agent. Th
en the prepared MDTs were subjected to evaluation o
f post compression parameters such as
thickness and diameter, weight variation, wetting t
ime, hardness, friability, disintegration and disso
lution. The results obtained were compared
with that of ethical and non-ethical marketed ondan
setron hydrochloride 4 mg tablets.
Results:
The λ
max
was found at 310 nm. FTIR
study revealed that excipients used in the prepared
formulations are compatible with the drug. The
thickness and diameter was in the range of 2.646 to
3.27 mm and 6.0 to 8.12 mm, respectively. Friabili
ty was in the range of 0.43 to 0.88 % and had
a slightly higher friability (1.27%) for sublimated
tablets. Wetting time and disintegration time were
in the range of 15 to 40 sec and 23 to 50 sec,
respectively. The 100 % drug release was found with
in 180 sec for all the codes. These results were th
en compared with non-ethical film coated
ondansetron marketed tablets.
Conclusion:
Ondansetron hydrochloride MDT 4 mg tablets prepared
in the laboratory were under specified IP limits.
The experimental findings
demonstrated that any of these ethical and non-ethi
cal tablets of ondansetron hydrochloride can be sel
ected, advised by the physician or
pharmacist, as per the patient’s need and economica
l status.