Dextromethorphan Hydrobromide Orally Disintegrating Tablets: Development and Evaluation using Different Formulation Variables
Journal Article
Mostafa, Haitham F. . 2014
Publication Work Type:
Master
Publication Online URL:
Magazine \ Newspaper:
Pharmind
Issue Number:
8
Volume Number:
76
Pages:
1300 to 1310
Publication Abstract:
The objective of this work is to develop a simple inexpensive
method for manufacturing dextromethorphan hydrobromide
oral disintegrating tablets (ODTs) and to study the effect of
some formulation variables. Two factors, three levels (32) full
factorial design was used to optimize the diluent, dextrates,
NF (X1) and superdisintegrant, croscarmellose sodium (X2)
concentrations. Disintegration time (Y1), hardness (Y2) and
time required for 50 % release of the drug, T50 (Y3) values for
all the formulations varied from 17.33 to 279.5 s, 3.58 to 4.97
kp and 1.2 to 5 min, respectively. The results indicated that
the selected variables have a strong influence on the selected
responses “disintegration time, hardness and T50” of the ODTs.
The manufactured ODTs formula composed of 30.6 % dextrates
in combination with 4.2 % croscarmellose sodium was
chosen as optimized formula using multiple response optimization.
The predicted and observed values for the optimized
formula showed no significant difference which indicates the
validity of the experimental design. The optimized formula
showed a very significant lower disintegration time and T50
when compared to marketed conventional tablets. Also, it
was compared to pharmburstTM based formula and it showed
a significant higher disintegration time and lower hardness