Pharmaceutical Technology: Controlled Drug Release, Volume 2

58 MATRIX FORMULATIONS [CH. 5
Pevikon PE 737 P (PVC) (SEPPIC) 45.9%
Magnesium stearate (Prophac) 1.0%
Talc USP (Prophac) 2.0%
For the wet granulation formulation, 2.12% Glucidex 2B (Roquette) was added as binder.
METHODS AND TESTS PERFORMED
The following responses (Yi) and properties were studied:
(1) the powder flow rate (Y 1 ), the cohesion index PS/TS (Y 2 ), the tablet weight variation (Y3), the
friability (Y 4 ), the amount of drug dissolved at 8 h (Y 5 ) and its coefficient of variation (Y 7 ), the
area under the dissolution curve AUC (Y 6 ) and its coefficient of variation (Y 8 );
(2) the volume before and after tapping (V10−V500), the lubrication index (R), the ejection force
(F e ), the residual force (F r ), the total energy (E t ) and the coefficient of variation of the applied
upper punch force (CV UPF);
(3) the compressibility factor (f), the plasticity index (PI) and the compressibility index (Comp);
(4) the porosity factor (f por ) and the flowability index (ic).
Optimization will concern the following aspects:
(a) the parameters of the mathematical models,
(b) the optimized responses and evaluated properties,
(c) analysis of the data and the statistical strategies,
(d) the dissolution profiles and the fitted physical models,
(e) the processes.
The parameters of the mathematical models
The applied upper punch force (UPF) exhibited a poor influence on several optimized responses.
Nevertheless, it is possible to observe that the increment of this parameter is related to adequate
values of the responses. In fact, the increase of UPF value (Table 1)
Table 1—Effect of the UPF increase on the optimized responses