7.2 Optimization of Megaloporous Matrix system: 7.3.

1 Experimental design A full factorial 23 design was used for optimization procedure. It is suitable for investigating the responses of disintegrants and release retardant on onset of action and sustained release of drug. Mathematical modeling, evaluation of the ability to fit to the model and response surface modeling were performed with employing Design-Expert software. The studied factors (independent variables) were percentage weight of Sodium starch Glycolate, Cross povidone, and HPMC. Preliminary studies provided a setting of the levels for each formulation variable. The responses (dependent variables) were cumulative % drug released in 2 hrs and Cumulative % drug released in 12 hrs. Table 7.2 summarizes the independent and dependent variables along with their levels.

Table 7.2: Experimental design: factors and responses Factors (Independent variables) -1 +1 Levels Responses (Dependent variables)

X1 = % of Sodium starch glycolate

5%

8%

Y1= onset of action,

X2 = % of Cross povidone

10%

15%

Y2 = cumulative % drug released in 2 hrs

X2 = % HPMC

12.5%

15%

Y3 = Cumulative % drug released in 12 hrs

Table 7.3: Formulation Design of Megaloporous tablet system Ingredients HMG Ketoprofen Cross povidone Sodium starch Glycolate Lactose Talc RMG Ketoprofen 100 100 100 100 100 100 100 100 100 18 20 23.75 8 100 20 24 19.75 8 100 22 20 16.60 8 100 22 24 11 8 100 22 20 21 8 100 25 24 16 8 100 25 20 14.5 8 100 25 24 12 8 KF-1 (mg) KF-2 (mg) KF-3 (mg) KF-4 (mg) KF-5 (mg) KF-6 (mg) KF-7 (mg) KF-8 (mg)

HPMC Lactose Polyvinyl Pyrrolidine (% w/v) Talc Magnesium Stearate

23.75 23.75 10 8 7

19.75 18.12 10 8 7

16.60 14.6 10 8 7

11 9 10 8 7

21 19 10 8 7

16 13.7 10 8 7

14.5 10.2 10 8 7

12 5 10 8 7