X1 (A)—level of disintegrant gelatinization (categorical) |
Partially gelatinized—Starch 1500 |
Fully gelatinized—Spress® B825 |
X2 (B)—tablet compression force (Pmax) (numerical) |
12 kN |
16 kN |
X3 (C)—speed of granulator after roller compaction (numerical) |
50 rpm |
25 rpm |
X4 (D)—roll pressure (dry granulation) (numerical) |
80 bar |
140 bar |
X5 (E)—API particle size (categorical) |
Cipro unsieved (d(0.5) = 15.47 μ) |
Cipro sieved (d(0.5) = 8.87 μ) |
X6 (F)—source/supplier of lubricant (categorical) |
Vegetable source—Covidien |
Animal source—Spectrum |
X7 (G)—filler particle size (numerical) |
Avicel PH 102 (90 μ) |
Avicel PH 101 (50 μ) |
X8 (H)—binder grade (hydroxypropyl cellulose) (categorical) |
Low viscosity and small particle size—Klucel® EXF |
Medium viscosity and larger particle size Klucel® JF |
X9(J)—ratio of roll speed to feed screw speed (numerical) |
Ratio = 5 (35/7) |
Ratio = 7 (49/7) |
X10(K)—blending time (API/excipient blend + lubricant blend + extragranular blend) (numerical) |
5 + 2 + 2 min |
20 + 2 + 2 min |
X11(L)—glidant level (numerical) |
No aerosil (0%) |
Aerosil (0.25%) |