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Granulation with Dow Cellulosic Polymers II. High Shear Granulation

Granulation with Dow Cellulosic Polymers II. High Shear Granulation

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products; the amount of fines was<br />

about 25% at the lower binder level.<br />

Increasing binder causes a small<br />

decrease in the 20 mesh material,<br />

but a significant increase in the 40<br />

and 60 mesh granules at the expense<br />

of the fines. In other words,<br />

METHOCEL K3P LV showed a<br />

somewhat more classical shift in PSD<br />

<strong>with</strong> binder level.<br />

The PSD of the HPC products were<br />

very similar (Figure 38). Here,<br />

increasing binder concentration<br />

caused a decrease in the quantity of<br />

granules < 80 mesh, but gave a very<br />

large fraction that was retained on 40<br />

mesh screen.<br />

The performance of PVP (K29-32)<br />

(Figure 39) was unusual in that upon<br />

increasing the binder level, all of the<br />

sieve fractions except that retained on<br />

20 mesh and the fines remained the<br />

same. At 6%, there was less material<br />

at 20 mesh and more fines than at<br />

3% binder. The PVP (K90) also<br />

showed an increase in fines at the<br />

higher binder level. Finally, Figure 40<br />

compares the PSD for METHOCEL<br />

K3P LV and PVP (K29-32), two<br />

binders that will be further compared<br />

later in this section.<br />

Tablet Physical Properties<br />

The hardness and friability values of<br />

the methazolamide tablets<br />

compressed at 2000 lbs. total<br />

compression force are given in Table<br />

10. For both measurements, 20<br />

tablets were used; the reported<br />

friabilities are those after 4 minutes in<br />

a Roche friabilator.<br />

Acceptably hard tablets were<br />

produced <strong>with</strong> all binders, <strong>with</strong> the<br />

possible exception of METHOCEL<br />

E15P LV, having values ≈ 6 SCU (but<br />

note the % friability). For the<br />

METHOCEL products, the hardest<br />

tablets by a fairly wide margin were<br />

produced when METHOCEL K3P LV<br />

at 3% was utilized. In fact, for 3 of the<br />

5, the tablets at 3% were softer from<br />

a statistical standpoint; only for<br />

<strong>High</strong> <strong>Shear</strong> <strong>Granulation</strong>: Methazolamide Model<br />

23

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