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The effect of mixing time of magnesium stearate on crushing ...

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• Raman spectra<br />

Raman mapping<br />

Raman mapping – preliminary results<br />

1 min<br />

5 min<br />

• MCC<br />

0.8<br />

• MS<br />

80 l<br />

• Data processing<br />

0.7<br />

30 min<br />

CS/m<br />

0.6<br />

0.5<br />

13<br />

0.4<br />

0 20 40 60 80 100<br />

Mixing <str<strong>on</strong>g>time</str<strong>on</strong>g> (min)<br />

14<br />

C<strong>on</strong>clusi<strong>on</strong>s<br />

• MCC is sensitive to the strength reducti<strong>on</strong> <str<strong>on</strong>g>effect</str<strong>on</strong>g>s <str<strong>on</strong>g>of</str<strong>on</strong>g> MS<br />

and magnitude <str<strong>on</strong>g>of</str<strong>on</strong>g> this is dependent <strong>on</strong> the <str<strong>on</strong>g>mixing</str<strong>on</strong>g> <str<strong>on</strong>g>time</str<strong>on</strong>g><br />

• <str<strong>on</strong>g>The</str<strong>on</strong>g> <strong>crushing</strong> strength <str<strong>on</strong>g>of</str<strong>on</strong>g> the tablets exhibited a clear<br />

decrease as the <str<strong>on</strong>g>mixing</str<strong>on</strong>g> <str<strong>on</strong>g>time</str<strong>on</strong>g> was increased with all binary<br />

mixture batches tested<br />

• <str<strong>on</strong>g>The</str<strong>on</strong>g> negative <str<strong>on</strong>g>effect</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>mixing</str<strong>on</strong>g> <str<strong>on</strong>g>time</str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> MS was found to be<br />

slightly str<strong>on</strong>ger with the pilot-scale and producti<strong>on</strong>-scale<br />

batches than that observed with small-scale batches<br />

• Raman spectroscopy with optical microscopy can detect<br />

differences in the compressed tablets<br />

Discussi<strong>on</strong><br />

• M<strong>on</strong>itoring and learning about MS <str<strong>on</strong>g>mixing</str<strong>on</strong>g> is complicated<br />

• Tablets as sec<strong>on</strong>dary resp<strong>on</strong>se<br />

• Raman mapping<br />

• Binary mixture → more complex mass<br />

• MS c<strong>on</strong>centrati<strong>on</strong> is small → intensity <str<strong>on</strong>g>of</str<strong>on</strong>g> the peaks is low<br />

• <str<strong>on</strong>g>The</str<strong>on</strong>g> measurement and modeling parameters are crucial<br />

• Slow measurement<br />

• Resoluti<strong>on</strong><br />

15<br />

16<br />

4

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