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

Mixtures <strong>of</strong> MCC and MS
• Microcrystalline cellulose (MCC) is widely use excipient in
pharmaceutical industry and its properties are well known
Materials - Methods
• Binary mixture <strong>of</strong>
• Microcrystalline Cellulose 99% (w/w)
• Magnesium Stearate 1% (w/w)
• MCC is sensitive for lubricant because it is a plastic
material
• Mixture <strong>of</strong> MS and MCC is example <strong>of</strong> ordered mixture as
MS covers the MCC particles
• Stable and segregation is hindered
• Three scales
• Laboratory (1 l), pilot (10 l), production
(80 l)
• Mixing <strong>time</strong>s
• 1, 2, 3, 5, 10, 30, 60 and 90 min
• Other variables were set as constant:
• the powder loading in the container
• the rate <strong>of</strong> rotation (48 rpm)
• the relative humidity
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Reference method
Methods - Analyzing the tablets
• <strong>The</strong> monitoring and measuring the lubricant <strong>mixing</strong> is a
very challenging task which is not solved yet
• <strong>The</strong>re are no valid method to measure primary response
in the lubricant <strong>mixing</strong> process
• Scanning electron microscopy (SEM)
• Energy Dispersive X-ray Analysis (EDX)
• Raman mapping
→ Secondary reference method
• <strong>The</strong> crushing strengths <strong>of</strong> tablets were selected as a
secondary reference for lubrication monitoring
• <strong>The</strong> crushing strength with an indirect diametral
compression tester
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