Microsoft Word - Jason Dawes

نویسندگان

  • Jason Dawes
  • John Gamble
  • Mike Tobyn
  • Phillip Robbins
  • Richard Greenwood
چکیده

Roller compaction is a dry granulation technique used in the pharmaceutical industry, in which a powder formulation is compressed into a ‘ribbon’ compact between two counter rotating rolls. The ribbon is subsequently milled into granules of a desired size range. Whilst simple in principle, successful control of a roller compaction process is often difficult as it is multivariate in design. Further complicating the process is the ‘ad hoc’ addition of magnesium stearate. Magnesium stearate is commonly used in formulations as a lubricant to reduce frictional forces during tabletting. However, inclusion of magnesium stearate within a formulation can have adverse effects on the final product, such as; ▫ formation of a hydrophobic film ▫ reduction in tablet strength ▫ interaction with some drugs The extent of these effects is related to the degree of magnesium stearate coverage on the surface of a host particle. As such the general strategy employed during pharmaceutical tablet manufacture is to limit the amount of mixing of the formulation with magnesium stearate, see Figure 1, such that magnesium stearate is not homogenously mixed. As a result of this inhomogeneity of magnesium stearate in the blend it is difficult to ensure reproducible lubricty. More over the extra mixing that can occur during further downstream processing is likely to increase the degree of surface coverage and hence accentuate the deleterious effects.

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تاریخ انتشار 2011