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Modification of α-lactose monohydrate as a direct compression excipient using roller compaction.

Deeb Abu Fara1, Iyad Rashid2, Khouloud Alkhamis3

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Drug Development and Industrial Pharmacy
|August 11, 2018
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Summary

Roller compaction modifies crystalline alpha-lactose monohydrate, reducing its crystallinity and altering particle shape. This processed lactose exhibits direct compression excipient properties comparable to spray-dried lactose.

Keywords:
Co-processingcrystallinitydry granulationlactoseroller compactionspray dried lactosexrpd

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Direct compression is a preferred method for tablet manufacturing.
  • Lactose is a widely used excipient in direct compression.
  • Modifying lactose properties can enhance its direct compression performance.

Purpose of the Study:

  • To investigate the effects of roller compaction on crystalline alpha-lactose monohydrate.
  • To evaluate the suitability of roller-compacted lactose as a direct compression excipient.
  • To understand how process parameters influence lactose characteristics.

Main Methods:

  • Roller compaction of crystalline alpha-lactose monohydrate.
  • X-ray powder diffraction (XRPD) analysis to assess crystallinity.
  • Scanning electron microscopy (SEM) to examine particle morphology.
  • Comparison with industrial spray-dried lactose.

Main Results:

  • Roller compaction significantly reduced the crystallinity of alpha-lactose monohydrate.
  • The process altered particle morphology from torpedo-shaped to cylindrical with rounded edges.
  • Compaction pressure and repetition were key factors influencing crystallinity modification.
  • Roller-compacted lactose demonstrated behavior similar to spray-dried lactose as a direct compression excipient.

Conclusions:

  • Roller compaction is an effective method to improve the direct compression properties of crystalline alpha-lactose monohydrate.
  • The induced changes in crystallinity and particle morphology are beneficial for excipient performance.
  • Process parameters offer control over the modification of lactose characteristics.