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

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.