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

Abstract

Roller compaction was used to prepare a direct-compressed lactose excipient using crystalline α-lactose monohydrate. The effect of various roller compaction process parameters (compaction pressure, compaction repetition, and speed ratio) on the characteristics of compacted α-lactose monohydrate was investigated. Results were compared with data obtained using industrial spray-dried lactose and lactose samples with different degrees of crystallinity. XRPD analysis revealed that roller compaction reduced the crystallinity of α-lactose monohydrate, and the resulting material is similar to spray-dried lactose in behavior as a direct compression excipient. Roller compaction introduced desirable characteristics to the raw α-lactose monohydrate by inducing changes in crystallinity and particle morphology. Scanning electron microscopy results indicated that the compaction process converted some of the original torpedo-shaped crystals of α-lactose monohydrate into a more cylindrical shape with rounded edges. Compaction pressure and repetition of compaction have a significant effect on the modification of the crystallinity of the processed, raw α-lactose monohydrate.

Keywords:

• Co-processing
• crystallinity
• dry granulation
• lactose
• roller compaction
• spray dried lactose
• xrpd

Acknowledgements

The authors would like to acknowledge the University of Jordan for their support through the sabbatical leave for Dr Abu Fara and the Jordanian Pharmaceutical Manufacturing Company (JPM) for providing their lab facilities.

Disclosure statement

No potential conflict of interest was reported by the authors.