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Modification of α-lactose Monohydrate as a Direct Compression Excipient Using Roller Compaction

Modification of α-lactose Monohydrate as a Direct Compression Excipient Using Roller Compaction

Deeb Abu Fara, Iyad Rashid, Khouloud Alkhamis, Mahmoud Al-Omari, B Z Chowdhry, Adnan Badwan

Drug Dev Ind Pharm. 2018 Dec;44(12):2038-2047.

PMID: 30095020

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
IAR42410230	D-Lactose-1-13C monohydrate			Price

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