DuraLac® H – MEGGLE’s anhydrous lactose grade for direct compression

General information

Direct compression (DC) tablet manufacture is a popular choice because it provides the least complex, most cost effective process to produce tablets compared to other tablet manufacturing approaches. Manufacturers can blend APIs with excipients and compress, making dosage forms simple to produce [1, 2].

DC technology and the use of modern tableting equipment require that excipients and APIs form a compactible mixture with excellent flowability and low particle segregation tendency [3].

In the pharmaceutical industry, lactose is one of the most commonly used excipients; however, like many other excipients, lactose may not be suitable for direct compression without modification due to insufficient powder flow or/and compaction properties (figure 1).

Product description

DuraLac® H is produced by roller-drying a lactose solution at high temperature to form anhydrous beta-lactose and alpha-lactose crystals at levels approximating 80 % and 20 %, respectively. During anhydrous lactose crystallization, no water is incorporated in the crystal lattice [4].

Subsequent to roller-drying, anhydrous lactose is milled and sieved to the desired particle size distribution, optimizing powder flow and compactibility. DuraLac® H complies with the monograph „Lactose, anhydrous“ (Ph. Eur., USP-NF and JP). Because DuraLac® H deforms by brittle fracture during compaction, it is well suited for directly  compressed and dry granulated formulations (roller compaction, slugging).