MicroceLac® 100 – MEGGLE’s co-processed lactose grades 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 compactable 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

Alpha-lactose monohydrate and microcrystalline cellulose are functional excipients used in oral solid dosage forms. Both are naturally derived and commonly used in the pharmaceutical industry, either individually or in combination. To develop synergistic functional performance, such as increased compactability and powder flow, alpha-lactose monohydrate and microcrystalline cellulose were co-spray-dried, creating a monoparticulate system having two compaction mechanisms, brittle fracture and plastic deformation, within individual particles. MicroceLac® 100 provides the flow and compaction properties desired for direct compression tableting. MicroceLac® 100 comprises 75 % alphalactose monohydrate and 25 % microcrystalline cellulose (MCC), both maintaining their individual chemical identities.

Figure 2 shows typical laser diffraction particle size distribution data for MicroceLac® 100. MicroceLac® 100 possesses a narrow PSD that supports homogenous powder blend preparation, a requirement for achieving good tablet quality.

Batch-to-batch consistency

Batch-to-batch consistency for all lactose products can be attributed to MEGGLE’s long history and experience in lactose manufacture, and broad technical expertise. Constant in-process and final product testing ensures consistency and quality (figure 4).

Isotherms

MicroceLac® 100 exhibits moderate moisture uptake while exposed to high relative humidity conditions due to the MCC influence on observed equilibrium moisture content (figure 5).