Cellactose® 80 – 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 cellulose powder are functional excipients used in oral solid dosage forms. Both are naturally derived and well-established for use in the pharmaceutical industry. In an effort to create synergistic functional performance, such as improved compactability and mixing characteristics, co-spraydrying was used to integrate alpha-lactose monohydrate and cellulose powder into a monoparticulate system. Cellactose® 80 was developed to provide the flow and compaction properties necessary for direct compression tableting. Cellactose® 80 comprises 75 % alpha-lactose monohydrate and 25 % powdered cellulose, both maintaining their individual chemical identities.

Figure 2 shows typical laser diffraction particle size distribution data for Cellactose® 80. Cellactose® 80 possesses a narrow PSD that is effective in preparing homogenous powder blends, a prerequisite in achieving good tablet quality.

Figure 3 depicts the specified PSD range and typical average values by air-jet sieving. These parameters are constantly monitored through in-process control (IPC) testing and are part of the Cellactose® 80 particle size distribution specification.

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

Cellactose® 80 exhibits moderate moisture uptake under high relative humidity conditions due to the cellulose powder influence on the observed equilibrium moisture content (figure 5)