StarLac – 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 maize starch (corn starch) are functional excipients used in oral solid dosage forms. Both are naturally derived and well established in the pharmaceutical industry. Lactose is frequently used as a diluent or direct compression binder. Starch can be used as a binder for wet or dry applications, disintegrant, and diluent. In an effort to establish synergistic functional performance, such as enhanced compactibility and faster tablet disintegration, lactose and starch were co-spray-dried to form a monoparticulate system. StarLac® comprises 85 % alpha-lactose monohydrate and 15% native maize starch. StarLac® provides compaction and lubricant insensitivity characteristics desired for direct compression, and the hydration properties desired for rapid API release. Additionally, StarLac®’s flowability is superior compared to a physical blend of the individual components in equivalent ratio.

Figure 2 shows typical laser diffraction particle size distribution data for StarLac®. StarLac® possesses a narrow PSD that supports homogenous powder blend preparation, essential for 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 StarLac® particle size distribution specification.