Issue link: https://www.e-digitaleditions.com/i/525960
5 MEGGLE | Co-processed lactose CombiLac ® Isotherms CombiLac ® 's moisture sorption isotherms at 20 °C exhibit a moderate water uptake due to the MCC and corn starch content, as shown by dynamic vapor sorption (DVS). Increase and subse- quent decrease of equilibrium moisture content demonstrates hysteresis (Figure 4). Sorption isotherm (Dynamic vapor sorption at 20 °C) CombiLac ® Weight change (%) 7.0 0.0 0 20 40 60 80 100 Relative humidity (%) Sorption Desorption Figure 4: CombiLac ® 's moisture sorption isotherms at 20 °C. Moisture uptake is driven by MCC and corn starch and is proportional to the surrounding atmosphere. Analysis performed by SPSx-1µ moisture sorption test system. 6.0 4.0 5.0 3.0 2.0 1.0 Figure 5: SEM of MEGGLE's triple co-processed excipient CombiLac ® . Scanning electron micrograph (SEM) MEGGLE's triple co-processed excipient, CombiLac ® , appears as a white, or almost white, odourless powder. It is a spray-dried composition of 70 % alpha-lactose monohydrate, 20 % MCC, and 10 % GMO-free, white, native corn starch, where each component meets Ph.Eur., USP-NF, and JP compendial standards. It is freely flowing and partially soluble in cold water. A well-defined production process generates a porous, spherical morphology. Although triple in composition, it is monoparticulate structurally. CombiLac ® 's SEM demonstrates the conversion of the irregularly shaped lactose, MCC and corn starch particles into a highly spherical, integrated system (Figure 5). The individual components cannot be separated by physical means. Flow and compaction performance is improved in comparison to a simple physical admixture of the individual ingredients. Morphology of irregularly shaped lactose, MCC and corn starch is adjusted to the particle requirements needed for excellent flow and compaction performance in DC. CombiLac ® 800 µm