Issue link: https://www.e-digitaleditions.com/i/525960
4 MEGGLE | Co-processed lactose CombiLac ® Particle size distribution (PSD) Figure 2 shows typical laser diffraction particle size distribution data for CombiLac ® . The narrow PSD supports homogenous powder blend preparation, an important requirement in tableting manufacture. Figure 3 depicts the specified PSD range and typical average values by air-jet sieving. These parameters are constantly moni- tored through in-process-control (IPC) testing and are part of the CombiLac ® particle size distribution specification (Typical values shown for orientation only). Figure 2: Typical cumulative PSD and distribution density of MEGGLE's CombiLac ® . Analyzed by Sympatec ® /Helos & Rhodos Particle size analyzer. Figure 3: Specified PSDs for CombiLac ® by air jet sieve in bold letters. Typical values obtained from a permanent in-process-control are shown for orientation. Core benefit CombiLac ® is highly appropriate for DC, as it synergistically com- bines the benefits of its individual components through intelligent particle design. The monoparticulate structure of CombiLac ® clearly outperforms the physical blend in flow, hardness, and disintegra- tion performance. Typical particle size distribution (Laser diffraction) CombiLac ® – co-processed grade, cumulative PSD Cumulative distribution Q3(x)/% 100 90 80 70 60 50 40 30 20 10 0 1 10 100 1000 Particle size (µm) Typical particle size distribution (Laser diffraction) CombiLac ® – co-processed grade, distribution density Distribution density q3lg(x) 2.2 0 1 10 100 1000 Particle size (µm) 2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 Sieve data – co-processed lactose Lactose type CombiLac ® specified/typical Particle size distribution Method: Air jet sieving < 32 µm NMT 15 %/5 % < 160 µm 35 – 65 %/56 % < 250 µm NLT 85 %/93 % Core benefit of CombiLac ® CombiLac ® MicroceLac ® 100 StarLac ® Flowability ++ ++ ++ Compactibility +++ +++ ++ Tablet hardness ++ +++ + Tablet disintegration ++ + +++