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7 MEGGLE | Co-processed lactose CombiLac ® Disintegration Co-processed CombiLac ® vs. physical admixture Disintegration time (s) 250 0 0 250 Tablet hardness (N) CombiLac ® Physical admixture Disintegration Co-processed CombiLac ® vs. MicroceLac ® 100 and StarLac ® Disintegration time (s) 3000 0 0 350 Tablet hardness (N) CombiLac ® MicroceLac ® 100 StarLac ® Disintegration CombiLac ® is ideal when rapid disintegration at high tablet hard- ness is desired. CombiLac ® 's disintegration is quick and indepen- dent of tablet hardness. A co-processed excipient consisting of lactose and MCC shows a significant disintegration time depen- dence on tablet hardness, challenging the limits of immediate release formulations. Corn starch, as a traditional disintegration agent, may be helpful by ensuring rapid water uptake, either in a classical physical admixture or incorporated in a co-processed excipient (CombiLac ® , StarLac ® ), but at the expense of tablet hardness. In CombiLac ® high tablet hardness and low disintegration time have been balanced (Figure 10, 11). Packaging and shelf life Packaging material complies with Regulation (EC) No. 1935/2004 and 21 CFR 174, 175, 176, 177 and 178. Stability tests have been performed according to ICH guidelines and an ongoing stability program is implemented. Figure 12 provides an overview about packaging size, -material and product shelf life. Figure 12: Packaging and shelf life of MEGGLE's CombiLac ® . Figure 10: Tablet disintegration of CombiLac ® , MEGGLE's triple co-processed excipient compared to the corresponding physical admixture (spray-dried lactose grade FlowLac ® 100, MCC 102, and pregelatinized DC starch grade Starch ® 1500). Tablets were produced using a tablet press IMA Styl'One 105 ML, with a tablet diameter of 11.3 mm, and a weight of 500 mg, 0.5 % Mg-stearate. Figure 11: Tablet disintegration of CombiLac ® compared to the co-processed excipients MicroceLac ® 100 (75 % alpha-lactose monohydrate and 25 % MCC), and StarLac ® (85 % alpha-lactose monohydrate and 15 % native corn starch). Tablets were produced using a tablet press IMA Styl'One 105 ML, with a tablet diameter of 11.3 mm, and a weight of 500 mg, 0.5 % Mg-stearate. 100 100 50 50 150 150 200 200 250 300 Packaging and shelf life Size Material Shelf life CombiLac ® 20 kg Carton box with PE-EVOH-PE-inliner 24 months 150 2500 2000 1500 1000 500 100 50 Literature [1] Meeus, L. (2011). Direct Compression versus Granulation. Pharmaceutical Technology, 23 (3). [2] Kristensen, H. G., & Schaefer, T. (1987). Granulation: A Review on Pharmaceutical Wet-Granulation. Drug Develop- ment and Industrial Pharmacy, 13 (4 – 5), 803 – 872. [3] Mîinea, L. A., Mehta, R., Kallam, M., Farina, J. A., & Deorkar, N. (2011). Evaluation and Characteristics of a New Direct Compression Performance Excipient, 35 (3). MEGGLE App: MEGGLE warrants that its products conform to MEGGLE's written specification and makes no other expressed or implied warrantees or representations. For any specific usage, the determination of suitability of use or application of MEGGLE products is the sole responsibility of the user. The determination of the use, application, and compliance of this product with regard to any national, regional, or local laws and/or regulations is the sole responsibility of the user, and MEGGLE makes no representation with regards to same. Nothing herein shall be construed as a recommendation or license to use the product or any information that conflicts with any patent or intellectual property of MEGGLE or others and any such determination of use is the sole responsibility of the user. © MEGGLE HEAD OFFICE GERMANY: www.meggle-pharma.de service.pharma@meggle.de Phone +49 8071 73 476 MEGGLE USA: www.meggle-pharma.com customer.service@meggle.com Phone +1 844 4MEGGLE (+1 844 463 4453)