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www.techceuticals.com Solid Dosage Training, Troubleshooting, and Problem Solving Since 1989 Operator & Supervisor Training Your facility or ours • Formulating • Granulating • Tabletting • Blending • Coating • Packaging Get RESULTS! 44 May 2016 Tablets & Capsules SEDDS pre-concentrate containing an optimized mixture of functional lipids, which form an emulsion upon dilution with GI fluids. The development of a SEDDS pre-concentrate focuses on optimizing API solubility in the SEDDS while still generating a stable micro-emulsion that increases API aqueous solubility. Both neat lipid for- mulations and SEDDS formulations can be loaded in either soft or hard capsules for oral administration. Additionally, SEDDS pre-concentrates are candidates for loading in or on vari- ous multi-particulate systems for incor- poration into hard capsules or tablets. Furthermore, lipid-based excipients are being used in a variety of new areas of drug delivery, ranging from spray congealing for solid oral dosages to the application of nano-structured lipid carriers for the non-invasive delivery of macromolecules. The ver- satility and functionality of the lipid excipients available today provides drug formulators with numerous options and capabilities to address and overcome many historic delivery and performance challenges. While there is an ongoing requirement to further understand the physical and chemical stability of various API classes within lipid-based systems, it is clear that lipids will play an expanding and piv- otal role in enhancing bioavailability of poorly soluble NCEs. T&C References 1. Pouton, Colin W. Lipid formu- lations for oral administration of drugs: non-emulsifying, self-emulsi- fying, and "self-microemulsifying" drug delivery systems. Eur. J. Pharm. Sci. 11 Suppl. 2. 2000, S93-S98. 2. Prajapati, Hetal N. et al. Effect of difference in fatty acid chain lengths of medium chain lipids on lipid-surfactant-water phase diagrams and drug solubility. J. Excipients and Food Chem. 2 (3). 2011, 73-88. 3. Keown P. and Niese D. Cyclo - sporine microemulsion increases drug exposure and reduces acute rejection without incremental toxicity in de novo renal transplantation. Kidney Int. Sep 54 (3). 1998, 938-944. 4. Prajapati, Hetal N. et al. In vitro dispersion test that could serve as a predictive method for assessing performance of lipid-based drug delivery systems. J. Excipients and Food Chem. 4 (4). 2013, 111-125. 5. Patil, H. et al. Continuous pro- duction of fenofibrate solid lipid nanoparticles by hot-melt extrusion technology: a systematic study based on a quality by design approach. The AAPS Journal. (17) 1. 2015. 6. Almeida, AJ and Souto E. Solid lipid nanoparticles as a drug delivery system for peptides and proteins. Adv. Drug Deliv. Rev. (59) 6. 2007, 478-490. John K. Tillotson, R.Ph., Ph.D., is pharmaceutical technical business direc- tor at Abitec, 501 West 1st Avenue, Columbus, OH 43215. Tel: 614 429 6464. Email: jtillotson@abiteccorp.com. His research areas include functional lipids, SEDDS system development, and direct-compression tabletting.