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Tablets & Capsules July 2015 13 starter pellets with a narrow particle size distribution that begins at 100 microns. Wax. Wax-based pellets—often made from carnauba wax—include C-Wax from Pharmatrans Sanaq. They provide a hydrophobic core and are manufactured by prilling, a process that can produce a range of particle sizes. For this material, 850 to 1,250 microns is typical, but smaller sizes are possible. Melting points are 80° to 87°C. Silicon dioxide. Silica-based pellets contain a mini- mum of 75 percent colliodial silicon dioxide. The prod- ucts offered by Idealcures of India are described as hard, low-friability, and free-flowing spheres with uniform par- ticle sizes of 250 to 1,680 microns. Information about the process used to make them was not available. Functional starter pellets As mentioned earlier, functional starter pellets are the opposite of neutral starter pellets: They are intended to interact with the API and thereby achieve the targeted drug release profile. It is possible to use acidic or basic carriers, but we'll limit our discussion to tartaric acid pel- lets. Acid pellets have been used to modulate the micro- environmental pH and thereby enhance API solubility. Examples include verapamil HCl, propiverine HCl, papaverine, and dipyridamole. Tartaric acid. These pellets are used in sustained- release formulations, where they act as pH-modifiers of weakly basic APIs. Typically, the pellets are layered with the API to improve its solubility in a relatively higher pH environment, such as the lower GI tract. Once there, the highly soluble tartaric acid dissolves, decreasing the pH and facilitating API dissolution. Tartaric acid pellets can be manufactured using a coat- ing pan or a continuous fluid-bed granulator, and the lat- ter is used to make the TAP pellets offered by Pharmatrans Sanaq. The resulting product is highly spherical and has a narrow particle size distribution between 200 and 800 microns. Conclusion The large variety of excipients used to manufacture starter pellets has enabled formualtors to develop new methods of delivery. While sugar spheres remain the standard for multiparticulate formulations, their contin- ued dominance is not a foregone conclusion. In fact, alternatives—including functional cores—are likely to grow as specific and innovative solutions are sought to overcome different formulation challenges. At the same time, process techniques have evolved beyond the well- known extrusion-spheronization and granulation tech- nologies. These newer processes provide a reliable means of manufacturing API-matrix and pure API pellets. T&C References 1. Pöllinger, Norbert. Pellet Power. Pharmaceutical Manufacturing and Packing Sourcer, Spring 2011. 2. Godek, Ed. Comparing drug layering and direct pelletization processes. Pharmaceutical Technology 38:3. March 2014. 3. Jensen, Brian. Back Page: Economical multiparticu- lates. Tablets & Capsules, 11:3. April 2013, p. 48. Philippe Tschopp is head of sales and marketing at Ingredient Pharm, Kraftwerkstrasses 6, 4163 Pratteln, Switzerland. Web- site: www.ingredientpharm.com. He is also head of business development at Glatt Pharmaceutical Services and served for 12 years as chief executive officer of Pharmatrans Sanaq. Scanning electron micrograph of Beneo-Palatinit's GalenIQ 960 isomalt pellets at 40X magnification. 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! Courtesy of Beneo-Palatinit