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From Tablets & Capsules April 2007

www.nicomac.com

tablet coating
Some advantages of non-perforated coating pans
Francesco Nigris Nicomac

This article briefly describes some advantages of using nonperforated pans to coat tablets and pellets.

ost tablet coating systems in the pharmaceutical industry use perforated coating pans, and most pellet manufacturing (pellet coating) systems use fluid-bed processors, which mix, moisten, and agglomerate powders or apply successive layers of API to a core (powder layering). This article describes how non-perforated coating pans (also called solid-wall pans) can improve tablet coating and powder layering operations.

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passing through the help ease the switch from perforated to non-perforated product bed and thus drying the coating. their airflow can photo on page 41 shows one type of baffle [5] that offers interfere with spray patterns. the product. The humid air pans. It is notoriously by creating a different system to blow and exhaust air difficult to switch coating systems after registration and. many of the fool-proof: High-velocity airflow occasionally caused products and processes registered with the FDA have referproducts to stick to the sword surfaces. non-perforated pans were well suited to applying sugar coatings and organic solvent-based coatings. the new technology wasn’t atile organic compounds. taking into account their shape and mixing efficiency . and the introduction of inject air and one to exhaust air. low volumes of air circulated through the mouth of the pan in an open environment. air enters the able air guide comprising two concentric tubes. Tablet coating systems with perforated pans role in mixing the product and thus they influence how use large volumes of air for high-efficiency drying and uniformly the system coats and dries the product. and atomizing air (as well as pan. coating solutions. installations. one for pan enclosure. the industry perceived that the pans were limited to these applications and. equipment manufacturers began building coating systems that used perforated pans. The systems consumed little air and energy. As a result. exposing each side of the product to pronon-rotating section. They were a good choice for applications where controlling cost was important. With so many difthey cannot easily coat different products and batch sizes. the high cost of explosion-proof This mixing baffle [5] has a unique shape that offers gentle yet efficient mixing in a non-perforated pan. mainly because they were not suitable for applying aqueous coatings or for processing hydroscopic products. which require high drying efficiency. equipment manufacturers created systems that added “immersed swords. One system [1] used two swords. At the same time. Another system [2] the Clean Air Act and its amendments in the early 1990s. As in perforated pans. The provide repeatable results. injected air from the back of the pan and exhausted it Those laws mandated a reduction in the emissions of volthrough the swords. which became necessary in the 1980s to account for that volatility. which maximizes the rate of coating applicaFurthermore. It since perforated pans could coat large volumes of product. through a high-volume air diffuser-exhauster [3]. the pan can rotate quickly without damaging sure that each perforation is clean inside and underneath. the pans lack flexibility in the sense that tion and thus shortens processing time. the pans fell out of favor. Baffle design and configuration play a (lower left).” which are perforated diffusers. one to Perforated pans Perforated pans became popular when pharmaceutical manufacturers switched from organic solvent-based coatings to aqueous coatings. However. divided the back of the pan into rotating and non-rotatperforated pans became dominant. The switch was a natural response to the volatility of organic solvents. baffles are important in the pan’s circumference. However. to be routed through the the pan rotates. and the pan perforations gentle yet efficient mixing due to its unique shape. Furthermore. Today’s non-perforated pans To improve the drying and heat exchange that non-perforated pans provide. as coating processes evolved.com While perforated pans are popular today. You can use SUPAC [4] to (upper right) and flows diagonally. spray guns apply the coating to the product while wires connecting to sensors). typically from the 45-degree position inlet air and one for exhaust air. However. allowing all the ducts and hoses supplying In a typical film coating operation with a perforated drying air. the first coating systems used non-perforated pans. Since that time. enced coating systems that use perforated pans. The design also included an adjustmote coating uniformity. often at the 225-degree position non-perforated pans. evaluate them carefully.nicomac. If mixmake them difficult to clean because you can never be ing is gentle. that results then exits the pan through the perforations in Baffles. As the pan rotated. because neither required high volumes of air. and the smooth pan surface was easy to clean. ferent types of mixing baffles available.From Tablets & Capsules April 2007 www. then the My company sought to improve non-perforated pans best technology to apply aqueous coatings. ing sections.

07 milligrams. the more quickly and efficiently the system dries the cannot perform that process because the small powder product. since perforated pans port.gov/cder/guidance/supac.htm.when you analyze 10 rpm. the closer the product is to the air-induction lar comparison for the second trial. After coating. my company conducted two trials in a lab-scale coater [6]. After coating. T&C size doesn’t strongly influence product loss or air usage. for tablet coating and fluid-bed processors for pellet manuAnother advantage of non-perforated pans is their abilfacturing. non-perforated aqueous films. all other factors been as high as 15 percent. out modifying the equipment. Air turbu. References which should have a product volume large enough to 1. and batch and higher accuracy than fluid-bed processors. a batch to evaluate 16 percent gain. Norof 415-milligram tablets. Using an adjustable air-induction port that is particles would be lost through the perforations. rounder pellets. highly viscous solutions (such as sugar pans provide better coating uniformity. non-perforated pans are easy to clean Changes (SUPAC) of immediate-release solid oral dosage (including WIP) and allow you to coat and polish prodforms. The process lasted 65 minutes. and inlet-air conduct a test by temperature was adding tablets of a 50°C. A previous version of Nicomac’s coating system cover the perforations in the swords. wood. ture was 70°C. You can also 36°C. Tel. For powder layering.fda. 80 Oak Street. The exception is coating pans with immersed swords. They can also apply and cleaning is easier. fax 201 768 9504. while prodthe overall coating uct temperature was system. They are also generally cheaper SUPAC is designed to lower the regulatory burden assothan systems that use perforated pans and cheaper than ciated with alterations in components and composition. manufacturing site. we conducted the proportional to the tablet coating trial product’s distance from the air-induction port (also known using a perforated pan. FDA guidance for Scale-Up and Postapproval forated pans. and manufacturing (process and equipment) of a marketed product. and total product loss was 3 percent. a mem427. and powders. a gain of 2.949 kilograms. First trial. E-mail: while product temperature was 42°C. tals to 50-millimeter-diameter chewing gum cores) withDrying efficiency is comparable to that of perforated pans. ber of the International Society for Pharmaceutical Engineering Second trial. syrup). different color to an the batch weighed existing rotating 26.9 percent.com. 201 768 9501. today’s non-perforated pans offer greater flexibility to coat virtually any size of product (from sugar crysity than before thanks to better baffles and air systems. Website: www. Nicomac coating system little as 15 percent of maximum capacity. In this trial.coatingnicomac. The how efficiently the process lasted 186 baffles mix the minutes.com. IMA GS coating system antees satisfactory performance at batch sizes that use as 3. scale-up or scale-down. NJ. percent. It’s impossible to make a simibeing equal. In other words. My company guar2. product loss would likely have as the blowing point). and total product. ucts in the same vessel. and president of the company since 1991. Another factor that The small prodinfluences how uct losses in these quickly and thotrials show that roughly a coating most of the material system can dry a dosed into the product is air turbuprocess coated the lence. centered over the product bed gives you precise control Conclusion over air direction and lets you select the point at which Although the industry has long favored perforated pans the air contacts the product. Had lence is inversely system to transfer powder into the pan.160-kilogram since 1991. batch of sugar spheres with ibuprofen. The pan rotated at 8 to 10 rpm. And unlike per4. In this trial. Coating examples 5. The pan rotated at . we coated a 23. product loss was 2 Air turbulence. 3D Nicomac shark fin baffles To demonstrate some of the advantages of non-perfo6.Powder layering in a perforated pan requires a dosing screw to dose powder and a pneumatic tablet or pellet. Batch size is also flexible. See www. A 50-kilogram Nicomac LAB 50 rated pans cited in this article. we coated and dried 40 kilograms Francesco Nigris is president of Nicomac. the average tablet weight was He has been in the pharmaceutical industry since 1987. and inlet air temperatcarticle@nicomac. fluid-bed processors.