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Tablets & Capsules April 2020 13 ers with a perforated drum type specifically designed for multiparticulate oral solid dosage forms. Minitablet production and testing For the study, researchers produced 2.5-millimeter diameter placebo minitablets on an IMA Prexima 300 rotary tablet press. The tablet press used a standard feeder system equipped with flat paddles rotating at 40 rpm. The placebo formulation was supplied by Meggle and contained lactose monohydrate, cellulose, aluminum oxide, and magnesium stearate as lubricant. The minitablets were compressed at 7 kilonewtons main compression force and tested for uniformity of mass, friability (Roche friabilator), and crushing strength (Erweka), and their surface characteristics were observed by scanning electron microscopy (FEI ESEM Quanta 200). The tableting process yielded smooth, stable mini- tablets that weighed 13 milligrams and had a hardness of 30 newtons and a friability below 0.1 percent—ideal characteristics for coating. Achieving this level of quality required careful config- uration of the tablet press feeding system. The research- ers tested different feeder paddle shapes and determined that standard paddles delivered the best tablet weight consistency. Once the feeding system was defined, the researchers carefully adjusted the punch penetration into the die bores to ensure adequate tablet strength in all minitablets produced. Because the parameters were opti- mized, the process performed best at the highest turret speed possible—90 rpm. Coating formulation A taste-masking coating formulation was prepared using a combination of Surelease (Colorcon) and Opadry (Colorcon), which are both well-known, fully formulated, and pH-independent aqueous polymers. Surelease con- tains ethyl cellulose, which is insoluble in water and acts as the taste-masking agent by delaying the release of the ric patients, who tend to experience difficulty swallowing large tablets or capsules. Minitablets usually provide a more reliable in vivo dis- solution performance and a higher degree of dispersion in the gastrointestinal (GI) tract than single-unit dosage forms. This can result in more consistent dose-to-dose bioavailability and clinical effect, with a lower risk of dose dumping. Minitablet production has fewer constraints than extrusion and spheronization, which is used to create multiparticulate pellets. When manufactured using direct compression (DC) (as opposed to granulation or extru- sion and spheronization), minitablet production is a sin- gle step, which can result in low manufacturing costs and high production yields. Additionally, DC tableting does not require the use of liquids, which makes minitablets an attractive alternative to pellets. Minitablets can be also coated and combined to achieve various drug release profiles within a single dosage form, allowing for easier and more successful treatment of dis- eases that require a multi-target therapy approach. Film coating minitablets As with traditional tablets, film coating of minitablets provides several advantages, including: • masking unpleasant tastes or odors; • improving swallowability; • helping to positively impact patient preference; • differentiating the product's visual appearance to minimize dispensing errors; • improving packaging efficiency; • preventing cross contamination; and • reducing tablet breakage and chipping during manufacture. Most pharmaceutical drug substances have a moder- ately to highly unpleasant taste that can range from a lin- gering chemical taste to harsh bitterness. As a result, taste masking has become a necessary process step for many drug products, and manufacturers have developed differ- ent technical approaches for various dosage forms and drug substances. Taste masking is particularly important for patient adherence in the pediatric field, especially if the taste-masking polymer also eases the product's swallowability. Until recently, manufacturers have primarily used flu- id-bed processes rather than drum coaters to taste mask minitablets. However, drum coating can have several advantages over fluid-bed coating, including higher pro- duction capabilities, reduced coating-material waste, and faster equipment cleanup. Drum coating of minitab- lets is usually performed using a solid drum, but a perfo- rated drum increases the air volume moving through the machine and can improve performance. The following study evaluates a minitablet production process, including compression in a rotary tablet press, formulation of a taste-masking coating, and coating appli- cation feasibility in pilot- and production-scale drum coat- Table 1 Coating formulation for both pilot- and production-scale batches Parameter Pilot Production Pan load (kilograms) 23 82.50 Theoretical weight gain (%) 10 10 Solids concentration (%) 12 12 Opadry 03K19229 (kilograms) 0.46 1.65 Surelease E-7-19020 (kilograms) 7.36 26.4 Water (kilograms) 11.347 40.7 Total quantity to be applied (kilograms) 19.167 68.75