Issue link: https://www.e-digitaleditions.com/i/1349974
Tablets & Capsules March/April 2021 45 Figure 1 Comparison of coated vitamin tablets using TiO 2 -free coating formulation (left) versus TiO 2 coating formulation (right) TiO 2 -free formulation (SheffCoat TF, Kerry) TiO 2 formulation (SheffCoat White, Kerry) 15 percent dispersion in water 15 percent dispersion in water 6 percent weight gain 3 percent weight gain 42°-44°C tablet bed temperature 42°-44°C tablet bed temperature able. Consult your internal regulatory group or coating manufacturer for further guidance. T&C Yasemin Koybasi is global regulatory and scientific affairs manager and Chris Venczel is global senior R&D manager for excipients at Kerry, a global supplier of excipients and coating solutions to the pharmaceutical and nutraceutical indus- tries (www.kerry.com/pharma). required a higher weight gain because the tablet cores were quite dark, while the TiO 2 coating required just 3 per- cent weight gain. Also, maintaining the same tablet bed temperature with a TiO 2 -free coating as you would with a TiO 2 coating, as we have done here is desirable. The different TiO 2 -free options Kerry has developed may also be used in combination with various pigments, allowing you to achieve any color you might need, but keep in mind that nat- ural pigments may not have the same stability as synthetic pigments, which may impact the product's shelf life. TiO 2 replacement change control When switching an existing drug product from a TiO 2 coating to a TiO 2 -free coating, the EU will likely consider it as a Type 1A change, having only a minimal impact, or no impact at all, on the product's qual- ity, safety, or efficacy. In the US, it's usually considered an annual report- to the production process (Kerry pro- vides this technical assistance free of charge). These are fully formulated dry powder dispersions that you just mix for approximately 45 minutes and then you're ready to coat. However, these formulas can be modified as needed to suit a particular application. Figure 1 compares tablets with a very dark core that have been coated using a TiO 2 -free coating on the left versus a TiO 2 coating on the right. The TiO 2 -free formulation contained calcium carbonate, hydroxypro- pyl methylcellulose (HPMC) as the polymer, medium chain triglycerides (MCT) as the plasticizer, and talc. Both coatings were applied at 15 percent solids with a tablet bed tempera- ture between 42° and 44°C. As the figure shows, the TiO 2 pro- vided a slightly brighter finish than the calcium carbonate. However, adding isomalt to the TiO 2 -free formulation would provide a brighter, whiter finish. Note that the TiO 2 -free coated tablets