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40 March 2019 Tablets & Capsules eye on Federica Giatti, and Caterina Funaro IMA Active Vera Fichtner and Franz Penz Meggle excipients This edition of the column describes a study conducted to measure the tableting performance of vitamin B 2 and C mini- tablets using lactose-based excipients. Mini-tablet use continues to grow as an accepted option for small-vol- ume, high-value products, especially for specific patient populations. Mini-tablet applications, as either single- or multi-tablet units, allow for fixed-dose combinations and dose titrations [1]. Because of their small size (typically less than 3.0 millime- ters in diameter), mini-tablets also offer an approach for populations that have difficulty swallowing tradi- tional tablets and capsules, such as pediatric and geriatric patients or patients suffering from dysphagia. This article describes a study that was designed to demonstrate experi- mental design, equipment feasibility, lactose-based excipient performance, and critical material attributes within a typical mini-tablet manufacturing operation. Example formulations were chosen to investigate compac- tion and release performance, as well as the impact of particle size using two different active pharmaceutical ingredients (APIs) and three func- tional excipients. Each formulation consisted of a powder blend compris- ing 10 percent API, 89 percent excip- ient, and 1 percent lubricant. Materials and methods The materials used in the study are listed in Table 1. Vitamin B 2 (ribofla- vin) and vitamin C (ascorbic acid) were chosen as the APIs for handling and functionality reasons. Table 2 shows the laser-diffraction parti- cle-size-analysis data for the APIs. The excipients examined included spray-dried lactose (FlowLac 100), and two lactose-based, co-processed excipients (CPEs) (CombiLac and RetaLac). The d 50 values for the three excipients were comparable and ranged between 120 and 160 microns. Magnesium stearate, at 1 percent, was used as a lubricant. Table 1 Materials used in study Material type Grade Composition Lot number API Vitamin C—Merck Ascorbic acid 17C014106 Vitamin B 2 —BASF Riboflavin RIB 0832FP Lubricant Magnesium stearate—Peter Greven Magnesium stearate MGS-150097 Spray-dried lactose FlowLac 100 α-lactose monohydrate/ modified L101501217 A537 Lactose-based co-processed excipients CombiLac 70% α-lactose monohydrate, 20% MCC, and 10% white, native corn starch L100060516 A535 RetaLac 50% α-lactose monohydrate and 50% HPMC type 2208, K4M L104394500017351 A990