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m-MiniCH_48-62_MINICH 12/30/13 2:09 PM Page 53 January 2014 53 Tablets & Capsules Product Review Lab Scale Tablet Press Predicts Rotary Press Behavior Introduction The Gamlen GTP-1 Benchtop Tablet Press (now available with optional RH control) revolutionizes tablet formulation and process development by facilitating small scale testing of materials and processes. The GTP-1 generates highly-scalable measurements of tablet compaction pressure, punch displacement, and tablet take-off and ejection forces. In addition, measurements of tablet fracture stress under controlled conditions are accurately performed on the GTP-1. In this study we have used the instrument to successfully predict the compression behavior of two widely different products on a full scale production tablet press running at 120K tablets per hour. The tabletability plot in Fig 1 shows a linear relationship between the compaction pressure applied and the tensile strength of the tablets for most of the pressure range. The tabletability, compressibility, and compactibility plots for tablets produced via direct compression on the GTP-1 show excellent correlation with data generated on the Fette, and in fact, the GTP data and Fette data are virtually super imposable despite large differences both in compression weight and in tablet shape. The range of solid fractions observed for tablet formation is between 0.70 and 0.95, which is well within expected norms. Conclusion: The GTP-1 was successfully used to predict production behavior using only minimal (100 mg) quantities of material. Despite vast difference in size and geometry, tablets produced on both the GTP-1 and the Fette Rotary press can be successfully compared using tensile strength and solid fraction measurements with a high degree of predictability. Furthermore, measurements of ejection shear stress on a small scale production via the GTP-1 were able to predict accurately tablet failure on the Fette commercial rotary press. Based on ongoing in-house research, these data are borne out for a wide range of formulations and tablets, thus the GTP-1 can play an important role in tableting QbD from early stage Formulation thru Process Development, preProduction Optimization, and in routine Quality Control testing. At Gamlen, we like to think of our economical benchtop GTP technology as "Intelligent Tableting-by-Design". Discussion Two formulations were compared using both the GTP-1 laboratory tablet press and the Fette 2090 Rotary Tablet Press. A direct compression formulation (DC1) consisting of a blend of active pharmaceutical ingredients (API) with microcrystalline cellulose, sodium starch glycolate, silicon dioxide and magnesium stearate. The scalability of compressibility (solid fraction vs. compaction pressure), tabletability (tensile strength vs. compaction pressure), compactibility (tensile strength vs. solid fraction) and ejection shear stress were examined over an eight-fold range in tablet size. Tablets produced on the Fette production press had a compression weight of 800mg and a caplet shape, whereas tablets produced on the GTP-1 were round flat face compacts with a compression weight of 100mg. Typical data are shown in Fig 1. FIGURE 1 Tabletability Plot of DC1 Direct Compression Formulation Comparing Tablets Produced on Fette Rotary Press (red squares) and Tablets Produced on Gamlen GTP-1 Benchtop Press (blue triangles) Gamlen Tableting Ltd Biocity Nottingham Pennyfoot Street Nottingham NG1 1GF, UK Tel: +44 (0) 115 912 4271 Website: www.gamlen.co.uk E-mail: enquiries@gamlen.co.uk North America inquiries e-mail: scimark@att.net