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Tablets & Capsules October 2020 35 coupling developed by Thabet and Breitkreutz [9]. To determine the acceptance value (AV) of enalapril maleate according to Ph.Eur. 2.9.40, ten minitablets were dissolved in the mobile phase of acetonitrile/phos- phate buffer pH 2.2 (50/50) and fil- tered through a 0.45-micron poly- propylene membrane filter before injecting 20 microliters. The investi- gations were performed in triplicate on a Nucleosil RP-18 column (240 x 4 millimeters, 5-micron pore size) at a temperature of 30°C and a flow rate of 0.7 ml/min. The wavelength to measure the absorption was set to 220 nanometers. To determine the stability of the enalapril maleate ODMTs, the following critical quality attributes were measured: tensile strength, API release, and disintegration time. The batches were stored in polyethylene bags under ambient conditions, with unprotected samples also tested was placed into a Plexiglas cylin- der, which was then locked with a 710-micron mesh sieve at the top and bottom (Photo 4). The locked cylinder was placed into a conven- tional disintegration apparatus and weighted with a metal cover. The disintegration time of six minitab- lets was measured at 37 ± 2°C in demineralized water. Dissolution studies were per- formed in a basket apparatus accord- ing to USP 39-NF 34 monograph [7]. API release of the ODMTs was measured in a phosphate buffer pH 6.8 stirred at 50 rpm. The wave- length was set to 208 nanometers. Mass variation was performed according to Ph.Eur. 2.9.5. Twenty minitablets were randomly chosen and weighed on an analytical bal- ance [8]. Content uniformity was determined by a validated method using high performance liquid chro- matography (HPLC) with UV-Vis Property Method Initial After 6 months Hardness (newtons) Ph.Eur. 2.9.8 4 ± 1 4 ± 1 Disintegration time (seconds) modified method Ph.Eur. 2.9.1 9 ± 2 7 ± 3 Acceptance value Ph.Eur. 2.9.40 15 Mass Ph.Eur. 2.9.5 conforms Table 2 Tablet properties Figure 2 Dissolution of enalapril maleate ODMTs Initial after 3 months after 6 months 160 140 120 100 80 60 40 20 0 API release (percent) 0 5 10 15 20 25 30 Time (minutes) n = 6, mean ± standard deviation • Lean, dense phase, plug-flow conveying of powders & small particles • Gentle - segregation & damage free • Conveying rates up to 10,000 lbs/hr • Safe, explosion free • Quiet, hygienic, reliable • No tools assembly Simply the best vacuum conveyor 609-265-0101 www.volkmannUSA.com PUT US TO THE TEST Courtesy of Weiss Pharmatechnik GmbH