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34 October 2020 Tablets & Capsules It is manufactured from milled iso- malt using a fluid-bed process fol- lowed by a sieving operation. The ratio of GPS to GPM can influence isomalt's water solubility. Isomalt with a ratio of 1:1 GPS to GPM has an aqueous solubility of 25 grams in 100 grams at 20°C, while isomalt with a ratio of 3:1 GPS to GPM has an aqueous solubility of 42 grams. Table 1 shows the typical powder characteristics of each grade. Figure 1 shows the porous structure and spherical particle shape of each grade, characteristics that promote good mixing and high content uni- formity in a powder mixture. To develop the ODMTs for this study, the higher-solubility agglomerate form (3:1 GPS:GPM) was used. A prerequisite of the therapeutic success of low-dose dosage forms is high content uniformity (CU) and low mass variation (MV). The abil- ity to achieve CU by direct com- pression is linked to the physical and morphological properties of the API and excipients, their amounts in the formulation, the resulting flow- ability, the mixing process, and the tableting process. To produce a 1-milligram enal- april maleate ODMT, enalapril maleate (16 percent), 3:1 GPS:GPM agglomerated isomalt (79 percent), and cross-linked polyvinylpyrroli- done (4 percent) as superdisintegrant were mixed together in a Turbula mixer for 15 minutes. Magnesium stearate (1 percent) as lubricant was then added, and the formulation was mixed for an additional 2 minutes. This blend was then compressed on a rotary tablet press into 6.25-milli- gram round bi-convex tablets using 2-millimeter, 19-tip punches and a compression force of 5 to 6 kilonew- tons (71 to 85 megapascals). Evaluation of ODMTs The tablets were tested to deter- mine disintegration time, rate of dissolution, mass variation, content uniformity, acceptance value, and stability. The disintegration time was mea- sured using a method developed by Kleinebudde [6]. One ODMT Isomalt is a polyol manufactured from sucrose and comprised of two mutually diastereomeric disaccha- ride alcohols called 6-O-α-D-glu- copyranoside-D-sorbitol (GPS) and 1-O-α-D-glucopyranoside-D-man- nitol-dihydrate (GPM). Agglom- erated isomalt is widely used as a filler-binder for direct-compression tableting due to its high compress- ibility, flowability, and workability. ODMT formulation and tableting process Enalapril is a member of the drug class angiotensin converting enzyme (ACE) inhibitors and is used for var- ious treatments, including heart fail- ure, high blood pressure, and hyper- tensive emergency. It is listed as an essential medicine, emphasizing the need for a suitable dosage therapy for children [5]. 1:1 GPS:GPM 3:1 GPS:GPM Solubility in water at 20°C (g/100 g) 25 42 Bulk density (g/l) 400 400 Tapped density (g/l) 480 480 Angle of repose (°) 38 37 Table 1 Typical agglomerated isomalt characteristics Figure 1 Scanning electron micrograph images of agglomerated isomalt (Philips XL-30 FEG) a. 1:1 GPS:GPM b. 3:1 GPS:GPM Photo 3: A modified test apparatus was used to measure the minitablet dissolution.