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42 April 2018 Tablets & Capsules Tablet mass uniformity and friability The mass uniformity of the tablets was characterized according to European Pharmacopoeia (Ph. Eur.) 2.9.5. Friability was analyzed according to Ph. Eur. 2.9.7. Results and discussion Surface characteristics. Isomalt is a blend of the diastereomers 1-O-α- D - g l u c o p y r a n o s y l - D - m a n n i t o l dihydrate (GPM) and 6-O-α-D- glucopyranosyl-D-sorbitol (GPS). Each of these two components has a distinct crystal shape, as shown in the SEM images in Figure 1. The material consists of agglomerated primary particles with an average particle size of 1 micron that contain crystallites with a median particle size of 0.1 micron [6]. T h e S E M i m a g e o f d i r e c t - compression-grade isomalt in Figure 2 reveals a sponge-like structure with a multitude of cavities. Also, the G P M a n d G P S c r y s t a l s d o n ' t interlock seamlessly, which creates additional void space. Liquid APIs granulation process and a full-scale rotary tablet press. Characterization. The surface characteristics of the absorbent carrier isomalt were determined by SEM-analysis using a scanning electron microscope (Hitachi type S-510). Blending. For each tablet type, 2.5 kilograms of isomalt were placed into a Diosna model P 1-6 high-shear mixer-granulator and then the whole quantity of liquid was added in one step to the powder bed. The mixture was blended at 250 rpm for 180 seconds to create a homogeneous blend. Tableting. Tablets were produced immediately after the blending step on a full-scale and fully instrumented, 24-station tablet press (Fette type P1200iG) using a 12-millimeter concave punch. The press speed was adjusted to produce 30,000 tablets per hour. No pre-compression step was used. Tablet hardness was adjusted in two steps between 60 and 110 newtons. The target tablet weight was 600 milligrams. can be absorbed onto the surface and into these cavities and void space. Compactability. Tablet hardness increased gradually with increased compression force, as shown in Figure 3. The compression forces applied were well below the punch limit of 54 kilonewtons. Neither capping nor adherence to the tablet punches were observed. T a b l e t f r i a b i l i t y a n d m a s s uniformity. Tablet mass uniformity and tablet friability complied with pharmacopoeial requirements, as evidenced by the data in Table 2. Conclusion This study demonstrated isomalt to be a convenient carrier for liquid APIs in the manufacture of direct- c o m p r e s s i o n c h e w a b l e t a b l e t s . Linseed oil and two simethicone fluids with different viscosities were each loaded at 7 percent w/w onto a direct compression type of isomalt in a simple blending process. The loaded isomalt showed suitable flow p r o p e r t i e s f o r t a b l e t i n g i n a n industrial-scale rotary tablet press Table 2 Tablet hardness, friability, and mass variation Formulation Mean tablet hardness (newtons) Tablet friability (percentage) n=25 Tablet mass (milligrams) n=20 galenIQ 721 + 7 percent linseed oil 66 0.5 Mean = 600 Minimum = 591 Maximum = 609 108 0.3 Mean = 599 Minimum = 576 Maximum = 612 galenIQ 721 + 7 percent simethicone Q7 L2243 LVA 72 0.5 Mean = 604 Minimum = 585 Maximum = 605 95 0.4 Mean = 603 Minimum = 590 Maximum = 609 galenIQ 721 + 7 percent simethicone antifoam C100EP 60 0.5 Mean = 599 Minimum = 591 Maximum = 606 96 0.4 Mean = 598 Minimum = 590 Maximum = 605

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