Tablet Design Producing a tablet that has a unique shape and/or tablet face design can signifieantly enhance a products recognition. The “uniqueness” of any design is limited by the compression force required to produce the tablet, the formulation’s characteristics, the design's impact on tooling performance, and the table's ability to withstand packaging and shipping processes. Althongh tablet shape is not the only factor to consider in the design of a new tablet, the choice of geometric configuration can affect the output of the tablet press and, with some sharp- angled tablet configurations, possibly cause damages t0 the punches, dies, and cams. Some other effects of poor tablet design include the following: + Product becomes contaminated with metal from bro- ken punch tps. * Broken punch tips produce deformed tablets, which could be rejected by Quality Control * Costly reworking of tablets occurs (fablets are ground up and reprocessed). + Higher quantities of broken tablets are present in waste output of sorter (tablets are not reprocessed) * Filled bottles contain broken tablets, which could be rejected by Quality Control or, if distributed, diminish corporate image. * Labor costs are increased, which could result in higher prices to users and affect the product’s competitive position in the marketplace. * Time is lost in distributing the product, which could delay introducing a new product or cause a purchaser to run out of an existing product. * Some shaped tablets break easily when fed through the printer, sorte, and/or tablet filler Tablet Terminology ‘The basic construction of a round or shaped tablet isthe same; therefore, many of the terms used in describing tablets apply to both tablet categories. Definitions for general terminology are presented first, followed by the ‘erms specific to round or shaped tablets © American Phormacisls Association General Terminology Figures 22 and 23 (pages $2 and 54) illustrate the dimensions and profile, respectively, for round tablets. Figure 24 (page 55) illustrates the dimensions of the ‘most common configurations of shaped tablets. Figure 25 (page 56) shows the face and band of the tablet shapes used most often in tablet designs. Band: The area between the opposing cup profiles. The dle wall forms the tablet band, Coating: The function of applying a thin film of an aqueous or solvent solution to the tablet after the compression process. Circle: Circumscribed Circle: The smallest circle that can be drawn around a geometric shape so that it intersects each corner of the inner figure. A circumscribed circle restricts the external boundaries of agiven tablet shape. Inscribed Circle: The largest circle that can be drawn inside a geometric shape so that theit boundaries touch at as many points as possible, An inscribed circle restricts the internal boundaries of a given tablet shape. Cup: The depression or cavity within the tip of the punch. Compound Cup: A cup design in which multipte ares (radii) are generated from the cup’s center Point across the cup’s diameter, minor axis, or major axis Standard Cup: A cup design in which a single arc is generated from the cup’s center point across the cup’s diameter, minor axis, or major axis Cup Depth: The distance from the cup’s lowest point, usually the center point of the punch face, to its highest point, usually the highest point of the land area This measurement does not include identification embossing and debassing, Cup Radius: A single arc generated from the tablet's center point across the tablet’s diameter, minor axis, ‘or major axis, This configuration, which increases the 5152 FLAT-FACED aa “eae abusence ——SEYELEDGE ‘SPHERICAL - ‘cup mice puP (0. 38) CUP RADIUS = ee a pee ise a eDGe TABLET THICKNESS — ! F FLAT-FACED RADIUS- eras oe COMPOUND CUP AND BEVEL-EDGED . (ILLUS. BY (ILLUS C.) euposseo DEROSSED ROT SAT ea EMBOSSED DEBOSSED TABLET TABLET (ILLUS, D) (ILLUS. E) FIGURE 22. TERMINOLOGY FOR ROUND TABLETS BeOS Bunce ss, _— TABLET TABLET i ee Ca wie . > PWC NO Toy oo © American Pharmacists Associationcup volume by maintaining a required cup depth and reducing the band thickness, is used for round and shaped tablets (ee Figure 22, Illus. B; and Figure 24, lus. C.) Engraving: The function of cutting away or cutting into the surface of the hob to form the tablet configuration and identification. Engraving Area: The area across the face of the hob that can be used with minimum stroke distortion. Formulation: the result of blending all the ingredients in a recipe (sce definition below) for a pharmaceutical, food, or nutritional product Hob: A hardened steel device containing the detailed tablet design, which is used as the master to produce the puneh tips Identification: The application of letters, numbers, andor symbols to an object’ surface Land, Tablet: 4 narrow plane perpendicular to the tablet’s band, which creates a junction between the band and the cup radius Logo: ‘The name, symbol, ot trademark applied to the tablet face for easy recognition, Pad: An area on a hob or tablet face that is surrounded ‘on four sides by an alpha/numeric character or symbol. Certain characters, such as those shown in Figure 30 (page 64), or certain symbols form pads. Peninsula: An area on a hob or tablet face that is surrounded on three sides by an alpha/numeric character or symbol, Certain characters, such as those shown in Figure 31 (page 65), or certain symbols form pads Picking: A defect in the tablet in which part of the compressed material remains in a pad or peninsula area of character. Recipe: The formula and quantities for the ingredients (active and inactive) ofa tablet. Stroke: The width, depth, angle, and radius cut of the cutting too! used fo manufacture a hob. Stroke Distortion: A stroke that protrudes into the curvature of the tablet face, causing unequal depths from the surface across the stroke. ‘Tablet Debossing: A tablet identification marking that is embedded in the tablet’s surface, forming a groove or indented pocket (see Figure 22, Mls. E) © Amevicon Phormecists Assaciation ‘Tablet Embossin; marking above the tablet’ surface (see Figure 22, Is. D). ‘Tablet Identification: Any logo, product or company name, identification code, or three-dimensional character contours applied toa tablet’s face by means of debossing or embossing, (See the discussion of “Tablet Identification” on pages 57~73 for more information.) ‘Tablet Printing: A method of applying an identification, which is mechanically printed on the tablet face with liquid ink. ‘Tablet Thickness: The combined height of the upper and lower punch tip cup and the band, along with the expansion of the materials after the compression of the tablet, determines the total thickness of a tablet. Round Tablet Terminology Outside Diameter with a Spherical Cup Radius: ‘The length of a line segment passing from the centerline to any point on the tablet’s periphery. A spherical cup design is merely a chord segment of spherical ball (ee Figure 22, tlus. 4) Round Tablet: A tablet configuration in which all axes are equal from the center point ofthe tip face Flat-Faced Bevel-Rdged (FF.B.E.): A cup con- figuration consisting of an angle between the cup’s and the tabler’s fat face and a land. A 30° bevel is preferred to maximize the strength of punch edges. When the bevel is first applied, its contact area with the tablet face is a sharp beveled edge. Ifthe sharp edge remains, 4 punch tip will fracture at this point. A minimum. 0.015-inch [0.38-millimeter] radius is recommended to remove the sharp edge (sce Figure 22, lus.) Flat-Faced Radius-Edged (F.F.R.E.): A cup configuration similar to FEB.E. consisting of a radius between the cup’s and the tablet’s flat face and a land, ‘The radius from the tablet’s periphery or land should not exceed the comparable 30° bevel used for the EFB.E, design to ensure the strength of punch edges. ‘This limitation on the radius will reduce the flat area on the tablet’ face, thus limiting the surface area available for the identification, Shaped Tablet Terminology ‘Axis: A straight line serving to orient 2 geometric object. Major: Length of a shaped tablet. Minor: Width of a shaped tablet 3354 FIGURE 23. PROFILES OF CONVEX, F.F.B.E., AND F.F.R.E. TABLETS MODIFIED BALL (| EXTRA-DEEP pet SHALLOW STANDARD — sHaLLow | -———— STANDARD Sa easeeeceaerrret DEEP EXTRA-DEEP FLAT-FACED RADIUS EDGE FLAT-FACED BEVEL EDGE MODIFIED BALL ; FLAT-FACED RADIUS~ AND BEVEL-EDGED Pe NO TSM-N28FIGURE 24, TERMINOLOGY FOR SHAPED TABLETS MAYOR SIDE RADUS OVAL (LLUS. B) CAPSULE wan (ILLUS. A) Sethi WAJOR CUP RADIUS “Ue MINoR CUP RADWS: COMPOUND CUP (iuLus. ¢) seegguct Cue RADU HEXAGON—SHAPED SHERICAL RADIUS WITH NATURAL EDGE (iLLUS. D) Tom ay ' oo IF sees ! RF i ‘RADIUS, CHORD co 4 ‘cup RaoUs — HEXAGON=SHAPED RADIUS CHORD (luwus. E) ee ~ SEGMENT WITH SQUARE EDGE Saeien aeee e aa tts pee TSM-N24, © American Pharmacists Association 55ie 25. Soman TABLET SHARES. Sel O OD ( STANDARD. CONVEX STANDARD CONVEX STANDARD CONVEX STANDARD CONVEX BISECT NOT FLUSH QUADRISECT FLUSH STRAIGHT—THRU BISECT| O () © | cowpouno cup | CONVEX wT BEVEL | FLAT-FAGED PLAN | FLAT-FAGED BevEL-EocED 3 j 75 7 ( 73 | aT Fag sey cboc | raT-[Ag eeat-eooe [raT-FACED RADU eo0c0 LozeNce 73 —- "® 75 ( ( 7 0 LH MODIFIED BALL at R°ZER Re CAPSULE WoD CAPSULE : 0 (| | | ( , 7 : 4 0 OVAL BULLET "ARROW HEAD TRIANGLE a O j 3 oa c i a ine rao a and4Skine) RECTANGLE = 0) oe j a ( aE p MODIFIED RECTANGLE DIAMOND PENTAGON HEXAGON a 35 i B 0 ( OCTAGON, NATURAL ALF Moon ON NA HEART [B94 ‘ALMOND P= NO TSMoNDS © Anerican Pharmacists AssociationRadius: A line segment that joins the center point of a sphere with any point on its surface Corner Radius: The curvature used to eliminate sharp corners on peripheral surfaces where two lines or curves meet. A minimum recommended corner radius 1s 0,04 inch [1.01 millimeters]. (See Figure 24, Illus. D) End Radius: The radius located at either end of a capsule-shaped tablet. Major Axis Cup Radius: A single arc generated from the tabler’s center point across the tip’s major axis. This radius forms the major axis cup profile. Minor Axis Cup Radius: 4 single arc generated from the tablets center point across the tip's rainor axis, This radius forms the minor axis cup profile. Tablet Shapes: Capsule: A tablet configuration having only one radius—the end radius—and parallel sides. Modified Capsule: A tablet configuration having ‘one end radius and a large radius t0 the sides. This tablet configuration looks almost identical to the -apsule but does not have the flat side surface. Oval: A tablet configuration formed by using only two radii, the major side radius, and the minor end radius. Geometrie Shapes: Tablet configurations in shapes other than round or oval, such as triangles, squares, rectangles, trapezoids, pentagons, octagons, and tiexagons, or in shapes that have circumscribed and inscribed circles, which determine the tablets size and configuration, Tablet Identification The Food and Drug Administration (FDA) has ruled that all human drug products in solid oral dosage form muust bear a code (imprinted or otherwise applied) that identifies the drug product and the holder of the product’s approved application for marketing. (For the complete ruling, see the Federal Register. Sep. 1993:58(175):47948.) The ruling gave manufacturers ‘of pharmaceutical, nonprescription, biological, and homeopathic drugs who were not in full compliance with the ruling at that time until September 13, 1995, to ‘meet all FDA requirements. ‘The following factors can affect the optimal design of a tablet identification © Americon Pharmocisis Association + Compressibilty of formulations “Maximum area available forthe identification + Complexity ofthe identification * Location of the identification + ‘Tablet coating + ‘Techniques to prevent picking + Bisecs or scores * Tablet land Formulation Compressibility During the compression stage of tablet production, a formulation (granulation) may exhibit unusual characteristics. Common problems with formulation compressibility include: 1 is hard to compress; a higher tonnage s required. + A over tonnage than normal is required to compress the formulation * The formulation sticks to the punch face * Abrasives are higher than normal ‘The characteristics of a formulation’s compressibility must be considered in a tablet design. Any problems with formulation compressibility also should be discussed with the tooling manufacturer. Formulation characteristics can dictate the (1) stroke specifications for the identification and (2) location of the identification on the tablet face. Taking formulation ‘compressibility into consideration at the design stage ould prevent problems during tablet production, Maximum Identification Area Before an identification (logo, code, company or product name) is applied to a tablet’s face, the tabler’s form Ge, its geometric shape, contour, and identification) must first be transferred to the punch tip's face. Using the information on a tablet detail drawing, a toolmaker produces a metal fixture called a lob, one end of which contains 2 reproduction of the tablet detail dimensions. By means of a hydraulic press, the hob is pushed into the soft steel of the punch tip, thereby leaving a duplicate, opposing impression of the tablet’s form. Many restrictions on tablet identifications are duc to the constraints related to manufacturing 2 hob, To deboss or transfer the tablet identification into the hob’s surface, the toolmaker uses a tool that cuts a groove or pocket, called a stroke, in the metal (see Figure 26, page 58). Although the cutting tool is not shown on the tablet detail drawing, a cross-section of 37FIGURE 26. APPLYING TABLET DETAIL O SS HOB REPRODUCTION OF TABLET DETAIL TO PUNCH FACE TABLET IDENTIFICATION 1 HARDENED | STEEL HOB PUNCH TIP FACE AFTER PRESSING SOFT STEEL PUNCH’ BLANK [DWE NO. TSM—N26 the stroke with dimensional specifications is detailed, allowing the toolmaker to produce the correct cutting tool ‘The maximum identification area is the percentage of the tablet face that is available to produce the least distortion of the stroke depth. ‘The identification area dictates the dimensions of any debossing or embossing that will be applied to the tablet’s surface. Figure 27 shows the maximum identification area for the various ‘cup depths of round tablets as a circular dashed line on ceach tablets face. AS a rule, the identification area and the dimensions of an identification—in this case the letter A—lecrease as the cup depth increases. ‘Three factors determine the maximum identification area: (1) the cup radius, (2) stroke specifications, and @) stroke distortion (Cup Radius ‘The cup radius, which is used to generate the tablet’s ‘contour, is dictated by the size of the tabler’s periphery, ‘cup depth, presence of land, and cup design. As the cup radius increases, the tablet face becomes flatter and the maximum identification area increases. Stroke Specifications Greating a tablet identification on the tablet/hob surface requires a stroke, which is a term used to describe the basic construction for either a debossing (ee Figure 22, lus. £, of Hlustration 1, below), or an embossing (ee Ttastration STROKE BREAK [a _WIDTH RADIUS STROKE STROKE ANGLE RADIUS STROKE DEPTH DEBOSSED STROKE Figure, 22 Illus. D, or Illustration 2, below). Constructing a debossing or an embossing requires the following siroke specifications: stroke width, depth (if debossed), height Gf embossed), and angle, as well as the radius and break radius dimensions. When dimensioned, the siroke depth and height will be considered the “average” © American Phormocisis AssociationSTROKE ANGLE + STROKE WIDTH —) STROKE, RADIUS BREAK RADIUS ai AVERAGE STROKE DEPTH SEC. A-A OF SHALLOW CONVEX TABLET REQUIRED STROKE WIDTH INSIDE STROKE ANGLE OUTSIDE a STROKE ANGLE “yy DETAIL_B OF DEEP CONVEX TABLET NOTES: 1. DOTTED LINE ON FACE VIEWS INDICATES USABLE SURFACE AREA FOR TABLET IDENTIFICATION. 2.ALL PERCENTAGES FOR MAXIMUM IDENTIFICATION AREA ARE BASED ON A 30° STROKE ANGLE, .006 INCH STROKE DEPTH, AND NO LAND. INCREASING THE STROKE ANGLE OR DESIGNATING A LAND WILL DECREASE THE PERCENTAGE OF IDENTIFICATION AREA, S.THE MAX. LD. AREA FOR A SHALLOW CONVEX CUP DEPTH AT THE TABLET'S EDGE. FIGURE 27. MAXIMUM IDENTIFICATION AREA FOR ROUND TABLETS MAX. One. SHALLOW CONVEX ® | MAX. LD. AREA = 93% [STANDARD CONVEX sid [BREAKOUT G DETAIL “a! i MAX. 1.D. AREA = 70% DEEP CONVEX MAX. 45% 1D. AREA = EXTRA—DEEP CONVEX MAX. @) LD. AREA = 35% MODIFIED BALL CONVEX TABLET IS SMALLER THAN THAT FOR A STANDARD CONVEX TABLET BECAUSE THE STROKE DEPTH CANNOT EXCEED THE PWG. NO. TSM-N27 © An 19 Phormacists 5960 specification for each tablet/hob, as discussed in “Stroke Distortion.” Tsation? STROKE WIDTH smo [>| ANGLE | stroke / | RADIUS eREAK sa) RADIUS s vt STROKE HEIGHT EMBOSSED STROKE Stroke Distortion Unless the tablet/hob cup contour is flat faced, some percentage of stroke distortion will occur on debossing and embossing if one or more radii are used to form the tablet cup contour, Stroke distortion is a deviation in the debossing stroke depth or embossing stroke height, ‘with the percentage of deviation being controlled by the following variables: cup height, cup contour design, siroke angle, siroke break radius, and location of the debossed or embossed tablet identification on the tablet surface. It is very possible that, if no stroke formation is located at the tablet cup peak (see Figure 28, lilus B), only the average stroke depth or height can be used to determine if the required specification is achieved. ‘The average stroke depth or height can be verified by using a dial or digital indicator similar to (See Section 5, Iustrations 5 and 6, page 101). A sharp pointed brass anvil may be required to locate the anvil at the peak of the stroke radius and break radius. Adding the outside stroke depth and inside stroke depth (see Figure 28, Illus. C) and then dividing the sum by two will provide the average stroke depth or height. As illustrated on Figure 28, tllus. C, locating the stroke farther away from the tablet cup peak or closer to the tablet perimeter will affect the percentage of stroke distortion. The stroke location should be used to determine the stroke distortion percentage as related to the outside stroke depth or height as compared with the average stroke depth or height. Ideally the tablet identification stroke should be located on the tablet surface to provide a minimum stroke distortion percentage. Although locating the identification near the tablet perimeter may help to minimize picking, it will affect the percentage of stroke distortion and should be considered in determining the tablet identification location on the tablet surface. As compared with the average stroke depth or height, no more than the following percentages should be lost due to stroke distortion: uncoated tablets 35%, coated tablets 30% or less depending on minimum required stroke depth or height required to achieve identification clarity ‘The percentage of stroke distortion can be difficult for the user to determine. It should be determined uring modeling of the tablet so the information can be indicated on the tablet detail drawing and used to evaluate design feasibility, On FEB.E. tablets, the beve! angle intersects the tablet’s face and creates a sharp beveled edge. As shown in IMtustration 3, an identification character or symbol should be positioned at least 0.006 inch 10.152 millimeter] plus a stroke width from the beveled edge Mustvation 3 10.006 [0.182] \# STROKE WIDTH Joa SHARP $y BEVELED FI EDGE 0.015 BREAK 1h (0.98) RADIUS. il |+— STROKE WIDTH Complexity of Identification Unless modified or simplified, an identification designed primarily for advertising copy, letterhead, and packaging ‘may not be practical for tablet designs. Illustration 4 below shows how a design can be simplified by changing the font and applying radii on the corners. A tablet's dosage size and maximum identification area also determine the clarity of the final product's identification Tiusiration IMPRACTICAL FONT FOR SIMPLIFIED ‘TABLET DESIGNS 7 Sesion TSM Oo one: RADIUS, ean DESIGN DESION © American Pharmacists AssociationFIGURE 28. STROKE SPECIFICATIONS AND STROKE DISTORTION STROKE ANGLE — STROKE BREAK RADIUS ee STROKE RADIUS AVERAGE STROKE DEPTH STROKE SPECIFICATIONS (SECTION VIEW) CUTTING TOOL, LOCATED AT CUP PEAK (iuus. A) Hoe (tus. B) AVERAGE STROKE CUTTING TOOL. LOCATED NEAR * TABLET PERIMETER INSIDE OUTSIDE STROKE DEPTH STROKE DEPTH Lape M Nees [—— Hos (ittus. ¢) STROKE DISTORTION NOTES: NOMINAL STROKE DEPTH MINUS OUTSIDE STROKE DEPTH EQUALS STROKE DISTORTION. 2. STROKE DISTORTION DIVIDED BY AVERAGE STROKE DEPTH EQUALS MAXIMUM DISTORTION 30% MAX. DISTORTION FOR FILM-COATED DESIGNS; WENO. 35% MAX. DISTORTION FOR UNCOATED DESIGNS. » NO TSM-N28 © American Pharmacists Association 62 Location of Identification After establishing the maximum identification area, the next step is to locate the required tablet identification within the confined area. The number of characters, as well as the cup depth and design, determines the ‘optimal location for the identification. Depending on the number of engraved characters, the identification may be restricted to only one location within the identification area. Centering the identification horizontally across the tablet’s face can optimize the identification Illustration 5, below, shows the largest optimal identification size. Tiustration § In some circumstances, characters located in a potentially soft zone of the tablet cup can result in picking or sticking of the formulation to the punch face. When a punch begins compressing a powder into ‘tablet form, the compression force is initially higher at the land. The dwell time and applied tonnage can affect the equal distribution of the compression force across the entire surface of the cup. Ifthe force is not distributed equally, 2 soft zone can occur on the face of tablets that have a cup depth category of deep, extra- deep, or modified ball. The soft zone normally appears at the apex of the cup as capping, picking or sticking, or abnormal surface abrasion (see Illustration 6). IF reducing the press speed or increasing dwell time does not improve or eliminate the problem, a soft zone is strongly indicated. Reducing the cup depth is the next step in solving the problem; however, if this is not possible, moving the identification away from the cup apex should be considered (see Tlustration 7). Tustation 6 PUNGH TIP h_o\-F— porenmiat SOFT ZONE Tastvation 7 es) ©) If design restrictions, such as numerous characters or a ‘cup depth category that provides a small identification area, cannot be changed, the following measures should be considered: * Usea 35° or greater stroke angle, * Increase the stroke break radius. * Use techniques to prevent picking. Techniques to Prevent Picking ‘Techniques that prevent picking reduce the amount of force needed to compress powder within smail confined areas of a tablet identification, referred to as pads or peninsulas. As a result, the incidence of granulation sticking to the punch faces is reduced. Figure 29 shows two techniques to prevent picking in pad areas: (1) increasing the stroke break radius around pads and (2) decreasing the pad depth. Ifthe required cutter depth is less than 0.006 inch [0.152 millimeter], the break radius on the pads can be increased 1.5 to 2 times the outside break radius. If the cutter depth is 0.006 [0.152 millimeter] or greater, decreasing the depth of pad areas by 25-50% and increasing the breaks radius can also alleviate picking in pad areas, Figure 30 (page 64) shows techniques to prevent picking in two other problem areas: peninsulas and corners, Tapering a peninsula by 25-50% of the total cut depth should alleviate picking in this ype of confined area. Generating a corner radius in all sharp corners eliminates compound angles, which should alleviate picking in these areas. The minimum value recommended for a corner radius is 0.002 to 0.003 inch [0.051 to 0.076 millimeter]; the maximum recommended value is 0.004 to 0.006 inch [0.102 to 0.152 millimeter], Although all of these techniques alleviate problems with picking and sticking, the lack of a stroke break radius is a main contributor to the problems. As a rrule, the designated stroke break radius should remove approximately one-third of the stroke depth (see Ilustration 8). © American Pharmacists AssociationFIGURE 29, TECHNIQUES TO PREVENT PICKING IN PAD AREAS INCREASE BREAK RADIUS LOWER & INCREASE PAD AREAS BREAK RADIUS INCREASE BREAK RADIUS ON THE PAD 1.5~2 TIMES THE OUTSIDE BREAK RADIUS Us” INCREASE THE BREAK RADIUS ON PADS IF THE REQUIRED CUTTER DEPTH IS LESS THAN .006 INCH. EXAMPLES: - [) DECREASE DEPTH OF PAD AREAS AND INCREASE BREAK RADIUS. PAD AREAS ARE DECREASED 25-50% OF THE TOTAL DEPTH OF THE CUT. DECREASE DEPTH OF PAD AREAS AND INCREASE BREAK RADIUS IF AND ONLY JE THE CUTTER DEPTH IS .006 INCH OR GREATER. EXAMPLES: Q O OVA ( Ee) DWC. NO. TSM-N29 © Americon Phormacisle Association 63FIGURE 30. TECHNIQUES TO PREVENT PICKING IN PENINSULAS AND CORNERS TAPER _PENINSULAS TAPER PENINSULAS 25-50% OF THE TOTAL DEPTH OF ae EXAMPLES: ~ KZ< Jc VY PI USE CORNER RADII CORNER RADII ~~ COMPOUND ANGLE ~ SHARP NOTE: AS LETTER HEIGHT INCREASES, THE CORNER RADIUS. INCREASES. MIN. CORNER RADIUS = .002/.003 INCH; MAX. CORNER RADIUS = .004/.006 INCH EXAMPLES: WY NY MI BWS.NO. TF Si_ng0 © American Pharmacists AssociationFIGURE 31. SAMPLE DESIGNS FOR BOLD CHARACTERS BOLD DESIGN A\(ICOlElr HIIJKLAN OPQARST UVW AYE STANDARD DESIGN 012345 O18 mee}VY DO eH = w s/O — 22 w << SH @E #2|/Q Se SE 62 ESM © F/O OIG WSF FIQ2hmVASN woThastation 8 STROKE 1/8 STROKE BREAK DEPTH RADIUS, \ STROKE $ _bePTH Figures 31 and 32 (pages 65 and 66) show sample designs of bold and narrow letters and numerals used by some tooling manufacturers. These and other similar fonts can reduce the incidence of picking and sticking ‘See Section 6, Table 21, page 116 for other factors that can cause picking and sticking.) If these problems cannot be resolved, printing the identification on the tablet might be an option. Tablet Coating Film-Coated Tablets Fillm coating can affect the complexity, font style, and stroke specifications of a tablet identification. As a film coating adheres to a tablet’s surface, the coating begins to consume the stroke width and depth, which in turn diminishes the clarity of the identification. The degree to which the clarity is affected depends on the method of application, and the percentage and type of coating applied. For film-coated tablets the stroke width should equal 22-24% of the font’s height (see Figure 33). Stroke depths smaller than 0.007 inch [0.178 millimeter] are not recommended unless the tablet manufacturer can verify that smaller stroke depths worked on film- coated. tablets produced in the past. Stroke angles can vary from 35—45°, with 35° and a 0,005- to 0.007-inch TSIM UNCOATED DESIGN 007 OPTIMAL STROKE SPECIFICATIONS f FIGURE 33. GUIDELINES FOR FILM COATING on MOI APTER T | FILM COATING .007 007 1 , FILM— — COATING '~ :093 STROKE BEFORE COATING AFTER COATING 2005 “DEPTH FILM—COATED DESIGN 35° “Le COATING 905, BOS DWG. NO. TSM-N33 © American Pharmacists Association or[0.127- to 0.178-millimeter] flat in the bottom of the stroke being the optimal design. If these parameters cannot be met, the following conditions may exist: *+ The designated cup depth is too large. + The tablet i too stall for the number of digits spect- fied for engraving. * The identification {s located outside the maximum ‘dentfcation area ofthe tablet face. * The identification is too complex. Uncoated Tablets Because design specifications for uncoated tablets are less restrictive, the tablet identification can be more complex. The specifications for uncoated tablets are as follows: * Stroke width is 18-20% of the font eight © Stroke depth is 50% of stroke width, or no less than 0.008 inch [0.076 millimeter] + Sttoke angle is 30-45°. * The minimum font height is 0.035 inch [0.889 mil- limeter] with a 30° stroke angle, Bisects and Scores Applying a bisect or score to a tablet’s surface creates a stress line along which the tablet breaks easily. The bisect types shown in Figure 34 range from the most functional bisect (the ‘ype G, or pressure sensitive bisect) to the least functional (the Type H, or partial bisect) ‘The bisect’s purpose—to produce a desired dosage amount of a tablet—is affected by the tablet’s cup depth, band thickness, and hardness. Specifications for the bisecr’s size are determined by the tablets size, the tablet identification, and the bisect design, (See Table 9, page 70 for standard bisect specifications.) ‘To avoid ejection problems with bisected tablets, the biscct should be placed on the upper punch when the biseet's depth exceeds 40% of the cup depth, unless the tablets will contain a large quantity of embossed characters. With bisected debossed tablets, the bisect height on the punch is generally higher than the engraving; therefore, placing a bisect on a lower punich ‘mates it more difficult to scrape the tablet off the face of the punch at ejection.! With bisected embossed tablets, however, placing embossed characters on the lower 68 punch may create more ejection problems than placing the bisect there. ‘The standard SM bisect has two different configurations for concave tablets, protruding and cut flush. The protruding bisect style follows the curvature of a radiused cup and extends past the tip edge ofthe punch, ‘This style helps break the tablet into equal parts because the extended bisect is pressed into the tablet band. ‘The protruding bisect may run into the tip edge of the lower punches if they become too close during the compression cycle of the press. Running the bisect into the fower punch edge leaves deep impressions in the lower tip edge while smashing and swelling the protrusion of the bisect on the upper punch. For this reason, the standard cut-flush bisect style has become more popular.! A cut-through bisect, also known as a European style bisect, can only be used on radiused cup designs. tt has an advantage over the standard bisect by allowing the consumer to better break the tablet into the prescribed dosages. The cut-through biseet is wider at the center of the tablet than the standard bisect is, which reduces the available engraving space on the tablet face. ‘The height of the cut-through bisect is generally the same as the cup depth.! Bisects are often modified to meet specialized requirements. The most common modified bisect style is the partial bisect, which is used when the bisect interferes with a code or logo on the tablet surface." Al bisect specifications for concave tooling are based on the standard cup depths as shown in Table 10 (page 71). Bisects for EEB.E/EERE tooling, should also be based on the cup depths shown in Table 10. The table presupposes that the bisect’s line radius, or stress line, is parallel to the cup surface, similar to the A, E, B, and H bisects shown in Figure 34. IF one of these bisects is to be used with a nonstandard concave depth, the bisect’s depth should equal 33% of the required cup depth. Tablet Land ‘The tablet land is the narrow plane perpendicular to the tablet’s periphery, which creates a junction between the tablet’s periphery and cup (see Figure 35, tllus. A; page 72). The two reasons for incorporating a land into a tablet’s design are to (1) reduce nicks on punch tip edges and (2) increase the strength of tip edges. ‘The following discussion of the separate illustrations in Figure 35 explains why adding a land to a tablet design improves the function of tip edges. © American Phormacisis AssociationFIGURE 34, TYPES OF BISECT LINES FACE VIEW END VIEW © PRESSURE SENSITIVE BISECT G TYPE ee ‘SIDE VIEW . co ite MAX OF BAND THICKNESS ® CUT THROUGH BISECT a ates 7 { 95% OF — CUP DEPTH DECREASING BISECT CUP RADIUS im LL 75% oF | C TYPE ® STANDARD Bre rRUsie biseet A TYPE pisect CUP DEPTH ® STANDARD. BISECT E TYPE a RADIUS, © SHORT BISECT |B TYPE = ® ~ PARTIAL \ BISECT } H TYPE a7 5 S NOTES Make it EASIER TO BREAK THE TABLET. 1. ALL BISECT LINES ARE BASED ON A 90° ANGLE. 2. AN UPPER PUNCH DESIGNATION IS SUGGESTED IF THE BISECT'S DEPTH CONSUMES A HIGH PERCENTAGE OF THE CUP, (8 IF THE BISECT PROTRUDES INTO THE TABLET'S BAND, AS IN BISECTS 1 ESTe—yo, AND 4, OTHER TYPES OF BISECTS MAY ALSO PROTRUDE INTO THE BAND TO - -TSM-N34 © American Phormacists Association 670 TABLE 9. STANDARD BISECT SPECIFICATIONS. - 8 a a “He as = TABLET SIZE | CONVEX & F-F.B.EJF.F.R.E. INCH [MILLIMETER] Ww cea. 18 (3.475) 0.014 10.586) 0.006 10.153] /32___13.970) 001 (0.405) | (0.178) 36 [4.763] 0.018 10.457) (0.203) 732 (6.565) _0.020 [0.508 (0.225) “4 16:350) | 0.022 (0.559) 10.254) 932 (7.142) 0.024 (0.610) (0.279) 58 [7.938] 0.026 10.660) (0.305) {182___[8.730) 0028 «0.71 [ (0.330) ae 19.525) (0.762) (0.356) 13/82 [10.318] ~ (0.813) (0.381) TH6 (11.173) (0.343] (eset) [152 117.906), (0.843) (0.381 12 [12.700] (0.813) "[0.281), 72 [18.493] (0.813) (0.384) 96 (14.268) (0.813) (0.381) | 19782 (15.080) (0.843) 0015 (0.381) 38 (15.875) 10813] 0.015 (0.384) T1N6 (17.463) [1.016] ooig (0.483) 3/4 [19.050] (1.016) [| 0.019 (0.483) 1316 [20.638] [1.016] 0.019 (0.483) 778 (22.225) _| [1.076] 0.019 (0.483) 15/16 (23.813) (1.016) 0.019 10-483) 1 (25.400) {1.270} 0024 (0.610) NoTEs: 1) ALLBISECTS SHOULD HAVE AN APPROPRIATE 0,002-NCH [0.051-MILLINIETER] RADIUS AT THE BOTTOM OF THE 2, BISECT SPECIFICATIONS FOR SHAPED TABLETS ARE DETERMINED BY CORRELATING THEIR MINOA AXIS DIMENSION WITH THE APPROPRIATE TABLET SIZE DIMENSION IN THE ABOVE TABLE, 3. BISECT SPECIFICATIONS FOR CONGAVE TABLETS ARE BASED ON THE STANDARD CUP DEPTHS LISTED IN TABLE 10. FOR NONSTANDARD CUP DEPTHS, THE SISECT DEPTH SHOULD EQUAL 33% OF THE CUP DEPTH. 4, BISECT SPECIFICATIONS FOR F-F.B.E/F.F.R.E. TOOLING ARE BASED ON THE CUP DEPTHS LISTED IN TABLE 10. © American Pharmacists AssociationTABLE 10. PUNCH TIP TABULATIONS sce 1D AD 4 8 BHO ® © 6 INCHES SHALLOW | STANDARD DEEP EXTRA-DEEP} MOD, BALL |F.F.B.E/F.FRE [MILLIMETERS] | CUP DEPTH | CUP DEPTH | CUP DEPTH | CUP DEPTH | CUP DEPTH | CUP DEPTH ‘ve_(2.17e)_| 0.006 0127) | oor to4sal [0.024 sto) [ o0an f0.76aj [aoe 1.016) | 0.007 (0178 | 5182 [3.970] _| 0.007 {0.178} | 0.021 (0.533) | 0.030 0.762) | 0.036 (0.914) | 0.049 (7.245) | 0.008 [0.203] até (4763) | 0.008 {0.203} | 0.026 ee 10.914] | 0.042 (1.067) | 0.059 (1.499) | 0.009 [0.229] 7182 (6.555 | 0.009 {0.209} | 0.009 (0.7971 | 0.042 11.087] | 0.048 (1.219) | 0.069 (1.753) [ 0.010 [0.254] v4 16.350} | 0.010 (0.254 | 0.031 (0.787) | 0.045 [1.143] | 0.050 (1.270) [0.079 [2.0071 | 0011 (0.279) gia (7.142) | 0.012 (0.305) | 0.088 (0.838) | 0.046 [1.168] | 0.054 11.372) | 0.089 12.261) | 0.012 (0.308) 516 {7.938} | 0.013 (0.330) | 0.084 (0.864) | 0.047 [1.194] | 0.080 11.524) | 0.099 (2.515) | 0.013 (0.330) 11/32 [8.730] | 0.014 [0.356] | 0.035 [0.889] | 0.049 [1.245] } 0.066 [1.676] | 0.109 [2.769] } 0.014 0.356) 38 (9.525) | 0.016 (0.406) | 0.036 (0.914) | 0.050 (1.270) | 0.072 [1.829] | 0.119 (3.023) | 0.015 [0.384] 192 {10318} | o.ot7 (0.432) | 0.038 (0.965) | 0.052 [1.321] | 0.078 17.981) [0.128 13.251] | 0.016 (0.406) 76 [11.173] | 0.018 (0.457) | 0.040 [1.016] | 0.054 11.372] | 0.084 12.134) [0.133 (3.378) | 0.016 [0.406] 15/82 [11.905] | 0.020 (0.508) | a.oat (1.041) | 0.056 11.422) | 0.090 (2.286) | 0.148 (3.750) | 0.016 [0.406] v2 (12700) | 0.024 (0:53 [0.048 7.092) [059 (1.490) | ooa6 (2.413) [0.158 (4073) [016 (0406) 17/82. [13.493] | 0.022 [0.559] | 0.045 [1.143} | 0.061 (1.549) | 0101 (2.565) | 0.168 [4.267] | 0.016 [0.408] git6 (14.268) | 0.024 0.610) | 0.046 {1.168} | 0.063 (1.600) | 0.107 (2.718) | 0.178 (4.521) | 0.016 (0.406) 1932 [15.080] | 0.025 (0.635) | 0.048 [1.219] | 0.066 [1.676] [0.113 [2.870] [0.188 (4.775) | 0.016 [0.406] 58 (15.875) | 0.026 (0.660) | 0.050 [1.270] | 0.068 (1.727) ] 0.119 (8.023) [0.198 (5.029) | 0.016 [0.406] 116 [17.463] | 0.029 10.797] | 0.054 (1.372) | 0.073 (1.854) [0.131 (8.327) | o2t7 [5.512] | 0.020 (0.508) 34 (19.050) | 0.031 [a.787] | 0.058 (1.473) | 0.078 (7.981) [0.143 [3.632] | 0.287 (6.020) | 0.020 [0.508] tate (20.638) | 0.034 (0.864) | 0.061 [1.549] | 0.083 (2.108) | 0.155 [3.937] | 0.287 (6.528) | 0.020 (0.508) 718 (22.225) | 0.037 (0.940) | 0.065 (1.65%) | 0.089 (2.260) | 0.167 [4.242] [0.277 17-036) | 0.020 (0.508) 15/16 (28813) | 1089 (0.991) | 0.089 (7.753) | 0.094 [2.980] [0.179 [4.547] [0296 7-518) | 0.020 [0.508] 1 (25400) | 0.042 11.087] [0.073 11.854) | 0.009 (2.515) [O.191 [48st] | 0.916 (8.026) [0.025 (0.695) NOTES: ‘SHOULD BE CONSISTENT WITHIN A SET OF TOOLING. APPROPRIATE PUNCH TIP DIAMETER IN THIS TABLE, 4, BECAUSE OF DEFORMATION FROM THE HOBBING PROCESS, LARGE F.F.B.E, AND FF.R.E. PUNCH FACES MAY BE SLIGHTLY CONVEX. AS A RESULT, THE W.L. DIMENSION MAY VARY ACROSS THE PUNCH FACES; THE VARIATION 2, TIP TABULATIONS FOR SHAPED PUNCHES ARE DETERMINED BY CORRELATING THEIR MINOR AXIS WITH THE © American Pharmacists Association nn FIGURE 35. GUIDELINES TIP LAND ~ LAND c FOR PUNCH £ LAND Tr (ulus. A) SHALLOW CUP NO LAND SHARP TIP EDGE DEFORMED TIP EDGE FORCE CAN RESULT. IP MODIFIED BALL CUP DEFLECTION ae UNDER LOAD (lutus. 8) (ILLUS. ¢) LAND SHARP CORNER STD. CONC, CUP RADIUS EXTRA DEEP CUP RADIUS PUNCH iA PERIPHERY (uwus. 0) ae BLENDED RADIUS $ID. CONC. MEASURABLE <| CUP RADIUS EXTRA DEEP SE — SPAS PUNCH a PERIPHERY (wus. &) a (WG. NO TSM-N35, © American PhormacisisEffect of Land on Tip Edges Illustration B of Figure 35 shows that a punch tip without a land has @'sharp punch tip edge. As the cup dept increases, the tip’s edge strength decreases. Detail A shows a deformed tip edge, which can occur easily ‘on sharp edges during press setup oF when tooling mishandled. Adding 4 minimum 0.002-inch [0.051- millimeter] blended land will remove the sharp tip edge and minimize deformities to the edge caused by mishandling; however, a land this small will not cffectively improve the tip’s edge strength, Illustration € of Figure 35 shows deflection of the tip cexige caused by excessive compression force. When 2 purich begins compressing powder into a tablet form, the force is initially higher at the tip edge; then the compression force is distributed across the cup’s, surface. Cup depth, dwell time, and applied tonnage can affect the occurrence of tip edge deflection and the equal distribution of force across the entire cup surface. Choosing the appropriate tand width is essential to reclucing tip edge deflection, Because the dwell time and tonnage needed to produce a new tablet are usually not known at the tablet design stage, the cup depth category is used to determine the appropriate land width, Minimum Land Widths Land width is the straight fine distance starting at the punch’s periphery and ending at the junction of the land with the cup’s surface. ‘This junction forms a sharp comer (ee Figure 35, lus. D). Where applicable, tablet detail drawings should indicate the fand widths before the sharp comers are blended. ‘Table 11 lists the minimum fand widths for round and shaped tablets. ‘The appropriate land width is determined by the tablet’s cup depth category. For round tablets, the O.D. and actual cup depth determine if a tablet’s cup depth category is shallow, standard, deep, extraeep, or modified ball. Matching the tablets diameter and cup depth with the appropriate punch tip diameter and cup depth, respectively, in Table 10 (page 71) gives the cup depth category. For shaped tablets, the minor axis and actual eup depth determine a tablet’s cup depth category. Although the concave punch tip tabulations in Table 10 apply to round tablets, this table can also be used to determine 2 shaped tablet’s cup depth category. Matching the minor axis and cup depth of a shaped tablet with the appropriate punch tip diameter and cup depth, respectively, determines the tablet’s cup depth category. © American Pharmacists Association TABLE 11. MINIMUM LAND WIDTHS LAND WIDTHS CUP DEPTH SHAPES ROUNDS SHALLOW REMOVE: REMOVE SHARP TIP | SHARP TIP EDGE EDGE STANDARD | 0,004 [0.102] | 0.003 [0.076) DEEP 0.005 [0.127] | 0.004 [0.102] EXTRA-DEEP | 0.006 (0.152) | 0.005 [0.127] MOD. BALL | 0.008 0.203} | 0.007 [0.178] FFBE, 0.004 [0.102] | 0.003 0.076) NOTE: VALUES PERTAIN TO MINIMUM LAND WIDTHS: BEFORE BLENDING, The cup depth category is then correlated with the appropriate minimum land width in Table 11 Measurable Land Measurable land is the fand that remains after a blended radius is applied to the junction of the fand with the cup. A blended radius, which is a fillet or curved transition between two mating surfaces, is normally used to remove sharp corners on a contoured surface (Gee Figure 35, Mus. E) ‘The actual width of a measurable land is affected by the (1) size of the blended radius and (2) cup radius and depth. Based on the same land requirements, Illustration E shows the measurable land of wo cup depth categories. ‘The standard cup depth has a larger measurable land, Difficulty in controtling how much material is removed, or blended, increases as the cup depth increases. NOTE: The TSM Committee recommends that a land. be specified for all tablets or punches with a cup depth of standard or greater Tablet Printing When an identification is mechanically printed on a tablet’s surface, the tablet is usually film coated. OF the two types of tablet printing, linear and radial, linear printing is the method used most often. 73” Radial Printing Radial printing, also called spin printing, can be used only for caplet shapes that closely approximate the shape of a capsule, In this printing process, the tablet is rotated about its major axis as the characters are applied to the tabler’s surface (Gee Illustration 9). The size and number of characters are determined by the tablet's circumference. ra Ta onnceerence © saci Linear Printing In linear printing, the tablet’s major axis periphery and minor axis cup are aligned with the printing mechanism. This alignment allows the identification to be imprinted consistently across a major axis location (ee Milustration 10). Tablet orientation is critical to maintaining a consistent placement ofthe identification on the tablet and to avoiding side printing, or printing ‘on the tablet band (see llustration 11) istration 10 ™ © cS LINEAR: PRINTING should be as large as possible to reduce rocking of the tablet in the printer's carrier pockets (sce Illustration 12). Because the minor axis controls the degree of rocking, the size of the minor axis radius should be emphasized in the tablet cesign ustation 12 LARGE RADIUS TABLET ROCKED. ‘COMPOUND, OVER ONTO BAND CUP \ ‘SMALL CUP RADIUS ‘The cup radii will also affect the printing window. The size of the printing window determines the maximum, character size that can be printed on the tablet’s surface. Mhustration 13A shows that a large cup radius provides a wide printing window, whereas a medium cup radius provides only a narrow printing window. On tablet drawings, an approximation of the printing window is usually shown on the face view as a phantom, line (ee Illustration 138). Tustration 13 PRINTING WINDOW Sa PRINTING WINDOW stration 17 MISALIGNED << SIDE PRINTING "TERS ‘The two major factors to consider in designing a tablet for linear printing are (1) cup radii and Q) tablet proportions Cup Radi ‘The cup radii, which are the major and minor axis radii, form the table's contour, or surface, The cup radii ‘Tablet Proportions A tablet’s proportions can affect the degree to which rocking occurs. To reduce tablet rocking, the difference between the tablet's minor axis, or width, and the tablet thickness should not be less than 0,060 inch (1.524 millimeters); a difference range of 0.075-0.090 inch [1,905~2,286 millimeters] is preferable. Cup depth, which can also affect rocking, should be at least 24% of the total tablet thickness (See Mlustration 14). Both proportions must be met to prevent tablet rocking, If the stipulated difference between the minor axis and tablet thickness is met, but the cup depth is less than 24% of the tablet thickness, the resultant increase in band thickness may cause the tablet to rock onto its side. © American Phormacisis Associationustration 7 MINOR AXIS (wioTH) | cup 2s% ¥ TABLET THICKNESS Tablet Detail Drawings Prior to manufacturing of any tooling, a detailed drawing of the proposed tablets must be generated. Whether creating a design for a new product or modifying the design of an existing one, tooling manufacturers can aid in preparing tablet drawings. A tablet detail drawing should contain the following basic information: * A face view with Full dimensions of the tablet periphery + For round tablets, a single side view * For shaped tablets, side views of the major and minor axes * Cup depth, land, and cup radius + For compound cup tablets all rai locations If a tablet identification is present, the following information is needed: * Height, width, and spacing for each character * Location ofthe identification reative tothe periphery’s latiucle and the centerline’s longitude * Details and notes for techniques fo prevent pick * Stroke specifications Because drawings for most shaped tablets usually require at least three views, a B-size (11 by 17 inch) © American Pharmacisis Association sheet is suggested. An A-size (8 1/2 by 11 inch) sheet is usually sufficient for the face and side views required on drawings of round tablets. (A detail drawing of each side of the tablet printed on separate sheets is recommended.) If a drawing’s size is reduced for facsimile transmission, the text should be checked again for legibility. Tablet drawings created on a B-size sheet usually require a minimum text height of 1/8 inch [3.175 millimeters] If a tablet drawing lacks the required information and the tooling for the produet is purchased later from a ifferent vendor, an inconsistency in the product may occur. The new vendor needs the following information to ensure product consistency * Tablet detail drawing foreach side of the tablet * For round tablets, samples of the upper and lower punches * For shaped tablets, sample punches and a sample die + Description of any past problems with the tooling, including + Premature fatigue * Picking and cappi + Redluced press speed! nected to improve tablet quality * Tablet coating problems (e.g, chipping, abrasion, and Jack of identification clarity) * Printing problems (e.g, inconsistent tablet orienta- tion resulting in side printing and the need to reduce printer conveyor speed) With this information in hand, the tooling manufacturer may suggest changes in tablet design, tooling material, and punch variables that will improve tooling life and tablet quality. 592. Finally, fatigue damage is cumulative, When a part is, over-stressed, the microscopic damage inflicted reduces the useful life of that part by a percentage approximately equal to the number of cycles accumulated at that stress level divided by the predicted cycle life from the fatigue curve. Intermittent periods of excessive stress followed by fong periods of stress levels below the fatigue limit can extend the time to failure well beyond the range of one to four million cycles. This explains why some tooling sets produce hundreds of millions of tablets before the tools erack. References 1, Technical Information—Research and Engineering Department, Nottingham, England: J. Holland Lim- ited; 2005, 2. Beamalloy Technical Reports—Abrasive Wear of ‘Tableting Tools and Coatings, Plain City, OH: Beamnal- loy Technologies LLC; 2005, © American Phormocists Associotion