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Powder Technology 238 (2013) 169–175

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Powder Technology
journal homepage: www.elsevier.com/locate/powtec

Determination of the tensile strength of elongated tablets


Kendal G. Pitt a,⁎, Matthew G. Heasley b
a
Global Manufacturing and Supply, GlaxoSmithKline, Priory Street Ware SG12 0DJ, United Kingdom
b
Research & Development, GlaxoSmithKline, Park Road, Ware, SG12 0DP, United Kingdom

a r t i c l e i n f o a b s t r a c t

Available online 29 December 2011 The tensile strength of a tablet is an important attribute as the tablet needs to be mechanically strong enough
to withstand further handling such as film–coating, packaging, transport and end-use by the patient, but to
Keywords: be weak enough to break apart in the human body and so release its contents. Mathematical solutions to cal-
Tablet tensile strength culate tensile strength are known for flat-faced and convex-faced circular tablets. The work described here
Finite element analysis
aims to extend this knowledge to capsule-shaped and oval-shaped tablets by means of 2-dimensional (2D)
FEA
Shaped tablet
and 3-dimensional (3D) Finite Element Analysis (FEA). The stress analysis showed that as the tablet was
Oval tablet elongated from a standard circular tablet to become that of an extended tablet shape, the peak principal ten-
sile stress reached a limiting value. This limiting value was reached as the ratio of the length to width dimen-
sions exceeded 1.7:1, which encompasses most modern pharmaceutical tablets. In addition the stress
analysis shows that this limiting value approximated to 2/3 that calculated for circular tablets. Hence for a
convex-faced elongated tablet the calculation for tensile strength generated by Pitt et al. [1] would become:
 
σ t ¼ 23 πD2 2:84 t −0:126
10P
where σt is the tensile strength, P is the fracture load, D is the length of the
ð D t
W þ3:15 W
D þ0:01Þ
short axis, t is the overall thickness and W is the wall height of the tablet, as shown in Fig. 1c. The solution was
then checked by applying it to commercial tablets of differing shapes to demonstrate its utility.
© 2011 Elsevier B.V. All rights reserved.

1. Introduction and simultaneously developed by Carneiro and Barcellos [4] in Brazil,


and by Akazawa [5] in Japan. The test is referred to as the “Brazilian”
The strength of a compact can be defined simply in terms of the com- or “indirect” tensile test as a tensile fracture is induced by compres-
pressive force required to fracture a specimen across its diameter [2]. In sive loading.
the pharmaceutical industry this is referred to as a “hardness test”. More The test is simple and easy to perform and has been widely used to
complex shapes can also be crushed by this method. However the break- determine the tensile strength of a variety of brittle materials such as
ing load does not take into account either the dimensions and shape of concrete [6], coal briquettes [7], Gypsum [8] and lactose tablets [9]. A
the compact or the mode of failure. The conversion of a fracture load to complete analytical solution exists for the stress state induced by the
tensile strength, which takes these factors into account, allows for loads [10]. A more detailed analysis of the diametrical compression
ready comparisons to be made between samples of different shapes or tests, where the effects of contact flattening and plastic material be-
sizes. haviour were considered, was presented by Procopio et al. [11].
The tensile strength of a tablet is an important attribute as the tablet These papers [6–11] give the expression for tensile stress (σt), de-
needs to be mechanically strong enough to withstand further handling termination in a flat-face compact as:
such as film–coating, packaging, transport and end-use by the patient,
but to be weak enough to break apart in the human body and so release 2P
σt ¼ ð1Þ
its contents. Generally, a tensile strength greater than 1.7 MPa will usu- πDt
ally suffice in ensuring that a tablet is mechanically strong enough to
withstand commercial manufacture and subsequent distribution. Ten- This theory was further developed for determination of the tensile
sile strengths down to 1 MPa may suffice for small batches where the strength of cylindrical convex-faced compacts by Pitt et al. [1]:
tablets are not subjected to large mechanical stresses [3].
The solution for finding a tensile strength for a plane-faced round 10P
σt ¼   ð2Þ
specimen from the diametral compression test was independently πD2 2:84 Dt −0:126 Wt þ 3:15 W
D þ 0:01

Both Eqs. (1) and (2) are listed in monograph 1217 of the United
⁎ Corresponding author. States Pharmacopoeia [12] and are in routine use in the pharmaceutical
E-mail address: Kendal.5.pitt@gsk.com (K.G. Pitt). industry. Increasingly, however, shapes more complex than simple

0032-5910/$ – see front matter © 2011 Elsevier B.V. All rights reserved.
doi:10.1016/j.powtec.2011.12.060
170 K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175

Fig. 1. Tablet shape and dimensions. (a): For Eq. (1). (b): For Eq. (2). (c): For Eq. (4).

cylinders are in use for oral tablets. For example oval and capsule 2. Finite element simulation
shaped tablets are designed both to assist in product identification
and to assist in ease of patient swallowing. To date though solutions 2.1. Finite element simulation: initial setup
have not been calculated for the determination of the tensile strength of
these elongated tablets due to the complexity of the mathematical analy- 2D and 3D FEA simulations were conducted using commercial
sis required. In the work below FEA was used to determine the stress dis- software COMSOL Multiphysics® 3.4 along with the COMSOL MEMS
tribution when tablets are loaded diametrically. The FEA model was first module (COMSOL AB, Stockholm, Sweden).
validated by comparing with the accepted stress solutions for flat-faced Static plain strain analysis combined with a deforming mesh was
and convex-faced circular tablets, prior to being applied to elongated tab- performed on a 2D geometry in order to simulate the circular flat-
lets. The FEA model resulted in a simple conversion curve for comparing faced tablet and compare to the known solution in Eq. (1). The geom-
round tablets to elongated tablets. This conversion was then checked by etry used can be found in Fig. 2a. Only a quarter of the geometry was
applying it to commercial tablets of differing shapes to demonstrate its modelled as the rest could be simulated by symmetry. The tablet is
utility. represented by a quarter circle (bottom of Fig. 2b) and loading was

Fig. 2. (a): Whole geometry showing the complete system and symmetry lines with the section used in the simulation shown is shaded. (b): Geometry setup for the simulations.
K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175 171

Fig. 3. (a): Example mesh for the whole model, with a box showing the contact area. (b): Example starting mesh for the contact area before elastic deformation. (c): Example mesh
for the contact area with the applied load, showing the elastic deformation and contact flattening of the tablet.

performed by applying a pressure to the top face of the block (shown deformation. The compression plate was also constrained to move
at the top of Fig. 2a). In the initial geometry, there is an infinitely only in the y direction.
small contact area between the tablet and the compression plate,
which would result in a theoretical infinite pressure at this location. 2.2. Finite element simulation: meshing
In order to remove the infinite pressure and make the simulation
closer to reality, the model incorporated a deforming mesh, which en- Example meshes can be found in Fig. 3. A triangular mesh was
abled the software to simulate contact flattening due to elastic used, with higher resolution on all three edges of the quarter-tablet,
deformation. and along the bottom-most edge of the steel compression plate
The material used for the compression plate was steel (Young's than in the bulk of these materials. The maximum element size
Modulus of 2 × 10 11 Pa). In the absence of reliable mechanical proper- around these edges was 50 μm. The bulk of the tablet was set with a
ties for a tablet, it was decided to initially model the tablet as an iso- maximum element size of 200 μm and the bulk of the compression
tropic, elastic material, with a Young's Modulus of 2 × 10 6 Pa. The plate was set with a maximum element size of 400 μm. The resulting
choice of Young's Modulus was based on an understanding that the mesh had 9673 triangular elements.
bulk of the contact flattening would be deformation of the tablet rath-
er than deformation of the compression plates, and therefore was 3. Results and discussion
chosen to be significantly smaller than that of steel. The choice of an
isotropic, elastic material was based on photographs of fractured tab- 3.1. Finite element simulation: model verification using circular tablets
lets from Fell and Newton [9], which do not show significant plastic
deformation of tablets after undergoing this compression test. Both The simulation was first validated by comparing the results with
the tablet and the compression plate were modelled as having a the accepted stress solutions for circular tablets. The value of most in-
thickness of 5 mm. The pressure applied to the top face of the com- terest to us was the failure mode of the tablets in this test. The failure
pression plate was 1 × 10 4 Pa in the -y direction. This pressure is mode is tensile stress in the x (horizontal) direction. Fig. 4a shows
equivalent to a force of 0.5 N. The force was chosen to be small as tensile stress in the x direction, showing that the negative values
it is sufficient to show the relative tensile stress for a given com- are numerically much larger than the positive values. However, the
pressive force, without the model being affected by plastic negative values are showing compression, so the important values
172 K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175

Fig. 4. (a): Initial model, showing compression and tension in the x direction. (b): Initial model, showing positive stress in the x direction only. Hence this shows tension in the x
direction, which is the failure mode in the diametral compression test. Future models show positive tensile stress only. (c): Initial model, but with a high Young's Modulus, low
compression and high spatial resolution. (d): Initial model but with high spatial resolution.

are those above zero, which can be seen in Fig. 4b. The peak tensile would be expected with the higher forces used in a real test of tensile
stress of the model described thus far was 6447 Pa (4sf). Inserting strength.
the same numbers into Eq. (1), we have P = 0.5 N, D = 10 mm and In order to further check the accuracy of the initial simulation, a
t = 5 mm. Hence σt = 6366 Pa (4sf). These tensile stress values, third simulation was performed, at a much higher resolution. In this
while not identical are within 2% of each other. high resolution model, the maximum element size at the point of
As it is possible that the small difference in outcome is due to the contact was set to 2.5 μm and all other parts of the mesh were refined
deformation of the tablet in the simulation, the simulation was repeat- significantly. The resulting mesh had 171,168 elements. The results of
ed but with a higher Young's Modulus for the tablet, at 2 × 10 10 Pa. this high resolution model, which can be seen in Fig. 4d, were ex-
This value results in minimal deformation of the tablet and therefore tremely similar to those of the initial model, but with a higher spatial
shows the relative effect of the deforming mesh. As shown in Fig. 4c, resolution and less points that appeared anomalous. The peak tensile
the result looked extremely similar to the initial model, but the peak stress was identical, at 6447 Pa (4sf). This high resolution simulation
tensile stress was almost identical to the theoretical calculation of showed that the original resolution had sufficient accuracy for all fu-
Eq. (1), at 6366 Pa (4sf). This shows that the deforming mesh was ture models.
the cause of the discrepancy in results between the simulation and Similar comparisons were carried out between the initial simula-
the theoretical calculation. However, for all later models, the lower tion and Eq. (2), setting t = W, ie a flat-faced tablet. With Eq. (2), its
Young's Modulus (2 × 10 6 Pa) was used, as some elastic deformation accuracy requires 0.1 ≤ W/D ≤ 0.3 [1]. Hence further simulations
K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175 173

Fig. 5. Extended capsule shapes showing positive tensile stress in the x direction, with D = 10 mm. (a): L = 12.5 mm. (b): L = 18 mm. (c): L = 25 mm.

were generated for comparison with thicknesses of 1 mm, 2 mm and diameter of the semicircle that makes up the end of the tablet the
3 mm. These new thinner models, and the initial simulation, which same. The physics, mesh constraints and underlying equations were
had a thickness of 5 mm (W/D = 0.5), compared favourably with kept identical to the initial model, with the compression loading
Eq. (2), all giving results within about 15% of the calculated result, being along the longer axis. Fig. 5 shows the impact of lengthening
which is consistent with the margin of error discussed in [1]. This the body of the tablet on the tensile stress distribution.
shows that, within a small margin of error, Eq. (2) can also be ap- The peak tensile stress from each simulation was added to a graph
plied to flat-faced tablets. These simulations are not shown here for comparison, as shown in Fig. 6. As the ratio of length to diameter
as the key difference between them and the original simulation is was increased the stress reached a limiting value 2/3 that of a circular
the numbers. tablet, as shown in Fig. 6. This limiting value occurring at a length to
width ratio of greater than 1.7:1; this encompasses most modern
tablets.
3.2. Finite element simulation: elongated tablets
Hence for a flat-faced elongated tablet the calculation for tensile
strength would become:
Elongation of the tablet was carried out by adding a rectangle onto
the bottom of the quarter circle of the tablet and recalculating. Rect-  
2 2P
angles were added in 0.25 mm increments, which were equivalent σt ¼ ð3Þ
3 πDt
to adding 0.5 mm of length to the whole tablet, while keeping the

Similarly, for a convex-faced elongated tablet the calculation for


tensile strength derived by Pitt et al. [1] would become:
6500
!
2 10P
σt ¼   ð4Þ
6000
3 πD2 2:84 Dt −0:126 Wt þ 3:15 W
D þ 0:01
Peak tensile stress, Pa

5500
3.3. Finite element simulation: 3D

5000 The same simulation was extended to three dimensions. 3D simu-


lations of tablets with flat faces agreed with the 2D simulations of the
same and with Eq. (1) (for a circular tablet) or Eq. (3) (for an elongat-
4500 ed tablet). 3D simulations of elongated tablets with convex sides (as
shown in Fig. 1c) and of an unconventional tablet design having a dif-
ferent width at the centre than the diameter of the semicircle at the
4000
1 1.5 2 2.5 3 end of the tablet all agreed with Eq. (4), within a small margin of
Length / Width ratio error as discussed in [1].
The 3D simulations had smaller compression plates and lower spa-
Fig. 6. Effect of shape on tensile strength for a tablet. tial resolution than the 2D models in order to minimise computation
174 K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175

Fig. 7. 3D model of a circular tablet under compression, showing positive and negative tensile stress in the x direction.

requirements. However they did agree with the 2D models and the 3.5. Application to manufacturing
equations. An example 3D model is shown in Fig. 7.
During the development of a commercial tablet, product was
compressed on a rotary tablet press both in a convex-faced round
3.4. Experimental data tablet shape and in a capsule-shaped tablet. On further processing,
edge erosion was seen with the round tablets but not with the cap-
The validity of Eq. (4) was demonstrated by manufacturing two sule shape. The round tablet hardness (compressive fracture load)
sets of tablets of identical formulation. One set was flat-faced circu- was 60 to 90 N and the capsule shape hardness was 100 to 140 N.
lar tablets of 6 mm diameter and 100 mg compression weight. The Converting these hardness values to tensile strength using Eqs. (2)
other set was convex-faced oval tablets of 17 mm long by 7 mm and (4) respectively enabled the cause of the edge erosion to be
wide and 750 mg compression weight. Both sets of tablets were assessed. The hardness values were equivalent to a tensile strength
compressed over a range of compaction pressures and then frac- of below 1 MPa for the damaged round tablets and above 1 MPa for
tured to determine their tensile strength. Fig. 8 clearly shows the capsule shape (Fig. 9), indicating that low tensile strength of the
agreement between the tensile strength calculated from Eq. (1) round tablets was the cause of the damage.
for the circular tablets and the tensile strength calculated from
Eq. (4) for the oval tablets. It should be additionally noted that 4. Conclusion
this was despite a 7-fold difference in volume between the tablet
shapes. The tensile strength of elongated tablets that do not show signifi-
cant plastic deformation can now be readily estimated, so facilitating

Fig. 8. Tensile strength comparison of flat-faced and oval convex-faced tablets. Fig. 9. Tensile strength comparison of tablet shapes.
K.G. Pitt, M.G. Heasley / Powder Technology 238 (2013) 169–175 175

the development and transfer of formulations and processes between [3] D. McCormick, Evolutions in direct compression, Pharmaceutical Technology 17
(4) (2005) 52–62.
differently shaped tablets. [4] F.F.L. Carneiro, A. Barcellos, Tensile strength of concrete, RILEM Bulletin 18 (1953)
99–107.
List of symbols [5] T. Akazawa, RILEM Bulletin 16 (1953) 11–23.
[6] P.J.F. Wright, Comments on an indirect tensile test on concrete cylinders, Maga-
zine of Concrete Research 7 (1955) 87–96.
σt tensile strength [MPa] [7] R. Berenbaum, I. Brodie, Measurement of the tensile strength of brittle materials,
P fracture load [N] British Journal of Applied Physics 10 (1959) 281–287.
[8] E. Addinall, P. Hackett, The effect of platen conditions on the tensile strength of
D length of short axis (equivalent to disc diameter) [m] rock-like materials, Civil Engineering and Public Works Review 59 (1964)
L length of long axis [m] 1250–1253.
t overall thickness [m] [9] J.T. Fell, J.M. Newton, Determination of tablet strength by diametral compression
test, Journal of Pharmaceutical Sciences 59 (1970) 688–691.
W tablet wall height [m] [10] S. Timoshenko, J.N. Goodier, Theory of elasticity, 2nd Edn McGraw Hill, New York,
1970.
[11] A. Procopio, A. Zavaliangos, J.C. Cunningham, Analysis of the diametrical com-
pression test and its applicability to plastically deforming materials, Journal of
References Materials Science 38 (2003) 3629–3639.
[12] The United States Pharmacopeia 2011. 34th Edn. US Pharmacopeia Convention,
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[2] J.E. Rees, E. Shotton, Some observations on the ageing of sodium chloride com-
pacts, Journal of Pharmacy and Pharmacology 22 (1970) 17S–23S.

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