There are a variety of presentations for tablets as delivery systems for pharmaceutical agents, such as rapidly disintegrating, slowly disintegrating, eroding, chewable, and lozenge. Each of these presentations places a certain demand on the bonding, structure, and integrity of the compressed matrix. Tablets must be able to withstand the rigors of handling and transportation experienced in the manufacturing plant, in the drug distribution system, and in the field at the hands of the end users (patients/consumers). Manufacturing processes such as coating, packaging, and printing can involve considerable stresses, which the tablets must be able to withstand. For these reasons, the mechanical strength of tablets is of considerable importance and is routinely measured. Tablet strength serves both as a criterion by which to guide product development and as a quality control specification.

One commonly employed test of the ability of tablets to withstand mechanical stresses determines their resistance to chipping and surface abrasion by tumbling them in a rotating cylinder. The percentage weight loss after tumbling is referred to as the friability of the tablets. Standardized methods and equipment for testing friability have been provided in general chapter Tablet Friability 1216.

Another measure of the mechanical integrity of tablets is their breaking force, which is the force required to cause them to fail (i.e., break) in a specific plane. The tablets are generally placed between two platens, one of which moves to apply sufficient force to the tablet to cause fracture. For conventional, round (circular cross-section) tablets, loading occurs across their diameter (sometimes referred to as diametral loading), and fracture occurs in that plane.

The breaking force of tablets is commonly called hardness in the pharmaceutical literature; however, the use of this term is misleading. In material science, the term hardness refers to the resistance of a surface to penetration or indentation by a small probe. The term crushing strength is also frequently used to describe the resistance of tablets to the application of a compressive load. Although this term describes the true nature of the test more accurately than does hardness, it implies that tablets are actually crushed during the test, which often is not the case. Moreover, the term strength in this application can be questioned, because in the physical sciences that term is often used to describe a stress (e.g., tensile strength). Thus, the term breaking force is preferred and will be used in the present discussion.

Early measuring devices were typically hand operated. For example, the Monsanto (or Stokes) hardness tester was based on compressing tablets between two jaws via a spring gauge and screw. In the Pfizer hardness tester, the vertically mounted tablet was squeezed in a device that resembled a pair of pliers. In the Strong Cobb hardness tester, the breaking load was applied through the action of a small hydraulic pump that was first operated manually but was later motorized. Problems associated with these devices were related to operator variability in rates of loading and difficulties in proper setup and calibration. Modern testers employ mechanical drives, strain gauge–based load cells for force measurements, and electronic signal processing, and therefore are preferred. However, several important issues must be considered when using them for the analytical determination of breaking force; these are discussed below.

Platens

Rate and Uniformity of Loading

Dependence of Breaking Force on Tablet Geometry and Mass

Tablet Orientation

Units, Resolution, and Calibration

Sample Size

The measurement of tensile strengths provides a more fundamental measure of the mechanical strength of the compacted material and takes into account the geometry of the tablet. If tablets fail in tension, the breaking force can be used to calculate the tensile strength. Unfortunately, this is practical only for simple shapes. If flat-faced round tablets (right circular cylinders) fail in tension, as indicated by a clean split into halves under diametral compression, the breaking force may be used to compute the tensile strength from the following equation (4), which applies only to cylindrical tablets:

in which X is the tensile strength, F is the breaking force, D is the tablet diameter, and H is the tablet thickness. Because only tablets that fail in tension are counted, the data are based on tablets that fail in a consistent way. Thus, reproducibility of data should be enhanced when compared to conventional breaking-strength testing. Moreover, the data will be normalized with respect to tablet dimensions, because both diameter and thickness are included in the equation. The derivation of this equation may be found in standard texts (5, 6); it is based on elastic theory and the following assumptions:

The derivation has been extended to convex-faced tablets (7, 8):

where X is the tensile strength, F is the breaking force, D is the tablet diameter, H is the tablet thickness, and W is the central cylinder thickness (tablet wall height).

The slow and constant loading rate of modern motorized break force testers encourages tensile failure. However, ideal point loading may not occur, because of crushing and the induction of shear failure at the interface with the surface of the platens. The addition of padding to the platens helps prevent shear at contact points and promotes true tensile failure. On that basis, padding is strongly recommended when highly precise measurements are needed. Padding should be relatively thin so that any deviation from the assumption of true point-source force application will not be large. The padding should also collapse very easily so that its deformation does not become part of the force measured by the test apparatus. In more routine settings involving measurements on a large number of samples, the addition of padding could contribute to inaccuracies in measurement as powder from previously tested samples becomes embedded in the collapsible matrix and thereby alters its properties. Unless provisions for frequent and routine replacement of the padding are made, it can be considered acceptable to ignore the use of padding material to maintain constancy of the test conditions.

Bending or flexure of tablets is another option for determining the tensile strength of tablets. Under ideal loading conditions, a breaking load applied to the unsupported midpoint of one face will result in the generation of pure tensile stress in the opposite face. If the tablets are right circular cylinders and are subjected to three-point flexure, the tensile strength may be estimated using the following equation (9):

in which L is the distance between supports, and the other terms are as defined above. The assumptions are the same as those for calculating tensile strength from diametral compression. However, tensile strengths determined by flexure and diametral compression may not agree, because of likely nonideal loading and the induction of shear failure during testing.