Tablet orientation and failure should occur in a manner consistent with those used during the development of the dosage form. When they are oriented with their scores perpendicular to the platen faces, the likelihood that tensile failure will occur along the scored line increases. 0000009879 00000 n 11/22/2016 32(2) Second Interim Revision Announcement: <1216> TABLET FRIABILITY The functional calibration of a breaking force test apparatus should also confirm that the velocity and the constancy of velocity for load application or displacement are within prescribed tolerances throughout the range of platen movement.In order to achieve sufficient statistical precision for the determination of average breaking force, a minimum of 6 tablet samples should be tested. Manufacturing processes such as coating, packaging, and printing can involve considerable stresses, which the tablets must be able to withstand. Each of these presentations places a certain demand on the bonding, structure, and integrity of the compressed matrix. Literature issued JANUARY 2008 . Tablet splitting is a widely spread and accepted practice in the field of pharmacy. 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. Problems associated with these devices were related to operator variability in rates of loading and difficulties in proper setup and calibration. When scored tablets are oriented with their scores parallel to the platen faces, more general information about the strength of the matrix is derived.Capsule-shaped tablets or scored tablets may best be broken in a three-point flexure test (Modern breaking force testers are usually calibrated in kiloponds or newtons. 0000009112 00000 n 0000000872 00000 n Food and Drug Administration As a result, some manufacturers have dropped the practice, but many still include “USP” on the label after the ingredient name. The force sensor as well as the mechanics of the apparatus needs to be considered. xref 0000004169 00000 n Breaking forces should be readable to within 1 N.Breaking force testers should be calibrated periodically. Loss of mass: 15 tablets to be tested to ensure the loss of mass less than 3.0% between the individual segments when compared to the whole tablet.

Tablet Splitability (Mechanical and Non-mechanical) The tablets splitability to be tested at both ends of proposed hardness range. ELDEPRYL tablets are available containing 5 mg of selegiline hydrochloride. 0000004743 00000 n However, tablets with a unique or complex shape may have no obvious orientation for breaking force determination. Since there are certain advantages to each system of load application, both are found in practice. The relationship between these units of force (Generally, contemporary breaking force testers use modern electronic designs with digital readouts. 0000011200 00000 n Changing from testing units of different designs or from different manufacturers will require comparison of data to ensure that the two units are subjecting the dosage form to similar stress in a similar manner.

In general, tablets are tested either across the diameter or parallel to the longest axis. For these reasons, the mechanical strength of tablets is of considerable importance and is routinely measured. 0000002553 00000 n Tampa, FL 33607 . Perpendicularity must be preserved during platen movement, and the mechanism should be free of any bending or torsion displacements as the load is applied. 0000003200 00000 n Because the particular testing situation and the type of tablet matrix being evaluated will pose different constraints, there is also no basis to declare an absolute preference for one system over the other. 0000003926 00000 n In cases where breaking force may be particularly critical, the average plus individual breaking force values should be accessible.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. They are available as: NDC 39506-011-25 bottles of 60 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. The average breaking force alone may be adequate to fulfill the purpose of process or product quality control. Tablet orientation in diametral compression of round tablets without any scoring is unequivocal.