Novel platens to measure the hardness of a pentagonal shaped tablet.
Tablet hardness, a measure of the breaking force of a tablet, is based on numerous factors. These include the shape of the tablet and the mode of the application of force. For instance, when a pentagonal-shaped tablet was tested with a traditional hardness tester with flat platens, there was a large variation in hardness measurements. This was due to the propensity of vertices of the tablet to crush, referred to as an "improper break". This article describes a novel approach to measure the hardness of pentagonal-shaped tablets using modified platens. The modified platens have more uniform loading than flat platens. This is because they reduce loading on the vertex of the pentagon and apply forces on tablet edges to generate reproducible tablet fracture. The robustness of modified platens was assessed using a series of studies, which included feasibility and Gauge Repeatability & Reproducibility (R&R) studies. A key finding was that improper breaks, generated frequently with a traditional hardness tester using flat platens, were eliminated. The Gauge R&R study revealed that the tablets tested with novel platens generated consistent values in hardness measurements, independent of batch, hardness level, and day of testing, operator and tablet dosage strength.
a Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Jaya
J
Malladi
b Nonclinical Biostatistics, Global Biometrics Sciences, Research and Development, Bristol-Myers Squibb , Princeton , NJ , USA.
Kurex
K
Sidik
b Nonclinical Biostatistics, Global Biometrics Sciences, Research and Development, Bristol-Myers Squibb , Princeton , NJ , USA.
Sutan
S
Wu
c Global Manufacturing and Supply, Pharmaceutical Manufacturing, Bristol-Myers Squibb , Mount Vernon , IN , USA.
Ryan
R
McCann
a Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Jeffrey
J
Dougherty
d Global Manufacturing and Supply, Pharmaceutical Manufacturing, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Prakash
P
Parab
e Clinical Supply Manufacturing, Research and Development, Bristol-Myers Squibb , New Brunswick , NJ , USA.
Thomas
T
Carragher
D004339:Drug Compounding; D004867:Equipment Design; D006244:Hardness; D006245:Hardness Tests / Q000295:instrumentation* / Q000379:methods; D015203:Reproducibility of Results; D013607:Tablets / Q000737:chemistry*
D013607:Tablets
Hardness test tooling; mechanical property of tablets; pentagonal-shaped tablet; tablet fracture; tablet hardness testing