Effect of Stearic Acid Particle Size on Surface Characteristics of Film-Coated Tablets |
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Authors: | N H Shah C I Patel M H Infeld R J Margolis A M Railkar A W Malick |
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Affiliation: |
a Pharmaceutical Research and Development, Hoffmann-La Roche, Inc., Nutley, NJ |
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Abstract: | Raw material specifications are vital for many excipients used in the manufacture of tablets. Stearic acid powder is widely used in the pharmaceutical industry as a tablet lubricant. This study shows that the variation in particle size of stearic acid not only affects die wall lubrication properties (ejection force) but also affects surface characteristics of film-coated tablets. A coarser grade of stearic acid can dislodge from tablet surfaces during the film-coating process leaving pit marks, whereas a finer grade of stearic acid (less than 100 mesh) results in film-coated tablets having very smooth surfaces. The mechanism of pitting on the tablet surface is described. A specification for stearic acid particle size to overcome this problem is suggested. |
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