Aguirre Mendez, Claudia P.

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    Determination of Magnesium stearate in pharmaceutical powder with Raman and Near Infrared Spectroscopy (NIRS)
    (2006) Aguirre Mendez, Claudia P.; RomaƱach, Rodolfo J.; College of Arts and Sciencies - Sciences; Mina, Nairmen; AcuƱa FernƔndez, Edgar; Department of Chemistry; Colon, Omar
    Magnesium stearate is the most widely used lubricant. Its main use is to facilitate tablet ejection from compressing machines in pharmaceutical tablet formulations. But, adverse effects have been reported when it is used in excessive concentrations or the lubrication time is too long. Current analytical methodologies do not allow on-line detecting or correction of such problems and thus new alternative methodologies to deal with this problem are needed. New initiatives such as Process Analytical Technology (PAT) stimulate science based knowledge of processes encouraging the development of methodologies for monitoring pharmaceutical processes in real time. In this research a Raman spectroscopic method is described to detect magnesium stearate in powder blends and tablets. Formulations including magnesium stearate and one of the following excipients: lactose, mannitol, corn starch, and other commercially important excipients, were used. The detection limit was also computed and reported to be 0.1% (w/w) based on the 2848 cmā»Ā¹ band that corresponds to the symmetric stretch of the methylene group in magnesium stearate. NIR spectroscopy also was evaluated. The magnesium stearate spectra showed a strong absorption centered at 5780 cmā»Ā¹ and 4324 cmā»Ā¹corresponding to the first overtone of C-H stretching and combination of CH stretching respectively. The NIR spectra of this formulation overlapped with bands of mannitol. Near-infrared and Raman spectroscopy have each been demonstrated to be capable of rapid magnesium stearate analysis in the range of 0.25% to 5% (w/w) most typically encountered in pharmaceutical powders and solid dosage forms. Additionally, NIR and Raman spectroscopy are nondestructive and are more amenable to on-line applications due to reduced sample handling requirements. This study could increase manufacturing efficiency and help avoid the negative effects associated with magnesium stearate lubrication.