Research Article

AAPS PharmSciTech

, Volume 14, Issue 4, pp 1333-1340

First online:

Stability of Benzocaine Formulated in Commercial Oral Disintegrating Tablet Platforms

  • Melanie KöllmerAffiliated withDepartment of Biopharmaceutical Sciences, University of Illinois
  • , Carmen PopescuAffiliated withRoquette America Inc.
  • , Prashanth MandaAffiliated withRoquette America Inc.Department of Pharmaceutics, University of Mississippi
  • , Leon ZhouAffiliated withRoquette America Inc.
  • , Richard A. GemeinhartAffiliated withDepartment of Biopharmaceutical Sciences, University of IllinoisDepartment of Bioengineering, University of IllinoisDepartment of Ophthalmology and Visual Sciences, University of Illinois Email author 

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Pharmaceutical excipients contain reactive groups and impurities due to manufacturing processes that can cause decomposition of active drug compounds. The aim of this investigation was to determine if commercially available oral disintegrating tablet (ODT) platforms induce active pharmaceutical ingredient (API) degradation. Benzocaine was selected as the model API due to known degradation through ester and primary amino groups. Benzocaine was either compressed at a constant pressure, 20 kN, or at pressure necessary to produce a set hardness, i.e., where a series of tablets were produced at different compression forces until an average hardness of approximately 100 N was achieved. Tablets were then stored for 6 months under International Conference on Harmonization recommended conditions, 25°C and 60% relative humidity (RH), or under accelerated conditions, 40°C and 75% RH. Benzocaine degradation was monitored by liquid chromatography–mass spectrometry. Regardless of the ODT platform, no degradation of benzocaine was observed in tablets that were kept for 6 months at 25°C and 60% RH. After storage for 30 days under accelerated conditions, benzocaine degradation was observed in a single platform. Qualitative differences in ODT platform behavior were observed in physical appearance of the tablets after storage under different temperature and humidity conditions.

Key words

benzocaine degradation oral disintegrating tablet platform stability