Introduction: Pre-formulation research serves as the foundational gatekeeper in
pharmaceutical development, ensuring an active ingredient possesses the
necessary physicochemical profile for viable commercialization.
Objective: To perform a comprehensive preformulation study of cinnarizine and
dimenhydrinate, characterizing their key physicochemical properties to guide
rational formulation design.
Methods: The physiochemical characteristics of both medications were examined.
Additionally, solubility was assessed in a range of pH-varying solvents, and
FTIR and absorption maxima were used to assess purity. A standard calibration
curve was created to support more analytical research investigations. Finally,
research on the compatibility of drugs and excipients were conducted.
Results: Organoleptic characteristics showed that both medications were odorless
and nearly white in color. The partition coefficient and melting point were
noted in range. The infrared spectra, which displayed distinctive peaks, and UV
spectroscopy, which displayed maxima at 253 nm for cinnarizine and 276 nm for
dimenhydrinate, were used to establish the drug's purity. The derived standard
curve was linear, with an equation of y = 0.0788 + 0.069 and a correlation
coefficient of R2 = 0.996 & 0.999. Drug samples showed no discernible
alterations in terms of coloring, liquefaction, or odor, indicating that there
were no drug excipient interactions.
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