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Journal of Pharmaceutical Research

Article

A Study on the Synthesis and Characterization of Various Polymorphic Forms of Carbinoxamine Maleate and Orphenadrine Citrate
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v20.1.ankesh

Year: 2021, Volume: 20, Issue: 1, Pages: 21-26

Original Article

A Study on the Synthesis and Characterization of Various Polymorphic Forms of Carbinoxamine Maleate and Orphenadrine Citrate

Savaliya Ankesh Mansukhbhai1, Amit Kumar Das1,∗

1Department of Pharmaceutical Chemistry, Krupanidhi College of Pharmacy, Bangalore, Karnataka, India

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

Pharmaceutical polymorphisms can affect the solubility, stability, and bioavailability of compounds. The objective of this study was to synthesise and characterise different polymorphic forms of carbinoxamine maleate and orphenadrine citrate, which are antihistaminic drugs, to assess their physicochemical variations. This study was conducted at the Krupanidhi College of Pharmacy, Bangalore. Recrystallisation with various solvent systems and cooling methods was used to synthesise polymorphs of carbinoxamine maleate and orphenadrine citrate. Characterisation was carried out using Fourier Transform Infrared Spectroscopy, Differential Scanning Calorimetry, and Powder X-ray Diffraction, assisted by melting point, ¹H NMR, and mass spectrometry. Different polymorphic forms were successfully synthesised and characterised. Carbinoxamine maleate polymorphs showed melting point peaks ranging from 119.98°C to 122.54°C with enthalpies from -3.63 to -105.93 J/g, while orphenadrine citrate showed a peak at 139.27°C with an enthalpy of -129.51 J/g. PXRD confirmed structural variation, with major peaks for polymorphs ranging from 4.26 Å to 4.49 Å, indicating differences in crystallinity and stability. Fourier Transform Infrared Spectroscopic analysis showed functional group uniformity among polymorphs, whereas Differential Scanning Calorimetry indicated large melting point and enthalpy variations, suggesting thermodynamic differences. Powder X-ray Diffraction characterisation differentiated polymorphs through characteristic diffraction patterns, allowing them to be grouped according to their interplanar spacing and intensity. This study presents the first comparative polymorphic profile of carbinoxamine maleate and orphenadrine citrate, highlighting their structural variability and stability, which can be utilised to maximise formulation strategies for pharmaceutical development.

Keywords: Polymorphism, Carbinoxamine maleate, Orphenadrine citrate, Antihistamine, Bioavailable

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Copyright

© 2025 Published by Krupanidhi College of Pharmacy. This is an open-access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/) 

  • 04 June 2025

Year: 2021, Volume: 20, Issue: 1


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