Abstract

Background: In the present study, an attempt was made to develop and evaluate the ophthalmic suspension containing levocabastine hydrochloride.

Objective: The current research objective's rationale was to develop and assess ophthalmic suspension containing antihistamine to improve corneal penetration with corneal tissues and obtain therapeutic efficiency. Recently, ophthalmic drug delivery has become the modern pharmaceutical design standards and intensive research for achieving better drug product effectiveness, reliability, and safety. Topical medication by ocular drug delivery will continue to account for the largest share (up to 90%).

Methods: The prepared ophthalmic suspension had a minimum concentration of preservative preparation in appropriate packaging material. FTIR and UV spectrum of API was found as per specification. The individual IR spectra of the pure drug and the combination spectra of the drugs and other excipients indicated no interaction between API and other excipients than the infrared spectrum of the pure drug as all available group frequencies were present.

Results: The pH of all formulations was satisfactory in the range of 6.0-8.0; thus, there would be no irritation to the patient upon administration of the formulation. The particle size analysis revealed that the particles were in range, and all the formulations showed ideal surface morphology. All the formulations showed osmolality within the range, i.e., 250-500 mOsm/kg.

Conclusion: Finally it was confirmed that formulations of antihistamine ophthalmic suspension remained more stable at ambient temperature (25°C) and relative humidity (40%) as compared to other stability conditions as per ICH guidelines.

Keywords: Corneal Penetration; FTIR; Osmolality; Ambient Temperature; Relative Humidity

References

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Citation

Citation: Debashish Ghose., et al. “Formulation Development and Characterization of Levocabastine Hydrochloride Ophthalmic Suspension". Acta Scientific Pharmaceutical Sciences 5.2 (2020): 51-56.

Copyright

Copyright: © 2020 Debashish Ghose., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.