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Journal of Pharmaceutical Research

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Design and Evaluation of Injectable Suspension Containing Anti-inflammatory Glucocorticoids
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Journal of Pharmaceutical Research

DOI: 10.18579/jopcr/v18.2.anil

Year: 2019, Volume: 18, Issue: 2, Pages: 9-16

Original Article

Design and Evaluation of Injectable Suspension Containing Anti-inflammatory Glucocorticoids

Anil A Prabhu1, B A Vishwanath1,∗

1Department of Pharmaceutics, Krupanidhi College of Pharmacy, Bangalore, 560035, Karnataka,, India

Creative Commons License

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

Abstract

Objective: The aim of the present work was to formulate an intramuscular injection of Betamethasone acetate and Betamethasone sodium phosphate. Betamethasone acetate, an insoluble substance, was formulated as a depot suspension for parenteral use, whereas betamethasone sodium phosphate was used for immediate action, with excipients such as buffering agents, surfactants, complexing agents, and preservatives. Methods: The formulation involved batch optimisation of preservatives, surfactants, and homogenisation with consistent API quantities. The final formulation contained 3 mg each of Betamethasone acetate, betamethasone sodium phosphate, 3.4 mg monobasic sodium phosphate, 7.1 mg dibasic sodium phosphate, 0.01 ml polysorbate 80, 0.1 mg disodium edetate, and 0.2 mg benzalkonium chloride per 1 ml suspension. The in vitro assessments included compatibility, pH, assay, related substances, syringeability, particle size, zeta potential, sedimentation, resuspendability, dissolution, and SEM. All the in vitro evaluation parameters were within the limits specified by the USP. Findings: Stability studies conducted according to ICH guidelines concluded that the optimised formulation was stable. The drug was found to be compatible and stable with the excipients. Novelty: This study successfully developed a stable and effective intramuscular injection of betamethasone acetate and betamethasone sodium phosphate for depot action. This dual-action formulation, which combines immediate and sustained release properties, offers significant advancement in injectable corticosteroid therapies.

Keywords: Betamethasone acetate, Betamethasone sodium phosphate, DSC, SEM, Zeta potential, Depot suspensions

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Copyright

© 2018 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/) 

  • 02 October 2024

Year: 2019, Volume: 18, Issue: 2


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