PREPARATION, VALIDATION, EFFICACY AND SAFETY ASSESSMENT OF TOPICAL ANTI-INFLAMMATORY FORMULATION
Authors: D’souza MG , KASAR R, BORSE LB AND BYAHATTI VV

ABSTRACT
Inflammation is a biological defence mechanism, but chronic inflammation can contribute to conditions such as arthritis and musculoskeletal disorders. This study focuses on the formulation, validation, and evaluation of an anti-inflammatory formulation (ointment) containing glucosamine sulphate, methyl salicylate, magnesium sulphate, clove oil and sodium chloride as active pharmaceutical ingredients. The ointment was developed using a modified fusion method and assessed for physicochemical and pharmacological efficacy. Among the three formulations; F1, F2, and F3, F2 exhibited optimal pH, spreadability, viscosity and compatibility and demonstrated significant analgesic and anti-inflammatory activity making it the most suitable for topical application. Stability studies confirmed that F2 maintained its efficacy over twelve months without significant degradation. UV-visible spectroscopy analysis validated the presence of glucosamine sulfate and methyl salicylate at 210 nm and 270 nm, respectively, while FTIR analysis confirmed the structural integrity and compatibility of the formulation components. Skin sensitivity tests revealed no redness, irritation or adverse reactions. These findings indicate that F2 is a promising, stable, and effective anti-inflammatory ointment formulation. Keywords: Anti-inflammatory, Ointment, Glucosamine Sulfate, Methyl salicylate, Magnesium sulphate, Clove oil, Validation
Publication date: 01/05/2026
    https://www.ijbpas.com/pdf/2026/May/MS_IJBPAS_2026_10096.pdf
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https://doi.org/10.31032/IJBPAS/2026/15.5.10096