Author(s)
Miss. Shivani Vishwanath More, Miss. Shweta Vitthal Jadhav, Miss. Arpita Ganpatrao Jadhav, Mr. Gajanan D. Mogal
- Manuscript ID: 120686
- Volume 2, Issue 6, May 2026
- Pages: 675–686
Subject Area: Pharmaceutical Science and Pharmacology
Abstract
Diclofenac sodium is a widely used non-steroidal anti-inflammatory drug (NSAID) employed for the treatment of pain, inflammation, rheumatoid arthritis, osteoarthritis, muscular disorders, and sports injuries. The present study focuses on the formulation and evaluation of diclofenac ointment for topical drug delivery. Topical administration of diclofenac offers several advantages over oral administration, including localized drug action, improved patient compliance, prolonged therapeutic effect, and reduced gastrointestinal side effects.
The ointment was prepared by the fusion method using suitable ingredients such as white soft paraffin, liquid paraffin, beeswax, cetostearyl alcohol, propylene glycol, methyl paraben, propyl paraben, and purified water. Diclofenac sodium was incorporated into the ointment base with continuous stirring to ensure uniform distribution of the drug. The prepared formulation was evaluated for various physicochemical parameters including color, odor, appearance, texture, consistency, homogeneity, pH, spreadability, washability, viscosity, drug content uniformity, and stability.
The prepared ointment showed smooth texture, good homogeneity, acceptable consistency, and satisfactory spreadability. The pH of the formulation was found within the acceptable skin range, indicating suitability for topical application without causing irritation. Drug content analysis confirmed uniform distribution of diclofenac sodium throughout the ointment base. Stability studies indicated that the formulation remained stable under normal storage conditions without significant changes in appearance, pH, or consistency.
In-vitro drug release studies demonstrated satisfactory release of diclofenac from the ointment base, suggesting effective penetration through the skin. The use of propylene glycol as a penetration enhancer improved drug diffusion and therapeutic effectiveness. The formulation exhibited good physical stability and patient-acceptable characteristics.
The study concluded that diclofenac ointment can be successfully formulated using suitable ointment bases and excipients to provide effective topical anti-inflammatory therapy. The prepared formulation demonstrated desirable pharmaceutical properties and may serve as a promising topical dosage form for the management of pain and inflammation with minimized systemic adverse effects.