Formulation and Evaluation of a Natural Excipients-Based Diclofenac Sodium Topical Ointment

Year : 2026 | Volume : 13 | 02 | Page :
    By

    Meet Rathod,

  • Dhruv Patel,

  • Apurba Chakrabarty,

  • Nilesh Prakash Badgujar,

  1. Students, Department of Chemical Technology, UPL University of Sustainable Technology, Ankleshwar, Gujarat, India
  2. Students, Department of Chemical Technology, UPL University of Sustainable Technology, Ankleshwar, Gujarat, India
  3. Assistant Professor, Department of Chemical Technology, UPL University of Sustainable Technology, Ankleshwar, Gujarat, India
  4. Professor, Department of Chemical Technology, UPL University of Sustainable Technology, Ankleshwar, Gujarat, India

Abstract

The present study reports the formulation and evaluation of a diclofenac sodium topical ointment incorporating natural excipients to improve skin compatibility and formulation sustainability. Conventional topical non-steroidal anti-inflammatory drug (NSAID) formulations frequently rely on synthetic excipients that may cause dermal irritation and pose environmental concerns. To address these limitations, a 1% w/w diclofenac sodium ointment was developed using aloe vera gel, glycerin, xanthan gum, peppermint oil, vitamin E, and isopropyl alcohol as functional excipients. The formulation was evaluated for physicochemical properties, including pH, viscosity, spreadability, homogeneity, in-vitro drug release, microbial quality, and accelerated stability. The optimized formulation exhibited a skin-compatible pH of 6.2, viscosity of 62,000 mPa·s, and good spreadability (95.24 g·cm s⁻¹). In-vitro diffusion studies demonstrated sustained drug release, with 82.43% of diclofenac released within 6 h. Microbiological evaluation confirmed compliance with pharmacopeial limits, indicating adequate preservative efficacy. Stability studies showed that the formulation remained physically and chemically stable under ambient conditions for 30 days, with reduced stability observed at temperatures above 40 °C. These findings demonstrate that natural excipients can effectively replace synthetic components in topical diclofenac formulations without compromising performance. The developed formulation represents a promising, skin-friendly, and sustainable alternative for topical NSAID delivery, warranting further in-vivo and clinical investigations.

Keywords: Diclofenac sodium topical ointment, NSAIDs, TDDS, Topical Delivery, Pain and inflammation

How to cite this article:
Meet Rathod, Dhruv Patel, Apurba Chakrabarty, Nilesh Prakash Badgujar. Formulation and Evaluation of a Natural Excipients-Based Diclofenac Sodium Topical Ointment. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(02):-.
How to cite this URL:
Meet Rathod, Dhruv Patel, Apurba Chakrabarty, Nilesh Prakash Badgujar. Formulation and Evaluation of a Natural Excipients-Based Diclofenac Sodium Topical Ointment. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(02):-. Available from: https://journals.stmjournals.com/rrjodfdp/article=2026/view=240779


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Ahead of Print Subscription Original Research
Volume 13
02
Received 10/03/2026
Accepted 10/04/2026
Published 23/04/2026
Publication Time 44 Days
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