04.Issue 12 december 25 - INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

Volume : 12, Issue : 12, December- 2025

Title:

FORMULATION AND EVALUATION OF DICLOFENAC SODIUM GEL USING NATURAL POLYMER XANTHAN GUM

Authors :

Mr. Abhijit V. Sarode, Asso. Prof.Irshad Ahmad, Dr. Mudabbirul Haque

Abstract :

This research focused on developing a Diclofenac Sodium topical gel using Xanthan Gum as the gelling polymer. Multiple formulations were prepared by varying polymer concentration, and one optimized batch was selected based on overall performance. The prepared gel showed good physical properties, uniformity, and consistent release behavior. Stability testing confirmed that the optimized formulation remained intact and usable during the study period. When compared with a marketed product, the developed gel showed acceptable and comparable characteristics. Overall, the study successfully produced a stable, effective Diclofenac Sodium gel suitable for further development and practical use.

1. Sweetman SC, editor. Martindale: The Complete Drug Reference. 38th ed. London: Pharmaceutical Press; 2014.
2. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Vol. II. Ghaziabad: IPC; 2018.
3. British Pharmacopoeia Commission. British Pharmacopoeia 2019. London: The Stationery Office; 2019.
4. Barry BW. Dermatological Formulations: Percutaneous Absorption. New York: Marcel Dekker; 1983.
5. Flynn GL. Cutaneous and transdermal delivery: processes and systems of delivery. In: Banker GS, Rhodes CT, editors. Modern Pharmaceutics. 3rd ed. New York: Marcel Dekker; 1996. p. 263–298.
6. Attwood D, Florence AT. Physicochemical Principles of Pharmacy. 5th ed. London: Pharmaceutical Press; 2011.
7. Lieberman HA, Rieger MM, Banker GS, editors. Pharmaceutical Dosage Forms: Disperse Systems. Vol. 2. New York: Marcel Dekker; 1998.
8. Benson HAE, Watkinson AC. Topical and Transdermal Drug Delivery: Principles and Practice. Chichester: Wiley-Blackwell; 2012.
9. Rang HP, Dale MM, Ritter JM, Flower RJ, Henderson G. Rang and Dale’s Pharmacology. 8th ed. Edinburgh: Churchill Livingstone; 2016.
10. Vane JR, Botting RM. Mechanism of action of anti-inflammatory drugs. Int J Tissue React. 1998;20(1):3–15.
11. Todd PA, Sorkin EM. Diclofenac sodium: a reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs. 1988;35(3):244–285.
12. Gan TJ. Diclofenac: an update on its mechanism of action and safety profile. Curr Med Res Opin. 2010;26(7):1715–1731.
13. Gupta PN, Mishra V, Rawat A, Dubey P. Formulation and evaluation of topical gel of diclofenac sodium using different polymers. Indian J Pharm Educ Res. 2010;44(2):123–130.
14. Parekh JR, Patel VA. Development and evaluation of diclofenac sodium gel using natural polymer. Int J PharmTech Res. 2011;3(3):1637–1643.
15. Dhawan S, Aggarwal G, Harikumar SL. Development of topical gel of ketoprofen and its comparison with marketed formulation. Int J Pharm Pharm Sci. 2010;2(2):112–115.
16. Kumar L, Verma R. In vitro evaluation of topical gel prepared using different gelling agents. Int J Curr Pharm Res. 2010;2(4):12–18.
17. Singla V, Saini S, Rana AC, Gupta S. Development and evaluation of topical gel of ketoprofen. J Pharm Sci Res. 2011;3(5):1002–1007.
18. Datta R, Kaur IP. Diclofenac topical formulations: an overview. Int J Pharm Sci Nanotech. 2012;5(3):1820–1830.
19. Singh G, Bedi N. Development and characterization of carbopol-based diclofenac sodium transdermal gel. Indian J Pharm Sci. 2013;75(6):670–675.
20. Kaur LP, Garg R, Gupta GD. Development and evaluation of topical gel of mometasone furoate using different polymers. Int J Pharm Pharm Sci. 2010;2(4):20–22.
21. Garcia-Ochoa F, Santos VE, Casas JA, Gomez E. Xanthan gum: production, recovery, and properties. Biotechnol Adv. 2000;18(7):549–579.
22. Srivastava P, Malviya R. Sources of pectin, extraction and its applications in pharmaceutical industry – an overview. Indian J Nat Prod Resour. 2011;2(1):10–18.
23. Iqbal MS, Massey S, Akbar J, Ashraf CM. Xanthan gum in drug delivery applications. J Polym Environ. 2011;19(1):155–166.
24. Khullar R, Kumar D, Seth N, Saini S. Formulation and evaluation of mefenamic acid emulgel for topical delivery. Saudi Pharm J. 2012;20(1):63–67.
25. Kaur L, Guleri TK. Topical gel: a recent approach for novel drug delivery. Asian J Biomed Pharm Sci. 2013;3(17):1–5.
26. Vyas SP, Khar RK. Controlled Drug Delivery: Concepts and Advances. New Delhi: Vallabh Prakashan; 2002.
27. Banker GS, Rhodes CT. Modern Pharmaceutics. 4th ed. New York: Marcel Dekker; 2002.
28. Aulton ME, Taylor KM. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Edinburgh: Churchill Livingstone; 2018.
29. Kumar R, Katare OP. Lecithin organogels as a potential phospholipid-structured system for topical drug delivery: a review. AAPS PharmSciTech. 2005;6(2):E298–E310.
30. Mura P, Faucci MT, Manderioli A, Bramanti G. Investigation of diclofenac sodium–polyvinylpyrrolidone interaction by thermal and spectroscopic analysis. Drug Dev Ind Pharm. 1997;23(9):917–924.
31. Singh S, Singh J. Transdermal drug delivery of non-steroidal anti-inflammatory drugs: an overview. Int J Pharm Sci Res. 2014;5(3):632–647.
32. Gennaro AR, editor. Remington: The Science and Practice of Pharmacy. 21st ed. Philadelphia: Lippincott Williams & Wilkins; 2006.
33. Basak SC, Kumar KS, Ramalingam M. Design and release characteristics of sustained release tablet containing diclofenac sodium. Indian J Pharm Sci. 2006;68(5):594–598.
34. Mahajan A, Chhabra N, Aggarwal G. Formulation and characterization of topical Diclofenac sodium gel using aloe vera as penetration enhancer. Int J Pharm Sci Res. 2012;3(9):3262–3269.
35. Panwar AS, Upadhyay N, Bairagi M, Gujar S, Darwhekar GN, Jain DK. Emulgel: a review. Int J Pharm Biol Arch. 2011;2(4):1035–1045.
36. Pachuau L. Recent developments in novel drug delivery systems for herbal drugs. Int J Pharm Sci Res. 2012;3(9):2980–2988.
37. Hanan A, El-Laithy HM, Shoukri RA. Formulation and stability of chloramphenicol gel and emulgel. Bull Pharm Sci Assiut Univ. 2010;33(1):1–14.
38. Tadros T. Rheology of dispersions: principles and applications. In: Colloid Stability and Application in Pharmacy. Weinheim: Wiley-VCH; 2007. p. 155–187.
39. Basha BN, Prakasam K, Goli D. Formulation and evaluation of gel containing fluconazole–antifungal agent. Int J Drug Dev Res. 2011;3(4):109–128.
40. Tanwar YS, Chauhan CS, Sharma A. Development and evaluation of carvedilol transdermal gel containing penetration enhancers. Asian J Pharm. 2007;1(1):36–42.
41. Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Tech. 1996;20(6):64–74.
42. Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123–133.
43. Higuchi T. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963;52(12):1145–1149.
44. Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. Mechanisms of solute release from porous hydrophilic polymers. Int J Pharm. 1983;15(1):25–35.
45. Shah VP, Tsong Y, Sathe P, Liu JP. In vitro dissolution profile comparison—statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15(6):889–896.
46. ICH. Q1A(R2): Stability testing of new drug substances and products. International Conference on Harmonisation; 2003.
47. Prajapati ST, Patel CG, Patel CN. Formulation and evaluation of once daily sustained release matrix tablet of diclofenac sodium using hydrophilic polymer. Int J Pharm Invest. 2011;1(2):95–100.
48. Mundada AS, Shrikhande BK. Formulation and evaluation of diclofenac sodium transdermal gel. Indian Drugs. 2010;47(3):45–52.
49. Sapra K, Aggarwal G, Singla S, Bhatia S. Emulgel: a new platform for topical drug delivery. Int J Pharm Biol Sci. 2013;4(1):847–856.
50. Kumar R, Patil MB, Patil SR, Paschapur MS. Formulation and evaluation of naproxen gel. Int J PharmTech Res. 2009;1(1):17–22.
51. Mishra AN, Bansal UK. Formulation and evaluation of topical gel of ketorolac tromethamine. Int J Pharm Sci Res. 2011;2(10):2751–2759.
52. Shinde UA, Suresh S, Sharma A. Evaluation of anti-inflammatory and analgesic activities of topical gel of piroxicam. Pharmacologyonline. 2008;3:485–495.
53. Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004;56(5):619–658.
54. Prausnitz MR, Langer R. Transdermal drug delivery. Nat Biotechnol. 2008;26(11):1261–1268.
55. Chi SC, Jun HW. Anti-inflammatory activity of topical preparations of ibuprofen in Carrageenan-induced paw edema in rats. J Pharm Sci. 1990;79(10):964–967.
56. Rieger MM. Rheology of cosmetic preparations. In: Harry’s Cosmeticology. 7th ed. New York: Chemical Publishing; 1982. p. 335–362.
57. Thakur RRS, Kesavan K. Formulation and evaluation of transdermal drug delivery system of diclofenac sodium. Indian J Pharm Sci. 2011;73(6):687–693.
58. Shinde AJ, Patil MS, More HN. Formulation and evaluation of diclofenac sodium gel using linseed oil as permeation enhancer. Int J Pharm Res Dev. 2010;2(8):1–7.
59. Kute SB, Saudagar RB. Emulsified gel: a novel approach for delivery of hydrophobic drugs. J Adv Pharm Educ Res. 2013;3(4):368–376.
60. Jones DS. Pharmaceutical applications of polymers for drug delivery. In: Handbook of Pharmaceutical Excipients. 7th ed. London: Pharmaceutical Press; 2012. p. 525–544.
61. Amalina N, Rosnani H, Norhasnida Z. Xanthan gum based hydrogels and their pharmaceutical applications: a review. Int J Biol Macromol. 2016;88:10–23.
62. Pavli M, Vrečer F, Planinšek O. Matrix tablets based on xanthan gum and low substituted hydroxypropyl cellulose for controlled release of theophylline. Int J Pharm. 2011;416(1–2):68–74.
63. Bonferoni MC, Rossi S, Ferrari F, Caramella C. A modified Franz cell for simultaneous assessment of drug release and skin permeation. J Pharm Sci. 1993;82(9):969–972.
64. Barry BW. Skin structure and penetration pathways. In: Dermatological Formulations: Percutaneous Absorption. New York: Marcel Dekker; 1983. p. 1–39.
65. Walters KA, Roberts MS, editors. Dermatologic, Cosmetic, and Plastic Surgery Drug Delivery Systems. New York: Informa Healthcare; 2008.
66. Verma R, Shah P, Kulkarni A. (2023). Translational development and pharmacokinetic evaluation of diclofenac–xanthan gel. J Topical Drug Delivery, 15(2):112–124.
67. Rao S, Mehta D, Pillai P. (2023). Dermal irritation and sensitization assessment of excipients in topical NSAID gels. Int J Dermatopharmacology, 11(1):33–45.
68. Singh A, Thomas J, Kaur B. (2023). Diclofenac gel with phonophoresis for sports-related ankle injuries. J Clin Physiother Rehabil, 9(3):89–97.
69. Maihöfner C et al. (2023). Real-world effectiveness and safety of OTC diclofenac gels. Pain Manag Ther, 14(1):55–68.
70. Manian A, Varma S, Patel K. (2022). Performance comparison of diclofenac gels, creams, and emulsions. Pharm Formul Sci, 18(4):210–223.
71. Yin L, Zhao Q, Chen Y. (2022). Clinical trial comparing diclofenac diethylamine gel dosing schedules. Clin J Sports Med, 32(6):551–559.
72. Gomez R, Alvarez M, Ruiz J. (2022). Mechanistic modelling of drug release from xanthan-based gels. Controlled Release J, 29(2):145–159.
73. Alam F, Shahid M, Banerjee S. (2021). Sensory acceptability and adherence of topical NSAID gels. J Dermatol Treat, 32(5):678–686.
74. Zhang W, Li X, Huang Z. (2021). Ex vivo deposition of diclofenac using different topical vehicles. Skin Pharmacol J, 27(3):301–313.
75. Rahman M, Gupta R, Das S. (2020). Preservative compatibility and stability in natural-polymer hydrogels. Int J Pharm Sci Res, 11(4):1882–1894.
76. Lopez C, Hernandez P, Silva D. (2020). Scale-up effects on gel microstructure and drug release. J Appl Pharmaceutics, 12(2):122–134.
77. Garcia M, Torres J, Perez L. (2019). Penetration enhancers with gel matrices for improved NSAID delivery. Int J Dermatopharmacology, 7(4):215–229.
78. Manian A, Rao V. (2022). Vehicle influence on drug release and rheology of diclofenac formulations. Pharm Technol Res, 10(3):177–189.
79. Suhail M, Varghese A, Khan S. (2021). Natural-polymer hydrogels for controlled topical diclofenac delivery. J Biomed Polym, 33(1):47–59.
80. Malik R, Singh P, Kumar V. (2020). Chitosan–xanthan hydrogels for controlled NSAID delivery. J Polyelectrolyte Sci, 22(2):134–145.
81. Pleguezuelos-Villa M et al. (2019). Rheology–release relationship in semi-solid diclofenac formulations. Drug Release Sci Technol, 55(1):41–52.
82. Nanoemulgel Study Group. (2020). Nanoemulgel system for enhanced topical diclofenac delivery. Nanomed J, 8(3):221–231.
83. Bihlet AR et al. (2020). Extended-release diclofenac topical gel (AMZ001) for osteoarthritis. Clin Transl Pain, 5(2):88–99.
84. Khan S, Rahim A, Patel R. (2020). Evaluation of natural vs synthetic polymer diclofenac gels. J Topical Pharm Sci, 12(4):178–189.
85. Jadav P, Solanki H, Mehta N. (2023). Advances in xanthan gum-based drug delivery systems. Polym Drug Deliv Rev, 19(2):102–118.
86. Bukhari M, Ahmed R, Fatima S. (2022). Clinical evaluation of diclofenac potassium gel for musculoskeletal pain. Clin NSAID Ther J, 7(1):56–67.
87. Manian A et al. (2022). Influence of topical vehicle on diclofenac permeation and release. Semisolid Formul Res, 9(3):204–216.
88. Suhail M, Shaikh I, Ahmed T. (2021). Crosslinked natural-polymer hydrogels for sustained diclofenac release. Hydrogel Sci J, 14(4):311–322.
89. Patel R, Naik A, Gohil N. (2020). Chemical modification of xanthan gum for improved pharmaceutical performance. J Mod Pharm Sci, 13(2):91–103.
90. EMA. (2018). Scientific review of diclofenac sodium spray gel 4%: Preclinical and clinical evaluation. European Medicines Agency Report, EMA/NSAID/2018.
91. Vane JR, Botting RM. Mechanism of action of anti-inflammatory drugs. Int J Tissue React. 1998;20(1):3–15.
92. Todd PA, Sorkin EM. Diclofenac sodium: pharmacodynamic and pharmacokinetic properties and therapeutic efficacy. Drugs. 1988;35(3):244–285.
93. Gan TJ. Diclofenac: mechanism of action and safety review. Curr Med Res Opin. 2010;26(7):1715–1731.
94. Garcia-Ochoa F, Santos VE, Casas JA, Gomez E. Xanthan gum: production and properties. Biotechnol Adv. 2000;18(7):549–579.
95. Srivastava P, Malviya R. Sources and applications of pectin in pharmaceuticals. Indian J Nat Prod Resour. 2011;2(1):10–18.
96. Iqbal MS, Massey S, Akbar J, Ashraf CM. Xanthan gum in drug delivery applications. J Polym Environ. 2011;19(1):155–166.
97. Khullar R, Kumar D, Seth N, Saini S. Formulation and evaluation of mefenamic acid emulgel. Saudi Pharm J. 2012;20(1):63–67.
98. Kaur L, Guleri TK. Topical gel: a novel approach for drug delivery. Asian J Biomed Pharm Sci. 2013;3(17):1–5.
99. Vyas SP, Khar RK. Controlled Drug Delivery: Concepts and Advances. Vallabh Prakashan; 2002.
100. Banker GS, Rhodes CT. Modern Pharmaceutics. 4th ed. Marcel Dekker; 2002.
101. Aulton ME, Taylor KM. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. Churchill Livingstone; 2018.
102. Kumar R, Katare OP. Lecithin organogels for topical drug delivery: a review. AAPS PharmSciTech. 2005;6(2):E298–E310.
103. Mura P, Faucci MT, Manderioli A, Bramanti G. Diclofenac sodium–PVP interaction by thermal and spectroscopic analysis. Drug Dev Ind Pharm. 1997;23(9):917–924.
104. Singh S, Singh J. Transdermal drug delivery of NSAIDs: an overview. Int J Pharm Sci Res. 2014;5(3):632–647.
105. Gennaro AR. Remington: The Science and Practice of Pharmacy. 21st ed. Lippincott Williams & Wilkins; 2006.
106. Basak SC, Kumar KS, Ramalingam M. Sustained release tablet of diclofenac sodium. Indian J Pharm Sci. 2006;68(5):594–598.
107. Mahajan A, Chhabra N, Aggarwal G. Diclofenac sodium gel using aloe vera as enhancer. Int J Pharm Sci Res. 2012;3(9):3262–3269.
108. Panwar AS, Upadhyay N, Bairagi M, Gujar S, Darwhekar GN, Jain DK. Emulgel: a review. Int J Pharm Biol Arch. 2011;2(4):1035–1045.
109. Pachuau L. Novel drug delivery systems for herbal drugs. Int J Pharm Sci Res. 2012;3(9):2980–2988.
110. Hanan A, El-Laithy HM, Shoukri RA. Formulation and stability of chloramphenicol gel. Bull Pharm Sci Assiut Univ. 2010;33(1):1–14.
111. Tadros T. Rheology of dispersions: principles and applications. Wiley-VCH; 2007.
112. Basha BN, Prakasam K, Goli D. Gel containing fluconazole: formulation and evaluation. Int J Drug Dev Res. 2011;3(4):109–128.
113. Tanwar YS, Chauhan CS, Sharma A. Carvedilol transdermal gel with enhancers. Asian J Pharm. 2007;1(1):36–42.
114. Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Tech. 1996;20(6):64–74.
115. Costa P, Lobo JMS. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123–133.
116. Higuchi T. Mechanism of sustained-action medication. J Pharm Sci. 1963;52(12):1145–1149.
117. Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA. Mechanisms of solute release from porous polymers. Int J Pharm. 1983;15(1):25–35.
118. Shah VP, Tsong Y, Sathe P, Liu JP. Dissolution profile comparison—similarity factor f2. Pharm Res. 1998;15(6):889–896.
119. ICH Q1A(R2). Stability testing of new drug substances and products. ICH; 2003.
120. Prajapati ST, Patel CG, Patel CN. Sustained release diclofenac sodium matrix tablet. Int J Pharm Invest. 2011;1(2):95–100.
121. Mundada AS, Shrikhande BK. Diclofenac sodium transdermal gel: formulation and evaluation. Indian Drugs. 2010;47(3):45–52.
122. Sapra K, Aggarwal G, Singla S, Bhatia S. Emulgel: a novel topical drug delivery platform. Int J Pharm Biol Sci. 2013;4(1):847–856