FORMULATION AND EVALUATION OF DICLOFENAC SODIUM INJECTION

Authors

  • Dr. K. MADHANAGOPAL 1Professor, Department of Pharmacology, Aarupadai Veedu Medical College & Hospital, Vinayaka Mission’s Research Foundation (DU), Kirumampakkam, Puducherry. Author
  • K. BALAMURUGAN Associate Professor, Department of Pharmacy, FEAT, Annamalai University, Annamalai Nagar, Chidambaram - 608002, Tamil Nadu, India. Author

DOI:

https://doi.org/10.48047/t5701s80

Abstract

This study focuses on the formulation and evaluation of a stable injectable dosage form of diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) with exceptional analgesic properties. The aim was to develop an effective parenteral solution suitable for intramuscular and intravenous administration, addressing the challenges posed by diclofenac sodium's low solubility and ensuring patient comfort during administration. The injectable formulation was prepared using solubilizing agents and excipients, and evaluated for key parameters including solubility, pH, osmolarity, physical appearance, weight per mL, and assay by HPLC. Results confirmed that the formulation met pharmacopoeial standards, with a clear, colourless appearance, a pH of 8.5, osmolarity of 568 mosm/kg, and 98.6% drug content. The findings indicate that the developed diclofenac sodium injection is stable, effective, and clinically suitable for treating a variety of acute and chronic pain conditions, ensuring reliable drug delivery and patient safety.

Downloads

Download data is not yet available.

References

Bakshi R, Ezzet N, Frey L, Lasry D, Salliere D, Efficacy and tolerability of diclofenac dispersible in painful osteoarthrosis. Clin Rheumatol 1993;12(1):57-61

Bakshi R, Jacobs LD, Lehnert S, Picha B, Reuther J. A double- blind, placebo-controlled trial comparing the analgesic efficacy of two formulations diclofenac in postoperative dentalpain. Curr Ther Res 1992;52(3):435-42.

Brogden RN, Heel RC, Pakes GE, Speight TM, Avery GS. Diclofenac sodium: A review of its pharmacological properties and therapeutic use in rheumatic diseases and pain of varying origin. Drugs 1980,20 24-48.

4 Dahlof C, Bjorkman R. Diclofenac-K (50 and 100 mg) and placebo in the acute treatment of migraine Cephalalgia 1993, 13(2): 117-23.

Degen PH, Dieterle W. Schneider W, Theobald W. Sinterhaul U. Pharmacokinetics of diclofenac and five metabolites after single doses in healthy volunteers and after repeated doses in patients. Xenobiotica 1988, 18(12): 1449-55.

Indian Pharmacopoeia Goverment of India ministry of health and family Welfare 4th ed. The Controller of Publication, Delhi: 1996. p. 332.

United States Pharmacopoeia 24 and National Formulary 19 2000. The official compendia of standards, Asian ed. The United States Pharmacopeial Convention Inc, Rockville

Higuchi T, Shih FM, Kimura T, Rytting JH. Solubility determination of barely aqueous- soluble organic solids. J Pharm Sci 1979,68(10) 1267-72.

Boylan JC Liquids, In: Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy, 3rd ed. Varghese Publishing House Bombay 1991 p. 466

Maheshwari RK, Joshi G, Gehlot S, Mahajan SC. Novel application of hydrotropy in thin layer chromatography Indian Pharm 2010,8(10): 57-9

Downloads

Published

2024-08-12

How to Cite

FORMULATION AND EVALUATION OF DICLOFENAC SODIUM INJECTION (K. . MADHANAGOPAL & K. BALAMURUGAN , Trans.). (2024). Cuestiones De Fisioterapia, 53(03), 5003-5009. https://doi.org/10.48047/t5701s80