Research Article of Journal of Pharmaceutical Research and Reviews
Complexation of diclofenac sodium with hydroxy propyl betacyclodextrin improves its solubility and stability in ampoule solution which is determined by HPLC
Al-Rasheed University College,department of Pharmacy,Baghdad,Iraq
Diclofenac sodium injection is widely used in medicine as antinflamatory and antirheumatic agent with a therapeutic value of 25 mg / ml. However, diclofenac sodium is poorly soluble which forms a problem in its manufacturing as an injection.
The available commercial products of diclofenac sodium ampoules have used different types of solubilizing agents as benzyl alcohol which is an irritant in a concentration more than 3% while the other manufacturers used propylene glycol which has toxic impurities.
In this present work, Diclofenac Sodium injection is prepared by using Hydroxy Propyl Beta Cyclodextrine ; a natural and safe excipient in formulation of ampoule solution which formed an inclusion complex compounds with Diclofenac Sodium ,render it very soluble and more stable. The finished product of ampoules were subjected to the stability study by storing the samples at 40°C and 75% RH for six months and the physico-chemical properties of the samples were tested at different periods. The results showed no change in appearance of the ampoules solution along the study time .In addition a reversed –phase high pressure liquid chromatographic method was developed and applied in studying the behavior of diclofenac Sodium in solution and its resistance to the high temperature challenger. The developed HPLC method was proved to be accurate and able to detect the degradation products of Diclofenac Sodium in solution.
Keywords:Diclofenac sodium, Hydroxy propyl beta-cyclodextrin (HPB-CD), inclusion complex, Chromatography HPLC
How to cite this article:
Kahtan J.Hasson. Complexation of diclofenac sodium with hydroxy propyl beta-cyclodextrin improves its solubility and stability in ampoule solution which is determined by HPLC. Journal of Pharmaceutical Research and Reviews, 2018; 2:16. DOI:10.28933/jprr-2018-09-0101
1. Martindale;The Complete Drug Reference, 36 Edition ,Edit. By Sean C Sweetman,Pharmaceutical Press, ,London,2009,Page 2374.
2. GA Shazly et al., Solution Thermodynamics and Solubility Prediction of Glibenclamide in Transcutol + Water Co-Solvent Mixtures at 298.15-333.15 K Arch Pharm Res 37 (6), 746-751. 2013 Dec 17.
3. GA Shazly et al., Solution Thermodynamics and Solubilization Behavior of Diclofenac Sodium in Binary Mixture of Transcutol-Hp and Water, Pha Pharmazie. 2014 May;69(5):335-9.
4. Scavone C et al., Efficacy and Safety Profile of Diclofenac/Cyclodextrin and Progesterone/Cyclodextrin Formulations:A Review of the Literature Data. Drugs R D. 2016 Jun;16(2):129-40. doi: 10.1007/s40268-016-0123-2
5. Leeson RM, Dyloject, a novel injectable diclofenac formulation, offers greater safety and efficacy than voltarol for postoperative dental pain. Reg Anesth Pain Med.,2007 Jul-Aug;32(4):303-10.
6. Krunal Bhatt, et al., Formulation and Evaluation of Diclofenac Sodium Injection Using 2-Hydroxy Propyl Beta Cyclodextrin, International Journal of Pharmacy and Pharmaceutical Sciences ,Vol 3, Suppl 5, 2011
7. Saetern AM, et al,Effect of hydroxypropyl-beta-cyclodextrin-complexation and pH on solubility of camptothecin. . Int J Pharm. 2004 Oct 13;284(1-2):61-8-
8. Holvoet C, Inclusion complexation of lorazepam with different cyclodextrins suitable for parenteral use, Drug Dev Ind Pharm. 2005 Jul;31(6):567-75.
9. Holvoet C, Inclusion complexation of diazepam with different cyclodextrins in formulations for parenteral use. Pharmazie. 2005 Aug;60(8):598-603.
10. Safila Naveed, Fatima Qamar, UV spectrophotometric assay of Diclofenac sodium available brands,Journal of Innovations in Pharmaceuticals and Biological Sciences, Vol 1 (3), 92-96, 2014
11. Lopamudra Adhikari,Search for simple mobile phases in rapid LC separation analysis of drugs in complex matrix diclofenac gel and injections International Journal of Pharmacy and Pharmaceutical Sciences,Vol 3, Issue 1, 2011,136 -139 .
12. Shiv SankarBhattacharyaa.et al., A RP-HPLC method for quantification of diclofenac sodium released from biological macromolecules, international journal of biological macromolecules, Volume 58, July 2013, Pages 354-359.
13. Handbook of Pharmaceutical Excipients, Raymond C Rowe , Paul J Sheskey, Marian E Quinn ; Pharmaceutical Press and American Pharmacists Association,6th edition,2009,p 444.
This work and its PDF file(s) are licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.