Preparation and characterization of rufinamide HP-β-cyclodextrin complexes prepared by the kneading method for solubility enhancement.

Authors

  • Ravish J Patel Ramanbhai Patel College of Pharmacy, Charotar University of Science & Technology, CHARUSAT Campus, Anand, Gujarat, (India).
  • Dhara A Dave Ramanbhai Patel College of Pharmacy, Charotar University of Science & Technology, CHARUSAT Campus, Anand, Gujarat, (India).

Keywords:

Cyclodextrins, Differential Scanning Colorimetry, Hydroxy propyl β-cyclodextrin, kneading Method, Rufinamide

Abstract

Aims: The present investigation concerns the preparation and characterization of Rufinamide HP-β-cyclodextrin complexes prepared by the kneading method.

Material & methods: Rufinamide was procured as a gift sample from Torrent Pharmaceuticals limited. HP-β-cyclodextrin (HP-β-CD) was purchased from Himedia, India. Methanol and Hydrochloric Acid were purchased from S. D. Fine Chem. Pvt. Ltd., India. kneading method was selected to prepare inclusion complexation of Rufinamide. Phase solubility study was performed to check formation of inclusion complex. Prepared complex were characterize by different methods like DSC study, FTIR study, X-RPD study & in-vitro dissolution study.

Results: It was found that there is a formation of 1:1 inclusion complex between HP-β-CD as stability constant was found to be 221.27 M-1. DSC study, FTIR study had given supporting data for formation of inclusion complex. Amorphous nature of the complex was confirmed from the X-RPD study.

Conclusions: From in-vitro dissolution study it was found that 1:1.5 complex showed around 50% drug released in 30 min & more than 70% of Drug release in 60 mins.

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References

Sabrina Malvagiaa LF. Rapid assay of rufinamide in dried 1. blood spots by a new liquid chromatography–tandem mass spectrometric method. J Pharm Biomed Anal. 2011;54: 192-7.

Arroyo S. Rufinamide. Neurotherapeutics. 2007;4:155-62.2.

Perucca E. Rufinamide: Clinical pharmacokinetics and 3. concentration-response relationships in patients with epilepsy. Epilepsia. 2008; 49(7): 1123-41.

Douroumis D BN, Fahr A. Physicochemical characterization 4. of solid dispersions of three antiepileptic drugs prepared by solvent evaporation method. J Pharm Pharmacol. 2007;59(5): 645-53.

Bhise SD. Effect of hydroxypropyl β- cyclodextrin 5. inclusion complexation on solubility of fenofibrate. Int J Res Pharm Biomed Sci. 2011; 2(2): 596-604.

Loftsson T. Cyclodextrins and their pharmaceutical 6. applications. Int J Pharm. 2007; 329: 1–11.

Kushwaha Swatantra SK, Rai AK, Maurya Neelottama, 7. Singh Satyawan. Dissolution profile of ketoprofen cyclodextrin complex. Der Pharmacia Lettre. 2009;1(1): 126-34.

Jadhav GS. Danazol-β-cyclodextrin binary system: a 8. potential application in emergency contraception by the oral route. AAPS PharmSciTech. 2007;8(2).

PT Tayade PV. Inclusion complexes of Ketoprofen with 9. β-cyclodextrins: oral pharmacokinetics of ketoprofen in human. Ind J Pharm Sci. 2006; 68(2): 164-70.

Wang J, Cao Y, Sun B, Wang C. Characterisation of 10. inclusion complex of trans-ferulic acid and hydroxypropyl-β-cyclodextrin. Food Chem. 124(3): 1069-75.

Mura P, Bettinetti GP, Manderioli A, Faucci MT, Bramanti 11. G, Sorrenti M. Interactions of ketoprofen and ibuprofen with β-cyclodextrins in solution and in the solid state. Int J Pharm. 1998; 166(2): 189-203.

Published

2013-03-20

How to Cite

1.
Patel RJ, Dave DA. Preparation and characterization of rufinamide HP-β-cyclodextrin complexes prepared by the kneading method for solubility enhancement. Ars Pharm [Internet]. 2013 Mar. 20 [cited 2024 Jul. 22];54(1):33-8. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4579

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Original Articles