Formulation and evaluation of enteric coated microcapsules of diclofenac sodium for modified release by combination of wet granulation and thermal change method

Authors

  • Sanjib Bahadur Columbia Institute of Pharmacy, Vill. Tekari, Near Vidhan Sabha, Raipur (CG) 493111
  • Pragya Baghel Columbia Institute of Pharmacy, Vill. Tekari, Near Vidhan Sabha, Raipur (CG) 493111
  • Ranabir Chanda Bengal Institute of Technology, Sugandha, Delhi Road, Hoogly (W.B)
  • Amit Roy Columbia Institute of Pharmacy, Vill. Tekari, Near Vidhan Sabha, Raipur (CG) 493111
  • Suman Saha Columbia Institute of Pharmacy, Vill. Tekari, Near Vidhan Sabha, Raipur (CG) 493111
  • Ananta Choudhury Columbia Institute of Pharmacy, Vill. Tekari, Near Vidhan Sabha, Raipur (CG) 493111

Keywords:

Diclofenac sodium, microcapsules, factorial design, wet granulation, thermal change method

Abstract

The purpose of the present work was to develop optimized novel enteric microcapsules containing diclofenac sodium, a non steroidal anti inflammatory drug (NSAID) used for rheumatoid arthritis, for improved delivery and to diminish its adverse effect after oral administration. The microcapsule was prepared by using different polymers and the enteric coating was provided by using an innovative technique combining wet granulation method and thermal change method. This work also investigated different levels of enteric polymers like cellulose acetate phthalate (CAP) (X1) and ethyl cellulose (EC) (X2) and the stirring speed during coating ethyl cellulose (X3), by using 23 full factorial design. The dependent variables assessed were % yield (Y1), Q8 (% drug released after 8 hour) (Y2), n (Diffusion coefficient) (Y3), DEE (Drug entrapment efficiency) (Y4). The main effect and interaction terms were quantitatively evaluated using a mathematical model. The prepared microcapsules were evaluated for percentage drug dissolved, scanning electron microscopy, drug excipient interaction, angle of repose, particle size. Mean dissolution time (MDT) was used to compare dissolution patterns obtained. The results showed that X1 and X2 significantly affected the release properties.

Downloads

Download data is not yet available.

References

S. C Sweetman, Martindale–The complete drug reference. 33rd ed. Pharmaceutical Press, Great Britain 2002. pp. 30 – 32

T.J. Roseman, N.F. Cardinelli, in Controlled-release Technologies, Vol. 1 (A. F. Kydonieus, ed), CRC Press, Boca Raton, FL, 1980.

E.A. Hosny, G.M. el Mahrouk, M.W. Gouda, Formulation and in vitro and in vivo availability of diclofenac sodium enteric-coated beads, Drug Dev. Ind. Pharm. 24 (7) (1998) 661–663; DOI:10.3109/03639049809082368

J.I. Perez-Martinez, E. Morillo, C. Maqueda, J.M. Gines, Ethyl cellulose polymer microspheres for controlled release of norfluazon, Pest. Manag. Sci. 57 (2001) 688–694; DOI: 10.1002/ps.339

G.F. Palmieri, S. Michelini, P. Di Martino, S. Martelli, Polymers with pH-dependant solubility: possibility of use in the formulation of gastroresistant and controlled release matrix tablets, Drug Dev. Ind. Pharm. 26 (2000) 837–845; DOI:10.1081/DDC-100101307

J.B. Schwartz, R.E. O’Connor, Optimization techniques in pharmaceutical formulation and processing In Modern Pharmaceutics (Ed. G.S. Banker, C.T. Rhodes,) 3rd ed. Marcel Dekker, New York 1997 pp. 727–752.

M.F. Al-Omran, S.A. Al-Suwayeh, A.M. El-Helw, S.I. Saleh. Taste masking of diclofenac sodium using microencapsulation. J. Microencapsulation, 19 (1) 2002, 45 – 52 DOI:10.1080/ 02652040110055612

Subrahmanyam C.V.S, Setty J.T., Kusumdevi V., Suresh S. Laboratory manual of Pharmaceutical Engineering. 1st edition Vallabh Publications, New Delhi 2006. 27 – 34

H. Abdelkader, O.Y. Abdalla, H. Salem, Formulation of controlled release based biclofenac matrix tablets: Influence of some hydrophilic polymers on the release rate and in vitro evaluation. AAPS Pharm Sci Tech, 8(4) 2007: E100; DOI:10.1208/pt0804100

Y. Rane, R. Mashru, M. Sankalia, J. Sankalia, Effect of hydrophilic swellable polymers on dissolution enhancement of Carbamazepine solid dispersions studied using response surface methodology. AAPS PharmSciTech, 8(2) 2007 Article 27: DOI:10.1208/pt0802027

Moffat AC, Osselton MD, Widdop B, editors. Clarke’s Analysis of Drugs and Poisons. Great Britain: Pharmaceutical Press. 2004

A. Martin, Micromeritics In Physical Pharmacy (Ed. A Martin). 4th ed. B.I Waverly Pvt. Ltd., New Delhi, 1999 pp. 423 – 452

B.C. Hancock, M. Park, What is true solubility advantage for amorphous pharmaceuticals? Pharm Res 28 2000, 1001 – 1013

Published

2014-12-16

How to Cite

Bahadur, S., Baghel, P., Chanda, R., Roy, A., Saha, S., & Choudhury, A. (2014). Formulation and evaluation of enteric coated microcapsules of diclofenac sodium for modified release by combination of wet granulation and thermal change method. Journal of Applied Pharmaceutical Research, 2(4), 10-16. Retrieved from https://japtronline.com/index.php/joapr/article/view/37

Issue

Section

Articles