FORMULATION OF DICLOFENAC SODIUM SUSTAINED RELEASE TABLET USING COPROCESSED EXCIPIENTS OF CROSSLINKED AMYLOSE–XANTHAN GUM AS MATRIX
Keywords:
excipient coprocessed xanthan gum-crosslinked amylose, matrix, diclofenac sodium, sustained release tabletAbstract
Objective: This present study was intended to design sustained release tablet containing diclofenac sodium using a matrix of excipient co-processed xanthan gum-crosslinked amylose.
Methods: In the previous study, xanthan gum and amylose have been physically and chemically modified by the co-processed and crosslinking method, resulting co-processed excipient xanthan gum-crosslinked amylose are Co-CLA6-XG and Co-CLA12-XG (method A); CL6-Co-A-XG and CL12-Co-A-XG (method B) with each ratio 1:1, 1:2 and 2:1. All excipients had a good swelling index, high viscosity and good gel strength, good characteristics to be used as a matrix for sustained release tablet dosage form. In this study, a tablet with excipient Co-CLA6-XG, Co-CLA12-XG, CL6-Co-A-XG and CL12-Co-A-XG were formulated by direct compression method. The prepared formulations were evaluated for weight variation, thickness, and diameter, hardness, friability, drug content estimation, swelling index, in vitro drug release are within the acceptable standard.
Results: The release profile of diclofenac sodium which contained matrix from Co-CLA6-XG (F1–F3), Co-CLA12-XG (F4–F6), CL6-Co-A-XG (F7–F9) and CL12-Co-A-XG (F10–F12) in phospate buffer medium for 8 h, showed that the sustained release profile followed zero order kinetics (F1–F6, F9, F11) and Korsmeyer-Peppas (F7, F8, F10, F12). Formula F1 to F6 tablet formulations could be applied as sustained release tablet formula and could retard drug release up to 16 h. Then, formula F7 to F12 could be applied as sustained release tablet formula and could retard drug release up to 32 h.
Conclusion: It may be concluded that coprocessed excipients of crosslinked amylose–xanthan gum can be used for the preparation of sustained release tablets of diclofenac sodium and can retard the drug release for 16 h and 32 h.
Keywords: Excipient coprocessed xanthan gum-crosslinked amylose, Matrix, Diclofenac sodium, Sustained release tablet
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References
Krowcynsk L. Extended-release dosage forms. CRC Press, Inc; 1987.
Beringer P. Remington: The science and practice of pharmacy. 21st ed. Philadelphia Collage of Pharmacy and Science; 2005.
Ogaji IJ, Nep EI, Audu-Peter JD. Advances in natural polymers as pharmaceutical excipients: review article. Pharm Anal Acta 2011;3:1-16.
Cury BSF, Klein ST, Evangelista RC. Modeling a system of phosphate cross-linked high amylose for controlled drug release part 1: Synthesis and polymer characterization. React Funct Polym 2008;68:1200–6.
Cui SW, Xie SX, Liu Q. Starch modifications and applications in food carbohydrates: chemistry, physical properties, and applications. CRC Press: Taylor and Francis Group, LLC., Florida; 2005.
BeMiller J, Whistler R. Starch: chemistry and technology. 3rd ed. Academic Press: Elsevier Inc., New York; 2009. p. 629-57.
Carbinatto FM, Doris CA, Cury BSF, Magalhaes A, Evangelista RC. Physical properties of pectin–high amylose starch mixtures cross-linked with sodium tri metaphosphate. Int J Pharm 2012;423:281–8.
Onofre F, Wang YJ, Mauromoustakos A. Effects of structure and modification on sustained release properties of starches. Carbohydr Polym 2009;76:541-7.
Bejenariu A, Popa M, Dulong V, Picton L, Cerf DL. Trisodium tri metaphosphate crosslinked xanthan networks: synthesis, swelling, loading, and releasing behavior. Polym Bull 2009;62:525-38.
Nachaegari KS, Bansal AK. Coprocessed excipients for solid dosage form. Pharm Technol 2004;42:54-8.
Brunton L, Parker K, Blumenthal D, Buxton I. Goodman and Gilman’s manual of pharmacology and therapeutics. Mc Graw Hill, New York; 2008.
Anonymous, Phamacopeia of Indonesia. 3rd ed. Ministry of Health Republic of Indonesia, Jakarta; 1979.
Pasaribu IS. Assay of diclofenac sodium in tablet dosage form using spectrophotometer ultaviolet essay of Bachelor’s Degree. Faculty of Pharmacy University-Northern Sumatra, Medan; 2011.
The United States Pharmacopoeial Convention. United States Pharmacopoeia 32nd and National Formulary 27th. The USP Convention, Rockville; 2009.
Siepmann J, dan Peppas NA. Modelling of drug release from delivery systems based HPMC. Adv Drug Delivery Rev 2001;48:139-57.
Banakar UV. Pharmaceutical dissolution testing. Marcel Dekker Inc., New York; 1992.