In-vitro studies of diclofenac sodium controlled-release dosage from biopolymeric hydrophilic matrices

Authors

  • TNK Suriyaprakash Dept of Pharmaceutics, Periyar College of Pharm. Sciences
  • SL Prabu Dept. of Pharm. Technology, Anna University of Technology
  • T Satyam Dept of Pharmaceutics, Periyar College of Pharm. Sciences

Keywords:

Diclofenac sodium, HPMC, Eudragit NE 30D, Sustained release matrix, Tablet disintegrant

Abstract

The objective of the present study was to develop diclofenac sodium tablets from polymeric matrices [HPMC K-15 and Eudragit NE 30D] and characterization of its physicochemical properties, invitro release studies by using different disintegrants like sodium starch glycollate and polyplasdone in different ratios to optimize its release profile with the standard market product. Matrix tablets were prepared by wet granulation method using PVP K30 as binding agent. The method of preparation of matrix system and its concentration were found to have pronounced effect on the release of diclofenac sodium The matrix tablets were evaluated for its thickness, hardness, friability, weight variation, drug content and invitro release studies. The drug delivery was analyzed using the paddle method according to USP XXIII, all the studies were done in phosphate buffer pH 6.8. The dissolution release profile of formulation made with Eudragit NE 30 D (10%w/w) with polyplasdone (2%w/w) was comparable with the market formulation and the f1 and f2 value were found to be 6.28 and 67.17. Stability studies were carried out as per ICH guidelines and tested for its physicochemical properties and invitro studies. The stability study results revealed that the prepared formulation was stable in the stress condition.

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References

Davies NM. Sustained release and enteric coated NSAIDs: Are they really GI safe?. J Pharm Pharmaceu Sci. 1999; 2: 5-14.

Roseman TJ, Cardinelli NF. In Kydonieus AF. Controlled release technologies Vol 1, CRC Press, Boca Raton, FL, 1980.

Ranga Rao KV, Padmalatha Devi K. Swelling controlled release systems: Recent development and applications. Int J Pharma. 1988; 48: 1-13.

Salsa T, Veiga F, Pina ME. Oral controlled release dosage forms: I. Cellulose ether polymers in hydrophilic matrices. Drug Dev Ind Pharm. 1997; 239: 929-938.

Lakshmana Prabu S, Shirwaikar A, Shirwaikar AA, Ravikumar, Aravind Kumar G, Abraham Jacob. Formulation and evaluation of oral sustained release of Diltiazem Hydrochloride using rosin as

matrix forming material. ARS Pharma. 2009: 50(1): 32-42.

Sung KC, Nixon PR, Skoug JW, Ju TR, Gao P, Patel MV. Effect of formulation variables on drug and polymer release from HPMC based matrix tablets. Int J Pharm. 1996; 142: 53-60.

Siepmann J, Kranz H, Bodmeier R. HPMC matrices for controlled drug delivery: A new model combining diffusion, swelling and dissolution mechanism and predicting the release kinetics. Pharm Res. 1999; 16: 1748-1756.

Ford JL, Mitchell K, Rowe P, Armstrong DJ Elliot PNC, Rostron C. Mathematical modeling of drug release from hydroxyl propylmethyl cellulose matrices: Effectof the temperature. Int J Pharm 1991; 71: 95-104.

Arica B, Arica MY, Kas HS, Hincal AA, Hasirci V. In vitro studies of enteric coated Diclofenac sodium carboxymethylcellulose microspheres. J Microencaps 1996; 13: 689-699.

Todd PA, Sorkin EM. Diclofenac sodium, a reappraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy. Drugs 1988; 35: 244-285.

Loganathan V, Senthil Kumar K, Siva Prasada Reddy MV, Sreekanth N, Senthil Kumar B. Studies on preformulation

compatibility between lomefloxacin and tablet excipients through DSC and X-ray diffraction analysis. Int Journal of Pharmaceutical Excipients April-June, 2003; 38-49.

Giordano, F., Rossi, A., Pasquali, I., Bettini, R., Frigo, E., Gazzaniga, A., Sangalli, M.E., Mileo, V., Catinella, S., 2003. Thermal degradation and melting point determination of diclofenac. J. Thermal Anal. Calorim. 73, 509–518.

Banker GS, Anderson. In: Lachman L, Liberman HA, Kanig JL. The theory and practice of industrial pharmacy, 3rd ed. Varghese publishing house, Mumbai, 1987; p. 383.

Arora P, Mukherjee B., 2002. Design, development, physicochemical and in vitro and in vivo evaluation of transdermal patches containing diclofenac diehtylammonium salt. J. Pharma. Sci. 91(9), 2076-89.

Published

2011-06-20

How to Cite

1.
Suriyaprakash T, Prabu S, Satyam T. In-vitro studies of diclofenac sodium controlled-release dosage from biopolymeric hydrophilic matrices. Ars Pharm [Internet]. 2011 Jun. 20 [cited 2024 Jul. 16];52(2):20-4. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4720

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Original Articles