The limitations of conventional oral dosage forms, particularly those containing drugs with short biological half-lives has led to the development of sustained release formulations. The objective of this study was to develop a sustained release diclofenac sodium tablets using a hydrophobic (Eudragit RS PO) polymer in combination with hydrophilic polymers (Abelmoschus esculentus and polyethylene glycol) as release rate control agents. Nine (9) batches of diclofenac sodium granules (B1-B9) were prepared with a combination of Eudragit RS PO, Abelmoschus esculentus powder and polyethylene glycol (PEG) at different ratios and compressed into tablets via direct compression. The granules were evaluated for flow properties while the tablets were analyzed for their weight uniformity, dimensions, friability, crushing strength and in-vitro drug release. Drug-excipient interactions study was carried out using Fourier transform infra-red spectroscopy (FTIR). Bulk and tapped densities of the granules ranged 0.41-0.58 and 0.50-0.72 g/cm3, respectively, with Carr’s indices (11.9 - 20.8%), Hausner’s ratios (1.14 - 1.26) and angles of repose (< 30°). Formulated tablets had uniform weight, friability ≤ 0.50% and crushing strength range of 3.15 - 7.89 kp. Tablet showed variable sustained drug release with highest release of over 70% in 7 h. FTIR study showed no interaction between drug and excipients. Sustained release tablets of diclofenac sodium were successfully prepared with Eudragit RS PO and a combination of Abelmoschus esculentus powder and polyethylene glycol (PEG) as release modifiers. Batches B6 and B9 tablets released over 70% of drug within 7 h of dissolution testing.
Keywords: Coacervation, diclofenac, polymers, sustained release, tablets