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THE PHARMA REVIEW APRIL - MAY 2007

Modified Pulsincap Drug Delivery System of Diclofenac Sodium

Sindhu Abraham, S.Bharath, B.V .Basavaraj, R. Deveswaran and V. Madhavan

Abstract: Colon targeting is naturally of value for the topical treatment of colonic diseases and for the chronotherapeutic delivery of drugs. The present work is a time dependent formulation named 'Modified Pulsincap' that would ensure chronotherapeutic delivery of Diclofenac sodium (DFS) in the colon for the relief of rheumatoid arthritis. Bodies of gelatin capsules were made insoluble by formaldehyde treatment. Drug loaded pellets were prepared by Extrusion-Spheronization technique. The pellets equivalent to 100mg of the drug were filled into the treated capsule shells, plugged with hydrogel polymers Hydroxypropyl Methylcellulose, Hydroxypropyl cellulose and Sodium Alginate at different concentrations and completely enteric coated with 5% Cellulose Acetate Phthalate. The formulations were assayed to determine the drug content. Surface morphological studies revealed that Diclofenac sodium pellets were devoid of cracks. The ability of Modified Pulsincap to provide colon specific drug delivery was assessed by In vitro drug release studies in simulated gastric fluid for 2 hrs, simulated intestinal fluid for 3 hrs & simulated colonic fluid for 7 hours. The formulation was found to be intact for 2 hours in simulated gastric fluid. The enteric coating and cap of the capsule dissolved in simulated intestinal fluid, exposing the hydrogel plug and facilitated slow and controlled release of the drug from the pellets in the colonic medium. The accelerated stability studies carried out for three months as per ICH guidelines proved that the formulations were stable and thus Diclofenac Sodium could be successfully colon targeted with a time dependent formulation such as ‘Modified Pulsincap’.

 
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