Niridazole biodegradable inserts for local long-term treatment of periodontitis: possible new life for an orphan drug.

Romi Barat, A Srinatha, J K Pandit, D Ridhurkar, J Balasubramaniam, Neelam Mittal, Deena Nath Mishra

Ranbaxy Research Laboratories, Gurgaon, India.

Drug delivery 2006 Sep-Oct

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Periodontal pocket inserts of niridazole (NZ) made with Resomer(R) (grades RG 503H and RG858, designated as RH and RG, respectively) were studied. Various formulation variables were evaluated to obtain a biodegradable delivery systems showing device degradation and drug depletion parallel to each other in vitro. Drug release from the prepared inserts was evaluated using a static dissolution setup (for 1 month). Incorporation of 3 parts of RG in 1 part of RH inserts caused a 50% decrease in the initial release rate. The RH-NZ inserts showed a spurt in release around the 10th day of the study, which coincided with the decrease in device weight, suggesting onset of device degradation. Pilot-scale clinical trials in 12 patients indicated improvements in clinical indices from the baseline values. The average pocket depth was reduced significantly (alpha = 0.05) from 6.34 +/- 1.86 mm at baseline to 5.94 +/- 0.28 mm after 28 days of treatment.

Citation

Romi Barat, A Srinatha, J K Pandit, D Ridhurkar, J Balasubramaniam, Neelam Mittal, Deena Nath Mishra. Niridazole biodegradable inserts for local long-term treatment of periodontitis: possible new life for an orphan drug. Drug delivery. 2006 Sep-Oct;13(5):365-73