title: Niridazole biodegradable inserts for local long-term treatment of periodontitis: possible new life for an orphan drug.
abstract: 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.
authors.affiliation: Ranbaxy Research Laboratories, Gurgaon, India.
authors.forename: Romi
authors.initials: R
authors.lastname: Barat
authors.forename: A
authors.initials: A
authors.lastname: Srinatha
authors.forename: J K
authors.initials: JK
authors.lastname: Pandit
authors.forename: D
authors.initials: D
authors.lastname: Ridhurkar
authors.forename: J
authors.initials: J
authors.lastname: Balasubramaniam
authors.forename: Neelam
authors.initials: N
authors.lastname: Mittal
authors.forename: Deena Nath
authors.initials: DN
authors.lastname: Mishra
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D004337:Drug Carriers; D005884:Gingival Hemorrhage / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D009560:Niridazole / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D009965:Orphan Drug Production; D010512:Periodontal Index; D010518:Periodontitis / Q000188:drug therapy*; D010865:Pilot Projects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004337:Drug Carriers; D009560:Niridazole