Ethylcellulose inserts of an orphan drug for periodontitis: preparation, in vitro, and clinical studies.
Ethylcellulose inserts of niridazole fabricated by casting were studied for in vitro release and in vivo clinical effectiveness. The in vitro drug release was steady and sustained for over 7 days and followed diffusion kinetics. Selected batch, EN3, was evaluated clinically in patients with periodontitis for 6 months. A significant improvement (alpha < or = 0.05) in clinical indices from baseline was observed. Intergroup study revealed a significant (alpha < or = 0.01) change in the bleeding index, gingival index, plaque index, calculus criteria, and pocket depth. Significant reduction in total bacterial count in gingival crevicular fluid was observed before and postdevice insertion, as well as between control and treatment groups.
Barat
Romi
R
Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi, India.
Srinatha
Anegundha
A
Pandit
Jayantha K
JK
Mittal
Neelam
N
Anupurba
Shampa
S
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry; D003728:Dental Calculus / Q000188:drug therapy / Q000473:pathology; D003773:Dental Plaque / Q000188:drug therapy / Q000473:pathology; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000188:drug therapy / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009560:Niridazole / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D009965:Orphan Drug Production; D010510:Periodontal Diseases / Q000188:drug therapy / Q000473:pathology; D010512:Periodontal Index; D010514:Periodontal Pocket / Q000188:drug therapy / Q000473:pathology; D010518:Periodontitis / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; C013517:ethyl cellulose; D002482:Cellulose; D009560:Niridazole