Browsing by Author "Romi Barat"

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Chitosan Based Periodontal Pocket Inserts - Formulation, In vitro and Preliminary Clinical Evaluation
(2004) J. Balasubramaniam; M. Thilek Kumar; Romi Barat; J.K. Pandit; Neelam Mittal
The present paper concerns the in vitro and clinical evaluation of chitosan based periodontal inserts of ciprofloxacin hydrochloride (CPH). The effects of polymer concentration, plasticizer, drug loading and type and concentration of cross-linking agents (formaldehyde and glutaraldehyde) on CPH release were studied. The release of CPH followed a Q vs t1/2 profile. An increase in the plasticizer concentration (propylene glycol and glycerol) and drug loading resulted in a higher rate of CPH release, but the type of plasticizer did not show any significant effect on drug release, whereas retardation was observed with an increase in polymer concentration and cross-linking. Clinical evaluations of the inserts were carried out in patients suffering from periodontitis with an average pocket depth of > 5 mm. Significant improvements were observed in various clinical indices as: Peridontal Index (PI), Bleeding Index (BI), Periodontal Disease Index (PDI), Shick-Ash Modification of Plaque Criteria (SAPC) and Gingival Index (GI) and microbial parameters (% of G (+)and G (-) bacteria and Total Bacterial Count - TBC) at the device inserted site, thus affirming the therapeutic value of the inserts in the treatment of periodontal pocket formation.
Chitosan inserts for periodontitis: Influence of drug loading, plasticizer and crosslinking on in vitro metronidazole release
(Croatian Pharmaceutical Society, 2007) Romi Barat; Anegundha Srinatha; Jayanta K. Pandit; Shampa Anupurba; Neelam Mittal
Chitosan based metronidazole (MZ) inserts were fabricated by the casting method and characterized with respect to mass and thickness uniformity, metronidazole loading and in vitro metronidazole release kinetics. The fabricated inserts exhibited satisfactory physical characteristics. The mass of inserts was in the range of 5.63 ± 0.42 to 6.04 ± 0.89 mg. The thickness ranged from 0.46 ± 0.06 to 0.49 ± 0.08 mm. Metronidazole loading was in the range of 0.98 ± 0.09 to 1.07 ± 0.07 mg except for batch CM3 with MZ loading of 2.01 ± 0.08 mg. The inserts exhibited an initial burst release at the end of 24 h, irrespective of the drug to polymer ratio, plasticizer content or cross-linking. However, further drug release was sustained over the next 6 days. Cross-linking with 10% (m/m) of glutaraldehyde inhibited the burst release by ∼30% and increased the mean dissolution time (MDT) from 0.67 to 8.59 days. The decrease in drug release was a result of reduced permeability of chitosan due to cross-linking.
Ethylcellulose inserts of an orphan drug for periodontitis: Preparation, in vitro, and clinical studies
(2007) Romi Barat; Anegundha Srinatha; Jayantha K. Pandit; Neelam Mittal; Shampa Anupurba
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 (α ≤ 0.05) in clinical indices from baseline was observed. Intergroup study revealed a significant (α ≤ 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. Copyright © Informa Healthcare USA, Inc.
Niridazole biodegradable inserts for local long-term treatment of periodontitis: Possible new life for an orphan drug
(2006) Romi Barat; A. Srinatha; J. Pandit; D. Ridhurkar; J. Balasubramaniam; Neelam Mittal; Deena Mishra
Periodontal pocket inserts of niridazole (NZ) made with Resomer® (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 (α = 0.05) from 6.34 ± 1.86 mm at baseline to 5.94 ± 0.28 mm after 28 days of treatment. Copyright © Informa Healthcare.