The aim of the present investigation was to prepare and evaluate ofloxacin controlled release subgingival films using biodegradable calcium alginate prepared in situ. The equipment necessary for the present investigation was fabricated and employed for casting of sodium alginate subgingival films. Subgingival films of drug:polymer (10:90, 25:75, 50:50 and 75:25) were prepared using solvent casting method. A 10%w/v CaCl2 solution was used for converting sodium alginate into calcium alginate and gelation of the films. As polymer concentration is increased the smoothness of the films increased. The thickness of films varied from 135±0.5 to 292±1.3μm which is well below the recommended thickness (<300 µm) of the subgingival films. The average weight of the films was found to be between 15.32±1.04 and 22.07 ±0.49 mg. The percentage of drug content ranged from 41.64±0.41to 58.22±0.41%. The low values may be due to loss of drug during treatment with CaCl2 solution. In vitro release studies showed that all the films had an initial burst release for the first 8 h, followed by controlled release of ofloxacin (>3.0 µg/ml) up to 120 h which is sufficient to inhibit the growth of the micro-organisms. The rate of drug release was inversely proportional to polymer concentration in the formulations. The low K1 and ‘r’ values obtained may be due to biphasic drug release pattern. The formulations did not fit into Higuchi equation because of low values of <0.640846which indicate that the drug release might be due to diffusion only in second phase of dissolution. All the films have shown to have integrity even after 5 days of dissolution studies. The formulations O1 and O2 which contain 90 and 75%w/w of polymer could be employed for controlled delivery of ofloxacin for 5 days in subgingival infections. Calcium alginate, being a biodegradable polymer is a good choice in the present study.
Loading....