Objective: The intension of the present study includes fabrication and optimization of mouth dissolving film loaded with Chlorothalidone by solvent evaporation techniques using two components and their three levels as multilevel Categoric design. Methods: Major problem associated with the development of film loaded with BCS class II drug is to increase its solubility. Here the Chlorothalidone solubility achieved by co-solvents, such as methanol. After dissolving the drug in co-solvent, this drug solution is poured into an aqueous dispersion of Hydroxypropyl Methylcellulose E5 (HPMC E5) and Polyethylene glycol 400 (PEG 400). The two independent variables selected are factor A (concentration of HPMC E5) and factor B (concentration of PEG 400) was selected on the basis of preliminary trials. The percentage drug release (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Here HPMC E5 used as a film former, PEG 400 as plasticizer, mannitol as bulking agent, Sodium starch glycolate as a disintegrating agent, tween 80 as the surfactant, tartaric acid as saliva stimulating agent, sodium saccharin as a sweetener and orange flavour etc. These fabricated films were evaluated for physicochemical properties, disintegration time and In vitro drug release study. Results: The formulation F6 has more favorable responses as per multilevel categoric design is % drug release about 98.95 %, average disintegration time about 24.33 second and folding endurance is 117. Thus formulation F6 was preferred as an optimized formulation. Conclusion: The present formulation delivers medicament accurately with good therapeutic efficiency by oral administration, this mouth dissolving films having a rapid onset of action than conventional tablet formulations.

Aim:To prepare and characterize Nanoparticles of Antibacterial Agent for Drug Delivery. Method: Levofloxacin Hemihydrate laden Nanoparticles were prepared using the Ionic gelation method followed by the micro fluidization technique using 400 bar pressure for 5 cycles. The F1 Nanoparticles suspension obtained was subjected to spray drying at a 1400 aspirator rate. The selected F1 Nanoparticles having an entrapment efficiency of 63.46% were characterised by a particle size analyzer, Zeta Analyser, SEM, AFM, FTIR, XRD, EDS, and In-vitro Cytotoxicity. The present research work was carried out during the year 2019-2020. Results: The particle size of F1 was found to be 159.0 nm. The F1 Nanoparticles showed a PI of 0.255, exhibiting the Nanoparticles as homogeneously dispersed colloids. The zeta potential of F1 was found to be 48.7 mV. Predicting the stability of nanoparticles SEM and AFM elucidate the surface morphology of F1. FTIR fingerprints show 1793.80 cm1 of carbonyl C=O, 2881.65 cm1 of aromatic C-H and 3535.52 cm1 of the O-H group of the carboxyl group of Levofloxacin. EDS detected oxygen, fluorine, and nitrogen as the elements present in Levofloxacin Hemihydrate and XRD confirmed an amorphous material with a few crystalline phases as diposite. There were no signs of eukaryotic cell disruption, showing non-toxicity and no bio reaction by F1Nanoparticles at 0.01g Inhibitory Concentration (IC50%) when characterised by an In-Vitro Cytotoxicity Study. Conclusion: Levofloxacin Hemihydrate laden Nanoparticles were lucratively prepared using Ionic gelation technique followed by the Micro fluidization further successful Characterization of Nanoparticles directs its potential in drug delivery for Treatment of Bacterial Infections.

A new method of analysis with reverse phase chemistry was designed and developed. Validation for method of analysis was performed for its intended use to calculate assay and content uniformity of drug substance sitagliptin, metformin and empagliflozin in the drug products. The method has a run time of 10 minutes on X-bridge C18 column having 250 mm length, 4.6 mm internal diameter and Particle Size of 5µm, by the use of 0.1% Trifluoroacetic acid Buffer 40%: Methanol 40%: Acetonitrile 20% ratio as constituent composition in the proposed mobile phase and chromatography run at wavelength of 224 nm. The retention time of Metformin, Empagliflozin and Sitagliptin, were 3.383, 5.571 and 6.429 minutes, respectively. International Conference on Harmonization guideline was referred for validation. The method showed adequate sensitivity for precision, linearity and accuracy parameter (between the range 25-75μg/mL, 250-750μg/mL and 2.5-7.5μg/mL for sitagliptin, metformin and empagliflozin respectively). The percentage recoveries obtained for sitagliptin, metformin and empagliflozin are in the range of 98.0 – 102.0 %. As results are within the acceptance [1], hence the new developed and proposed method is suitable for quantification of one, two or three component drugs, separately or in combination.