Chitosan and chitosan-grafted-acrylamide were subjected to degradation in the presence and absence of a degrading agent at 378C by measuring the viscosity of polymer solutions. Extracts from the fresh rat droppings were used as the degrading agent to simulate the environmental degrading conditions. Results of this study indicated that the concentrations of acetic acid in solution and chemical modifications of chitosan affected the degradation both in the presence as well as in the absence of a degrading agent. Reduction in viscosity was used to study the degradation. Chitosan was stable up to sixteen days of immersion in acetic acid without the degrading agent, but it readily underwent degradation in the presence of a degrading agent. Chitosan-grafted-acrylamide also followed the same trend, but the extent of reduction in viscosity was much less than pure chitosan, indicating that the chemical modification has improved the stability of the polymer.
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.
The complex of Levofloxacin and Chitosan lead to formation of water soluble complex. This complex of Levofloxacin was then formulated into floating beads calcium alginate with maximum entrapment of Levofloxacin found to be about 75 %(f10) and the entrapment was found to be significantly higher as compared to the other formulations ( f1 to f9). In-Vitro Release studies of the beads f10 was found to significantly improve the release of Levofloxacin as compared to other formulations. The mean particle size of f10 microspheres and surface morphology were determined by SEM Resulting in Porous and Rough Surface of microspheres. The drug release kinetics were studied as zero order, first order , Higuchi , Koresmeyer-Peppas equations , good linearity was found in Higuchi's Equation (R 2 = 0.9310) indicating the release of the drug from Microspheres is based on Fickian Diffusion .
The manufacturing process of the tablet is a very complex process; it can be affected by the several process parameters or variables. The aim of this study was to understand and optimize the process parameters such as mixing, granulation, lubrication and tablets compression processes using quality by design (QbD) approach for a model Anti- Hyperlipidemic drug Fluvastatin sodium. During the processes there are several parameters which may influence or affect product quality. So the main objective of present work was to identify various process parameters and optimize this parameter, for the formulation of good quality product which needs to optimize Blending time, Roller force, Compression force and machine speed. A scale up batch was taken to evaluate and optimize the parameters. Critical quality attributes (CQA) such as flow behavior, granules parameters, Blend uniformity, tablet appearance, effect on tablet quality like physical appearance (surface, weight etc.) and tablet dissolution time as well as drug release. The test results of following parameters at various in-process phases are complies with the specified limits and finished product sample results were found to be within specified limits. This study results assures the manufacturing process is reproducible, robust and will yield consistent product, which meets specification.
Keywords: Process Parameters, Quality by Design, Fluvastatin, Granulation, Blending, Compression etc,.
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