Lactobacillus has long been considered the protective flora in the vagina that displaces and kills vaginal pathogens. Lactic acid, H2O2, and antibacterial agents such as lactocin and bacitracin produced by Lactobacillus act against the vaginal pathogens. The first objective of this research was to develop a local application pharmaceutical formulation of a vaginal suppository containing lyophilized culture of Lactobacillus. The second objective was to establish its in vivo performance by developing in vitro methods of evaluation. Lyophilized culture of Lactobacillus sporogenes was selected for this study. Three formulations of the suppositories were prepared by the molding method. Formulations I, II, and III contained cocoa butter, glycerinated gelatin, and PEG 1000 base, respectively. The prepared suppositories were characterized for physical properties. Assembly to simulate the application site was designed. Methods to evaluate the viability, production of lactic acid, and H2O2 produced by the released Lactobacillus at the application site were developed and the antagonistic activity was demonstrated. From the physical characteristics of the suppository formulations, the glycerinated gelatin suppository (formulation II) containing lyophilized Lactobacillus was found to be satisfactory. The developed assembly was satisfactory in simulating the application site. The Lactobacillus released was viable and exhibited the production of lactic acid, hydrogen peroxide, and antagonistic activity against the uropathogen. The suppository formulation containing Lactobacillus and the methods of its evaluation were successfully developed in this research work and have several applications in the vaginal diseases of women.
Objective: The main objective of this work was to understand the basic properties of crystalline nanocellulose (CNC) that can be useful as a novel excipient in pharmaceutical formulations. This covers the isolation and preparation of nanocellulose followed by characterization.
Methods: Cellulose was isolated from aquatic weed by autoclaving and bleaching. Cellulose to CNC conversion involved gluconic acid treatments at different concentrations (40%, 50% and 60%) followed by centrifugation and neutralization. CNC was further characterized by Differential Scanning Calorimetry (DSC) and Thermo gravimetric Analysis (TGA), Field Emission Scanning Electron Microscopy (FE-SEM) and Atomic Force Microscopy (AFM) for surface morphology, elemental analysis by Energy Dispersive Spectroscopy (EDS), Fourier Transform Infrared Spectroscopy (FTIR), crystallinity index by X-Ray Diffraction (XRD), and optical microscopy.
Results: Acid concentration affects the moisture uptake, particle size, and yield of CNC. CNC size ranged from 350 nm to 900 nm with a crystallinity index 80% to 85%. Moisture uptake was 6.38±0.12% at 33% relative humidity. DSC and TGA established thermal stability over 200 °C. Nanocellulose has shown Angle of repose (28.81°), Carrs index (12.32), zeta potential (33mV) values and heavy metals within pharmacopoeial limits.
Conclusion: CNC from water hyacinth was prepared successfully by sustainable process. CNC physico-chemical characterization revealed the stable nature of CNC, suitable to be used as an excipient in pharmaceutical formulations.
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