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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Development and in-vivo evaluation of dry powders for reconstitution of solubility enhanced derivative of azithromycin dihydrate

Abstract: The objective of this work was to formulate an antibiotic dry syrup, which would show improved physical and chemical stability during its intended shelf life. Antibiotic azithromycin dihydrate, used to treat bacterial infections, is not soluble and stable in water. Hence, pediatric oral powders for suspensions are available which are merely stable only for 5 days after reconstitution. Solubility of azithromycin dihydrate was first improved by solid dispersions, inclusion complexation and nanosuspensions and then used the same in dry syrups. By this, solubility, stability could be improved, and taste masking could be achieved. Solubility enhancement was carried out through use of poloxamer 188, poloxamer 407 and polyethylene glycol 20,000 as carriers in two different concentrations and two methods- solvent evaporation and freeze drying. Similarly, Inclusion complexation using ß-cyclodextrin, epichlorohydrin- ß-cyclodextrin and sulfobutyl ether cyclodextrin was attempted using solvent evaporation and freeze drying. Nanosuspensions were also prepared using poloxamers and PVP, by nanoprecipitation technique and nanoprecipitation with cryoprotectants. All the solid dispersions, inclusion complexes and nanosuspensions were characterised using In-Vitro dissolution profiles, kinetic modelling, X ray diffractometry and SEM images. In vitro dissolution profile data suggested a significant improvement in drug release with inclusion complexes using sulfobutyl ether cyclodextrin, prepared by freeze drying and nanosuspensions using poloxamer 188, prepared by nanoprecipitation with cryoprotectants. X ray diffractograms showed a reduction in crystallinity. Kinetic modelling suggested a zero-order release mechanism. Hence, 2 inclusion complexes and 2 nanosuspensions were used to formulate dry syrups using Viscarin ph 209 and Gelcarin ph 812 as suspending agents. Powdered dry syrups were evaluated before reconstitution for their flow properties, and results showed excellent flow properties. Post reconstitution evaluation results also suggested a stable, flocculated oral suspension with sedimentation volume closer to 1 over tested period.
Keyword: Dry syrups, Reconstituted Suspensions, Inclusion complexation, Nanoparticles, Poloxamer.
DOI: https://doi.org/10.31838/ijpr/2019.11.03.069
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