Design of Experiments to Study the Impact of Process Parameters on Droplet Size and Development of Non-Invasive Imaging Techniques in Tablet Coating

Autor: Julian Smith, Thomas J. Dennison, Michael P. Hofmann, Afzal-Ur-Rahman Mohammed, Ali Al-Khattawi, Raj K.S. Badhan, Charlotte E. Bland
Rok vydání: 2016
Předmět:
Confocal Microscopy
Polymers
lcsh:Medicine
02 engineering and technology
030226 pharmacology & pharmacy
Coating Materials
0302 clinical medicine
Coated Materials
Biocompatible
Coating
Microscopy
Composite material
lcsh:Science
Flow Rate
chemistry.chemical_classification
Microscopy
Confocal
Multidisciplinary
Physics
Experimental Design
Light Microscopy
Classical Mechanics
Polymer
021001 nanoscience & nanotechnology
Volumetric flow rate
Solutions
Chemistry
Macromolecules
Research Design
Physical Sciences
Engineering and Technology
Wetting
0210 nano-technology
Porosity
Tablets
Research Article
Materials science
Materials by Structure
Imaging Techniques
Drug Compounding
Materials Science
Material Properties
Fluid Mechanics
engineering.material
Research and Analysis Methods
Continuum Mechanics
03 medical and health sciences
Film coating
Coatings
Fluorescence Imaging
Materials by Attribute
Reproducibility
Surface Treatments
Nebulizers and Vaporizers
lcsh:R
Fluid Dynamics
X-Ray Microtomography
Polymer Chemistry
Manufacturing Processes
chemistry
Wettability
engineering
lcsh:Q
Factor Analysis
Statistical
Confocal Laser Microscopy
Zdroj: PLoS ONE
PLoS ONE, Vol 11, Iss 8, p e0157267 (2016)
ISSN: 1932-6203
Popis: Atomisation of an aqueous solution for tablet film coating is a complex process with multiple factors determining droplet formation and properties. The importance of droplet size for an efficient process and a high quality final product has been noted in the literature, with smaller droplets reported to produce smoother, more homogenous coatings whilst simultaneously avoiding the risk of damage through over-wetting of the tablet core. In this work the effect of droplet size on tablet film coat characteristics was investigated using X-ray microcomputed tomography (XμCT) and confocal laser scanning microscopy (CLSM). A quality by design approach utilising design of experiments (DOE) was used to optimise the conditions necessary for production of droplets at a small (20 μm) and large (70 μm) droplet size. Droplet size distribution was measured using real-time laser diffraction and the volume median diameter taken as a response. DOE yielded information on the relationship three critical process parameters: pump rate, atomisation pressure and coating-polymer concentration, had upon droplet size. The model generated was robust, scoring highly for model fit (R2 = 0.977), predictability (Q2 = 0.837), validity and reproducibility. Modelling confirmed that all parameters had either a linear or quadratic effect on droplet size and revealed an interaction between pump rate and atomisation pressure. Fluidised bed coating of tablet cores was performed with either small or large droplets followed by CLSM and XμCT imaging. Addition of commonly used contrast materials to the coating solution improved visualisation of the coating by XμCT, showing the coat as a discrete section of the overall tablet. Imaging provided qualitative and quantitative evidence revealing that smaller droplets formed thinner, more uniform and less porous film coats.
Databáze: OpenAIRE
Externí odkaz: