Table 1.
Low, medium and high levels for CPPs.
The medium level for each CPP was used for centre point measurements.
Fig 1.
Summary of fit plot showing model fit (R2), predictability (Q2), model validity and reproducibility.
The model has been fitted using RSM. Lack of Fit plot showing standard deviation (SD) due to lack of fit (SD-LoF), SD of pure error (SD-pe) and SD of pure error * the critical F-value (SD-pePsqrt(F(crit)). Effects plot for the three factors: pump rate (Pum), concentration of Kollicoat IR suspension (Conc) and atomisation pressure (Pre). Factors are ordered in terms of impact on droplet size. Confidence interval bars are included for each factor.
Fig 2.
Main Effect Plots for concentration, atomisation pressure and pump rate on droplet size.
Bottom right, Interaction Plot for the interaction between pump rate and atomisation pressure. The two lines show atomisation pressure at the low level (1 bar) and high level (2 bar).
Fig 3.
Response contour plot with respect to fixed levels of atomisation pressure, pump rate and polymer concentration.
Table 2.
Processing conditions for production of small and large droplets.
Fig 4.
Maximum projection images of the film coat surface, providing a visual representation of surface morphology and film coat uniformity.
Aqueous film coat consisting of Kollicoat IR 20% w/w and riboflavin 5’-monophosphate sodium 0.5% w/w as a fluorescent dye. Tablets coated by fluidised bed coating method at defined droplet sizes: 20μm (1) and 70 μm (2). Images were taken at 10x (A) and 25x (B) magnification.
Fig 5.
3D CLSM image showing fluorescence intensity at each image layer, providing a visual representation of surface morphology.
Film coat consisting of Kollicoat IR 20% w/w and riboflavin 5’-monophosphate sodium 0.5% w/w as a fluorescent dye. Tablets coated by fluidised bed coating method at defined droplet sizes: 20μm (1) and 70 μm (2). Images were taken at 10x (A) and 25x (B) magnification.
Fig 6.
Transverse view of maximum projection images showing the film coat thickness and morphology.
Film coat consisting of Kollicoat IR 20% w/w and riboflavin 5’-monophosphate sodium 0.5% w/w as a fluorescent dye. Tablets coated by fluidised bed coating method at defined droplet sizes: 20μm (1) and 70 μm (2). Images were taken at 10x (A) and 25x (B) magnification.
Fig 7.
Transverse view of XμCT reconstruction of placebo tablets (13mm) containing contrast material in the core.
Contrast material Bi2O3 is included at 5% w/w and 10% w/w (milled), A and B respectively. BaSO4 is included at 10% w/w and 20% w/w (milled), C and D respectively.
Fig 8.
Transverse view of XμCT reconstruction of placebo tablets (13mm) containing contrast material in the coat.
Contrast material Bi2O3 is included at 1% w/w and 2.5% w/w, A and B respectively. BaSO4 is included at 2% w/w and 5% w/w, C and D respectively.
Fig 9.
Maximum projection and heat map images of the tablet surface of XμCT reconstructed film coated tablets of either large or small droplet size.
Placebo tablets were coated with Kollicoat IR and bismuth oxide (2.5% w/w). Droplet size coatings of 20μm (1) and 70 μm (2) are shown in maximum projections (A) and heat maps (B). Heat maps demonstrate coat uniformity, with blue areas and red areas representing high and low intensity of radiopacity, respectively.
Table 3.
Surface porosity measurements of film coatings analysed by XμCT.
Porosity has been measured using either the CTAn or ImageJ technique.
Table 4.
Porosity, thickness and roughness measurements of fluorescent coatings.
Maximum projection images were analysed using ImageJ. Coatings produced by large and small droplets are compared.