Investigation of Optimum Coating Conditions for an Easy Swallow Coating

System
Jeffrey Gimbel, Daniel To and Ali Rajabi-Siahboomi
AAPS
Colorcon, Inc., Harleysville, PA, USA, www.colorcon.com Poster Reprint 2018

Purpose
Opadry® EZ, Easy Swallow Film Coating System is a fully formulated, aqueous film coating
designed to improve tablet mobility and reduce adhesion whilst in the oral cavity, as well as during
esophageal transit. The coating provides a smooth, high gloss finish to enhance the visual
perception for ease of swallowing. The aim of this study was to identify a design space for coating
parameters that enhance the wet slip and appearance (gloss) properties of the coated tablets.

Methods
Using design of experiments (DoE), eleven coating trials were performed to investigate the impact
of dispersion solids concentration, spray rate and bed temperature on the slip and gloss
performance for tablets coated with pigmented versions of Opadry EZ. Each trial used 15 kg of
acetaminophen caplets (500 mg), coated with Opadry EZ using a Labcoat II (O’Hara Technologies,
Inc.) fitted with a fully perforated 24″ coating pan. The range of coating process parameters used
are described in Table 1.

Table 1: Range of Coating Process Parameters Used in the DoE Study at Pilot Scale

Parameter Value
Charge (kg) 15.0
Solids Content (% w/w) 6 – 20
Spray Rate (g/min) 40 – 76
Bed Temp (°C) 35 - 55
Inlet Air Temperature (°C) 53 - 93
Air Flow (cfm/m3/hr) 265 / 450
No. of Spray Guns 2
Spray Gun Type VAU 1/8 VAU-SS930 7-1 S37
Pan Speed (rpm) 14
Atomization Air (psi/bar) 20 / 1.4
Pattern Air (psi/bar) 20 / 1.4
Coating Time (min) 25 – 125

In addition, 130 kg of placebo caplets (950 mg) were coated in an O’Hara Fastcoat 48″ pan
(production scale) with pigmented Opadry EZ at 18% solids (w/w), using coating conditions scaled
up from the 24″ pan. Opadry EZ clear was also coated over the pigmented system to a 2% WG at
8% solids (w/w). The processing conditions for the 48” pan are described in Table 2.

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Table 2: Range of Coating Process Parameters Used at Production Scale

Parameter Pigmented Opadry EZ Clear Opadry EZ

Charge (kg) 130 130
Solids Content (%w/w) 18 8
Spray Rate (g/min) 400 350
Bed Temp (°C) 45 45
Inlet Air Temperature (°C) 64 64
Air Flow (cfm/m3/hr) 1800 / 3060 1800 / 3060
No. of Spray Guns 3 3
Spray Gun Type Schlick 930 7-1 S37 Schlick 930 7-1 S37
Pan Speed (rpm) 9 9
Atomization Air (psi/bar) 25 / 1.7 25 / 1.7
Pattern Air (psi/bar) 25 / 1.7 25 / 1.7

The wet slip behavior of the coated tablets was characterized by determining the static and dynamic
friction coefficients, using an in-house Colorcon method with an Instron tensile tester. Three tablets
weighted with a 0.5 N normal force were dragged across a water saturated substrate at 500
mm/min. Tablet appearance was assessed by measuring gloss using a Tricor Surface Analysis
System and surface roughness using a Nanovea Optical Profilometer.

Results
Opadry EZ exhibited low static and dynamic friction coefficients of less than 1.54 and 1.00 for all
processing conditions evaluated. This indicates excellent wet slip behavior regardless of the
processing conditions used. The impact of bed temperature, spray rate and solids content on gloss
and surface roughness are shown in Figures 1 and 2.

Figure 1: Effect of Bed Temperature and Spray Rate on Gloss at (a) 15% Solids, (b) 18% Solids and (c)
20% Solids

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Figure 2: Effect of Bed Temperature and Spray Rate on Surface Roughness at (a) 15% Solids, (b) 18%
Solids and (c) 20% Solids

In Figure 3 the white area reflects the design space that provided optimum performance based on
wet slip behavior, surface roughness, gloss, and coating time. Dispersion solids concentration had
a strong impact on surface roughness, gloss, and coating time. At 15% solids, a wide range of
spray rates and product temperatures provided excellent performance. With 18% solids the coating
time was significantly reduced; however, the gloss was negatively affected at high product
temperatures, while both surface roughness and gloss were negatively affected by high spray rates.

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At 20% solids, the acceptable range was limited to lower spray rates to achieve the maximum gloss
and minimum surface roughness goals.

Figure 3: Design Space for Processing Conditions for a Pigmented Version of Opadry EZ.

Confirmation runs were performed on APAP caplets in the 24” scale to confirm the DoE model. The
spray rate and bed temperatures were chosen to provide ideal coating performance at 15, 18 and
20% solids as shown in Table 3.

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Table 3: Processing Parameters of Confirmation Runs Performed on 24″ Scale

Parameter Pigmented # 1 Pigmented # 2 Pigmented # 3

Solids Content (%w/w) 15 18 20
Spray Rate (g/min) 60 60 50
Bed Temp (°C) 45 45 45
Inlet Air Temperature (°C) 73 68 64
Coating Time (min) 50 42 45
Gloss (GU) 97 92 84
Surface Roughness (µm) 4.5 4.5 4.4

Figure 4: APAP Caplets Coated in the 24″ Pan with Pigmented Opadry EZ at 18% Solids

Placebo caplets were coated in the O’Hara Fastcoat 48″ pan using the processing conditions
described in Table 2. The production scale coating trial produced tablets with excellent appearance
as shown in Figure 5. A comparison of the tablet gloss and surface roughness, shown in Figures 6
and 7, indicates that comparable performance can be achieved on both the 24″ and 48″ scale.

Figure 5: Image of Placebo Caplets Coated on the 48″ Pan with (a) Pigmented Opadry EZ followed by
(b) Clear Opadry EZ

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 Figure 6: Gloss Coated of Placebo Caplets Coated with Pigmented Opadry EZ and Opadry EZ Clear on
the 24″ and 48″ Scale

Figure 7: Surface Roughness of Placebo Caplets Coated with Pigmented Opadry EZ and Opadry EZ
Clear on the 24″ and 48″ Scale

Conclusions
Opadry EZ is a novel film coating system that provides exceptional wet slip behavior and can
improve tablet mobility in the oral cavity. Desirable tablet appearance was obtained with tablets
coated with pigmented formulations from 15 – 20% solids. Application of Opadry EZ clear
significantly improved tablet gloss, providing elegance and appeal for easy swallowing.

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